39
Standards of Medical Care in Diabetes–2006 AMERICAN DIABETES ASSOCIATION CONTENTS I. CLASSIFICATION AND DIAGNOSIS, p. S4 A. Classification B. Diagnosis II. SCREENING FOR DIABETES, p. S5 III. DETECTION AND DIAGNOSIS OF GESTATIONAL DIABETES MELLITUS, p. S7 IV. PREVENTION/DELAY OF TYPE 2 DIABETES, p. S7 V. DIABETES CARE, p. S8 A. Initial evaluation B. Management C. Glycemic control 1. Assessment of glycemic control a.Self-monitoring of blood glucose b. A1C 2. Glycemic goals D. Medical nutrition therapy E. Diabetes self-management edu- cation F. Physical activity G. Psychosocial assessment and care H. Referral for diabetes management I. Intercurrent illness J. Hypoglycemia K. Immunization VI. PREVENTION AND MANAGE- MENT OF DIABETES COMPLICA- TIONS, p. S17 A. Cardiovascular disease 1. Hypertension/blood pres- sure control 2. Dyslipidemia/lipid man- agement 3. Antiplatelet agents 4. Smoking cessation 5. Coronary heart disease screen- ing and treatment B. Nephropathy screening and treatment C. Retinopathy screening and treatment D. Neuropathy screening and treatment E. Foot care VII. DIABETES CARE IN SPECIFIC POPULATIONS, p. S26 A. Children and adolescents B. Preconception care C. Older individuals VIII. DIABETES CARE IN SPECIFIC SETTINGS, p. S29 A. Diabetes care in the hospital B. Diabetes care in the school and day care setting C. Diabetes care at diabetes camps D. Diabetes management in cor- rectional institutions IX. HYPOGLYCEMIA AND EMPLOY- MENT/LICENSURE, p. S34 X. THIRD-PARTY REIMBURSEMENT FOR DIABETES CARE, SELF- MANAGEMENT EDUCATION, AND SUPPLIES, p. S34 XI. STRATEGIES FOR IMPROVING DIABETES CARE, p. S34 D iabetes is a chronic illness that re- quires continuing medical care and patient self-management education to prevent acute complications and to re- duce the risk of long-term complications. Diabetes care is complex and requires that many issues, beyond glycemic control, be addressed. A large body of evidence exists that supports a range of interventions to improve diabetes outcomes. These standards of care are intended to provide clinicians, patients, research- ers, payors, and other interested individ- uals with the components of diabetes care, treatment goals, and tools to evalu- ate the quality of care. While individual preferences, comorbidities, and other pa- tient factors may require modification of goals, targets that are desirable for most patients with diabetes are provided. These standards are not intended to pre- clude more extensive evaluation and management of the patient by other spe- cialists as needed. For more detailed in- formation, refer to refs. 1–3. The recommendations included are diagnostic and therapeutic actions that are known or believed to favorably affect health outcomes of patients with diabetes. A grading system (Table 1), developed by the American Diabetes Association (ADA) and modeled after existing methods, was utilized to clarify and codify the evidence that forms the basis for the recommenda- tions. The level of evidence that supports each recommendation is listed after each recommendation using the letters A, B, C, or E. I. CLASSIFICATION AND DIAGNOSIS A. Classification In 1997, the ADA issued new diagnostic and classification criteria (4); in 2003, modifications were made regarding the diagnosis of impaired fasting glucose (IFG) (5). The classification of diabetes includes four clinical classes: Type 1 diabetes (results from -cell de- struction, usually leading to absolute insulin deficiency). Type 2 diabetes (results from a progres- sive insulin secretory defect on the background of insulin resistance). Other specific types of diabetes due to other causes, e.g., genetic defects in ●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●● Originally approved 1988. Most recent review/revision, October 2005. Abbreviations: ABI, ankle-brachial index; AMI, acute myocatdial infarction; ARB, angiotensin receptor block- er; CAD, coronary artery disease; CBG, capillary blood glucose; CHD, coronary heart disease; CHF, congestive heart failure; CKD, chronic kidney disease; CVD, cardiovascular disease; DCCB, dihydropyridine calcium channel blocker; DCCT, Diabetes Control and Complications Trial; DKA, diabetic ketoacidosis; DMMP, diabetes medical management plan; DPN, distal symmetric polyneuropathy; DPP, Diabetes Prevention Program; DRI, dietary reference intake; DRS, Diabetic Retinopathy Study; DSME, diabetes self-management education; DSMT, diabetes self-management training; ECG, electrocardiogram; ESRD, end-stage renal disease; ETDRS, Early Treatment Diabetic Retinopathy Study; FDA, Food and Drug Administration; FPG, fasting plasma glucose; GDM, gestational diabetes mellitus; GFR, glomerular filtration rate; HRC, high-risk characteristic; ICU, intensive care unit; IFG, impaired fasting glucose; IGT, impaired glucose tolerance; MNT, medical nutrition therapy; NPDR, nonprolif- erative diabetic retinopathy; OGTT, oral glucose tolerance test; PAD, peripheral arterial disease; PDR, proliferative diabetic retinopathy; PPG, postprandial plasma glucose; RDA, recommended dietary allowance; SMBG, self- monitoring of blood glucose; TZD, thiazolidinedione; UKPDS, U.K. Prospective Diabetes Study. © 2006 by the American Diabetes Association. P O S I T I O N S T A T E M E N T S4 DIABETES CARE, VOLUME 29, SUPPLEMENT 1, JANUARY 2006

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Standards of Medical Care in Diabetes–2006AMERICAN DIABETES ASSOCIATION

CONTENTS

I. CLASSIFICATIONANDDIAGNOSIS,p. S4A. ClassificationB. Diagnosis

II. SCREENING FOR DIABETES,p. S5

III. DETECTION AND DIAGNOSISOF GESTATIONAL DIABETESMELLITUS, p. S7

IV. PREVENTION/DELAY OF TYPE 2DIABETES, p. S7

V. DIABETES CARE, p. S8A. Initial evaluationB. ManagementC. Glycemic control

1. Assessment of glycemiccontrola. Se l f -moni to r ing o f

blood glucoseb. A1C

2. Glycemic goalsD. Medical nutrition therapyE. Diabetes self-management edu-

cationF. Physical activityG. Psychosocial assessment and careH. Referral for diabetes managementI. Intercurrent illnessJ. Hypoglycemia

K. Immunization

VI. PREVENTION AND MANAGE-MENT OF DIABETES COMPLICA-TIONS, p. S17A. Cardiovascular disease

1. Hypertension/blood pres-sure control

2. Dyslipidemia/lipid man-agement

3. Antiplatelet agents4. Smoking cessation5. Coronaryheartdiseasescreen-

ing and treatmentB. Nephropathy screening and

treatmentC. Retinopathy screening and

treatmentD. Neuropathy screening and

treatmentE. Foot care

VII. DIABETES CARE IN SPECIFICPOPULATIONS, p. S26A. Children and adolescentsB. Preconception careC. Older individuals

VIII. DIABETES CARE IN SPECIFICSETTINGS, p. S29A. Diabetes care in the hospitalB. Diabetes care in the school and

day care settingC. Diabetes care at diabetes campsD. Diabetes management in cor-

rectional institutions

IX. HYPOGLYCEMIA AND EMPLOY-MENT/LICENSURE, p. S34

X. THIRD-PARTY REIMBURSEMENTFOR DIABETES CARE, SELF-MANAGEMENT EDUCATION,AND SUPPLIES, p. S34

XI. STRATEGIES FOR IMPROVINGDIABETES CARE, p. S34

D iabetes is a chronic illness that re-quires continuing medical care andpatient self-management education

to prevent acute complications and to re-duce the risk of long-term complications.Diabetes care is complex and requires thatmany issues, beyond glycemic control, beaddressed. A large body of evidence existsthat supports a range of interventions toimprove diabetes outcomes.

These standards of care are intendedto provide clinicians, patients, research-ers, payors, and other interested individ-uals with the components of diabetescare, treatment goals, and tools to evalu-ate the quality of care. While individualpreferences, comorbidities, and other pa-tient factors may require modification ofgoals, targets that are desirable for mostpatients with diabetes are provided.These standards are not intended to pre-clude more extensive evaluation andmanagement of the patient by other spe-cialists as needed. For more detailed in-formation, refer to refs. 1–3.

The recommendations included arediagnostic and therapeutic actions thatare known or believed to favorably affecthealth outcomes of patients with diabetes.A grading system (Table 1), developed bythe American Diabetes Association (ADA)and modeled after existing methods, wasutilized to clarify and codify the evidencethat forms the basis for the recommenda-tions. The level of evidence that supportseach recommendation is listed after eachrecommendation using the letters A, B, C,or E.

I. CLASSIFICATION ANDDIAGNOSIS

A. ClassificationIn 1997, the ADA issued new diagnosticand classification criteria (4); in 2003,modifications were made regarding thediagnosis of impaired fasting glucose(IFG) (5). The classification of diabetesincludes four clinical classes:

● Type 1 diabetes (results from �-cell de-struction, usually leading to absoluteinsulin deficiency).

● Type 2 diabetes (results from a progres-sive insulin secretory defect on thebackground of insulin resistance).

● Other specific types of diabetes due toother causes, e.g., genetic defects in

● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Originally approved 1988. Most recent review/revision, October 2005.Abbreviations: ABI, ankle-brachial index; AMI, acute myocatdial infarction; ARB, angiotensin receptor block-

er; CAD, coronary artery disease; CBG, capillary blood glucose; CHD, coronary heart disease; CHF, congestiveheart failure; CKD, chronic kidney disease; CVD, cardiovascular disease; DCCB, dihydropyridine calcium channelblocker; DCCT, Diabetes Control and Complications Trial; DKA, diabetic ketoacidosis; DMMP, diabetes medicalmanagement plan; DPN, distal symmetric polyneuropathy; DPP, Diabetes Prevention Program; DRI, dietaryreference intake; DRS, Diabetic Retinopathy Study; DSME, diabetes self-management education; DSMT, diabetesself-management training; ECG, electrocardiogram; ESRD, end-stage renal disease; ETDRS, Early TreatmentDiabetic Retinopathy Study; FDA, Food and Drug Administration; FPG, fasting plasma glucose; GDM, gestationaldiabetes mellitus; GFR, glomerular filtration rate; HRC, high-risk characteristic; ICU, intensive care unit; IFG,impaired fasting glucose; IGT, impaired glucose tolerance; MNT, medical nutrition therapy; NPDR, nonprolif-erative diabetic retinopathy; OGTT, oral glucose tolerance test; PAD, peripheral arterial disease; PDR, proliferativediabetic retinopathy; PPG, postprandial plasma glucose; RDA, recommended dietary allowance; SMBG, self-monitoring of blood glucose; TZD, thiazolidinedione; UKPDS, U.K. Prospective Diabetes Study.

© 2006 by the American Diabetes Association.

P O S I T I O N S T A T E M E N T

S4 DIABETES CARE, VOLUME 29, SUPPLEMENT 1, JANUARY 2006

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�-cell function, genetic defects in insu-lin action, diseases of the exocrine pan-creas (such as cystic fibrosis), and drugor chemical induced (such as in thetreatment of AIDS or after organ trans-plantation).

● Gestational diabetes mellitus (GDM)(diagnosed during pregnancy).

B. Diagnosis

Recommendations● The FPG is the preferred test to diag-

nose diabetes in children and nonpreg-nant adults. (E)

● The use of the A1C for the diagnosis ofdiabetes is not recommended at thistime. (E)

Criteria for the diagnosis of diabetes innonpregnant adults are shown in Table 2.Three ways to diagnose diabetes are avail-able, and each must be confirmed on asubsequent day unless unequivocalsymptoms of hyperglycemia are present.Although the 75-g oral glucose tolerancetest (OGTT) is more sensitive and mod-estly more specific than fasting plasmaglucose (FPG) to diagnose diabetes, it ispoorly reproducible and rarely performed

in practice. Because of ease of use, accept-ability to patients, and lower cost, theFPG is the preferred diagnostic test. Itshould be noted that the vast majority ofpeople who meet diagnostic criteria fordiabetes by OGTT, but not by FPG, willhave an A1C value �7.0%. The use of theA1C for the diagnosis of diabetes is notrecommended at this time.

Hyperglycemia not sufficient to meetthe diagnostic criteria for diabetes is cate-gorized as either IFG or impaired glucosetolerance (IGT), depending on whether itis identified through a FPG or an OGTT:

● IFG � FPG 100 mg/dl (5.6 mmol/l) to125 mg/dl (6.9 mmol/l)

● IGT � 2-h plasma glucose 140 mg/dl(7.8 mmol/l) to 199 mg/dl (11.0mmol/l)

Recently, IFG and IGT have been offi-cially termed “pre-diabetes.” Both catego-ries, IFG and IGT, are risk factors forfuture diabetes and cardiovascular dis-ease (CVD).

In the absence of unequivocal hyper-glycemia, these criteria should be con-firmed by repeat testing on a differentday. The OGTT is not recommended forroutine clinical use but may be requiredin the evaluation of patients with IFG (seetext) or when diabetes is still suspecteddespite a normal FPG, as with the post-partum evaluation of women with GDM.

II. SCREENING FORDIABETES

Recommendations● Screening to detect pre-diabetes (IFG

or IGT) and diabetes should be consid-ered in individuals �45 years of age,particularly in those with a BMI �25kg/m2. Screening should also be con-sidered for people who are �45 years ofage and are overweight if they have an-other risk factor for diabetes (Table 3).Repeat testing should be carried out at3-year intervals. (E)

● Screen for pre-diabetes and diabetes inhigh-risk, asymptomatic, undiagnosedadults and children within the healthcare setting. (E)

● To screen for diabetes/pre-diabetes, ei-ther an FPG test or 2-h OGTT (75-gglucose load) or both are appropriate.(B)

● An OGTT may be considered in pa-tients with IFG to better define the riskof diabetes. (E)

Table 1—ADA evidence grading system for clinical practice recommendations

Level ofevidence Description

A Clear evidence from well-conducted, generalizable, randomized controlled trialsthat are adequately powered including:● Evidence from a well-conducted multicenter trial● Evidence from a meta-analysis that incorporated quality ratings in the

analysis● Compelling nonexperimental evidence, i.e., “all or none” rule developed

by Center for Evidence Based Medicine at OxfordSupportive evidence from well-conducted randomized controlled trials that are

adequately powered including:● Evidence from a well-conducted trial at one or more institutions● Evidence from a meta-analysis that incorporated quality ratings in the

analysisB Supportive evidence from well-conducted cohort studies

● Evidence from a well-conducted prospective cohort study or registry● Evidence from a well-conducted meta-analysis of cohort studies

Supportive evidence from a well-conducted case-control studyC Supportive evidence from poorly controlled or uncontrolled studies

● Evidence from randomized clinical trials with one or more major or threeor more minor methodological flaws that could invalidate the results

● Evidence from observational studies with high potential for bias (such ascase series with comparison to historical controls)

● Evidence from case series or case reportsConflicting evidence with the weight of evidence supporting the

recommendationE Expert consensus or clinical experience

Table 2—Criteria for the diagnosis of diabetes

1. Symptoms of diabetes and a casual plasma glucose 200 mg/dl (11.1 mmol/l).Casual is defined as any time of day without regard to time since last meal.The classic symptoms of diabetes include polyuria, polydipsia, andunexplained weight loss.

OR2. FPG 126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for at least

8 h.OR

3. 2-h plasma glucose 200 mg/dl (11.1 mmol/l) during an OGTT. The test shouldbe performed as described by the World Health Organization, using aglucose load containing the equivalent of 75-g anhydrous glucose dissolvedin water.

Position Statement

DIABETES CARE, VOLUME 29, SUPPLEMENT 1, JANUARY 2006 S5

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There is a major distinction between di-agnostic testing and screening. Both uti-lize the same clinical tests, which shouldbe done within the context of the healthcare setting. When an individual exhibitssymptoms or signs of the disease, diag-nostic tests are performed, and such testsdo not represent screening. The purposeof screening is to identify asymptomaticindividuals who are likely to have diabe-tes or pre-diabetes. Separate diagnostictests using standard criteria are requiredafter positive screening tests to establish adefinitive diagnosis as described above.

Type 1 diabetesGenerally, people with type 1 diabetespresent with acute symptoms of diabetesand markedly elevated blood glucose lev-els. Because of the acute onset of symp-toms, most cases of type 1 diabetes aredetected soon after symptoms develop.Widespread clinical testing of asymptom-atic individuals for the presence of auto-antibodies related to type 1 diabetescannot be recommended at this time as ameans to identify individuals at risk. Rea-sons for this include the following: 1) cut-off values for some of the immune markerassays have not been completely estab-lished in clinical settings; 2) there is no con-sensus as to what action should be takenwhen a positive autoantibody test result isobtained; and 3) because the incidence oftype 1 diabetes is low, testing of healthychildren will identify only a very small num-ber (�0.5%) who at that moment may be“pre-diabetic.” Clinical studies are beingconducted to test various methods of pre-venting type 1 diabetes in high-risk individ-

uals (e.g., siblings of type 1 diabeticpatients). These studies may uncover an ef-fective means of preventing type 1 diabetes,in which case targeted screening may be ap-propriate in the future.

Type 2 diabetesType 2 diabetes is frequently not diag-nosed until complications appear, andapproximately one-third of all peoplewith diabetes may be undiagnosed. Indi-viduals at high risk should be screened fordiabetes and pre-diabetes. Criteria fortesting for diabetes in asymptomatic, un-diagnosed adults are listed in Table 3. Theeffectiveness of early diagnosis throughscreening of asymptomatic individualshas not been determined (6).

Screening should be carried outwithin the health care setting. Either anFPG test or 2-h OGTT (75-g glucose load)is appropriate. The 2-h OGTT identifiespeople with IGT, and thus, more peoplewho are at increased risk for the develop-ment of diabetes and CVD. It should benoted that the two tests do not necessarilydetect the same individuals (7). It is im-portant to recognize that although the ef-ficacy of interventions for primaryprevention of type 2 diabetes have beendemonstrated among individuals withIGT (8–10), such data among individualswith IFG (who do not also have IGT) arenot available. The FPG test is more con-venient to patients, more reproducible,less costly, and easier to administer thanthe 2-h OGTT (4,5). Therefore, the rec-ommended initial screening test for non-pregnant adults is the FPG. An OGTT

may be considered in patients with IFG tobetter define the risk of diabetes.

The incidence of type 2 diabetes inchildren and adolescents has increaseddramatically in the last decade. Consis-tent with screening recommendations foradults, only children and youth at in-creased risk for the presence or the devel-opment of type 2 diabetes should betested (11) (Table 4).

The effectiveness of screening mayalso depend on the setting in which it isperformed. In general, communityscreening outside a health care settingmay be less effective because of the failureof people with a positive screening test toseek and obtain appropriate follow-uptesting and care or, conversely, to ensureappropriate repeat testing for individualswho screen negative. That is, screeningoutside of clinical settings may yield ab-normal tests that are never discussed witha primary care provider, low compliancewith treatment recommendations, and avery uncertain impact on long-termhealth. Community screening may also bepoorly targeted, i.e., it may fail to reachthe groups most at risk and inappropri-ately test those at low risk (the worriedwell) or even those already diagnosed(12,13).

On the basis of expert opinion,screening should be considered by healthcare providers at 3-year intervals begin-ning at age 45, particularly in those with

Table 3—Criteria for testing for diabetes in asymptomatic adult individuals

1. Testing for diabetes should be considered in all individuals at age 45 years and above,particularly in those with a BMI 25 kg/m2*, and, if normal, should be repeated at3-year intervals.

2. Testing should be considered at a younger age or be carried out more frequently inindividuals who are overweight (BMI 25 kg/m2*) and have additional risk factors:● are habitually physically inactive● have a first-degree relative with diabetes● are members of a high-risk ethnic population (e.g., African American, Latino,

Native American, Asian American, Pacific Islander)● have delivered a baby weighing �9 lb or have been diagnosed with GDM● are hypertensive (�140/90 mmHg)● have an HDL cholesterol level �35 mg/dl (0.90 mmol/l) and/or a triglyceride level

�250 mg/dl (2.82 mmol/l)● have PCOS● on previous testing, had IGT or IFG● have other clinical conditions associated with insulin resistance (e.g. PCOS or

acanthosis nigricans)● have a history of vascular disease

*May not be correct for all ethnic groups. PCOS, polycystic ovary syndrome.

Table 4—Testing for type 2 diabetes in chil-dren

Criteria:● Overweight (BMI �85th percentile for

age and sex, weight for height �85thpercentile, or weight �120% of ideal forheight)

Plus any two of the following risk factors:● Family history of type 2 diabetes in first-

or second-degree relative● Race/ethnicity (Native American, African

American, Latino, Asian American,Pacific Islander)

● Signs of insulin resistance or conditionsassociated with insulin resistance(acanthosis nigricans, hypertension,dyslipidemia, or PCOS)

● Maternal history of diabetes or GDMAge of initiation: age 10 years or at onset of

puberty, if puberty occurs at a younger ageFrequency: every 2 yearsTest: FPG preferred

Clinical judgment should be used to test for diabetesin high-risk patients who do not meet these criteria.PCOS, polycystic ovary syndrome.

Standards of Medical Care

S6 DIABETES CARE, VOLUME 29, SUPPLEMENT 1, JANUARY 2006

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BMI �25 kg/m2. The rationale for thisinterval is that false negatives will be re-peated before substantial time elapses,and there is little likelihood of an individ-ual developing any of the complicationsof diabetes to a significant degree within 3years of a negative screening test result.Testing should be considered at a youngerage or be carried out more frequently inindividuals who are overweight and haveone or more of the other risk factors fortype 2 diabetes.

III. DETECTION ANDDIAGNOSIS OF GDM

Recommendations● Screen for diabetes in pregnancy using

risk factor analysis and, if appropriate,use of an OGTT. (C)

● Women with GDM should be screenedfor diabetes 6–12 weeks postpartumand should be followed up with subse-quent screening for the development ofdiabetes or pre-diabetes. (E)

Risk assessment for GDM should be un-dertaken at the first prenatal visit. Womenwith clinical characteristics consistentwith a high risk for GDM (those withmarked obesity, personal history of GDM,glycosuria, or a strong family history ofdiabetes) should undergo glucose testingas soon as possible (14). An FPG �126mg/dl or a casual plasma glucose �200mg/dl meets the threshold for the diagno-sis of diabetes and needs to be confirmedon a subsequent day unless unequivocalsymptoms of hyperglycemia are present.High-risk women not found to have GDMat the initial screening and average-riskwomen should be tested between 24 and28 weeks of gestation. Testing should fol-low one of two approaches:

● One-step approach: perform a diagnos-tic 100-g OGTT

● Two-step approach: perform an initialscreening by measuring the plasma orserum glucose concentration 1 h after a50-g oral glucose load (glucose chal-lenge test) and perform a diagnostic100-g OGTT on that subset of womenexceeding the glucose threshold valueon the glucose challenge test. When thetwo-step approach is used, a glucosethreshold value �140 mg/dl identifies�80% of women with GDM, and theyield is further increased to 90% by us-ing a cutoff of �130 mg/dl.

Diagnostic criteria for the 100-g OGTTare as follows: �95 mg/dl fasting, �180mg/dl at 1 h, �155 mg/dl at 2 h, and�140 mg/dl at 3 h. Two or more of theplasma glucose values must be met or ex-ceeded for a positive diagnosis. The testshould be done in the morning after anovernight fast of 8–14 h. The diagnosiscan be made using a 75-g glucose load,but that test is not as well validated fordetection of at-risk infants or mothers asthe 100-g OGTT.

Low-risk status requires no glucosetesting, but this category is limited tothose women meeting all of the followingcharacteristics:

● Age �25 years.● Weight normal before pregnancy.● Member of an ethnic group with a low

prevalence of GDM.● No known diabetes in first-degree rela-

tives.● No history of abnormal glucose toler-

ance.● No history of poor obstetric outcome.

IV. PREVENTION/DELAYOF TYPE 2 DIABETES

Recommendations● Individuals at high risk for developing

diabetes need to become aware of thebenefits of modest weight loss and par-ticipating in regular physical activity.(A)

● Patients with IGT should be givencounseling on weight loss as well as in-struction for increasing physical activ-ity. (A)

● Patients with IFG should be givencounseling on weight loss as well as in-struction for increasing physical activ-ity. (E)

● Follow-up counseling appears impor-tant for success. (B)

● Monitoring for the development of diabe-tes in those with pre-diabetes should beperformed every 1–2 years. (E)

● Close attention should be given to, andappropriate treatment given for, otherCVD risk factors (e.g., tobacco use, hy-pertension, dyslipidemia). (A)

● Drug therapy should not be routinelyused to prevent diabetes until more in-formation is known about its cost-effectiveness. (E)

Studies have been initiated in the last de-cade to determine the feasibility and ben-efit of various strategies to prevent or

delay the onset of type 2 diabetes. Fivewell-designed randomized controlled tri-als have been reported (8–10,15,16). Thestrategies shown to be effective in pre-venting diabetes relied on lifestyle modi-fication or glucose-lowering drugs thathave been approved for treating diabetes.

In the Finnish study (9), middle-agedobese subjects with IGT were randomizedto receive either brief diet and exercisecounseling (control group) or intensiveindividualized instruction on weight re-duction, food intake, and guidance on in-creasing physical activity (interventiongroup). After an average follow-up of 3.2years, there was a 58% relative reductionin the incidence of diabetes in the inter-vention group compared with the controlsubjects.

In the Diabetes Prevention Program(DPP) (8), enrolled subjects were slightlyyounger and more obese but had nearlyidentical glucose intolerance comparedwith subjects in the Finnish study. About45% of the participants were from minor-ity groups (e.g., African American, His-panic), and 20% were �60 years of age.Subjects were randomized to one of threeintervention groups, which included theintensive nutrition and exercise counsel-ing (“lifestyle”) group or either of twomasked medication treatment groups: thebiguanide metformin group or the pla-cebo group. The latter interventions werecombined with standard diet and exerciserecommendations. After an average fol-low-up of 2.8 years, a 58% relative reduc-tion in the progression to diabetes wasobserved in the lifestyle group and a 31%relative reduction in the progression ofdiabetes was observed in the metformingroup compared with control subjects.On average, 50% of the lifestyle groupachieved the goal of �7% weight reduc-tion and 74% maintained at least 150min/week of moderately intense activity.In the troglitazone arm of the DPP (dis-continued after a mean of 0.9 years whenthe drug was withdrawn from the mar-ket), troglitazone markedly reduced theincidence of diabetes during the periodthe drug was given (16a).

In the Da Qing Study (10), men andwomen from health care clinics in the cityof Da Qing, China, were screened withOGTT, and those with IGT were random-ized by clinic to a control group or to oneof three active treatment groups: dietonly, exercise only, or diet plus exercise.Subjects were reexamined biannually,and after an average of 6 years’ follow-up,the diet, exercise, and diet plus exercise

Position Statement

DIABETES CARE, VOLUME 29, SUPPLEMENT 1, JANUARY 2006 S7

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interventions were associated with 31,46, and 42% reductions in risk of devel-oping type 2 diabetes, respectively.

Three other studies, each using a dif-ferent class of glucose-lowering agent,have shown a reduction in progression todiabetes with pharmacological interven-tion. In the Troglitazone in Prevention ofDiabetes (TRIPOD) study (15), Hispanicwomen with previous GDM were ran-domized to receive either placebo or tro-glitazone (a drug now withdrawn fromcommercial sale in the U.S. but belongingto the thiazolidinedione [TZD] class). Af-ter a median follow-up of 30 months, tro-glitazone treatment was associated with a56% relative reduction in progression todiabetes. In the STOP-IDDM trial (16),participants with IGT were randomizedin a double-blind fashion to receive eitherthe �-glucosidase inhibitor acarbose or aplacebo. After a mean follow-up of 3.3years, a 25% relative risk reduction inprogression to diabetes, based on oneOGTT, was observed in the acarbose-treated group compared with the placebogroup. If this diagnosis was confirmed bya second OGTT, a 36% relative risk re-duction was observed in the acarbosegroup compared with the placebo group.

Finally, in the XENical in the pre-vention of Diabetes in Obese Subjects(XENDOS) study, orlistat was examinedfor its ability to delay type 2 diabeteswhen added to lifestyle change in a groupwith BMI �30 kg/m2 with or withoutIGT. After 4 years of treatment, the effectof orlistat addition corresponded to a45% risk reduction in the IGT group,with no effect observed in those withoutIGT (16b).

Our knowledge of the early stages ofhyperglycemia that portend the diagnosisof diabetes, and the recent success of ma-jor intervention trials, clearly show thatindividuals at high risk can be identifiedand diabetes delayed, if not prevented.The cost-effectiveness of interventionstrategies is unclear, but the huge burdenresulting from the complications of diabe-tes and the potential ancillary benefits ofsome of the interventions suggest that aneffort to prevent diabetes is worthwhile.

Lifestyle modificationIn well-controlled studies that included alifestyle intervention arm, substantial ef-forts were necessary to achieve only mod-est changes in weight and exercise, butthose changes were sufficient to achievean important reduction in the incidence

of diabetes. In the Finnish Diabetes Pre-vention Study, weight loss averaged 9.2 lbat 1 year, 7.7 lb after 2 years, and 4.6 lbafter 5 years (9); “moderate exercise,”such as brisk walking, for 30 min/day wassuggested. In the Finnish study, there wasa direct relationship between adherencewith the lifestyle intervention and the re-duced incidence of diabetes.

In the DPP (8), the lifestyle group lost�12 lb at 2 years and 9 lb at 3 years (meanweight loss for the study duration was�12 lb or 6% of initial body weight). Inboth of these studies, most of the partici-pants were obese (BMI �30 kg/m2).

A low-fat (�25% fat) intake was rec-ommended; if reducing fat did not pro-duce weight loss to goal, calorierestriction was also recommended. Par-ticipants weighing 120–174 lb (54–78kg) at baseline were instructed to follow a1,200-kcal/day diet (33 g fat), those 175–219 lb (79–99 kg) were instructed to fol-low a 1,500-kcal/day diet (42 g fat), those220 –249 lb (100 –113 kg) were in-structed to follow an 1,800-kcal/day diet(50 g fat), and those �250 lb (114 kg)were instructed to follow a 2,000-kcal/day diet (55 g fat).

Pharmacological interventionsThree diabetes prevention trials usedpharmacological therapy, and all have re-ported a significant lowering of the inci-dence of diabetes. The biguanidemetformin reduced the risk of diabetes by31% in the DPP (8), the �-glucosidaseinhibitor acarbose reduced the risk by32% in the STOP-IDDM trial (16), andthe TZD troglitazone reduced the risk by56% in the TRIPOD study (15).

In the DPP, metformin was about halfas effective as diet and exercise in delayingthe onset of diabetes overall, but it wasnearly ineffective in older individuals(�60 years of age) or in those who wereless overweight (BMI �30 kg/m2). Con-versely, metformin was as effective as life-style modification in individuals aged24–44 years or in those with a BMI �35kg/m2. Thus, the population of people inwhom treatment with metformin hasequal benefit to that of a lifestyle interven-tion is only a small subset of those who arelikely to have pre-diabetes (IFG or IGT).

There are also data to suggest thatblockade of the renin-angiotensin system(17) may lower the risk of developing di-abetes, but more studies are necessary be-fore these drugs can be recommended forpreventing diabetes.

Lifestyle or medication?The DPP is the only study in which a com-parison of the two was made, and lifestylemodification was nearly twice as effectivein preventing diabetes (58 vs. 31% rela-tive reductions, respectively). The greaterbenefit of weight loss and physical activitystrongly suggests that lifestyle modifica-tion should be the first choice to preventor delay diabetes. Modest weight loss (5–10% of body weight) and modest physicalactivity (30 min daily) are the recom-mended goals. Because this interventionnot only has been shown to prevent ordelay diabetes, but also has a variety ofother benefits, health care providersshould urge all overweight or sedentaryindividuals to adopt these changes, andsuch recommendations should be madeat every opportunity.

When all factors are considered, thereis insufficient evidence to support the useof drug therapy as a substitute for, or rou-tinely used in addition to, lifestyle modi-fication to prevent diabetes. Public healthmessages, health care professionals, andhealth care systems should all encouragebehavior changes to achieve a healthy life-style. Further research is necessary to un-derstand better how to facilitate effectiveand efficient programs for the primaryprevention of type 2 diabetes.

V. DIABETES CARE

A. Initial evaluationA complete medical evaluation should beperformed to classify the patient, detectthe presence or absence of diabetes com-plications, assist in formulating a manage-ment plan, and provide a basis forcontinuing care. If the diagnosis of diabe-tes has already been made, the evaluationshould review the previous treatment andthe past and present degrees of glycemiccontrol. Laboratory tests appropriate tothe evaluation of each patient’s generalmedical condition should be performed.A focus on the components of compre-hensive care (Table 5) will assist thehealth care team to ensure optimal man-agement of the patient with diabetes.

B. ManagementPeople with diabetes should receive med-ical care from a physician-coordinatedteam. Such teams may include, but arenot limited to, physicians, nurse practitio-ners, physician’s assistants, nurses, dieti-tians, pharmacists, and mental healthprofessionals with expertise and a special

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interest in diabetes. It is essential in thiscollaborative and integrated team ap-proach that individuals with diabetes as-sume an active role in their care.

The management plan should be for-mulated as an individualized therapeutic

alliance among the patient and family, thephysician, and other members of thehealth care team. Any plan should recog-nize diabetes self-management education(DSME) as an integral component of care.In developing the plan, consideration

should be given to the patient’s age,school or work schedule and conditions,physical activity, eating patterns, socialsituation and personality, cultural factors,and presence of complications of diabetesor other medical conditions. A variety of

Table 5—Components of the comprehensive diabetes evaluation

Medical history● Symptoms, results of laboratory tests, and special examination results related to the diagnosis of diabetes● Prior A1C records● Eating patterns, nutritional status, and weight history; growth and development in children and adolescents● Details of previous treatment programs, including nutrition and diabetes self-management education, attitudes, and health beliefs● Current treatment of diabetes, including medications, meal plan, and results of glucose monitoring and patients’ use of data● Exercise history● Frequency, severity, and cause of acute complications such as ketoacidosis and hypoglycemia● Prior or current infections, particularly skin, foot, dental, and genitourinary infections● Symptoms and treatment of chronic eye; kidney; nerve; genitourinary (including sexual), bladder, and gastrointestinal function

(including symptoms of celiac disease in type 1 diabetic patients); heart; peripheral vascular; foot; and cerebrovascular complicationsassociated with diabetes

● Other medications that may affect blood glucose levels● Risk factors for atherosclerosis: smoking, hypertension, obesity, dyslipidemia, and family history● History and treatment of other conditions, including endocrine and eating disorders● Assessment for mood disorder● Family history of diabetes and other endocrine disorders● Lifestyle, cultural, psychosocial, educational, and economic factors that might influence the management of diabetes● Tobacco, alcohol, and/or controlled substance use● Contraception and reproductive and sexual history

Physical examination● Height and weight measurement (and comparison to norms in children and adolescents)● Sexual maturation staging (during pubertal period)● Blood pressure determination, including orthostatic measurements when indicated, and comparison to age-related norms● Fundoscopic examination● Oral examination● Thyroid palpation● Cardiac examination● Abdominal examination (e.g., for hepatomegaly)● Evaluation of pulses by palpation and with auscultation● Hand/finger examination● Foot examination● Skin examination (for acanthosis nigricans and insulin-injection sites)● Neurological examination● Signs of diseases that can cause secondary diabetes (e.g., hemochromatosis, pancreatic disease)

Laboratory evaluation● A1C● Fasting lipid profile, including total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol, liver function tests with further

evaluation for fatty liver or hepatitis if abnormal● Test for microalbuminuria in type 1 diabetic patients who have had diabetes for at least 5 years and in all patients with type 2 diabetes;

some advocate beginning screening of pubertal children before 5 years of diabetes● Serum creatinine and calculated GFR in adults (check creatinine in children if proteinuria is present)● Thyroid-stimulating hormone (TSH) in all type 1 diabetic patients; in type 2 if clinically indicated● Electrocardiogram in adults, if clinically indicated● Urinalysis for ketones, protein, sediment

Referrals● Eye exam, if indicated● Family planning for women of reproductive age● MNT, as indicated● Diabetes educator, if not provided by physician or practice staff● Behavioral specialist, as indicated● Foot specialist, as indicated● Other specialties and services as appropriate

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strategies and techniques should be usedto provide adequate education and devel-opment of problem-solving skills in thevarious aspects of diabetes management.Implementation of the management planrequires that each aspect is understoodand agreed on by the patient and the careproviders and that the goals and treat-ment plan are reasonable.

C. Glycemic control1. Assessment of glycemic control.Techniques are available for health pro-viders and patients to assess the effective-ness of the management plan on glycemiccontrol.

a. Self-monitoring of blood glucose

Recommendations● Clinical trials using insulin that have

demonstrated the value of tight glyce-mic control have used self-monitoringof blood glucose (SMBG) as an integralpart of the management strategy. (A)

● SMBG should be carried out three ormore times daily for patients using mul-tiple insulin injections. (A)

● For patients using less frequent insulininjections or oral agents or medical nu-trition therapy (MNT) alone, SMBG isuseful in achieving glycemic goals. (E)

● To achieve postprandial glucose tar-

gets, postprandial SMBG may be appro-priate. (E)

● Instruct the patient in SMBG and rou-tinely evaluate the patient’s techniqueand ability to use data to adjust therapy.(E)

The ADA’s consensus statements onSMBG provide a comprehensive review ofthe subject (18,19). Major clinical trialsassessing the impact of glycemic controlon diabetes complications have includedSMBG as part of multifactorial interven-tions, suggesting that SMBG is a compo-nent of effective therapy. SMBG allowspatients to evaluate their individual re-sponse to therapy and assess whether gly-cemic targets are being achieved. Resultsof SMBG can be useful in preventing hy-poglycemia and adjusting medications,MNT, and physical activity.

The frequency and timing of SMBGshould be dictated by the particular needsand goals of the patients. Daily SMBG isespecially important for patients treatedwith insulin to monitor for and preventasymptomatic hypoglycemia and hyper-glycemia. For most patients with type 1diabetes and pregnant women taking in-sulin, SMBG is recommended three ormore times daily. The optimal frequencyand timing of SMBG for patients with type2 diabetes on oral agent therapy is not

known but should be sufficient to facili-tate reaching glucose goals. Patients withtype 2 diabetes on insulin typically needto perform SMBG more frequently thanthose not using insulin. When adding toor modifying therapy, type 1 and type 2diabetic patients should test more oftenthan usual. The role of SMBG in stablediet-treated patients with type 2 diabetesis not known.

Because the accuracy of SMBG is in-strument and user dependent (20), it isimportant for health care providers toevaluate each patient’s monitoring tech-nique, both initially and at regular inter-vals thereafter. In addition, optimal use ofSMBG requires proper interpretation ofthe data. Patients should be taught how touse the data to adjust food intake, exer-cise, or pharmacological therapy toachieve specific glycemic goals. Healthprofessionals should evaluate at regularintervals the patient’s ability to use SMBGdata to guide treatment.

b. A1C

Recommendations● Perform the A1C test at least two times

a year in patients who are meeting treat-ment goals (and who have stable glyce-mic control). (E)

● Perform the A1C test quarterly in pa-tients whose therapy has changed orwho are not meeting glycemic goals. (E)

● Use of point-of-care testing for A1C al-lows for timely decisions on therapychanges, when needed. (E)

By performing an A1C test, health provid-ers can measure a patient’s average glyce-mia over the preceding 2–3 months (20)and, thus, assess treatment efficacy. A1Ctesting should be performed routinely inall patients with diabetes, first to docu-ment the degree of glycemic control atinitial assessment and then as part of con-tinuing care. Since the A1C test reflectsmean glycemia over the preceding 2–3months, measurement approximately ev-ery 3 months is required to determinewhether a patient’s metabolic control hasbeen reached and maintained within thetarget range. Thus, regular performanceof the A1C test permits detection of de-partures from the target (Table 6) in atimely fashion. For any individual patient,the frequency of A1C testing should bedependent on the clinical situation, thetreatment regimen used, and the judg-ment of the clinician.

The A1C test is subject to certain lim-

Table 6—Summary of recommendations for adults with diabetes

Glycemic controlA1C �7.0%*Preprandial capillary plasma glucose 90–130 mg/dl (5.0–7.2 mmol/l)Peak postprandial capillary plasma glucose† �180 mg/dl (�10.0 mmol/l)Blood pressure �130/80 mmHg

Lipids‡LDL �100 mg/dl (�2.6 mmol/l)Triglycerides �150 mg/dl (�1.7 mmol/l)HDL �40 mg/dl (�1.1 mmol/l)§

Key concepts in setting glycemic goals:● A1C is the primary target for glycemic control● Goals should be individualized● Certain populations (children, pregnant women, and

elderly) require special considerations● More stringent glycemic goals (i.e., a normal A1C, �6%)

may further reduce complications at the cost of increasedrisk of hypoglycemia

● Less intensive glycemic goals may be indicated in patientswith severe or frequent hypoglycemia

● Postprandial glucose may be targeted if A1C goals are notmet despite reaching preprandial glucose goals

*Referenced to a nondiabetic range of 4.0–6.0% using a DCCT-based assay. †Postprandial glucose mea-surements should be made 1–2 h after the beginning of the meal, generally peak levels in patients withdiabetes. ‡Current NCEP/ATP III guidelines suggest that in patients with triglycerides �200 mg/dl, the“non-HDL cholesterol” (total cholesterol minus HDL) be utilized. The goal is �130 mg/dl (34). §For women,it has been suggested that the HDL goal be increased by 10 mg/dl.

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itations. Conditions that affect erythro-cyte turnover (hemolysis, blood loss) andhemoglobin variants must be considered,particularly when the A1C result does notcorrelate with the patient’s clinical situa-tion (20). The availability of the A1C re-sult at the time that the patient is seen(point of care testing) has been reportedto result in the frequency of intensifica-tion of therapy and improvement in gly-cemic control (21,22).

Glycemic control is best judged bythe combination of the results of the pa-tient’s SMBG testing (as performed) andthe current A1C result. The A1C shouldbe used not only to assess the patient’scontrol over the preceding 2–3 monthsbut also as a check on the accuracy of themeter (or the patient’s self-reported re-sults) and the adequacy of the SMBG test-ing schedule. Table 7 contains thecorrelation between A1C levels and meanplasma glucose levels based on data fromthe Diabetes Control and ComplicationsTrial (DCCT) (23).

2. Glycemic goals

Recommendations● Lowering A1C has been associated with

a reduction of microvascular and neu-ropathic complications of diabetes. (A)

● The A1C goal for patients in general is anA1C goal of �7%. (B)

● The A1C goal for the individual patient isan A1C as close to normal (�6%) aspossible without significant hypoglyce-mia. (E)

● Less stringent treatment goals may beappropriate for patients with a historyof severe hypoglycemia, patients withlimited life expectancies, very youngchildren or older adults, and individu-als with comorbid conditions. (E)

● Aggressive glycemic management withinsulin may reduce morbidity in pa-

tients with severe acute illness, periop-erat ively, fol lowing myocardialinfarction, and in pregnancy. (B)

Glycemic control is fundamental to themanagement of diabetes. The goal of ther-apy is to acheive an A1C as close to nor-mal as possible (representing normalfasting and postprandial glucose concen-trations) in the absence of hypoglycemia.However, this goal is difficult to achievewith present therapies (24). Prospectiverandomized clinical trials such as theDCCT (25) and the U.K. Prospective Di-abetes Study (UKPDS) (26,27) haveshown that improved glycemic control isassociated with sustained decreased ratesof retinopathy, nephropathy, and neu-ropathy (28). In these trials, treatmentregimens that reduced average A1C to�7% (�1% above the upper limits ofnormal) were associated with fewer long-term microvascular complications; how-ever, intensive control was found toincrease the risk of severe hypoglycemiaand weight gain (29,30). The potential ofintensive glycemic control to reduce CVDis supported by epidemiological studies(25–30) and a recent meta-analysis (31),but this potential benefit on CVD eventshas not yet been demonstrated in a ran-domized clinical trial.

Recommended glycemic goals fornonpregnant individuals are shown in Ta-ble 6. A major limitation to the availabledata is that they do not identify the opti-mum level of control for particular pa-tients, as there are individual differencesin the risks of hypoglycemia, weight gain,and other adverse effects. Furthermore,with multifactorial interventions, it is un-clear how different components (e.g., ed-ucational interventions, glycemic targets,lifestyle changes, pharmacologicalagents) contribute to the reduction ofcomplications. There are no clinical trialdata available for the effects of glycemiccontrol in patients with advanced compli-cations, the elderly (�65 years of age), oryoung children (�13 years of age). Lessstringent treatment goals may be appro-priate for patients with limited life expect-ancies, in the very young or older adults,and in individuals with comorbid condi-tions. Severe or frequent hypoglycemia isan indication for the modification of treat-ment regimens, including setting higherglycemic goals.

More stringent goals (i.e., a normalA1C, �6%) should be considered in in-dividual patients based on epidemiologi-cal analyses suggesting that there is no

lower limit of A1C at which further low-ering does not reduce the risk of compli-cat ions, at the r isk of increasedhypoglycemia (particularly in those withtype 1 diabetes). However, the absoluterisks and benefits of lower targets are un-known. The risks and benefits of an A1Cgoal of �6% are currently being tested inan ongoing study (ACCORD [Action toControl Cardiovascular Risk in Diabetes])in type 2 diabetes.

Elevated postchallenge (2-h OGTT)glucose values have been associated withincreased cardiovascular risk indepen-dent of FPG in some epidemiologicalstudies. Postprandial plasma glucose(PPG) levels �140 mg/dl are unusual innondiabetic individuals, although largeevening meals can be followed by plasmaglucose values up to 180 mg/dl. There arenow pharmacological agents that primar-ily modify PPG and thereby reduce A1Cin parallel. Thus, in individuals who havepremeal glucose values within target butwho are not meeting A1C targets, consid-eration of monitoring PPG 1–2 h after thestart of the meal and treatment aimed atreducing PPG values �180 mg/dl maylower A1C. However, it should be notedthat the effect of these approaches on mi-cro- or macrovascular complications hasnot been studied (32).

As regards goals for glycemic controlfor women with GDM, recommendationsfrom the Fourth International Workshop-Conference on Gestational Diabetes sug-gest lowering maternal capillary bloodglucose concentrations to �95 mg/dl (5.3mmol/l) fasting, �140 mg/dl (7.8mmol/l) at 1 h, and/or �120 mg/dl (6.7mmol/l) at 2 h after the meal (32a). Forfurther information on GDM, refer to theADA position statement (14). For infor-mation on glycemic control during preg-nancy in women with preexistingdiabetes, refer to ref. 33.

D. MNT

Recommendations● People with diabetes should receive in-

dividualized MNT as needed to achievetreatment goals, preferably provided bya registered dietitian familiar with thecomponents of diabetes MNT. (B)

● Both the amount (grams) of carbohy-drate as well as the type of carbohydratein a food influence blood glucose level.Monitoring total grams of carbohy-drate, whether by use of exchanges orcarbohydrate counting, remains a key

Table 7—Correlation between A1C level andmean plasma glucose levels on multiple test-ing over 2–3 months (23)

A1C (%)

Mean plasma glucose

mg/dl mmol/l

6 135 7.57 170 9.58 205 11.59 240 13.510 275 15.511 310 17.512 345 19.5

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strategy in achieving glycemic control.(A)

● The use of the glycemic index/glycemicload may provide an additional benefitover that observed when total carbohy-drate is considered alone. (B)

● Low-carbohydrate diets (restricting to-tal carbohydrate to �130 g/day) are notrecommended in the management ofdiabetes. (E)

● To reduce the risk of nephropathy, pro-tein intake should be limited to the rec-ommended dietary allowance (RDA)(0.8 g/kg) in those with any degree ofCKD. (B)

● Saturated fat intake should be �7% oftotal calories. (A)

● Intake of trans fat should be minimized.(E)

● Weight loss is recommended for alloverweight (BMI 25.0–29.9 kg/m2) orobese (BMI �30.0 kg/m2) adults whohave, or are at risk for developing, type2 diabetes. (E)

● The primary approach for achievingweight loss is therapeutic lifestylechange, which includes a reduction inenergy intake and an increase in phys-ical activity. A moderate decrease in ca-loric balance (500–1,000 kcal/day) willresult in a slow but progressive weightloss (1–2 lb/week). For most patients,weight loss diets should supply at least1,000–1,200 kcal/day for women and1,200–1,600 kcal/day for men. (E)

● Initial physical activity recommenda-tions should be modest and based onthe patient’s willingness and ability,gradually increasing the duration andfrequency to 30–45 min of moderateaerobic activity, 3–5 days/week (goal atleast 150 min/week). Greater activitylevels of at least 1 h/day of moderate(walking) or 30 min/day of vigorous(jogging) activity may be needed toachieve successful long-term weightloss. (E)

● Drug therapy for obesity and surgery toinduce weight loss may be appropriatein selected patients. (E)

● Nonnutritive sweeteners are safe whenconsumed within the acceptable dailyintake levels established by the Foodand Drug Administration (FDA). (A)

● If adults with diabetes choose to usealcohol, daily intake should be limitedto a moderate amount (one drink perday or less for adult women and twodrinks per day or less for adult men);one drink is defined as 12 oz beer, 5 ozwine, or 1.5 oz distilled spirits. (A)

● Routine supplementation with antioxi-

dants, such as vitamins E and C and�-carotene, is not advised because oflack of evidence of efficacy and concernrelated to long-term safety. (A)

● Benefit from chromium supplementa-tion in people with diabetes or obesityhas not been conclusively demon-strated and, therefore, cannot be rec-ommended. (E)

MNT is an integral component of diabetesprevention, management, and self-management education. In addition to itsrole in preventing and controlling diabe-tes, the ADA recognizes the importance ofnutrition as an essential component of anoverall healthy lifestyle . These guidelinesare based on principles of good nutritionfor the overall population from the 2005Dietary Guidelines and the RDAs from theInstitute of Medicine of the NationalAcademies of Sciences. A review of theevidence and detailed information can befound in the 2002 ADA technical reviewon this topic (35) and the 2004 ADAStatements regarding dietary carbohy-drate (36) and weight management. (37).

Goal of MNT that applies to individ-uals with pre-diabetes:

● Decrease the risk of diabetes and CVDby promoting physical activity andhealthy food choices that result in mod-erate weight loss that is maintained or,at a minimum, prevents weight gain.

Goal of MNT that applies to all individu-als with diabetes:

● Prevent and treat the chronic complica-tions of diabetes by attaining and main-taining optimal metabolic outcomes,including blood glucose and A1C level,LDL and HDL cholesterol and triglyc-eride levels, blood pressure, and bodyweight (Table 6).

Achieving nutrition-related goals requiresa coordinated team effort that includesthe active involvement of the person withpre-diabetes or diabetes. Because of thecomplexity of nutrition issues, it is recom-mended that a registered dietitian who isknowledgeable and skilled in implement-ing nutrition therapy into diabetes man-agement and education be the teammember who provides MNT. However, itis essential that all team members areknowledgeable about nutrition therapyand are supportive of the person with di-abetes who needs to make lifestylechanges.

MNT involves a nutrition assessmentto evaluate the patient’s food intake, met-abolic status, lifestyle, readiness to makechanges, goal setting, dietary instruction,and evaluation. To facilitate adherence,the plan should be individualized andtake into account individual cultural, life-style, and financial considerations. Moni-toring of glucose and A1C, lipids, bloodpressure, and renal status is essential toevaluate nutrition-related outcomes. Ifgoals are not met (Table 6), changes mustbe made in the overall diabetes care andmanagement plan.

Weight management (37)Overweight and obesity are stronglylinked to the development of type 2 dia-betes and can complicate its management.Obesity is also an independent risk factorfor hypertension and dyslipidemia as wellas CVD, which is the major cause of deathin those with diabetes. Moderate weightloss improves glycemic control, reducesCVD risk, and can prevent the develop-ment of type 2 diabetes in those with pre-diabetes. Therefore, weight loss is animportant therapeutic strategy in all over-weight or obese individuals who havetype 2 diabetes or are at risk for develop-ing diabetes. The primary approach forachieving weight loss, in the vast majorityof cases, is therapeutic lifestyle change,which includes a reduction in energy in-take and an increase in physical activity. Amoderate decrease in caloric balance(500–1,000 kcal/day) will result in a slowbut progressive weight loss (1–2 lb/week). For most patients, weight loss di-ets should supply at least 1,000–1,200kcal/day for women and 1,200 –1,600kcal/day for men.

In selected patients, drug therapy toachieve weight loss as an adjunct to life-style change may be appropriate (38).However, it is important to note that re-gain of weight commonly occurs on dis-continuation of medication. In patientswith severe/morbid obesity, surgical op-tions, such as gastric bypass and gastro-plasty, may be appropriate and allowsignificant improvement in glycemic con-trol with reduction or discontinuation ofmedications (39). It is important to fullyevaluate the patient for existing or risk forCVD and improve glycemic control pre-operatively in order to decrease the risk ofcomplications. It is important to counselpatients on the risks of surgery, includingmortality, depression, hypoglycemia, nu-tritional deficiencies, osteoporosis, andweight regain over the long term. Very

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little data are currently available on thelong-term consequences of surgery forweight loss in people with diabetes. Thepotential benefits should be weighedagainst short- and long-term risks (40).

Physical activity is an important com-ponent of a comprehensive weight-managemen t p rog ram. Regu l a rmoderate-intensity physical activity en-hances long-term weight maintenance.Regular activity also improves insulinsensitivity, glycemic control, and selectedrisk factors for CVD (i.e., hypertensionand dyslipidemia), and increased aerobicfitness decreases the risk of coronary heartdisease (CHD). Initial physical activityrecommendations should be modest,based on the patient’s willingness andability, gradually increasing the durationand frequency to 30–45 min of moderateaerobic activity, 3–5 days/week, whenpossible. Greater activity levels of at least1 h/day of moderate (walking) or 30 min/day of vigorous (jogging) activity may beneeded to achieve successful long-termweight loss.

Dietary carbohydrate (36)Regulation of blood glucose to achievenear-normal levels is a primary goal in themanagement of diabetes, and thus, di-etary techniques that limit hyperglycemiafollowing a meal are important in limitingthe complications of diabetes. Both theamount (grams) and type of carbohydratein a food influence blood glucose level.The total amount of carbohydrate con-sumed is a strong predictor of glycemicresponse, and thus, monitoring totalgrams of carbohydrate, whether by use ofexchanges or carbohydrate counting, re-mains a key strategy in achieving glycemiccontrol. A recent analysis of the random-ized controlled trials that have examinedthe efficacy of the glycemic index (a mea-sure of the effect of type of carbohydrate)on overall blood glucose control indicatesthat the use of this technique may providean additional benefit over that observedwhen total carbohydrate is consideredalone.

Low-carbohydrate diets are not rec-ommended in the management of diabe-tes. Although dietary carbohydrate is themajor contributor to postprandial glucoseconcentration, it is an important source ofenergy, water-soluble vitamins and min-erals, and fiber. Thus, in agreement withthe National Academy of Sciences–Foodand Nutrition Board (41), a recom-mended range of carbohydrate intake is45–65% of total calories. In addition, be-

cause the brain and central nervous sys-tem have an absolute requirement forglucose as an energy source, restrictingtotal carbohydrate to �130 g/day is notrecommended.

Dietary proteinIn the U.S., mean protein intake fromfoods (not including supplements) ac-counts for 15–20% of average energy in-take, is fairly consistent across all agesfrom childhood to old age, and appears tobe similar in individuals with diabetes.The dietary reference intake (DRI)-acceptable macronutrient distributionrange for protein is 10–35% of energy in-take and the RDA is 0.8 g high-qualityprotein � kg body wt�1 � day�1 (41).

Dietary intake of protein is similar tothat of the general public in individualswith diabetes and usually does not exceed20% of energy intake. Intake of protein inthis range may be a risk factor for the de-velopment of diabetic nephropathy (42).Based on studies in patients with varyingstages of nephropathy (42–44), it seemsprudent to limit protein intake in thosewith diabetes to the RDA (0.8 g/kg),which would be �10% of total calories.

Dietary fatSaturated and trans fatty acids are theprincipal dietary determinant of plasmaLDL cholesterol, the major risk factor forCVD. In nondiabetic individuals, reduc-ing saturated and trans fatty acids andcholesterol intake decreases plasma totaland LDL cholesterol but may also reduceHDL cholesterol. Importantly, the ratio ofLDL to HDL cholesterol is not adverselyaffected. Studies in individuals with dia-betes demonstrating the effects of specificpercentages of dietary saturated and transfatty acids and specific amounts of dietarycholesterol on CVD risk are not available.However, those with diabetes are consid-ered to be at similar risk to those with apast history of CVD. Therefore, because ofa lack of specific information, the goal fordietary fat intake (amount and type) forindividuals with diabetes is the same asfor those without diabetes with a historyof CVD. The most recent guidelines fromthe National Cholesterol Education Pro-gram recommend that total fat be 25–35% of total calories and saturated fat�7% (34). Guidelines from the AmericanHeart Association also recommend thatsaturated fat be �7% in those with diabe-tes, given their increased risk of CVD(45,46). Intake of trans fat should beminimized.

Optimal macronutrient mixFor those individuals seeking guidanceregarding macronutrient distribution, theDRIs may be helpful The DRI report rec-ommends that to meet the body’s dailynutritional needs while minimizing riskfor chronic diseases, adults (in general,not specifically those with diabetes)should consume 45–65% of total energyfrom carbohydrate, 20 –35% from fat,and 10–35% from protein (41). Althoughnumerous studies have attempted toidentify the optimal combination of ma-cronutrients for those with diabetes, it is un-likely that any one such combination ofmacronutrients exists. The best mix of car-bohydrate, protein, and fat appears to varydepending on individual circumstances.

FiberSimilar to the general population, peoplewith diabetes are encouraged to choose avariety of fiber-containing foods, such aslegumes, fiber-rich cereals (�5 g fiber/serving), as well as fruits, vegetables, andwhole-grain products because they pro-vide vitamins, minerals, fiber, and othersubstances important for good health.

Reduced calorie sweetnersReduced calorie sweeteners approved bythe FDA include sugar alcohols (erythri-tol, hydrogenated starch hydrolysates,isomalt, lactitol, maltitol, mannitol, sorbi-tol, and xylitol) and tagatose. Studies us-ing subjects with and without diabeteshave shown that sugar alcohols produce alower postprandial glucose response thansucrose or glucose and have lower avail-able energy. Sugar alcohols contain, onaverage, �2 calories/gram (one-half thecalories of other sweeteners such as su-crose). With foods containing sugar alco-hols, subtraction of one-half of sugaralcohol grams from total carbohydrategrams is appropriate, particularly whenusing the carbohydrate counting methodfor meal planning. There is no evidencethat the amounts of sugar alcohol likely tobe consumed will result in significant re-duction in energy intake or long-term im-provement in glycemia. The use of sugaralcohols appears to be safe.

The FDA has approved five nonnutri-tive sweeteners for use in the U.S.: acesul-fame potassium, aspartame, neotame,saccharin, and sucralose. All have under-gone rigorous scrutiny and have beenshown to be safe when consumed by thepublic, including people with diabetesand women who are pregnant.

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AntioxidantsSince diabetes may be a state of increasedoxidative stress, there has been interest inprescribing antioxidant vitamins to indi-viduals with diabetes. While observa-tional studies have shown a correlationbetween dietary or supplemental con-sumption of antioxidants and a variety ofclinical outcomes such as prevention ofdisease states (35,47), large placebo-controlled clinical trials have failed toshow a benefit and, in some instances,have suggested adverse effects (35,47).

ChromiumSeveral small studies have suggested arole for chromium supplementation inthe management of glucose intolerance,body weight, GDM, and corticosteroid-induced diabetes (48–50). Also, placebo-controlled studies conducted in Chinafound that chromium supplementationhad beneficial effects on glycemia, al-though it is important to note that thestudy population in China may have hadmarginal baseline chromium status. A re-cent FDA statement indicated that there isinsufficient evidence to support any of theproposed health claims for chromiumsupplementation. The FDA concludedthat although a small study suggested thatchromium picolinate may reduce the riskof insulin resistance, the existence of a re-lationship between chromium picolinateand either insulin resistance or type 2 di-abetes was highly uncertain (see “chro-mium picolinate and insulin resistance” atwww.cfsan.fda.gov/�dms/qhccr.html).In addition, a meta-analysis of random-ized controlled trials suggested no benefitof chromium picolinate supplementationin reducing body weight (51).

AlcoholFor individuals with diabetes, the sameprecautions apply regarding the use of al-cohol that apply to the general popula-tion. If individuals choose to use alcohol,alcohol-containing beverages should belimited to a moderate amount (less thanone drink per day for adult women andless than two drinks per day for adult men).One alcohol containing beverage is definedas 12 oz beer, 5 oz wine, or 1.5 oz distilledspirits. Each contains �15 g alcohol.

E. DSME

Recommendations● People with diabetes should receive

DSME according to national standards

when their diabetes is diagnosed and asneeded thereafter. (B)

● DSME should be provided by healthcare providers who are qualified to pro-vide that DSME based on their profes-s ional tra ining and cont inuingeducation. (E)

● DSME should address psychosocial is-sues, since emotional well-being isstrongly associated with positive diabe-tes outcomes. (C)

● DSME should be reimbursed by third-party payors. (E)

DSME is an essential element of diabetescare (52–58), and National Standards forDSME are based on evidence for its ben-efits. Education helps people with diabe-tes initiate effective self-care when theyare first diagnosed. Ongoing DSME alsohelps people with diabetes maintain effec-tive self-management as their diabetespresents new challenges and treatmentadvances become available. DSME helpspatients optimize metabolic control, pre-vent and manage complications, andmaximize quality of life, in a cost-effectivemanner.

Evidence for the benefits of DSMESince the 1990s, there has been a shiftfrom a didactic approach with DSME fo-cusing on providing information to askill-based approach that focuses onhelping those with diabetes make in-formed self-management choices. Severalstudies have found that DSME is associ-ated with improved diabetes knowledge(53), improved self-care behavior (53),improved clinical outcomes such as lowerA1C (54,55,57,58), lower self-reportedweight (53), and improved quality of life(56). Better outcomes were reported forDSME that were longer and included fol-low-up support (53), were tailored to in-dividual needs and preferences (52), andaddressed psychosocial issues (52,53,57).

The national standards for DSMEADA-recognized DSME programs havestaff that includes at least a registerednurse and a registered dietitian; these staffmust be certified diabetes educators orhave recent experience in diabetes educa-tion and management. The curriculum ofADA-recognized DSME programs mustcover all areas of diabetes management,with the assessed needs of the individualdetermining which areas are addressed.All ADA-recognized DSME programs uti-lize a process of continuous quality im-

provement to evaluate the effectiveness ofthe DSME provided and to identify op-portunities for improvement.

Reimbursement for DSMEDSME is reimbursed as part of the Medi-care program as overseen by the Centerfor Medicare and Medicaid Services(CMS) (http://www.hcfa.gov/coverage).

F. Physical activity

Recommendations● To improve glycemic control, assist

with weight maintenance, and reducerisk of CVD, at least 150 min/week ofmoderate-intensity aerobic physical ac-tivity (50–70% of maximum heart rate)is recommended and/or at least 90 min/week of vigorous aerobic exercise(�70% of maximum heart rate). Thephysical activity should be distributedover at least 3 days/week and with nomore than 2 consecutive days withoutphysical activity. (A)

● In the absence of contraindications,people with type 2 diabetes should beencouraged to perform resistance exer-cise three times a week, targeting allmajor muscle groups, progressing tothree sets of 8 –10 repetitions at aweight that cannot be lifted more than8–10 times. (A)

Indications for graded exercise testwith electrocardiogram monitoring● A graded exercise test with electrocar-

diogram (ECG) monitoring should beseriously considered before undertak-ing aerobic physical activity with inten-sity exceeding the demands of everydayliving (more intense than brisk walk-ing) in previously sedentary diabetic in-dividuals whose 10-year risk of acoronary event is likely to be �10%.

ADA technical reviews on exercise in pa-tients with diabetes have summarized thevalue of exercise in the diabetes manage-ment plan (59,60). Regular exercise hasbeen shown to improve blood glucosecontrol, reduce cardiovascular risk fac-tors, contribute to weight loss, and im-prove well-being. Furthermore, regularexercise may prevent type 2 diabetes inhigh-risk individuals (8–10).

DefinitionsThe following definitions are based onthose outlined in “Physical Activity andHealth,” the 1996 report of the SurgeonGeneral (61). Physical activity is defined

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as bodily movement produced by thecontraction of skeletal muscle that re-quires energy expenditure in excess ofresting energy expenditure. Exercise is asubset of physical activity: planned, struc-tured, and repetitive bodily movementperformed to improve or maintain one ormore components of physical fitness. Aer-obic exercise consists of rhythmic, re-peated, and continuous movements of thesame large muscle groups for at least 10min at a time. Examples include walking,bicycling, jogging, swimming, water aer-obics, and many sports. Resistance exer-cise consists of activities that usemuscular strength to move a weight orwork against a resistive load. Examplesinclude weight lifting and exercises usingweight machines.

Effects of structured exerciseinterventions on glycemic controland body weight in type 2 diabetesBoule et al. (62) undertook a systematicreview and meta-analysis on the effects ofstructured exercise interventions in clini-cal trials of duration �8 weeks on HbA1cand body mass in people with type 2 di-abetes. Twelve aerobic training studiesand two resistance training studies wereincluded (totaling 504 subjects), and theresults were pooled using standard meta-analytic statistical methods. Postinterven-tion HbA1c was significantly lower inexercise than control groups. Metaregres-sion confirmed that the beneficial effect ofexercise on HbA1c was independent ofany effect on body weight. Therefore,structured exercise programs had a statis-tically and clinically significant beneficialeffect on glycemic control, and this effectwas not mediated primarily by weightloss.

Boule et al. (63) later undertook ameta-analysis of the interrelationshipsamong exercise intensity, exercise vol-ume, change in cardiorespiratory fitness,and change in HbA1c. This meta-analysisprovides support for higher-intensity aer-obic exercise in people with type 2 diabe-tes as a means of improving HbA1c. Theseresults would provide support for en-couraging type 2 diabetic individuals whoare already exercising at moderate inten-sity to consider increasing the intensity oftheir exercise in order to obtain additionalbenefits in both aerobic fitness and glyce-mic control.

Frequency of exerciseThe U.S. Surgeon General’s report (61)recommended that most people accumu-

late �30 min of moderate intensity activ-ity on most, ideally all, days of the week.The American College of Sports Medicinenow recommends resistance training beincluded in fitness programs for adultswith type 2 diabetes (64). Resistance ex-ercise improves insulin sensitivity toabout the same extent as aerobic exercise(65). Two clinical trials published in 2002provided strong evidence for the value ofresistance training in type 2 diabetes(66,67).

Evaluation of the diabetic patientbefore recommending an exerciseprogramBefore beginning a program of physicalactivity more vigorous than brisk walk-ing, people with diabetes should be as-sessed for conditions that might beassociated with increased likelihood ofCVD or that might contraindicate certaintypes of exercise or predispose to injury,such as uncontrolled hypertension, se-vere autonomic neuropathy, severe pe-ripheral neuropathy, and preproliferativeor proliferative retinopathy or macularedema. The patient’s age and previousphysical activity level should be consid-ered.

A recent systematic review for theU.S. Preventive Services Task Force cameto the conclusion that stress tests shouldusually not be recommended to detectischemia in asymptomatic individuals atlow CAD risk (�10% risk of a cardiacevent over 10 years) because the risks ofsubsequent invasive testing triggered byfalse-positive tests outweighed the ex-pected benefits from detection of previ-ously unsuspected ischemia (68,69)

Exercise in the presence ofnonoptimal glycemic controlHyperglycemia. When people with type1 diabetes are deprived of insulin for12–48 h and ketotic, exercise can worsenhyperglycemia and ketosis (70). Vigorousactivity should probably be avoided in thepresence of ketosis. Therefore, providedthe patient feels well and urine and/orblood ketones are negative, it is not nec-essary to postpone exercise based simplyon hyperglycemia.Hypoglycemia. In individuals taking in-sulin and/or insulin secretagogues, phys-ical activity can cause hypoglycemia ifmedication dose or carbohydrate con-sumption is not altered. Hypoglycemiawould be rare in diabetic individuals whoare not treated with insulin or insulinsecretagogues. Added carbohydrate

should be ingested if pre-exercise glucoselevels are �100 mg/dl (5.6 mmol/l) (71).We agree with this recommendation forindividuals on insulin and/or an insulinsecretagogue. However, the revisedguidelines clarify that supplementary car-bohydrate is generally not necessary forindividuals treated only with diet, met-formin, �-glucosidase inhibitors and/orTZDs without insulin or a secretagogue(72).

Exercise in the presence of specificlong-term complications of diabetesRetinopathy. In the presence of prolif-erative diabetic retinopathy (PDR) or se-vere nonproliferative diabetic retinopathy(NPDR), vigorous aerobic or resistanceexercise may be contraindicated becauseof the risk of triggering vitreous hemor-rhage or retinal detachment (73).Peripheral neuropathy. Decreased painsensation in the extremities would resultin increased risk of skin breakdown andinfection and of Charcot joint destruc-tion. Therefore, in the presence of severeperipheral neuropathy, it may be best toencourage non–weight-bearing activitiessuch as swimming, bicycling, or arm ex-ercises (74,75).Autonomic neuropathy. Autonomicneuropathy can increase the risk of exer-cise-induced injury by decreasing cardiacresponsiveness to exercise, postural hy-potension, impaired thermoregulationdue to impaired skin blood flow andsweating, impaired night vision due toimpaired papillary reaction, impairedthirst increasing risk of dehydration, andgastroparesis with unpredictable food de-livery (74). Autonomic neuropathy is alsostrongly associated with CVD in peoplewith diabetes (76,77). People with dia-betic autonomic neuropathy should defi-nitely undergo cardiac investigationbefore beginning physical activity moreintense than they are accustomed to.Microalbuminuria and nephropathy.Physical activity can acutely increase uri-nary protein excretion. There is no evi-dence from clinical trials or cohort studiesdemonstrating that vigorous exercise in-creases the rate of progression of diabetickidney disease. There may be no need forany specific exercise restrictions for peo-ple with diabetic kidney disease (78).

G. Psychosocial assessment and care

Recommendations● Preliminary assessment of psychologi-

cal and social status should be included

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as part of the medical management ofdiabetes. (E)

● Psychosocial screening should includebut is not limited to attitudes about theillness, expectations for medical man-agement and outcomes, affect/mood,general and diabetes-related quality oflife, resources (financial, social, andemotional), and psychiatric history. (E)

● Screening for psychosocial problemssuch as depression, eating disorders,and cognitive impairment is neededwhen adherence to the medical regi-men is poor. (E)

● It is preferable to incorporate psycho-logical treatment into routine carerather than wait for identification of aspecific problem or deterioration inpsychological status. (E)

Psychological and social state can impactthe patient’s ability to carry out diabetescare tasks (79–84). As a result, health sta-tus may be compromised. Family conflictaround diabetes care tasks is also com-mon and may interfere with treatmentoutcomes (85). There are opportunitiesfor the clinician to assess psychosocial sta-tus in a timely and efficient manner sothat referral for appropriate services canbe accomplished (86).

Key opportunities for screening ofpsychosocial status occur at diagnosis,during regularly scheduled managementvisits, during hospitalizations, at discov-ery of complications, or at the discretionof the clinician when problems in glucosecontrol, quality of life, or adherence areidentified (87). Patients are likely to ex-hibit psychological vulnerability at diag-nosis and when their medical statuschanges: the end of the honeymoon pe-riod, when the need for intensified treat-ment is evident and when complicationsare discovered (82,84).

Psychosocial screening should in-clude but is not limited to attitudes aboutthe illness, expectations for medical man-agement and outcomes, affect/mood, gen-eral and diabetes-related quality of life,resources (financial, social, and emo-tional) (83), and psychiatric history(84,87,88). Particular attention needs tobe paid to gross noncompliance withmedical regimen (due to self or others)(79,88), depression with the possibility ofself-harm (80,81), indications of an eat-ing disorder (89) or a problem that ap-pears to be organic in origin, andcognitive functioning that significantlyimpairs judgment (81). In these cases, im-mediate referral for further evaluation by

a mental health specialist familiar with di-abetes management should occur. Behav-ioral assessment of management skills isalso recommended.

It is preferable to incorporate psycho-logical treatment into routine care ratherthan waiting for identification of a specificproblem or deterioration in psychologicalstatus (86). Screening tools can facilitatethis goal, and although the clinician maynot feel qualified to treat psychologicalproblems, utilizing the patient-providerrelationship as a foundation for furthertreatment can increase the likelihood thatthe patient will accept referral for otherservices. It is important to establish thatemotional well-being is part of diabetesmanagement (87).

H. Referral for diabetes managementFor a variety of reasons, some people withdiabetes and their health care providersdo not achieve the desired goals of treat-ment (Table 6). Intensification of thetreatment regimen is suggested and in-cludes identification (or assessment) ofbarriers to adherence, culturally appro-priate and enhanced DSME, comanage-ment with a diabetes team, change inpharmacological therapy, initiation of orincrease in SMBG, more frequent contactwith the patient, and referral to an endo-crinologist.

I. Intercurrent illnessThe stress of illness, trauma, and/or sur-gery frequently aggravates glycemic con-trol and may precipitate diabeticketoacidosis (DKA) or nonketotic hyper-osmolar state. Any condition leading todeterioration in glycemic control necessi-tates more frequent monitoring of bloodglucose and urine or blood ketones. Avomiting illness accompanied by ketosismay indicate DKA, a life-threatening con-dition that requires immediate medicalcare to prevent complications and death;the possibility of DKA should always beconsidered (90). Marked hyperglycemiarequires temporary adjustment of thetreatment program and, if accompaniedby ketosis, frequent interaction with thediabetes care team. The patient treatedwith oral glucose-lowering agents orMNT alone may temporarily require insu-lin. Adequate fluid and caloric intakemust be assured. Infection or dehydrationis more likely to necessitate hospitaliza-tion of the person with diabetes than theperson without diabetes. The hospitalizedpatient should be treated by a physicianwith expertise in the management of dia-

betes, and recent studies suggest thatachieving very stringent glycemic controlmay reduce mortality in the immediatepostmyocardial infarction period (91).Aggressive glycemic management withinsulin may reduce morbidity in patientswith severe acute illness (92).

For further information on manage-ment of patients in the hospital with DKAor nonketotic hyperosmolar state, refer tothe ADA position statement (90).

J. Hypoglycemia

Recommendations● Glucose (15–20 g) is the preferred

treatment for hypoglycemia, althoughany form of carbohydrate that containsglucose may be used, and treatment ef-fects should be apparent in 15 min. (E)

● Treatment effects on hypoglycemiamay only be temporarily corrected.Therefore, plasma glucose should betested again in �15 min as additionaltreatment may be necessary. (B)

● Glucagon should be prescribed for allpatients at significant risk of severe hy-poglycemia and does not require ahealth care professional for its adminis-tration. (E)

Hypoglycemia, especially in insulin-treated patients, is the leading limitingfactor in the glycemic management oftype 1 and type 2 diabetes (93). Treat-ment of hypoglycemia (plasma glucose�70 mg/dl) requires ingestion of glucose-or carbohydrate-containing foods. Theacute glycemic response correlates betterwith the glucose content than with thecarbohydrate content of the food. Al-though pure glucose may be the preferredtreatment, any form of carbohydrate thatcontains glucose will raise blood glucose.Adding protein to carbohydrate does notaffect the glycemic response and does notprevent subsequent hypoglycemia. Add-ing fat, however, may retard and thenprolong the acute glycemic response (94).

Rare situations of severe hypoglyce-mia (where the individual requires the as-sistance of another person and cannot betreated with oral carbohydrate) should betreated using emergency glucagon kits,which require a prescription. Those inclose contact with, or having custodialcare of, people with diabetes, such as fam-ily members, roommates, school person-nel, child care providers, correctionalinstitution staff, and coworkers, shouldbe instructed in use of such kits. An indi-vidual does not need to be a health care

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professional to safely administer gluca-gon. Care should be taken to ensure thatunexpired glucagon kits are available.

K. Immunization

Recommendations● Annually provide an influenza vaccine

to all diabetic patients �6 months ofage. (C)

● Provide at least one lifetime pneumo-coccal vaccine for adults with diabetes.A one-time revaccination is recom-mended for individuals �64 years ofage previously immunized when theywere �65 years of age if the vaccine wasadministered �5 years ago. Other indi-cations for repeat vaccination includenephrotic syndrome, chronic renal dis-ease, and other immunocompromisedstates, such as after transplantation. (C)

Influenza and pneumonia are common,preventable infectious diseases associatedwith high mortality and morbidity in theelderly and in people with chronic dis-eases. There are limited studies reportingthe morbidity and mortality of influenzaand pneumococcal pneumonia specifi-cally in people with diabetes. Observa-tional studies of patients with a variety ofchronic illnesses, including diabetes,show that these conditions are associatedwith an increase in hospitalizations for in-fluenza and its complications. Based on acase-control series, influenza vaccine hasbeen shown to reduce diabetes-relatedhospital admission by as much as 79%during flu epidemics (95). People with di-abetes may be at increased risk of the bac-teremic form of pneumococcal infectionand have been reported to have a high riskof nosocomial bacteremia, which has amortality rate as high as 50%.

Safe and effective vaccines are avail-able that can greatly reduce the risk ofserious complications from these diseases(96,97). There is sufficient evidence tosupport that people with diabetes haveappropriate serologic and clinical re-sponses to these vaccinations. The Cen-ters for Disease Control’s AdvisoryCommittee on Immunization Practicesrecommends influenza and pneumococ-cal vaccines for all individuals �65 yearsof age, as well as for all individuals of anyage with diabetes.

For a complete discussion on the pre-vention of influenza and pneumococcaldisease in people with diabetes, consultthe technical review and position state-ment on this subject (98,99).

VI. PREVENTION ANDMANAGEMENT OFDIABETES COMPLICATIONS

A. CVDCVD is the major cause of mortality forindividuals with diabetes. It is also a ma-jor contributor to morbidity and directand indirect costs of diabetes. Type 2 di-abetes is an independent risk factor formacrovascular disease, and its commoncoexisting conditions (e.g., hypertensionand dyslipidemia) are also risk factors.

Studies have shown the efficacy of re-ducing cardiovascular risk factors in pre-venting or slowing CVD. Evidence issummarized in the following sections andreviewed in detail in the ADA technicalreviews on hypertension (100), dyslipide-mia (101), aspirin therapy (102), andsmoking cessation (103) and the consen-sus statement on CHD in people with di-abetes (104). Emphasis should be placedon reducing cardiovascular risk factors,when possible, and clinicians should bealert for signs and symptoms of athero-sclerosis.

1. Hypertension/blood pressurecontrol

Recommendations

Screening and diagnosis● Blood pressure should be measured at

every routine diabetes visit. Patientsfound to have systolic blood pressure�130 mmHg or diastolic blood pres-sure �80 mmHg should have bloodpressure confirmed on a separate day.(C)

Goals● Patients with diabetes should be treated

to a systolic blood pressure �130mmHg. (C)

● Patients with diabetes should be treatedto a diastolic blood pressure �80mmHg. (B)

Treatment● Patients with hypertension (systolic

blood pressure �140 or diastolic bloodpressure �90 mmHg) should receivedrug therapy in addition to lifestyle andbehavioral therapy. (A)

● Multiple drug therapy (two or moreagents at proper doses) is generally re-quired to achieve blood pressure tar-gets. (B)

● Patients with a systolic blood pressureof 130–139 mmHg or a diastolic blood

pressure of 80–89 mmHg should begiven lifestyle and behavioral therapyalone for a maximum of 3 months andthen, if targets are not achieved, in ad-dition, be treated with pharmacologicalagents that block the renin-angiotensinsystem. (E)

● Initial drug therapy for those with ablood pressure �140/90 mmHgshould be with a drug class demon-strated to reduce CVD events in pa-tients with diabetes (ACE inhibitors,ARBs, �-blockers, diuretics, and cal-cium channel blockers). (A)

● All patients with diabetes and hyper-tension should be treated with a regi-men that includes either an ACEinhibitor or an ARB. If one class is nottolerated, the other should be substi-tuted. If needed to achieve blood pres-sure targets, a thiazide diuretic shouldbe added. (E)

● If ACE inhibitors, ARBs, or diuretics areused, monitor renal function and se-rum potassium levels. (E)● In patients with type 1 diabetes, with

hypertension and any degree of albu-minuria, ACE inhibitors have beenshown to delay the progression of ne-phropathy. (A)

● In patients with type 2 diabetes, hy-pertension, and microalbuminuria,ACE inhibitors and ARBs have beenshown to delay the progression tomacroalbuminuria. (A)

● In those with type 2 diabetes, hyper-tension, macroalbuminuria, and re-nal insufficiency, ARBs have beenshown to delay the progression of ne-phropathy. (A)

● In pregnant patients with diabetes andchronic hypertension, blood pressuretarget goals of 110–129/65–79 mmHgare suggested in the interest of long-term maternal health and minimizingimpaired fetal growth. ACE inhibitorsand ARBs are contraindicated duringpregnancy. (E)

● In elderly hypertensive patients, bloodpressure should be lowered graduallyto avoid complications. (E)

● Patients not achieving target bloodpressure despite multiple drug therapyshould be referred to a physician expe-rienced in the care of patients with hy-pertension. (E)

● Orthostatic measurement of bloodpressure should be performed in peo-ple with diabetes and hypertensionwhen clinically indicated. (E)

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Hypertension (blood pressure �140/90mmHg) is a common comorbidity of dia-betes, affecting the majority of peoplewith diabetes, depending on type of dia-betes, age, obesity, and ethnicity. Hyper-tension is also a major risk factor for CVDand microvascular complications such asretinopathy and nephropathy. In type 1diabetes, hypertension is often the resultof underlying nephropathy. In type 2 di-abetes, hypertension may be present aspart of the metabolic syndrome (i.e., obe-sity, hyperglycemia and dyslipidemia)that is accompanied by high rates of CVD.

Randomized clinical trials have dem-onstrated the benefit (reduction of CHDevents, stroke, and nephropathy) of low-ering blood pressure to �140 mmHg sys-tolic and �80 mmHg diastolic inindividuals with diabetes (105–108). Ep-idemiologic analyses show that bloodpressures �115/75 mmHg are associatedwith increased cardiovascular event ratesand mortality in individuals with diabetes(105,109,110). Therefore, a target bloodpressure goal of �130/80 mmHg is rea-sonable if it can be safely achieved.

Although there are no well-controlledstudies of diet and exercise in the treat-ment of hypertension in individuals withdiabetes, reducing sodium intake andbody weight (when indicated), increasingconsumption of fruits, vegetables, andlow-fat dairy products, avoiding excessivealcohol consumption, and increasing ac-tivity levels have been shown to be effec-tive in reducing blood pressure innondiabetic individuals (111). Thesenonpharmacological strategies may alsopositively affect glycemia and lipid con-trol. Their effects on cardiovascularevents have not been well measured.

Lowering of blood pressure with reg-imens based on antihypertensive drugs,including ACE inhibitors, angiotensin re-ceptor blockers (ARBs), �-blockers, di-uretics, and calcium channel blockers,has been shown to be effective in loweringcardiovascular events. Several studiessuggest that ACE inhibitors may be supe-rior to dihydropyridine calcium channelblockers (DCCBs) in reducing cardiovas-cular events (112,113). Additionally, inpeople with diabetic nephropathy indi-cate that ARBs may be superior to DCCBsfor reducing heart failure but not overallcardiovascular events (114). Conversely,in the recently completed InternationalVerapamil Study (INVEST) of �22,000people with CAD and hypertension, thenon-DCCB verapamil demonstrated asimilar reduction in cardiovascular mor-

tality to a �-blocker. Moreover, this rela-tionship held true in the diabeticsubgroup (115).

ACE inhibitors have been shown toimprove cardiovascular outcomes inhigh–cardiovascular risk patients with orwithout hypertension (116,117). In pa-tients with congestive heart failure (CHF),the addition of ARBs to either ACE inhib-itors or other therapies reduces the risk ofcardiovascular death or hospitalizationfor heart failure (118–120). In one study,an ARB was superior to a �-blocker as atherapy to improve cardiovascular out-comes in a subset of diabetic patients withhypertension and left ventricular hyper-trophy (121). The compelling effect ofACE inhibitors or ARBs in patients withalbuminuria or renal insufficiency pro-vide additional rationale for use of theseagents (see section VI, B below).

The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart At-tack Trial (ALLHAT), a large randomizedtrial of different initial blood pressurepharmacological therapies, found nolarge differences between initial therapywith a chlorthalidone, amlodipine and lis-inopril. Diuretics appeared slightly moreeffective than other agents, particularlyfor reducing heart failure (122). The�-blocker arm of the ALLHAT was termi-nated after interim analysis showed thatdoxazosin was substantially less effectivein reducing CHF than diuretic therapy(123).

Before beginning treatment, patientswith elevated blood pressure should havetheir blood pressure reexamined within 1month to confirm the presence of hyper-tension. Systolic blood pressure �160mmHg or diastolic blood pressure �100mmHg, however, mandates that immedi-ate pharmacological therapy be initiated.Patients with hypertension should beseen as often as needed until the recom-mended blood pressure goal is obtainedand then seen as necessary (105). In thesepatients, other cardiovascular risk factors,including obesity, hyperlipidemia, smok-ing, presence of microalbuminuria (as-sessed before initiation of treatment), andglycemic control, should be carefully as-sessed and treated. Many patients will re-quire three or more drugs to reach targetgoals.

During pregnancy in diabetic womenwith chronic hypertension, target bloodpressure goals of systolic blood pressure110 –129 mmHg and diastolic bloodpressure 65–79 mmHg are reasonable, asthey may contribute to long-term mater-

nal health. Lower blood pressure levelsmay be associated with impaired fetalgrowth. During pregnancy treatmentwith ACE inhibitors and ARBs is contra-indicated, since they are likely to causefetal damage. Antihypertensive drugsknown to be effective and safe in preg-nancy include methyldopa, labetalol, dil-tiazem, clonidine, and prazosin. Chronicdiuretic use during pregnancy has beenassociated with restricted maternalplasma volume, which might reduceuteroplacental perfusion.

2. Dyslipidemia/lipid management

Recommendations

Screening● In adult patients, test for lipid disorders

at least annually and more often ifneeded to achieve goals. In adults withlow-risk lipid values (LDL �100 mg/dl,HDL �50 mg/dl, and triglycerides�150 mg/dl), lipid assessments may berepeated every 2 years. (E)

Treatment recommendations andgoals● Lifestyle modification focusing on the

reduction of saturated fat and choles-terol intake, weight loss (if indicated),and increased physical activity has beenshown to improve the lipid profile inpatients with diabetes. (A)

● In individuals without overt CVD● The primary goal is an LDL �100

mg/dl (2.6 mmol/l). (A)● For those over the age of 40 years,

statin therapy to achieve an LDL re-duction of 30 – 40% regardless ofbaseline LDL levels is recommended.(A)

● For those under the age of 40 yearsbut at increased risk due to other car-diovascular risk factors who do notachieve lipid goals with lifestyle mod-ifications alone, the addition of phar-macological therapy is appropriate. (C)

● In individuals with overt CVD● All patients should be treated with a

statin to achieve an LDL reduction of30–40%. (A)

● A lower LDL cholesterol goal of �70mg/dl (1.8 mmol/l), using a high doseof a statin, is an option. (B)

● Lower triglycerides to �150 mg/dl (1.7mmol/l) and raise HDL cholesterol to�40 mg/dl (1.15 mmol/l). In women,an HDL goal 10 mg/dl higher (�50 mg/dl) should be considered. (C)

● Lowering triglycerides and increasingHDL cholesterol with a fibrate is asso-

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ciated with a reduction in cardiovascu-lar events in patients with clinical CVD,low HDL, and near-normal levels ofLDL. (A)

● Combination therapy using statins andother lipid-lowering agents may be nec-essary to achieve lipid targets but hasnot been evaluated in outcomes studiesfor either CVD event reduction orsafety. (E)

● Statin therapy is contraindicated inpregnancy. (E)

Patients with type 2 diabetes have an in-creased prevalence of lipid abnormalitiesthat contributes to higher rates of CVD.Lipid management aimed at loweringLDL cholesterol, raising HDL cholesterol,and lowering triglycerides has beenshown to reduce macrovascular diseaseand mortality in patients with type 2 dia-betes, particularly in those who have hadprior cardiovascular events. In studies us-ing HMG (hydroxymethylglutaryl)-CoAreductase inhibitors (statins), patientswith diabetes achieved significant reduc-tions in coronary and cerebrovascularevents (124–127). In two studies usingthe fibric acid derivative gemfibrozil, re-ductions in cardiovascular end pointswere also achieved (128,129).

Target lipid levels are shown in Table6. Lifestyle intervention, including MNT,increased physical activity, weight loss,and smoking cessation, should allowsome patients to reach these lipid levels.Nutrition intervention should be tailoredaccording to each patient’s age, type ofdiabetes, pharmacological treatment,lipid levels, and other medical conditionsand should focus on the reduction of sat-urated fat, cholesterol, and transunsat-urated fat intake. Glycemic control canalso beneficially modify plasma lipid lev-els. Particularly in patients with very hightriglycerides and poor glycemic control,glucose lowering may be necessary tocontrol hypertriglyceridemia. Pharmaco-logical treatment is indicated if there is aninadequate response to lifestyle modifica-tions and improved glucose control.However, in patients with clinical CVDand LDL �100 mg/dl, pharmacologicaltherapy should be initiated at the sametime that lifestyle intervention is started.In patients with diabetes aged �40 years,similar consideration for LDL-loweringtherapy should be given if they have in-creased cardiovascular risk (e.g., addi-tional cardiovascular risk factors or longduration of diabetes). Very little clinicaltrial data exist in patients in this age-group.

The first priority of pharmacologicaltherapy is to lower LDL cholesterol to atarget goal of �100 mg/dl (2.60 mmol/l)or therapy to achieve a reduction in LDLof 30–40%. For LDL lowering, statins arethe drugs of choice. Other drugs thatlower LDL include nicotinic acid,ezetimbe, bile acid sequestrants, and fe-nofibrate (34,130).

The Heart Protection Study (127)demonstrated that in individuals with di-abetes over the age of 40 years with a totalcholesterol �135 mg/dl, LDL reductionof �30% from baseline with the statinsimvastatin was associated with an �25%reduction in the first event rate for majorcoronary artery events independent ofbaseline LDL, preexisting vascular dis-ease, type or duration of diabetes, or ade-quacy of glycemic control. Similarly, inthe Coronary Artery Diabetes Study(CARDS) (131), patients with type 2 dia-betes randomized to 10 mg atorvastatindaily had a significant reduction in car-diovascular events including stroke.

Recent clinical trials in high-risk pa-tients, such as those with acute coronarysyndromes or previous cardiovascularevents (132–134), have demonstratedthat more aggressive therapy with highdoses of statins to achieve an LDL of �70mg/dl led to a significant reduction in fur-ther events. The risk of side effects withhigh doses of statins is significantly out-weighed by the benefits of such therapy inthese high-risk patients. Therefore, a re-duction in LDL to a goal of �70 mg/dl isan option in very-high-risk patients withovert CVD (130). The combination of st-atins with other lipid-lowering drugssuch as ezetimibe may allow achievementof the LDL goal with a lower dose of astatin in such patients (135), but no dataare available as to whether such combina-tion therapy is more effective than a statinalone in preventing cardiovascularevents.

Relatively little data are available onlipid-lowering therapy in subjects withtype 1 diabetes. In the Heart ProtectionStudy, �600 patients with type 1 diabeteshad a proportionately similar, but not sta-tistically significant, reduction in riskcompared with patients with type 2 dia-betes. Although the data are not defini-tive, consideration should be given forsimilar lipid-lowering therapy in type 1diabetic patients as in type 2 diabetic pa-tients, particularly if they have other car-diovascular risk factors or features of themetabolic syndrome.

If the HDL is �40 mg/dl and the LDL

is between 100 and 129 mg/dl, a fibricacid derivative or niacin might be used.Niacin is the most effective drug for rais-ing HDL but can significantly increaseblood glucose at high doses. More recentstudies demonstrate that at modest doses(750–2,000 mg/day), significant benefitwith regards to LDL, HDL, and triglycer-ide levels are accompanied by only mod-est changes in glucose that are generallyamenable to adjustment of diabetes ther-apy (136,137).

Combination therapy, with a statinand a fibrate or statin and niacin, may beefficacious for patients needing treatmentfor all three lipid fractions, but this com-bination is associated with an increasedrisk for abnormal transaminase levels,myositis, or rhabdomyolysis. The risk ofrhabdomyolysis seems to be lower whenstatins are combined with fenofibratethan gemfibrozil. There is also a risk of arise in plasma creatinine, particularlywith fenofibrate. It is important to notethat clinical trials with fibrates and niacinhave demonstrated benefits in patientswho were not on treatment with statinsand that there are no data available onreduction of events with such combina-tions. The risks may be greater in patientswho are treated with combinations ofthese drugs with high doses of statins.

3. Antiplatelet agents

Recommendations● Use aspirin therapy (75–162 mg/day)

as a secondary prevention strategy inthose with diabetes with a history ofCVD. (A)

● Use aspirin therapy (75–162 mg/day)as a primary prevention strategy inthose with:● Type 2 diabetes at increased cardio-

vascular risk, including those whoare �40 years of age or who haveadditional risk factors (family historyof CVD, hypertension, smoking, dys-lipidemia, or albuminuria). (A)

● Type 1 diabetes at increased cardio-vascular risk, including those whoare �40 years of age or who have ad-ditional risk factors (family history ofCVD, hypertension, smoking, dyslip-idemia, or albuminuria). (C)

● Consider aspirin therapy in people be-tween the age of 30 and 40 years, par-ticularly in the presence of othercardiovascular risk factors. (E)

● Aspirin therapy should not be recom-mended for patients under the age of 21years because of the increased risk of

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Reye’s syndrome associated with aspi-rin use in this population. People �30years have not been studied. (E)

● Combination therapy using other anti-platelet agents such as clopidrogel inaddition to aspirin should be used inpatients with severe and progressiveCVD. (C)

● Other antiplatelet agents may be a rea-sonable alternative for high-risk pa-tients with aspirin allergy, bleedingtendency, receiving anticoagulant ther-apy, recent gastrointestinal bleeding,and clinically active hepatic diseasewho are not candidates for aspirin ther-apy. (E)

The use of aspirin in diabetes is reviewedin detail in the ADA technical review(102) and position statement (138) on as-pirin therapy. Aspirin has been recom-mended as a primary (139,140) andsecondary therapy to prevent cardiovas-cular events in diabetic and nondiabeticindividuals. One large meta-analysis andseveral clinical trials demonstrate the effi-cacy of using aspirin as a preventive mea-sure for cardiovascular events, includingstroke and myocardial infarction. Manytrials have shown an �30% decrease inmyocardial infarction and a 20% decreasein stroke in a wide range of patients, in-cluding young and middle-aged patients,patients with and without a history ofCVD, males and females, and patientswith hypertension.

Dosages used in most clinical trialsranged from 75 to 325 mg/day. There isno evidence to support any specific dose,but using the lowest possible dosage mayhelp reduce side effects. There is no evi-dence for a specific age at which to startaspirin, but at ages �30 years, aspirin hasnot been studied.

Clopidogrel has been demonstratedto reduce CVD rates in diabetic individu-als (141). Adjunctive therapy in very-high-risk patients or as alternativetherapy in aspirin-intolerant patientsshould be considered.

4. Smoking cessation

Recommendations● Advise all patients not to smoke. (A)● Include smoking cessation counseling

and other forms of treatment as a rou-tine component of diabetes care. (B)

Issues of smoking in diabetes are re-viewed in detail in the ADA technical re-view (103) and position statement (142)

on smoking cessation. A large body of ev-idence from epidemiological, case-control, and cohort studies providesconvincing documentation of the causallink between cigarette smoking andhealth risks. Cigarette smoking contrib-utes to one of every five deaths in the U.S.and is the most important modifiablecause of premature death. Much of theprior work documenting the impact ofsmoking on health did not separately dis-cuss results on subsets of individuals withdiabetes, suggesting that the identifiedrisks are at least equivalent to those foundin the general population. Other studiesof individuals with diabetes consistentlyfound a heightened risk of morbidity andpremature death associated with the de-velopment of macrovascular complica-tions among smokers. Smoking is alsorelated to the premature development ofmicrovascular complications of diabetesand may have a role in the development oftype 2 diabetes.

A number of large randomized clini-cal trials have demonstrated the efficacyand cost-effectiveness of counseling inchanging smoking behavior. Such stud-ies, combined with others specific to in-dividuals with diabetes, suggest thatsmoking cessation counseling is effectivein reducing tobacco use (143,144).

The routine and thorough assessmentof tobacco use is important as a means ofpreventing smoking or encouraging ces-sation. Special considerations should in-clude assessment of level of nicotinedependence, which is associated with dif-ficulty in quitting and relapse.

5. CHD screening and treatment

Recommendations● In patients �55 years of age, with or

without hypertension but with anothercardiovascular risk factor (history ofCVD, dyslipidemia, microalbuminuria,or smoking), an ACE inhibitor (if notcontraindicated) should be consideredto reduce the risk of cardiovascularevents. (A)

● In patients with a prior myocardial in-farction or in patients undergoing ma-jor surgery, �-blockers, in addition,should be considered to reduce mortal-ity. (A)

● In asymptomatic patients, consider arisk factor evaluation to stratify patientsby 10-year risk and treat risk factorsaccordingly. (B)

● In patients with treated CHF, met-formin use is contraindicated. The

TZDs are associated with fluid reten-tion, and their use can be complicatedby the development of CHF. Caution inprescribing TZDs in the setting ofknown CHF or other heart diseases, aswell as in patients with preexistingedema or concurrent insulin therapy, isrequired. (C)

CHD screening and treatment are re-viewed in detail in the ADA consensusstatement on CHD in people with diabe-tes (104). To identify the presence ofCHD in diabetic patients without clear orsuggestive symptoms of CAD, a risk fac-tor–based approach to the initial diagnos-tic evaluation and subsequent follow-upis recommended. However, a recentstudy concluded that using current guide-lines fails to detect a significant percent-age of patients with silent ischemia (76).

At least annually, cardiovascular riskfactors should be assessed. These risk fac-tors include dyslipidemia, hypertension,smoking, a positive family history of pre-mature coronary disease, and the pres-ence of micro- or macroalbuminuria.Abnormal risk factors should be treated asdescribed elsewhere in these guidelines.Patients at increased CHD risk should re-ceive aspirin and may warrant an ACEinhibitor.

Candidates for a diagnostic cardiacstress test include those with 1) typical oratypical cardiac symptoms and 2) an ab-normal resting ECG. The screening ofa symptoma t i c pa t i en t s r ema inscontroversial.

Studies have demonstrated that a sig-nificant percentage of patients with diabe-tes who have no symptoms of CAD haveabnormal stress tests, either by ECG orecho and nuclear perfusion imaging.Some of these patients, though clearly notall, have significant coronary stenoses ifthey proceed to angiography. It has alsobeen demonstrated that patients with si-lent myocardial ischemia have a poorerprognosis than those with normal stresstests. Their risk is further accentuated ifcardiac autonomic neuropathy coexists.Candidates for a screening cardiac stresstest include those with 1) a history of pe-ripheral or carotid occlusive disease and2) sedentary lifestyle, age �35 years, andplans to begin a vigorous exercise pro-gram. There are no data to suggest thatpatients who start to increase their phys-ical activity by walking or similar exerciseincrease their risk of a CVD event andtherefore are unlikely to need a stress test.

It has previously been proposed to

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screen those with two or more additionalcardiac risk factors. However, this likelyincludes the vast majority of patients withtype 2 diabetes (given that the risk factorsfrequently cluster). The Detection of Si-lent Myocardial Ischemia in Asymptom-atic Diabetic Subjects (DIAD) studysuggested that conventional cardiac riskfactors did not help to identify those pa-tients with abnormal perfusion imaging(76).

Current evidence suggests that non-invasive tests can improve assessment offuture CHD risk. There is, however, nocurrent evidence that such testing inasymptomatic patients with risk factorsimproves outcomes or leads to better uti-lization of treatments (69).

Approximately 1 in 5 will have an ab-normal test, and �1 in 15 will have a ma-jor abnormality. More information isneeded concerning prognosis, and thevalue of early intervention (invasive ornoninvasive) before widespread screen-ing is recommended. All patients irre-spective of their CAD status should haveaggressive risk factor modification, in-cluding control of glucose, lipids, andblood pressure and prophylactic aspirintherapy.

Patients with abnormal exercise ECGand patients unable to perform an exer-cise ECG require additional or alternativetesting. Currently, stress nuclear perfu-sion and stress echocardiography arevaluable next-level diagnostic proce-dures. A consultation with a cardiologist isrecommended regarding further work-up.

When identified, the optimal thera-peutic approach to the diabetic patientwith silent myocardial ischemia is un-known. Certainly if major CAD is identi-fied, aggressive intervention appearswarranted. If minor stenoses are detected,however, whether there is any benefit tofurther invasive evaluation and/or therapyis unknown. There are no well-conductedprospective trials with adequate controlgroups to shed light on this question. Ac-cordingly, there are no evidence-basedguidelines for screening the asymptom-atic diabetic patient for CAD.

B. Nephropathy screening andtreatment

Recommendations

General recommendations● To reduce the risk and/or slow the pro-

gression of nephropathy, optimize glu-cose control. (A)

● To reduce the risk and/or slow the pro-gression of nephropathy, optimizeblood pressure control. (A)

● To reduce the risk of nephropathy, pro-tein intake should be limited to theRDA (0.8 g/kg) in those with any degreeof CKD. (B)

Screening● Perform an annual test for the presence

of microalbuminuria in type 1 diabeticpatients with diabetes duration of �5years and in all type 2 diabetic patients,starting at diagnosis and during preg-nancy. (E)

● Serum creatinine should be measuredat least annually for the estimation ofglomerular filtration rate (GFR) in alladults with diabetes regardless of thedegree of urine albumin excretion. Theserum creatinine alone should not beused as a measure of kidney functionbut instead used to estimate GFR andstage the level of chronic kidney disease(CKD). (E)

Treatment● In the treatment of both micro- and

macroalbuminuria, either ACE inhibi-tors or ARBs should be used except dur-ing pregnancy. (A)

● While there are no adequate head-to-head comparisons of ACE inhibitorsand ARBs, there is clinical trial supportfor each of the following statements:● In patients with type 1 diabetes, with

hypertension and any degree of albu-minuria, ACE inhibitors have beenshown to delay the progression of ne-phropathy. (A)

● In patients with type 2 diabetes, hy-pertension, and microalbuminuria,ACE inhibitors and ARBs have beenshown to delay the progression tomacroalbuminuria. (A)

● In patients with type 2 diabetes, hy-pertension, macroalbuminuria, andrenal insufficiency (serum creatinine�1.5 mg/dl), ARBs have been shownto delay the progression of nephrop-athy. (A)

● If one class is not tolerated, the othershould be substituted. (E)

● With presence of nephropathy, initiateprotein restriction to �0.8 g � kg bodywt�1 � day�1 (�10% of daily calories),the current adult RDA for protein. Fur-ther restriction may be useful in slow-ing the decline of GFR in patientswhose nephropathy is progressing de-spite maximized glycemic and blood

pressure control and use of ACE inhib-itors and/or ARBs. (B)

● With regards to slowing the progres-sion of nephropathy, the use of DCCBsas initial therapy is not more effectivethan placebo. Their use in nephropathyshould be restricted to additional ther-apy to further lower blood pressure inpatients already treated with ACE in-hibitors or ARBs. (B)

● In the setting of albuminuria or ne-phropathy, in patients unable to toler-ate ACE inhibitors and/or ARBs,consider the use of non-DCCBs,�-blockers, or diuretics for the manage-ment of blood pressure. Use of non-DCCBs may reduce albuminuria indiabetic patients, including duringpregnancy. (E)

● If ACE inhibitors, ARBs, or diuretics areused, monitor serum potassium levelsfor the development of hyperkalemia.(B)

● Continued surveillance of microalbu-minuria/proteinuria to assess both re-sponse to therapy and progression ofdisease is recommended. (E)

● Consider referral to a physician experi-enced in the care of diabetic renal dis-ease when the estimated (GFR) hasfallen to �60 ml/min per 1.73 m2 or ifdifficulties occur in the management ofhypertension or hyperkalemia. (B)

Diabetic nephropathy occurs in 20–40%of patients with diabetes and is the singleleading cause of end-stage renal disease(ESRD). Persistent albuminuria in therange of 30–299 mg/24 h (microalbu-minuria) has been shown to be the earlieststage of diabetic nephropathy in type 1diabetes and a marker for development ofnephropathy in type 2 diabetes. Mi-croalbuminuria is also a well-establishedmarker of increased CVD risk (145,146).

Patients with microalbuminuria whoprogress to macroalbuminuria (�300mg/24 h) are likely to progress to ESRDover a period of years (147,148). Over thepast several years, a number of interven-tions have been demonstrated to reducethe risk and slow the progression of renaldisease.

Intensive diabetes management withthe goal of achieving near normoglycemiahas been shown in large prospective ran-domized studies to delay the onset of mi-croalbuminuria and the progression ofmicro- to macroalbuminuria in patientswith type 1 (149,150) and type 2 (26,27)diabetes. The UKPDS provided strong ev-idence that control of blood pressure can

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reduce the development of nephropathy(106). In addition, large prospective ran-domized studies in patients with type 1diabetes have demonstrated that achieve-ment of lower levels of systolic bloodpressure (�140 mmHg) achieved withtreatment using ACE inhibitors provides aselective benefit over other antihyperten-sive drug classes in delaying the progressionfrom micro- to macroalbuminuria and canslow the decline in GFR in patients withmacroalbuminuria (151–153).

In addition, ACE inhibitors have beenshown to reduce severe CVD (i.e., myo-cardial infarction, stroke, death), thus fur-ther supporting the use of these agents inpatients with microalbuminuria (116).ARBs have also been shown to reduce therate of progression from micro- to mac-roalbuminuria as well as ESRD in patientswith type 2 diabetes (154–156). Some ev-idence suggests that ARBs have a smallermagnitude of rise in potassium comparedwith ACE inhibitors in people with ne-phropathy (115). With regards to slowingthe progression of nephropathy, the useof DCCBs as initial therapy is not moreeffective than placebo. Their use in ne-phropathy should be restricted to addi-tional therapy to further lower bloodpressure in patients already treated withACE inhibitors or ARBs (114). In the set-ting of albuminuria or nephropathy, in pa-tients unable to tolerate ACE inhibitorsand/or ARBs, consider the use of non-DCCBs, �-blockers, or diuretics for themanagement of blood pressure (115,157).

Studies in patients with varying stagesof nephropathy have shown that proteinrestriction is of benefit in slowing the pro-gression of albuminuria, GFR decline,and occurrence of ESRD (42–44). Proteinrestriction should be considered particu-larly in patients whose nephropathyseems to be progressing despite optimalglucose and blood pressure control anduse of ACE inhibitor and/or ARBs (158).

Screening for microalbuminuria canbe performed by three methods: 1) mea-surement of the albumin-to-creatinine ra-tio in a random spot collection (preferredmethod); 2) 24-h collection with creati-nine, allowing the simultaneous measure-ment of creatinine clearance; and 3) timed(e.g., 4-h or overnight) collection.

The analysis of a spot sample for thealbumin-to-creatinine ratio is stronglyrecommended by most authorities(159,160). The other two alternatives(24-h collection and a timed specimen)are rarely necessary. Measurement of aspot urine for albumin only, whether by

immunoassay or by using a dipstick testspecific for microalbumin, without simul-taneously measuring urine creatinine, isless expensive than the recommendedmethods but is susceptible to false-negative and -positive determinations as aresult of variation in urine concentrationdue to hydration and other factors.

At least two of three tests measuredwithin a 6-month period should show ele-vated levels before a patient is designated ashaving microalbuminuria. Abnormalities ofalbumin excretion are defined in Table 8.

Screening for microalbuminuria is in-dicated in pregnancies complicated by di-abetes, since microalbuminuria in theabsence of urinary tract infection is astrong predictor of superimposed pre-eclampsia. In the presence of macroalbu-minuria or urine dipstick proteinuria,estimation of GFR by serum creatinine(see below) or 24-h urine creatinine clear-ance is indicated to stage the patient’s re-nal disease, and other tests may benecessary to diagnose preeclampsia.

Information on presence of urine al-bumin excretion in addition to level ofGFR may be used to stage CKD accordingto the National Kidney Foundation. The

current National Kidney Foundation clas-sification (Table 9) is primarily based onGFR levels and therefore differs fromsome earlier staging systems used by oth-ers, in which staging is based primarily onurinary albumin excretion (161). Studieshave found decreased GFR in the absenceof increase urine albumin excretion in asubstantial percentage of adults with dia-betes (162,163). Thus, these studies dem-onstrate that significant decline in GFRmay be noted in adults with type 1 andtype 2 diabetes in the absence of increasedurine albumin excretion. It is now clear thatstage 3 or high CKD (GFR �60 ml/min per1.73 m2) occurs in the absence of urine al-bumin excretion in a substantial proportionof adults with diabetes. Screening this pop-ulation for increased urine albumin ex-cretion alone, therefore, will miss aconsiderable number of CKD cases (161).

Serum creatinine should be measuredat least annually for the estimation of GFRin all adults with diabetes regardless of thedegree of urine albumin excretion. Serumcreatinine alone should not be used as ameasure of kidney function, but used toestimate GFR and stage the level of CKD.The GFR can be easily estimated usingformulae like the Cockroft-Gault formulaor a newer prediction formula developedby Levy et al. (164) using data collectedfrom the Modification of Diet and RenalDisease (MDRD) study. The estimatedGFR can easily be calculated by going tohttp://www.kidney.org/professionals/kdoqi/gfr_calculator.cfm.

The role of annual microalbumuriaassessment is less clear after diagnosis ofmicroalbuminuria and institution of ACEinhibitor or ARB therapy and blood pres-sure control. Most experts, however, rec-ommend continued surveillance to assessboth response to therapy and progressionof disease. Some experts suggest that re-ducing urine microalbuminuria to thenormal or near-normal range, if possible,may improve renal and cardiovascular

Table 8—Definitions of abnormalities in al-bumin excretion

Category

Spotcollection(�g/mg

creatinine)

Normal �30Microalbuminuria 30–299Macro (clinical)-albuminuria �300

Because of variability in urinary albumin excretion,two of three specimens collected within a 3- to6-month period should be abnormal before consid-ering a patient to have crossed one of these diagnos-tic thresholds. Exercise within 24 h, infection, fever,CHF, marked hyperglycemia, and marked hyper-tension may elevate urinary albumin excretion overbaseline values.

Table 9—Stages of CKD

Stage DescriptionGFR (ml/min per 1.73 m2

body surface area)

1 Kidney damage* with normal or increased GFR �902 Kidney damage* with mildly decreased GFR 60–893 Moderately decreased GFR 30–594 Severely decreased GFR 15–295 Kidney failure �15 or dialysis

*Kidney damage defined as abnormalities on pathologic, urine, blood, or imaging tests. Adapted from ref.167.

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prognosis. This approach has not beenformally evaluated in prospective trials.

Consider referral to a physician expe-rienced in the care of diabetic renal dis-ease either when the GFR has fallen to�60 ml/min per 1.73 m2 or if difficultiesoccur in the management of hypertensionor hyperkalemia. It is suggested that con-sultation with a nephrologist be obtainedwhen the GFR is �30 ml/min per 1.73m2. Early referral of such patients hasbeen found to reduce cost and improvequality of care and keep people off dialysislonger (165,166).

Because of variability in urinary albu-min excretion, two of three specimenscollected within a 3- to 6-month periodshould be abnormal before considering apatient to have crossed one of these diag-nostic thresholds. Exercise within 24 h,infection, fever, CHF, marked hypergly-cemia, and marked hypertension may el-evate urinary albumin excretion overbaseline values.

C. Retinopathy screening andtreatment

Recommendations

General recommendations● Optimal glycemic control can substan-

tially reduce the risk and progression ofdiabetic retinopathy. (A)

● Optimal blood pressure control can re-duce the risk and progression of dia-betic retinopathy. (A)

● Aspirin therapy does not prevent reti-nopathy or increase the risks of hemor-rhage. (A)

Screening● Adults and adolescents with type 1 di-

abetes should have an initial dilatedand comprehensive eye examination byan ophthalmologist or optometristwithin 3–5 years after the onset of dia-betes. (B)

● Patients with type 2 diabetes shouldhave an initial dilated and comprehen-sive eye examination by an ophthalmol-ogist or optometrist shortly after thediagnosis of diabetes. (B)

● Subsequent examinations for type 1and type 2 diabetic patients should berepeated annually by an ophthalmolo-gist or optometrist. Less frequent exams(every 2–3 years) may be considered inthe setting of a normal eye exam. Exami-nations will be required more frequentlyif retinopathy is progressing. (B)

● Women who are planning pregnancyor who have become pregnant should

have a comprehensive eye examinationand should be counseled on the risk ofdevelopment and/or progression of di-abetic retinopathy. Eye examinationshould occur in the first trimester withclose follow-up throughout pregnancyand for 1 year postpartum. This guide-line does not apply to women who de-velop GDM because such individualsare not at increased risk for diabetic ret-inopathy. (B)

Treatment● Laser therapy can reduce the risk of vi-

sion loss in patients with high-riskcharacteristics (HRCs). (A)

● Promptly refer patients with any level ofmacular edema, severe NPDR, or anyPDR to an ophthalmologist who isknowledgeable and experienced in themanagement and treatment of diabeticretinopathy. (A)

Diabetic retinopathy is a highly specificvascular complication of both type 1 andtype 2 diabetes. The prevalence of reti-nopathy is strongly related to the durationof diabetes. Diabetic retinopathy is esti-mated to be the most frequent cause ofnew cases of blindness among adults aged20–74 years. Glaucoma, cataracts, andother disorders of the eye may occur ear-lier in people with diabetes and shouldalso be evaluated.

Intensive diabetes management withthe goal of achieving near normoglycemiahas been shown in large prospective ran-domized studies to prevent and/or delaythe onset of diabetic retinopathy (25–27).In addition to glycemic control, severalother factors seem to increase the risk ofretinopathy. The presence of nephropa-thy is associated with retinopathy. Highblood pressure is an established risk fac-tor for the development of macular edemaand is associated with the presence ofPDR. Lowering blood pressure, as dem-onstrated by the UKPDS, has been shownto decrease the progression of retinopathy.Several case series and a controlled prospec-tive study suggest that pregnancy in type 1diabetic patients may aggravate retinopathy(168). During pregnancy and 1 year post-partum, retinopathy may be transiently ag-gravated; laser photocoagulation surgerycan minimize this risk (168a).

Patients with type 1 diabetes shouldhave an initial dilated and comprehensiveeye examination by an ophthalmologist oroptometrist within 5 years after the onsetof diabetes. Patients with type 2 diabetesshould have an initial dilated and com-

prehensive eye examination by an oph-thalmologist or optometrist shortly afterthe diagnosis of diabetes. Subsequent ex-aminations for type 1 and type 2 diabeticpatients should be repeated annually byan ophthalmologist or optometrist who isknowledgeable and experienced in diag-nosing the presence of diabetic retinopa-thy and is aware of its management. Lessfrequent exams (every 2–3 years) may beconsidered with the advice of an eye careprofessional in the setting of a normal eyeexam (169–171). Examinations will berequired more frequently if retinopathy isprogressing.

Examinations can also be done by thetaking of retinal photographs (with orwithout dilation of the pupil) and havingthese read by experienced experts in thisfield. In-person exams are still necessarywhen the photos are unacceptable and forfollow up of abnormalities detected. Thistechnology has it greatest potential inareas where qualified eye care profession-als are not available. Results of eye exam-inations should be documented andtransmitted to the referring health careprofessional.

One of the main motivations forscreening for diabetic retinopathy is the es-tablished efficacy of laser photocoagulationsurgery in preventing visual loss. Two largeNational Institutes of Health–sponsored tri-als, the Diabetic Retinopathy Study (DRS)and the Early Treatment Diabetic Retinop-athy Study (ETDRS), provide the strongestsupport for the therapeutic benefit of pho-tocoagulation surgery.

The DRS tested whether scatter (pan-retinal) photocoagulation surgery couldreduce the risk of vision loss from PDR.Severe visual loss (i.e., best acuity of5/200 or worse) was seen in 15.9% of un-treated vs. 6.4% of treated eyes. The ben-efit was greatest among patients whosebaseline evaluation revealed HRCs(chiefly disc neovascularization or vitre-ous hemorrhage with any retinal neovas-cularization). Of control eyes with HRCs,26% progressed to severe visual loss vs.11% of treated eyes. Given the risk of amodest loss of visual acuity and of con-traction of visual field from panretinal la-ser surgery, such therapy has beenprimarily recommended for eyes ap-proaching or reaching HRCs.

The ETDRS established the benefit offocal laser photocoagulation surgery ineyes with macular edema, particularlythose with clinically significant macularedema. In patients with clinically signifi-cant macular edema after 2 years, 20% of

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untreated eyes had a doubling of the vi-sual angle (e.g., 20/50 to 20/100) com-pared with 8% of treated eyes. Otherresults from the ETDRS indicate that, pro-vided careful follow-up can be main-tained, scatter photocoagulation surgeryis not recommended for eyes with mild ormoderate NPDR. When retinopathy ismore severe, scatter photocoagulationsurgery should be considered, and usu-ally should not be delayed, if the eye hasreached the high-risk proliferative stage.In older-onset patients with severe NPDRor less-than-high-risk PDR, the risk of se-vere visual loss and vitrectomy is reduced�50% by laser photocoagulation surgeryat these earlier stages.

Laser photocoagulation surgery inboth the DRS and the ETDRS was beneficialin reducing the risk of further visual loss,but generally not beneficial in reversing al-ready diminished acuity. This preventive ef-fect and the fact that patients with PDR ormacular edema may be asymptomatic pro-vide strong support for a screening programto detect diabetic retinopathy.

For a detailed review of the evidenceand further discussion, see the ADA’stechnical review and position statementon this subject (172,173).

D. Neuropathy screening andtreatment (174,175)

Recommendations● All patients should be screened for dis-

tal symmetric polyneuropathy (DPN) atdiagnosis and at least annually thereaf-ter, using simple clinical tests. (A)

● Electrophysiological testing is rarelyever needed, except in situations wherethe clinical features are atypical. (E)

● Once the diagnosis of DPN is estab-lished, special foot care is appropriatefor insensate feet to decrease the risk ofamputation. (B)

● Simple inspection of insensate feetshould be performed at 3- to 6-monthintervals. An abnormality should trig-ger referral for special footwear, pre-ventive specialist, or podiatric care. (B)

● Screening for autonomic neuropathyshould be instituted at diagnosis of type2 diabetes and 5 years after the diagno-sis of type 1 diabetes. Special electro-physiological testing for autonomicneuropathy is rarely needed and maynot affect management and outcomes.(E)

● Education of patients about self-care ofthe feet and referral for special shoes/

inserts are vital components of patientmanagement. (B)

● A wide variety of medications is recom-mended for the relief of specific symp-toms related to autonomic neuropathyand are recommended, as they improvethe quality of life of the patient. (E)

The diabetic neuropathies are heteroge-neous with diverse clinical manifesta-tions. They may be focal or diffuse. Mostcommon among the neuropathies arechronic sensorimotor DPN and auto-nomic neuropathy. Although DPN is adiagnosis of exclusion, complex investi-gations to exclude other conditions arerarely needed.

The early recognition and appropri-ate management of neuropathy in the pa-tient with diabetes is important for anumber of reasons: 1) nondiabetic neu-ropathies may be present in patients withdiabetes and may be treatable; 2) a num-ber of treatment options exist for symp-tomatic diabetic neuropathy; 3) up to50% of DPN may be asymptomatic andpatients are at risk of insensate injury totheir feet; 4) autonomic neuropathy mayinvolve every system in the body; and 5)cardiovascular autonomic neuropathycauses substantial morbidity and mortal-ity. Specific treatment for the underlyingnerve damage is currently not available,other than improved glycemic control,which may slow progression but rarelyreverses neuronal loss. Effective symp-tomatic treatments are available for themanifestations of DPN and autonomicneuropathy.

Diagnosis of neuropathyPatients with diabetes should be screenedannually for DPN using tests such as pin-prick sensation, temperature and vibra-tion perception (using a 128-Hz tuningfork), 10-g monofilament pressure sensa-tion at the dorsal surface of both greattoes, just proximal to the nail bed, andankle reflexes. Combinations of morethan one test have �87% sensitivity indetecting DPN. Loss of 10-g monofila-ment perception and reduced vibrationperception predict foot ulcers. A mini-mum of one clinical test should be carriedout annually, and the use of two tests willincrease diagnostic ability.

Focal and multifocal neuropathy as-sessment requires clinical examinationin the area related to the neurologicalsymptoms.

Diabetic autonomic neuropathy(176)The symptoms of autonomic dysfunctionshould be elicited carefully during thehistory and review of systems, particu-larly since many of these symptoms arepotentially treatable. Major clinical man-ifestations of diabetic autonomic neurop-athy include resting tachycardia, exerciseintolerance, orthostatic hypotension,constipation, gastroparesis, erectile dys-function, sudomotor dysfunction, im-paired neurovascular function, “brittlediabetes,” and hypoglycemic autonomicfailure.

Cardiovascular autonomic neuropa-thy is the most studied and clinically im-portant form of diabetic autonomicneuropathy. Cardiac autonomic neurop-athy may be indicated by resting tachycar-dia (�100 bpm), orthostasis (a fall insystolic blood pressure �20 mmHg uponstanding), or other disturbances in auto-nomic nervous system function involvingthe skin, pupils, or gastrointestinal andgenitourinary systems.

Gastrointestinal disturbances (e.g.,esophageal enteropathy, gastroparesis,constipation, diarrhea, fecal inconti-nence) are common, and any section ofthe gastrointestinal tract may be affected.Gastroparesis should be suspected in in-dividuals with erratic glucose control.Upper gastrointestinal symptoms shouldlead to consideration of all possiblecauses, including autonomic dysfunction.Evaluation of solid-phase gastric empty-ing using double-isotope scintigraphymay be done if symptoms are suggestive,but test results often correlate poorly withsymptoms. Barium studies or referral forendoscopy may be required to rule outstructural abnormalities. Constipation isthe most common lower gastrointestinalsymptom but can alternate with episodesof diarrhea. Endoscopy may be requiredto rule out other causes.

Diabetic autonomic neuropathy isalso associated with genitourinary tractdisturbances, including bladder and/orsexual dysfunction. Evaluation of bladderdysfunction should be performed forindividuals with diabetes who have recur-rent urinary tract infections, pyelonephri-tis, incontinence, or a palpable bladder.In men, diabetic autonomic neuropathymay cause loss of penile erection and/orretrograde ejaculation.

Symptomatic treatmentsDPN. The first step in management ofpatients with DPN should be to aim for

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stable and optimal glycemic control. Al-though controlled trial evidence is lack-ing, several observational studies suggestthat neuropathic symptoms improve notonly with optimization of control but alsowith the avoidance of extreme blood glu-cose fluctuations. Most patients will re-quire pharmacological treatment forpainful symptoms: many agents have ef-ficacy confirmed in published random-ized controlled trials, though none arespecifically licensed for the managementof painful DPN.Tricyclic drugs. The usefulness of thetricyclic drugs such as amitriptyline andimipramine has been confirmed in severalrandomized controlled trials, althoughthey do not have formal FDA approval forthis condition. Although cheap and gen-erally efficacious in the management ofneuropathic pain, side effects limit theiruse in many patients. Tricylcic drugs mayalso exacerbate some autonomic symp-toms such as gastroparesis.Anticonvulsants. Gabapentin is a com-monly prescribed anticonvulsant that hasbeen shown to be efficacious in the treat-ment of neuropathic pain, although notapproved for this condition. It is advisableto start at a small dose and then increaseover days to weeks to the dosage that iswell tolerated and produces symptomaticrelief. The structurally related compoundpregabalin is longer acting, has recentlybeen confirmed to be useful in painful di-abetic neuropathy in a randomized con-trolled trial, and is approved for use inthis condition. Other anticonvulsantdrugs may also be efficacious in the man-agement of neuropathic pain.Other agents. The 5-hydroxytrypta-mine and norepinephrine reuptake inhib-itor duloxetine has been approved by theFDA for the treatment of neuropathicpain.

Treatment of autonomic neuropathyA wide variety of agents are used to treatthe symptoms of autonomic neuropathyincluding metoclopramide for gastropa-resis and several medications for bladderand erectile dysfunction. These treat-ments are frequently used to providesymptomatic relief to patients. Althoughthey do not change the underlying pathol-ogy and natural history of the disease pro-cess, their use is recommended due to theimpact they may have on the quality of lifeof the patient.

E. Foot care

Recommendations● Perform a comprehensive foot exami-

nation and provide foot self care educa-tion annually on patients with diabetesto identify risk factors predictive of ul-cers and amputations. (B)

● The foot examination can be accom-plished in a primary care setting andshould include the use of a monofila-ment, tuning fork, palpation, and a vi-sual examination. (B)

● A multidisciplinary approach is recom-mended for individuals with foot ulcersand high-risk feet, especially those witha history of prior ulcer or amputation.(B)

● Refer patients who smoke or with priorlower-extremity complications to footcare specialists for ongoing preventivecare and life-long surveillance. (C)

● Initial screening for peripheral arterialdisease (PAD) should include a historyfor claudication and an assessment ofthe pedal pulses. Consider obtaining anankle-brachial index (ABI), as many pa-tients with PAD are asymptomatic. (C)

● Refer patients with significant claudica-tion or a positive ABI for further vascu-lar assessment and consider exercise,medications, and surgical options. (C)

Amputation and foot ulceration are themost common consequences of diabeticneuropathy and major causes of morbid-ity and disability in people with diabetes.Early recognition and management of in-dependent risk factors can prevent or de-lay adverse outcomes.

The risk of ulcers or amputations isincreased in people who have had diabe-tes �10 years, are male, have poor glu-cose control, or have cardiovascular,retinal, or renal complications. The fol-lowing foot-related risk conditions are as-sociated with an increased risk ofamputation:

● Peripheral neuropathy with loss of pro-tective sensation.

● Altered biomechanics (in the presenceof neuropathy).

● Evidence of increased pressure (ery-thema, hemorrhage under a callus).

● Bony deformity.● Peripheral vascular disease (decreased

or absent pedal pulses).● A history of ulcers or amputation.● Severe nail pathology.

All individuals with diabetes should re-ceive an annual foot examination to iden-

tify high-risk foot conditions. Thisexamination should include assessmentof protective sensation, foot structure andbiomechanics, vascular status, and skinintegrity. People with one or more high-risk foot condition should be evaluatedmore frequently for the development ofadditional risk factors. People with neu-ropathy should have a visual inspection oftheir feet at every visit with a health careprofessional. Evaluation of neurologicalstatus in the low-risk foot should includea quantitative somatosensory thresholdtest, using the Semmes-Weinstein 5.07(10-g) monofilament. The skin should beassessed for integrity, especially betweenthe toes and under the metatarsal heads.The presence of erythema, warmth, orcallus formation may indicate areas of tis-sue damage with impending breakdown.Bony deformities, limitation in joint mo-bility, and problems with gait and balanceshould be assessed.

People with neuropathy or evidenceof increased plantar pressure may be ad-equately managed with well-fitted walk-ing shoes or athletic shoes. Patientsshould be educated on the implications ofsensory loss and the ways to substituteother sensory modalities (hand palpation,visual inspection) for surveillance of earlyproblems. People with evidence of in-creased plantar pressure (e.g., erythema,warmth, callus, or measured pressure)should use footwear that cushions and re-distributes the pressure. Callus can be de-brided with a scalpel by a foot carespecialist or other health professionalwith experience and training in foot care.People with bony deformities (e.g., ham-mertoes, prominent metatarsal heads, orbunions) may need extra-wide shoes ordepth shoes. People with extreme bonydeformities (e.g., Charcot foot) that can-not be accommodated with commercialtherapeutic footwear may need custom-molded shoes.

Initial screening for PAD should in-clude a history for claudication and anassessment of the pedal pulses. Considerobtaining an ABI, as many patients withPAD are asymptomatic. Refer patientswith significant or a positive ABI for fur-ther vascular assessment and consider ex-ercise, medications, and surgical options(176a).

Patients with diabetes and high-riskfoot conditions should be educated re-garding their risk factors and appropriatemanagement. Patients at risk should un-derstand the implications of the loss ofprotective sensation, the importance of

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foot monitoring on a daily basis, theproper care of the foot, including nail andskin care, and the selection of appropriatefootwear. The patient’s understanding ofthese issues and their physical ability toconduct proper foot surveillance and careshould be assessed. Patients with visualdifficulties, physical constraints prevent-ing movement, or cognitive problems thatimpair their ability to assess the conditionof the foot and to institute appropriateresponses will need other people, such asfamily members, to assist in their care.Patients at low risk may benefit from ed-ucation on foot care and footwear.

For a detailed review of the evidenceand further discussion, see the ADA’stechnical review and position statementin this subject (176b,176c).

Problems involving the feet, espe-cially ulcers and wound care, may requirecare by a podiatrist, orthopedic surgeon,or rehabilitation specialist experienced inthe management of individuals with dia-betes. For a complete discussion onwound care, see the ADA’s consensusstatement on diabetic foot wound care(176d).

VII. DIABETES CARE INSPECIFIC POPULATIONS

A. Children and adolescents

1. Type 1 diabetesAlthough approximately three-quartersof all cases of type 1 diabetes are diag-nosed in individuals �18 years of age,historically, ADA recommendations formanagement of type 1 diabetes have per-tained most directly to adults with type 1diabetes. Because children are not simply“small adults,” it is appropriate to con-sider the unique aspects of care and man-agement of children and adolescents withtype 1 diabetes. Children with diabetesdiffer from adults in many respects, in-cluding insulin sensitivity related to sex-ual maturity, physical growth, ability toprovide self-care, and unique neurologicvulnerability to hypoglycemia. Attentionto such issues as family dynamics, devel-opmental stages, and physiologic differ-ences related to sexual maturity all areessential in developing and implementingan optimal diabetes regimen. Althoughcurrent recommendations for childrenand adolescents are less likely to be basedon evidence derived from rigorous re-search because of current and historicalrestraints placed on conducting researchin children, expert opinion and a review

of available and relevant experimentaldata are summarized in a recent ADAStatement (177). The following repre-sents a summary of recommendationsand guidelines pertaining specifically tothe care and management of children andadolescents that are included in thatdocument.

Ideally, the care of a child or adoles-cent with type 1 diabetes should be pro-vided by a multidisciplinary team ofspecialists trained in the care of childrenwith pediatric diabetes, although this maynot always be possible. At the very least,education of the child and family shouldbe provided by health care providerstrained and experienced in childhood di-abetes and sensitive to the challengesposed by diabetes in this age-group. Atthe time of initial diagnosis, it is essentialthat diabetes education be provided in atimely fashion, with the expectation thatthe balance between adult supervisionand self-care should be defined by, andwill evolve according to, physical, psy-chologic, and emotional maturity. MNTshould be provided at diagnosis, and atleast annually thereafter, by an individualexperienced with the nutritional needs ofthe growing child and the behavioral is-sues that have an impact on adolescentdiets.a. Glycemic control. While currentstandards for diabetes management re-flect the need to maintain glucose controlas near to normal as safely possible, spe-cial consideration must be given to theunique risks of hypoglycemia in youngchildren. Glycemic goals need to be mod-ified to take into account the fact thatmost children �6 or 7 years of age have aform of “hypoglycemic unawareness,” inthat counterregulatory mechanisms areimmature, and young children lack thecognitive capacity to recognize and re-spond to hypoglycemic symptoms, plac-ing them at greater risk for hypoglycemiaand its sequelae. In addition, extensiveevidence indicates that near normaliza-tion of blood glucose levels is seldom at-tainable in children and adolescents afterthe honeymoon (remission) period. TheA1C level achieved in the “intensive” ad-olescent cohort of the DCCT group was�1% higher than that achieved for olderpatients and current ADA recommenda-tions for patients in general (178).

In selecting glycemic goals, the bene-fits of achieving a lower A1C must beweighed against the unique risks of hypo-glycemia and the disadvantages of target-ing a higher, although more achievable,

goal that may not promote optimal long-term health outcomes. Age-specific glyce-mic and A1C goals are presented in Table10.b. Screening and management of chroniccomplications in children and adoles-cents with type 1 diabetes.i. Nephropathy

Recommendations● Annual screening for microalbumin-

uria should be initiated once the child is10 years of age and has had diabetes for5 years. Screening may be done with arandom spot urine sample analyzed formicroalbumin-to-creatinine ratio. (E)

● Confirmed, persistently elevated mi-croalbumin levels should be treatedwith an ACE inhibitor, titrated to nor-malization of microalbumin excretion(if possible). (E)

ii. Hypertension

Recommendations● Treatment of high-normal blood pres-

sure (systolic or diastolic blood pres-sure consistently above the 90thpercentile for age, sex, and height)should include dietary interventionand exercise, aimed at weight controland increased physical activity, if ap-propriate. If target blood pressure is notreached within 3–6 months of lifestyleintervention, pharmacologic treatmentshould be initiated. (E)

● Pharmacologic treatment of hyperten-sion (systolic or diastolic blood pres-sure consistently above the 95thpercentile for age, sex, and height orconsistently greater than 130/80mmHg, if 95% exceeds that value)should be initiated as soon as the diag-nosis is confirmed. (E)

● ACE inhibitors should be considered forthe initial treatment of hypertension. (E)

● Hypertension in childhood is definedas an average systolic or diastolic bloodpressure �95th percentile for age, sex,and height percentile measured on atleast three separate days. “High-normal” blood pressure is defined as anaverage systolic or diastolic blood pres-sure �90th but �95th percentile forage, sex, and height percentile mea-sured on at least 3 separate days. Nor-mal blood pressure levels for age, sex,and height and appropriate methodsfor determinations are available onlineat www.nhlbi.nih.gov/health/prof/heart/hbp/hbp_ped.pdf.

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iii. Dyslipidemia

Recommendations

Screening● Prepubertal children: a fasting lipid

profile should be performed on all chil-dren �2 years of age at the time of di-agnosis (after glucose control has beenestablished) if there is a family historyof hypercholesterolemia (total choles-terol �240 mg/dl), if there is a historyof a cardiovascular event before age 55years, or if family history is unknown. Iffamily history is not of concern, thenthe first lipid screening should be per-formed at puberty (�12 years). If val-ues are within the accepted risk levels(LDL �100 mg/dl [2.6 mmol/l]), a lipidprofile should be repeated every 5years. (E)

● Pubertal children (�12 years of age): afasting lipid profile should be per-formed at the time of diagnosis (afterglucose control has been established).If values fall within the accepted risklevels (LDL �100 mg/dl [2.6 mmol/l]),the measurement should be repeatedevery 5 years. (E)

● If lipids are abnormal, annual monitor-ing is recommended in both age-groups. (E)

Treatment● Treatment should be based on fasting

lipid levels (mainly LDL) obtained afterglucose control is established. (E)

● Initial therapy should consist of optimi-zation of glucose control and MNT

aimed at a decrease in the amount ofsaturated fat in the diet. (E)

● The addition of a pharmacologic lipid-lowering agents is recommended forLDL �160 mg/dl (4.1 mmol/l), and isalso recommended in patients whohave LDL cholesterol values of 130–159 mg/dl (3.4–4.1 mmol/l) based onthe patient’s CVD risk profile, after fail-ure of MNT and lifestyle changes. (E)

● The goal of therapy is an LDL value�100 mg/dl (2.6 mmol/l). (E)

iv. Retinopathy

Recommendations● The first ophthalmologic examination

should be obtained once the child is�10 years of age and has had diabetesfor 3–5 years. (E)

● After the initial examination, annualroutine follow-up is generally recom-mended. Less frequent examinationsmay be acceptable on the advice of aneye care professional. (E)

Although retinopathy most commonlyoccurs after the onset of puberty and after5–10 years of diabetes duration, it hasbeen reported in prepubertal childrenand with diabetes duration of only 1–2years. Referrals should be made to eyecare professionals with expertise in diabeticretinopathy, an understanding of the riskfor retinopathy in the pediatric population,and experience in counseling the pediatricpatient and family on the importance ofearly prevention/intervention.

c. Other issues. A major issue deservingemphasis in this age-group is that of “ad-herence.” No matter how sound the med-ical regimen, it can only be as good as theability of the family and/or individual toimplement it. Family involvement in dia-betes remains an important component ofoptimal diabetes management through-out childhood and into adolescence.Health care providers who care for chil-dren and adolescents, therefore, must becapable of evaluating the behavioral,emotional, and psychosocial factors thatinterfere with implementation and thenmust work with the individual and familyto resolve problems that occur and/or tomodify goals as appropriate.

Since a sizable portion of a child’s dayis spent in school, close communicationwith school or day care personnel is es-sential for optimal diabetes management.Information should be supplied to schoolpersonnel, so that they may be madeaware of the diagnosis of diabetes in thestudent and of the signs, symptoms, andtreatment of hypoglycemia. In most casesit is imperative that blood glucose testingbe performed at the school or day caresetting before lunch and when signs orsymptoms of abnormal blood glucose lev-els are present. Many children may re-quire support for insulin administrationby either injection or continuous subcu-taneous insulin infusion before lunch(and often also before breakfast) at schoolor in day care. For further discussion, seethe ADA position statement (179) and thereport from the National Diabetes Educa-tion Program (180).

Table 10—Plasma blood glucose and A1C goals for type 1 diabetes by age group

Plasma blood glucose goal range(mg/dl)

Values by age (years) Before meals Bedtime/overnight A1C Rationale

Toddlers and preschoolers (0–6) 100–180 110–200 �8.5% (but �7.5%) High risk and vulnerability tohypoglycemia

School age (6–12) 90–180 100–180 �8% Risks of hypoglycemia and relatively lowrisk of complications prior to puberty

Adolescents and young adults (13–19) 90–130 90–150 �8% ● Risk of severe hypoglycemia● Developmental and psychological

issues● A lower goal (�7.0%) is reasonable if

it can be achieved without excessivehypoglycemia

Key concepts in setting glycemic goals:● Goals should be individualized and lower goals may be reasonable based on benefit-risk assessment.● Blood glucose goals should be higher than those listed above in children with frequent hypoglycemia or hypoglycemia unawareness.● Postprandial blood glucose values should be measured when there is a disparity between preprandial blood glucose values and A1C levels.

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2. Type 2 diabetesFinally, the incidence of type 2 diabetes inchildren and adolescents has been shownto be increasing, especially in ethnic mi-nority populations (181,182). Distinctionbetween type 1 and type 2 diabetes inchildren can be difficult, since autoanti-gens and ketosis may be present in a sub-stantial number of pat ients withotherwise straightforward type 2 diabetes(including obesity and acanthosis nigri-cans). Such a distinction at the time ofdiagnosis is critical since treatment regi-mens, educational approaches, and di-etary counsel will differ markedlybetween the two diagnoses. The ADAconsensus statement (11) provides guid-ance to the prevention, screening, andtreatment of type 2 diabetes, as well as itscomorbidities in young people.

B. Preconception care

Recommendations● A1C levels should be normal or as close

to normal as possible (�1% above theupper limits of normal) in an individualpatient before conception is attempted.(B)

● All women with diabetes and child-bearing potential should be educatedabout the need for good glucose controlbefore pregnancy. They should partici-pate in family planning. (E)

● Women with diabetes who are contem-plating pregnancy should be evaluatedand, if indicated, treated for diabeticretinopathy, nephropathy, neuropathy,and CVD. (E)

● Among the drugs commonly used inthe treatment of patients with diabetes,statins are pregnancy category X andshould be discontinued before concep-tion if possible. ACE inhibitors andARBs are category C in the first trimes-ter (maternal benefit may outweigh fe-tal risk in certain situations), butcategory D in later pregnancy, andshould generally be discontinued be-fore pregnancy. Among the oral antidi-abetic agents, metformin and acarboseare classified as category B and all oth-ers as category C; potential risks andbenefits of oral antidiabetic agents inthe preconception period must be care-fully weighed, recognizing that suffi-cient data are not available to establishthe safety of these agents in pregnancy.They should generally be discontinuedin pregnancy. (E)

Major congenital malformations remainthe leading cause of mortality and seriousmorbidity in infants of mothers with type1 and type 2 diabetes. Observational stud-ies indicate that the risk of malformationsincreases continuously with increasingmaternal glycemia during the first 6–8weeks of gestation, as defined by first-trimester A1C concentrations. There is nothreshold for A1C values above which therisk begins or below which it disappears.However, malformation rates above the1–2% background rate seen in nondia-betic pregnancies appear to be limited topregnancies in which first-trimester A1Cconcentrations are �1% above the nor-mal range.

Preconception care of diabetes ap-pears to reduce the risk of congenital mal-formations. Five nonrandomized studieshave compared rates of major malforma-tions in infants between women who par-ticipated in preconception diabetes careprograms and women who initiated in-tensive diabetes management after theywere already pregnant. The preconcep-tion care programs were multidisci-plinary and designed to train patients indiabetes self-management with diet, in-tensified insulin therapy, and SMBG.Goals were set to achieve normal bloodglucose concentrations, and �80% ofsubjects achieved normal A1C concentra-tions before they became pregnant (183–187). In all five studies, the incidence ofmajor congenital malformations inwomen who participated in preconcep-tion care (range 1.0–1.7% of infants) wasmuch lower than the incidence in womenwho did not participate (range 1.4 –10.9% of infants). One limitation of thesestudies is that participation in preconcep-tion care was self-selected by patientsrather than randomized. Thus, it is im-possible to be certain that the lower mal-formation rates resulted fully fromimproved diabetes care. Nonetheless, theoverwhelming evidence supports theconcept that malformations can be re-duced or prevented by careful manage-ment of diabetes before pregnancy.

Planned pregnancies greatly facilitatepreconception diabetes care. Unfortu-nately, nearly two-thirds of pregnanciesin women with diabetes are unplanned,leading to a persistent excess of malfor-mations in infants of diabetic mothers. Tominimize the occurrence of these devas-tating malformations, standard care for allwomen with diabetes who have child-bearing potential should include 1) edu-cation about the risk of malformations

associated with unplanned pregnanciesand poor metabolic control and 2) use ofeffective contraception at all times, unlessthe patient is in good metabolic controland actively trying to conceive.

Women contemplating pregnancyneed to be seen frequently by a multidis-ciplinary team experienced in the man-agement of diabetes before and duringpregnancy. Teams may vary but shouldinclude a diabetologist, an internist or afamily physician, an obstetrician, a diabe-tes educator, a dietitian, a social worker,and other specialists as necessary. Thegoals of preconception care are to 1) inte-grate the patient into the management ofher diabetes, 2) achieve the lowest A1Ctest results possible without excessive hy-poglycemia, 3) assure effective contracep-tion until stable and acceptable glycemiais achieved, and 4) identify, evaluate, andtreat long-term diabetic complicationssuch as retinopathy, nephropathy, neu-ropathy, hypertension, and CAD.

For further discussion, see the ADA’stechnical review (188) and position state-ment (189) on this subject.

C. Older individualsDiabetes is an important health conditionfor the aging population; at least 20% ofpatients over the age of 65 years have di-abetes. The number of older individualswith diabetes can be expected to growrapidly in the coming decades. A recentpublication (190) contains evidence-based guidelines produced in conjunc-tion with the American Geriatric Society.This document contains an excellent dis-cussion of this area, and specific guide-lines and language from it have beenincorporated below. Unfortunately, thereare no long-term studies in individuals�65 years of age demonstrating the ben-efits of tight glycemic control, blood pres-sure, and lipid control. Older individualswith diabetes have higher rates of prema-ture death, functional disability, and co-existing illnesses such as hypertension,CHD, and stroke than those without dia-betes. Older adults with diabetes are alsoat greater risk than other older adults forseveral common geriatric syndromes,such as polypharmacy, depression, cogni-tive impairment, urinary incontinence,injurious falls, and persistent pain.

The care of older adults with diabetesis complicated by their clinical and func-tional heterogeneity. Some older individ-uals developed diabetes in middle age andface years of comorbidity; others who arenewly diagnosed may have had years of

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undiagnosed comorbidity or few compli-cations from the disease. Some olderadults with diabetes are frail and haveother underlying chronic conditions,substantial diabetes-related comorbidity,or limited physical or cognitive function-ing, but other older individuals with dia-betes have little comorbidity and areactive. Life expectancies are also highlyvariable for this population. Clinicianscaring for older adults with diabetes musttake this heterogeneity into considerationwhen setting and prioritizing treatmentgoals.

All this having been said, patientswho can be expected to live long enoughto reap the benefits of long-term intensivediabetes management (�10 years) andwho are active, cognitively intact, andwilling to undertake the responsibility ofself-management should be encouragedto do so and be treated using the statedgoals for younger adults with diabetes.

There is good evidence from middle-aged and older adults suggesting thatmultidisciplinary interventions that pro-vide education on medication use, moni-toring, and recognizing hypo- andhyperglycemia can significantly improveglycemic control. Although control of hy-perglycemia is important, in older indi-viduals with diabetes, greater reductionsin morbidity and mortality may resultfrom control of all cardiovascular risk fac-tors rather than from tight glycemic con-trol alone. There is strong evidence fromclinical trials of the value of treating hy-pertension in the elderly. There is less ev-idence for lipid-lowering and aspirintherapy, although as diabetic patientshave such an elevated risk for CVD, ag-gressive management of lipids and aspirinuse when not contraindicated are reason-able interventions.

As noted above, for patients with ad-vanced diabetes complications, life-limiting comorbid illness, or cognitive orfunctional impairment, it is reasonable toset less intensive glycemic target goals.These patients are less likely to benefitfrom reducing the risk of microvascularcomplications and more likely to sufferserious adverse effects from hypoglyce-mia. Patients with poorly controlled dia-be tes may be subjec t to acutecomplications of diabetes, including hy-perglycemic hyperosmolar coma. Olderpatients can be treated with the same drugregimens as younger patients, but specialcare is required in prescribing and moni-toring drug therapy. Metformin is oftencontraindicated because of renal insuffi-

ciency or heart failure. Sulfonylureas andother insulin secretagogues can cause hy-poglycemia. Insulin can also cause hypo-glycemia as well as require good visualand motor skills and cognitive ability ofthe patient or a caregiver. TZDs shouldnot be used in patients with CHF (NewYork Heart Association class III and IV).Drugs should be started at the lowest doseand titrated up gradually until targets arereached or side effects develop. As well asregards blood pressure and lipid manage-ment, the potential benefits must alwaysbe weighed against potential risks.

VIII. DIABETES CARE INSPECIFIC SETTINGS

A. Diabetes care in the hospital

Recommendations● All patients with diabetes admitted to

the hospital should be identified in themedical record as having diabetes. (E)

● All patients with diabetes should havean order for blood glucose monitoring,with results available to all members ofthe health care team. (E)

● Goals for blood glucose levels:● Critically ill patients: blood glucose

levels should be kept as close to 110mg/dl (6.1 mmol/l) as possible andgenerally �180 mg/dl (10 mmol/l).These patients will usually require in-travenous insulin. (B)

● Non–critically ill patients: premealblood glucose levels should be keptas close to 90–130 mg/dl (5.0–7.2mmol/l; midpoint of range 110 mg/dl) as possible given the clinical situ-ation and postprandial blood glucoselevels �180 mg/dl. Insulin should beused as necessary. (E)

● Due to concerns regarding the risk ofhypoglycemia, some institutions mayconsider these blood glucose levels tobe overly aggressive for initial targets.Through quality improvement, gly-cemic goals should systematically bereduced to the recommended levels.(E)

● Scheduled prandial insulin dosesshould be given in relation to meals andshould be adjusted according to pointof care glucose levels. The traditionalsliding-scale insulin regimens are inef-fective and are not recommended. (C)

● A plan for treating hypoglycemiashould be established for each patient.Episodes of hypoglycemia in the hospi-tal should be tracked. (E)

● All patients with diabetes admitted to

the hospital should have an A1C ob-tained for discharge planning if the re-sult of testing in the previous 2–3months is not available. (E)

● A diabetes education plan including“survival skills education” and fol-low-up should be developed for eachpatient. (E)

● Patients with hyperglycemia in the hos-pital who do not have a diagnosis ofdiabetes should have appropriate plansfor follow-up testing and care docu-mented at discharge. (E)

The management of diabetes in the hos-pital is extensively reviewed in an ADAtechnical review by Clement et al. (191).This review forms the basis for theseguidelines. In addition, the American As-sociation of Clinical Endocrinologistsheld a conference on this topic (192), andthe recommendations from this meeting(193) were also carefully reviewed anddiscussed in the formulation of the guide-lines that follow. The management of di-abetes in the hospital is generallyconsidered secondary in importancecompared with the condition thatprompted admission.

Patients with hyperglycemia fall intothree categories:

● Medical history of diabetes: diabeteshas been previously diagnosed and ac-knowledged by the patient’s treatingphysician.

● Unrecognized diabetes: hyperglycemia(fasting blood glucose 126 mg/dl orrandom blood glucose 200 mg/dl) oc-curring during hospitalization and con-firmed as diabetes after hospitalizationby standard diagnostic criteria but un-recognized as diabetes by the treatingphysician during hospitalization.

● Hospital-related hyperglycemia: hyper-glycemia (fasting blood glucose 126mg/dl or random blood glucose �200mg/dl) occurring during the hospital-ization that reverts to normal after hos-pital discharge.

The prevalence of diabetes in hospitalizedadult patients is not precisely known. Inthe year 2000, 12.4% of hospital dis-charges in the U.S. listed diabetes as a di-agnosis. The prevalence of diabetes inhospitalized adults is conservatively esti-mated at 12–25%, depending on the thor-oughness used in identifying patients.Patients presenting to hospitals may havediabetes, unrecognized diabetes, or hos-pital-related hyperglycemia. Using the

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A1C test may be a valuable case-findingtool for identifying diabetes in hospital-ized patients.

A rapidly growing body of literaturesupports targeted glucose control in thehospital setting with potential for im-proved mortality, morbidity, and healthcare economic outcomes. Hyperglycemiain the hospital may result from stress, de-compensation of type 1 diabetes, type 2diabetes, or other forms of diabetesand/or may be iatrogenic due to adminis-tration or withholding of pharmaco-logic agents, including glucocorticoids,vasopressors, etc. Distinction betweendecompensated diabetes and stress hy-perglycemia is often not made.

1. Blood glucose targetsa. General medicine and surgery. Ob-servational studies suggest an associationbetween hyperglycemia and increasedmortality. General medical and surgicalpatients with a blood glucose value(s)�220 mg/dl (12.2 mmol/l) have higherinfection rates (194).

When admissions on general medi-cine and surgery units were studied, pa-tients with new hyperglycemia hadsignificantly increased inhospital mortal-ity, as did patients with known diabetes.In addition, length of stay was higher forthe new hyperglycemic group, and boththe patients with new hyperglycemia andthose with known diabetes were morelikely to require intensive care unit (ICU)care and transitional or nursing homecare. Better outcomes were demonstratedin patients with fasting and admissionblood glucose �126 mg/dl (7 mmol/l)and all random blood glucose levels�200 mg/dl (11.1 mmol/l) (195).b. CVD and critical care. The relation-ship of blood glucose levels and mortalityin the setting of acute myocatdial infarc-tion (AMI) has been reported. A meta-analysis of 15 previously publishedstudies compared in-hospital mortalityand CHF in both hyper- and normoglyce-mic patients with and without diabetes. Insubjects without known diabetes whoseadmission blood glucose was 109.8 mg/dl(6.1 mmol/l), the relative risk for in-hospital mortality was increased signifi-cantly. When diabetes was present andadmission glucose 180 mg/dl (10 mmol/l), risk of death was moderately increasedcompared with patients who had diabetesbut no hyperglycemia on admission(196). In another study (197), admissionblood glucose values were analyzed inconsecutive patients with AMI. Analysis

revealed an independent association ofadmission blood glucose and mortality.The 1-year mortality rate was significantlylower in subjects with admission plasmaglucose �100.8 mg/dl (5.6 mmol/l) thanin those with plasma glucose 199.8 mg/dl(11 mmol/l).

Finally, in the first Diabetes and Insu-lin-Glucose Infusion in Acute MyocardialInfarction (DIGAMI) study (91,198), in-sulin-glucose infusion followed by subcu-taneous insulin treatment in diabeticpatients with AMI was examined. Inten-sive subcutaneous insulin therapy for �3months improved long-term survival(91). Mean blood glucose in the intensiveinsulin intervention arm was 172.8 mg/dl(9.6 mmol/l) (compared with 210.6mg/dl [11.7 mmol/l] in the “conven-tional” group). The broad range of bloodglucose levels within each arm limits theability to define specific blood glucose tar-get thresholds.c. Cardiac surgery. Attainment of tar-geted glucose control in the setting of car-diac surgery is associated with reducedmortality and risk of deep sternal woundinfections in cardiac surgery patients withdiabetes (199,200) and supports the con-cept that perioperative hyperglycemia isan independent predictor of infection inpatients with diabetes (201), with thelowest mortality in patients with blood glu-cose �150 mg/dl (8.3 mmol/l) (199,202).d. Critical care. A mixed group of pa-tients with and without diabetes admittedto a surgical ICU were randomized to re-ceive intensive insulin therapy (targetblood glucose 80–110 mg/dl [4.4–6.1mmol/l]). The mean blood glucose of 103mg/dl (5.7 mmol/l) had reduced mortalityduring the ICU stay and decreased overallin-hospital mortality (92). Subsequentanalysis demonstrated that for each 20mg/dl (1.1 mmol/l) glucose was elevatedabove 100 mg/dl (5.5 mmol/l), the risk ofICU death increased. Hospital and ICUsurvival were linearly associated with ICUglucose levels, with the highest survivalrates occurring in patients achieving anaverage blood glucose �110 mg/dl (6.1mmol/l) (202a).e. Acute neurological disorders. Hy-perglycemia is associated with worsenedoutcomes in patients with acute strokeand head injury, as evidenced by the largenumber of observational studies in the lit-erature (203–205). A meta-analysis iden-tified an admission blood glucose �110mg/dl (6.1 mmol/l) for increased mortal-ity for acute stroke (206).

2. Treatment optionsa. Oral diabetes agents. No large stud-ies have investigated the potential roles ofvarious oral agents on outcomes in hospi-talized patients with diabetes. While thevarious classes of oral agents are com-monly used in the outpatient setting withgood response, their use in the inpatientsetting presents some specific issues.i. Sulfonylureas and meglitinides. The longaction and predisposition to hypoglyce-mia in patients not consuming theirnormal nutrition serve as relative contra-indications to routine use of sulfonylureasin the hospital for many patients (207).Sulfonylureas do not generally allowrapid dose adjustment to meet the chang-ing inpatient needs. Sulfonylureas alsovary in duration of action between indi-viduals and likely vary in the frequencywith which they induce hypoglycemia.While the two available meglitinides, re-paglinide and neteglinide, theoreticallywould produce less hypoglycemia thansulfonylureas, lack of clinical trial data forthese agents would preclude their use.ii. Metformin. The major limitation to met-formin use in the hospital is a number ofspecific contraindications to its use, manyof which occur in the hospital. All of thesecontraindications relate to lactic acidosis,a potentially fatal complication of met-formin therapy. The most common riskfactors for lactic acidosis in metformin-treated patients are cardiac disease, in-cluding CHF, hypoperfusion, renalinsufficiency, old age, and chronic pul-monary disease (208). Recent evidencecontinues to indicate lactic acidosis is arare complication (209), despite the rela-tive frequency of risk factors (210). How-ever, in the hospital, where the risk forhypoxia, hypoperfusion, and renal insuf-ficiency is much higher, it still seems pru-dent to avoid the use of metformin inmost patients.iii. TZDs. TZDs are not suitable for initia-tion in the hospital because of their de-layed onset of effect. In addition, they doincrease intravascular volume, a particu-lar problem in those predisposed to CHFand potentially a problem for patientswith hemodynamic changes related to ad-mission diagnoses (e.g., acute coronaryischemia) or interventions common inhospitalized patients.

In summary, each of the major classesof oral agents has significant limitationsfor inpatient use. Additionally, they pro-vide little flexibility or opportunity for ti-tration in a setting where acute changesdemand these characteristics. Therefore,

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insulin, when used properly, may havemany advantages in the hospital setting.b. Insulin. The inpatient insulin regi-men must be matched or tailored to thespecific clinical circumstance of the indi-vidual patient. A recent meta-analysisconcluded that insulin therapy in criti-cally ill patients had a beneficial effect onshort-term mortality in different clinicalsettings (211).i. Subcutaneous insulin therapy. Subcutane-ous insulin therapy may be used to attainglucose control in most hospitalized pa-tients with diabetes. The components ofthe daily insulin dose requirement can bemet by a variety of insulins, depending onthe particular hospital situation. Subcuta-neous insulin therapy is subdivided intoprogrammed or scheduled insulin andsupplemental or correction-dose insulin.Correction-dose insulin therapy is an im-portant adjunct to scheduled insulin,both as a dose-finding strategy and as asupplement when rapid changes in insu-lin requirements lead to hyperglycemia. Ifcorrection doses are frequently required,it is recommended that the appropriatescheduled insulin doses be increased thefollowing day to (212) accommodate theincreased insulin needs. There are nostudies comparing human regular insulinwith rapid-acting analogs for use as cor-rection-dose insulin. However, due to thelonger duration with human regular insu-lin, there is a greater risk of “insulin stack-ing” when the usual next blood glucosemeasurement is performed 4–6 h later.

The traditional sliding-scale insulinregimens, usually consisting of regular in-sulin without any intermediate or long-acting insulins, have been shown to beineffective (212–214). Problems citedwith sliding-scale insulin regimens arethat the sliding-scale regimen prescribedon admission is likely to be used through-out the hospital stay without modification(212). Second, sliding-scale insulin ther-apy treats hyperglycemia after it has al-ready occurred, instead of preventing theoccurrence of hyperglycemia. This “reac-tive” approach can lead to rapid changesin blood glucose levels, exacerbating bothhyper- and hypoglycemia.ii. Intravenous insulin infusion. The onlymethod of insulin delivery specifically de-veloped for use in the hospital is contin-uous intravenous infusion, using regularcrystalline insulin. There is no advantageto using insulin lispro or aspart in an in-travenous insulin infusion. The medicalliterature supports the use of intravenousinsulin infusion in preference to the sub-

cutaneous route of insulin administrationfor several clinical indications amongnonpregnant adults. These include DKAand nonketotic hyperosmolar state; gen-eral preoperative, intraoperative, andpostoperative care; the postoperative pe-riod following heart surgery; followingorgan transplantation; with cardiogenicshock; exacerbated hyperglycemia duringhigh-dose glucocorticoid therapy; pa-tients who are not eating (NPO) or in crit-ical care illness in general; and as a dose-finding strategy in anticipation ofinitiation or reinitiation of subcutaneousinsulin therapy in type 1 or type 2 diabetes.

Many institutions use insulin infusionalgorithms that can be implemented bynursing staff. Algorithms should incorpo-rate the concept that maintenance re-quirements differ between patients andchange over the course of treatment. Al-though numerous algorithms have beenpublished, there have been no head-to-head comparisons, and thus no single al-gorithm can be recommended for anindividual hospital. Ideally, intravenousinsulin algorithms should consider boththe glucose level and its rate of change.For all algorithms, frequent bedside glu-cose testing is required but the ideal fre-quency is not known.iii. Transition from intravenous to subcuta-neous insulin therapy. There are no specificclinical trials examining how to best tran-sition from intravenous to subcutaneousinsulin or which patients with type 2 di-abetes may be transitioned to oral agents.For those who will require subcutaneousinsulin, it is necessary to administershort- or rapid-acting insulin subcutane-ously 1–2 h before discontinuation of theintravenous insulin infusion. An interme-diate- or long-acting insulin must be in-jected 2–3 h before discontinuing theinsulin infusion. In transitioning from in-travenous insulin infusion to subcutane-ous therapy, the caregiver may ordersubcutaneous insulin with appropriateduration of action to be administered as asingle dose or repeatedly to maintainbasal effect until the time of day when thechoice of insulin or analog preferred forbasal effect normally would be provided.

3. Self-management in the hospitalSelf-management in the hospital may beappropriate for competent adult patientswho have a stable level of consciousnessand reasonably stable known daily insulinrequirements and successfully conductself-management of diabetes at home,have physical skills appropriate to suc-

cessfully self-administer insulin, performSMBG, and have adequate oral intake.Appropriate patients are those alreadyproficient in carbohydrate counting, useof multiple daily injections of insulin orinsulin pump therapy, and sick-daymanagement. The patient and physicianin consultation with nursing staff mustagree that patient self-management is ap-propriate under the conditions ofhospitalization.

4. Preventing hypoglycemiaHypoglycemia, especially in insulin-treated patients, is the leading limitingfactor in the glycemic management oftype 1 and type 2 diabetes (93). In thehospital, multiple additional risk factorsfor hypoglycemia are present, evenamong patients who are neither “brittle”nor tightly controlled. Patients who donot have diabetes may experience hypo-glycemia in the hospital, in associationwith factors such as altered nutritionalstate, heart failure, renal or liver disease,malignancy, infection, or sepsis (215). Pa-tients having diabetes may develop hypo-glycemia in association with the sameconditions (216). Additional triggeringevents leading to iatrogenic hypoglycemiainclude sudden reduction of corticoste-roid dose, altered ability of the patient toself-report symptoms, reduction of oralintake, emesis, new NPO status, re-duction of rate of administration of intra-venous dextrose, and unexpectedinterruption of enteral feedings or paren-teral nutrition. Altered consciousnessfrom anesthesia may also alter typical hy-poglycemic symptoms.

Despite the preventable nature ofmany inpatient episodes of hypoglyce-mia, institutions are more likely to havenursing protocols for the treatment of hy-poglycemia than for its prevention.

5. Diabetes care providersDiabetes management may be effectivelyoffered by primary care physicians or hos-pitalists, but involvement of appropri-ately trained specialists or specialty teamsmay reduce length of stay, improve glyce-mic control, and improve outcomes(217–220). In the care of diabetes, imple-mentation of standardized order sets forscheduled and correction-dose insulinmay reduce reliance on sliding-scale man-agement. A team approach is needed toestablish hospital pathways. To imple-ment intravenous infusion of insulin forthe majority of patients having prolongedNPO status, hospitals will need multidis-

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ciplinary support for using insulin infu-sion therapy outside of critical care units.

6. DSMETeaching diabetes self-management topatients in hospitals is a difficult and chal-lenging task. Patients are hospitalized be-cause they are ill, are under increasedstress related to their hospitalization anddiagnosis, and are in an environment thatis not conducive to learning Ideally, peo-ple with diabetes should be taught at atime and place conducive to learning: asan outpatient in a nationally recognizedprogram of diabetes education classes.

For the hospitalized patient, diabetes“survival skills” education is generallyconsidered a feasible approach. Patientsare taught sufficient information to enablethem to go home safely. Those newly di-agnosed with diabetes or who are new toinsulin and or blood glucose monitoringneed to be instructed before discharge tohelp ensure safe care upon returninghome. Those patients hospitalized be-cause of a crisis related to diabetes man-agement or poor care at home neededucation to hopefully prevent subse-quent episodes of hospitalization.

7. MNTEven though hospital diets continue to beordered by calorie levels based on the“ADA diet,” it has been recommendedthat the term “ADA diet” no longer beused (221). Since 1994, the ADA has notendorsed any single meal plan or speci-fied percentages of macronutrients. Cur-rent nutrition recommendations adviseindividualization based on treatmentgoals, physiologic parameters, and medi-cation usage.

Because of the complexity of nutritionissues, it is recommended that a registereddietitian, knowledgeable and skilled inMNT, serve as the team member who pro-vides MNT. The dietitian is responsiblefor integrating information about the pa-tient’s clinical condition, eating, and life-style habits and for establishing treatmentgoals in order to determine a realistic planfor nutrition therapy (221).

8. Bedside blood glucose monitoringImplementing intensive diabetes therapyin the hospital setting requires frequentand accurate blood glucose data. Thismeasure is analogous to an additional “vi-tal sign” for hospitalized patients with di-abetes. Bedside glucose monitoring usingcapillary blood has advantages over labo-ratory venous glucose testing because the

results can be obtained rapidly at the“point of care,” where therapeutic deci-sions are made. For this reason, the termsbedside and point-of-care glucose moni-toring are used interchangeably.

For patients who are eating, com-monly recommended testing frequenciesare premeal and at bedtime. For patientsnot eating, testing every 4–6 h is usuallysufficient for determining correction in-sulin doses. Patients controlled with con-tinuous intravenous insulin typicallyrequire hourly blood glucose testing untilthe blood glucose levels are stable, thenevery 2 h.

Bedside blood glucose testing is usu-ally performed with portable glucose de-vices that are identical or similar todevices for home SMBG.

B. Diabetes care in the school andday care setting (179)

Recommendations● An individualized diabetes medical

management plan (DMMP) should bedeveloped by the parent/guardian andthe student’s diabetes health care team.(E)

● An adequate number of school person-nel should be trained in the necessarydiabetes procedures (including moni-toring of blood glucose levels and ad-ministration of insulin and glucagon)and in the appropriate response to highand low blood glucose levels. Theseschool personnel need not be healthcare professionals. (E)

● The student with diabetes should haveimmediate access to diabetes supplies atall times, with supervision as needed. (E)

● The student should be permitted tomonitor his or her blood glucose leveland take appropriate action to treat hy-poglycemia in the classroom or any-where the student is in conjunctionwith a school activity if indicated in thestudent’s DMMP. (E)

There are �206,000 individuals �20years of age with diabetes in the U.S.,most of whom attend school and/or sometype of day care and need knowledgeablestaff to provide a safe environment. De-spite legal protections, children in theschool and day care setting still face dis-crimination. Parents and the health careteam should provide school systems andday care providers with the informationnecessary by developing an individual-ized DMMP, including information nec-essary for children with diabetes to

participate fully and safely in the school/day care experience. Appropriate diabetescare in the school and day care setting isnecessary for the child’s immediate safety,long-term well-being, and optimal aca-demic performance.

An adequate number of school per-sonnel should be trained in the necessarydiabetes procedures (e.g., blood glucosemonitoring and insulin and glucagon ad-ministration) and in the appropriate re-sponse to high and low blood glucoselevels. This will ensure that at least oneadult is present to perform these proce-dures in a timely manner while the stu-dent is at school, on field trips, and duringextracurricular activities or other school-sponsored events. These school person-nel need not be health care professionals.

The student with diabetes shouldhave immediate access to diabetes sup-plies at all times, with supervision asneeded. A student with diabetes shouldbe able to obtain a blood glucose level andrespond to the results as quickly and con-veniently as possible, minimizing theneed for missing instruction in the class-room. Accordingly, a student who is ca-pable of doing so should be permitted tomonitor his or her blood glucose level andtake appropriate action to treat hypogly-cemia in the classroom or anywhere thestudent is in conjunction with a schoolactivity. The student’s desire for privacyduring testing and should also be accom-modated.

C. Diabetes care at diabetes camps(222)

Recommendations● Each camper should have a standard-

ized medical form completed by his/herfamily and the physician managing thediabetes. (E)

● It is imperative that the medical staff isled by someone with expertise in man-aging type 1 and type 2 diabetes andincludes a nursing staff (including dia-betes educators and diabetes clinicalnurse specialists) and registered dieti-tians with expertise in diabetes. (E)

● All camp staff, including medical, nurs-ing, nutrition, and volunteer, shouldundergo background testing to ensureappropriateness in working with chil-dren. (E)

The concept of specialized residential andday camps for children with diabetes hasbecome widespread throughout the U.S.and many other parts of the world. The

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mission of camps specialized for childrenand youth with diabetes is to allow for acamping experience in a safe environ-ment. An equally important goal is to en-able children with diabetes to meet andshare their experiences with one anotherwhile they learn to be more personallyresponsible for their disease. For this tooccur, a skilled medical and camping staffmust be available to ensure optimal safetyand an integrated camping/educationalexperience.

The diabetes camping experience isshort term and is most often associatedwith increased physical activity relative tothat experienced while at home. Thus,goals of glycemic control are more relatedto the avoidance of extremes in blood glu-cose levels than to the optimization ofintensive glycemic control while away atcamp.

Each camper should have a standard-ized medical form completed by his/herfamily and the physician managing the di-abetes that details the camper’s past med-ical history, immunization record, anddiabetes regimen. The home insulin dos-age should be recorded for each camper,including number and timing of injec-tions or basal and bolus dosages given bycontinuous subcutaneous insulin infu-sion and type(s) of insulin used.

During camp, a daily record of thecamper’s progress should be made. Allblood glucose levels and insulin dosagesshould be recorded. To ensure safety andoptimal diabetes management, multipleblood glucose determinations should bemade throughout each 24-h period: be-fore meals, at bedtime, after or duringprolonged and strenuous activity, and inthe middle of the night when indicated forprior hypoglycemia. If major alterationsof a camper’s regimen appear to be indi-cated, it is important to discuss this withthe camper and the family in addition tothe child’s local physician. The record ofwhat transpired during camp should bediscussed with the family when thecamper is picked up.

A formal relationship with a nearbymedical facility should be secured foreach camp so that camp medical staff havethe ability to refer to this facility forprompt treatment of medical emergen-cies. It is imperative that the medical staffis led by someone with expertise in man-aging type 1 and type 2 diabetes. Nursingstaff should include diabetes educatorsand diabetes clinical nurse specialists.Registered dietitians with expertise in di-abetes should also have input into the de-

sign of the menu and the educationprogram. All camp staff, including medi-cal, nursing, nutrition, and volunteer,should undergo background testing toensure appropriateness in working withchildren.

D. Diabetes management incorrectional institutions (223)

Recommendations● Patients with a diagnosis of diabetes

should have a complete medical historyand undergo an intake physical exami-nation by a licensed health professionalin a timely manner. (E)

● Insulin-treated patients should have acapillary blood glucose (CBG) determi-nation within 1–2 h of arrival. (E)

● Medications and MNT should be con-tinued without interruption upon entryinto the correctional environment. (E)

● Correctional staff should be trained inthe recognition, treatment, and appro-priate referral for hypo- and hypergly-cemia. (E)

● Train staff to recognize symptoms andsigns of serious metabolic decompensa-tion and to immediately refer the pa-tient for appropriate medical care. (E)

● Institutions should implement a policyrequiring staff to notify a physician ofall CBG results outside of a specifiedrange, as determined by the treatingphysician. (E)

● Identify patients with type 1 diabeteswho are at high risk for DKA. (E)

● In the correctional setting, policies andprocedures need to be developed andimplemented to enable CBG monitor-ing to occur at the frequency necessi-tated by the individual patient’sglycemic control and diabetes regimen.(E)

● Include diabetes in correctional staffeducation programs. (E)

● For all interinstitutional transfers, com-plete a medical transfer summary to betransferred with the patient. (E)

● Diabetes supplies and medicationshould accompany the patient duringtransfer. (E)

● Begin discharge planning with ade-quate lead time to insure continuity ofcare and facilitate entry into commu-nity diabetes care. (E)

At any given time, �2 million people areincarcerated in prisons and jails in theU.S. It is estimated that nearly 80,000 ofthese inmates have diabetes. In addition,many more people with diabetes pass

through the corrections system in a givenyear.

People with diabetes in correctionalfacilities should receive care that meetsnational standards. Correctional institu-tions have unique circumstances thatneed to be considered so that all standardsof care may be achieved. Correctional in-stitutions should have written policiesand procedures for the management ofdiabetes and for training of medical andcorrectional staff in diabetes carepractices.

Reception screening should empha-size patient safety. In particular, rapididentification of all insulin-treated indi-viduals with diabetes is essential in orderto identify those at highest risk for hypo-and hyperglycemia and DKA. All insulin-treated patients should have a CBG deter-mination within 1–2 h of arrival. Patientswith a diagnosis of diabetes should have acomplete medical history and physical ex-amination by a licensed health care pro-vider with prescriptive authority in atimely manner. It is essential that medica-tion and MNT be continued without inter-ruption upon entry into the correctionalsystem, as a hiatus in either medication orappropriate nutrition may lead to either se-vere hypo- or hyperglycemia.

All patients must have access toprompt treatment of hypo- and hypergly-cemia. Correctional staff should betrained in the recognition and treatmentof hypo- and hyperglycemia, and appro-priate staff should be trained to admin-ister glucagon. Institutions shouldimplement a policy requiring staff to no-tify a physician of all CBG results outsideof a specified range, as determined by thetreating physician.

Correctional institutions should havesystems in place to ensure that insulin ad-ministration and meals are coordinated toprevent hypo- and hyperglycemia, takinginto consideration the transport of resi-dents off site and the possibility of emer-gency schedule changes.

Monitoring of CBG is a strategy thatallows caregivers and people with diabe-tes to evaluate diabetes management reg-imens. The frequency of monitoring willvary by patients’ glycemic control and di-abetes regimens. Policies and proceduresshould be implemented to ensure that thehealth care staff has adequate knowledgeand skills to direct the management andeducation of individuals with diabetes.

Patients in jails may be housed for ashort period of time before being trans-ferred or released, and it is not unusual for

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patients in prison to be transferred withinthe system several times during their in-carceration. Transferring a patient withdiabetes from one correctional facility toanother requires a coordinated effort asdoes planning for discharge.

IX. HYPOGLYCEMIA ANDEMPLOYMENT/LICENSURE

Recommendations● People with diabetes should be individ-

ually considered for employment basedon the requirements of the specific joband the individual’s medical condition,treatment regimen, and medical his-tory. (E)

Any person with diabetes, whether insu-lin treated or non–insulin treated, shouldbe eligible for any employment for whichhe/she is otherwise qualified. Despite thesignificant medical and technological ad-vances made in managing diabetes, dis-crimination in employment and licensureagainst people with diabetes still occurs.This discrimination is often based on ap-prehension that the person with diabetesmay present a safety risk to the employeror the public, a fear sometimes based onmisinformation or lack of up-to-dateknowledge about diabetes. Perhaps thegreatest concern is that hypoglycemia willcause sudden unexpected incapacitation.However, most people with diabetes canmanage their condition in such a mannerthat there is minimal risk of incapacita-tion from hypoglycemia.

Because the effects of diabetes areunique to each individual, it is inappro-priate to consider all people with diabetesthe same. People with diabetes should beindividually considered for employmentbased on the requirements of the specificjob. Factors to be weighed in this decisioninclude the individual’s medical condi-tion, treatment regimen (MNT, oral glu-cose-lowering agent, and/or insulin), andmedical history, particularly in regard tothe occurrence of incapacitating hypogly-cemic episodes.

X. THIRD-PARTYREIMBURSEMENT FORDIABETES CARE, SELF-MANAGEMENTEDUCATION, ANDSUPPLIES (224)

Recommendations● Patients and practitioners should have

access to all classes of antidiabetic med-

ications, equipment, and supplies with-out undue controls. (E)

● MNT and DSME should be covered byinsurance and other payors. (E)

To achieve optimal glucose control, theperson with diabetes must be able to ac-cess health care providers who have ex-pertise in the field of diabetes. Treatmentsand therapies that improve glycemic con-trol and reduce the complications of dia-betes will also significantly reduce healthcare costs. Access to the integral compo-nents of diabetes care, such as health carevisits, diabetes supplies and medications,and self-management education, is essen-tial. All medications and supplies, such assyringes, strips, and meters, related to thedaily care of diabetes must also be reim-bursed by third-party payors.

It is recognized that the use of formu-laries, prior authorization, and relatedprovisions, such as competitive bidding,can manage provider practices as well ascosts to the potential benefit of payors andpatients. However, any controls shouldensure that all classes of antidiabeticagents with unique mechanisms of actionand all classes of equipment and suppliesdesigned for use with such equipment areavailable to facilitate achieving glycemicgoals and to reduce the risk of complica-tions. To reach diabetes treatment goals,practitioners should have access to allclasses of antidiabetic medications,equipment, and supplies without unduecontrols. Without appropriate safe-guards, these controls could constitute anobstruction of effective care.

Medicare and many other third-partypayors cover DSME (diabetes self-management training [DSMT]) and MNT.The qualified beneficiary, who meets thediagnostic criteria and medical necessity,can receive an initial benefit of 10 h ofDSMT and 3 h of MNT with a potentialtotal of 13 h of initial education as long asthe services are not provided on the samedate. However, not all Medicare benefi-ciaries with a diagnosis of diabetes willqualify for both MNT and DSMT benefits.More information on Medicare policy, in-cluding follow-up benefits, is available athttp://www.diabetes.org/for-health-professionals-and-scientists/recognition/dsmt-mntfaqs.jsp.

XI. STRATEGIES FORIMPROVING DIABETESCARE — The implementation of thestandards of care for diabetes has beensuboptimal in most clinical settings. A re-

cent report (24) indicated that only 37%of adults with diagnosed diabetesachieved an A1C of �7%, only 36% had ablood pressure �130/80 mmHg, and just48% had a cholesterol �200 mg/dl. Mostdistressing was that only 7.3% of diabetessubjects achieved all three treatmentgoals.

While numerous interventions to im-prove adherence to the recommendedstandards have been implemented, thechallenge of providing uniformly effectivediabetes care has thus far defied a simplesolution. A major contributor to subopti-mal care is a delivery system that too oftenis fragmented, lacks clinical informationcapabilities, often duplicates services, andis poorly designed for the delivery ofchronic care. The Institute of Medicinehas called for changes so that delivery sys-tems provide care that is evidence based,patient centered, and systems orientedand takes advantage of information tech-nologies that foster continuous qualityimprovement. Collaborative, multidisci-plinary teams should be best suited toprovide such care for people with chronicconditions like diabetes and to empowerpatients’ performance of appropriate self-management. Alterations in reimburse-ment that reward the provision of qualitycare, as defined by the attainment of qual-ity measures developed by such activitiesas the ADA/National Committee for Qual-ity Assurance Diabetes Provider Recogni-tion Program will also be required toachieve desired outcome goals.

The National Diabetes Education Pro-gram recently launched a new online re-source to help health care professionalsbetter organize their diabetes care. Thewww.betterdiabetescare.nih.gov websiteshould help users design and implementmore effective health care delivery sys-tems for those with diabetes.

In recent years, numerous health careorganizations, ranging from large healthcare systems such as the U.S. Veteran’sAdministration to small private practices,have implemented strategies to improvediabetes care. Successful programs havepublished results showing improvementin important outcomes such as A1C mea-surements and blood pressure and lipiddeterminations as well as process mea-sures such as provision of eye exams. Suc-cessful interventions have been focused atthe level of health care professionals, de-livery systems, and patients. Features ofsuccessful programs reported in the liter-ature include:

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● Improving health care professional ed-ucation regarding the standards of carethrough formal and informal educationprograms.

● Delivery of DSME, which has beenshown to increase adherence to stan-dard of care.

● Adoption of practice guidelines, withparticipation of health care profession-als in the process. Guidelines should bereadily accessible at the point of service,such as on patient charts, in examiningrooms, in “wallet or pocket cards,” onPDAs, or on office computer systems.Guidelines should begin with a sum-mary of their major recommendationsinstructing health care professionalswhat to do and how to do it.

● Use of checklists that mirror guidelineshave been successful at improving ad-herence to standards of care.

● Systems changes, such as provision ofautomated reminders to health careprofessionals and patients, reporting ofprocess and outcome data to providers,and especially identification of patientsat risk because of failure to achieve tar-get values or a lack of reported values.

● Quality improvement programs com-bining continuous quality improve-ment or other cycles of analysis andintervention with provider perfor-mance data.

● Practice changes, such as clustering ofdedicated diabetes visits into specifictimes within a primary care practiceschedule and/or visits with multiplehealth care professionals on a single dayand group visits.

● Tracking systems with either an elec-tronic medical record or patient regis-try have been helpful at increasingadherence to standards of care by pro-spectively identifying those requiringassessments and/or treatment modifi-cations. They likely could have greaterefficacy if they suggested specific ther-apeutic interventions to be consideredfor a particular patient at a particularpoint in time (225).

● A variety of nonautomated systems,such as mailing reminders to patients,chart stickers, and flow sheets, havebeen useful to prompt both providersand patients.

● Availability of case or (preferably) caremanagement services, usually by anurse. Nurses, pharmacists, and othernonphysician health care professionalsusing detailed algorithms working un-der the supervision of physiciansand/or nurse education calls have also

been helpful. Similarly dietitians usingMNT guidelines have been demon-strated to improve glycemic control.

● Availability and involvement of expertconsultants, such as endocrinologistsand diabetes educators.

Evidence suggests that these individualinitiatives work best when provided ascomponents of a multifactorial interven-tion. Therefore, it is difficult to assess thecontribution of each component; how-ever, it is clear that optimal diabetesmanagement requires an organized,systematic approach and involvement of acoordinated team of heal th careprofessionals.

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224. American Diabetes Association: Third-party reimbursement for diabetes care,self-management education, and sup-plies (Position Statement). Diabetes Care29 (Suppl. 1):S68–S69, 2006

225. O’Connor PJ: Electronic medical recordsand diabetes care improvement: are wewaiting for Godot? (Editorial). DiabetesCare 26:942–943, 2003

Standards of Medical Care

S42 DIABETES CARE, VOLUME 29, SUPPLEMENT 1, JANUARY 2006