Standards of Medical Care in Diabetes · IGT 2-h plasma glucose 140 mg/dl (7.8 mmol/l) to 199 mg/dl (11.0 mmol/l) Recently, IFG and IGT have been ofﬁ-cially termed “pre-diabetes.”

Standards of Medical Care in DiabetesAMERICAN DIABETES ASSOCIATION

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 personswith the components of diabetes care,treatment goals, and tools to evaluate thequality of care. While individual prefer-ences, comorbidities, and other patientfactors may require modification of goals,targets that are desirable for most patientswith diabetes are provided. These stan-dards are not intended to preclude moreextensive evaluation and management ofthe patient by other specialists as needed.For more detailed information, refer toBode (Ed.): Medical Management of Type 1Diabetes (1), Zimmerman (Ed.): MedicalManagement of Type 2 Diabetes (2), andKlingensmith (Ed): Intensive DiabetesManagement (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 supports

each recommendation is listed after eachrecommendation using the letters A, B, C,or E.

CLASSIFICATION,DIAGNOSIS, ANDSCREENING

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�-cell function, genetic defects in insu-lin action, diseases of the exocrine pan-creas, drug or chemical induced).

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

DiagnosisCriteria 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 performedin practice. Because of ease of use, accept-ability to patients, and lower cost, theFPG is the preferred screening and diag-nostic test. It should be noted that the vastmajority of people who meet diagnosticcriteria for diabetes by OGTT, but not byFPG, will have an A1C value �7.0%. Theuse of the A1C for the diagnosis of diabe-tes is not recommended 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 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). Recent studies have shownthat modest weight loss and regular phys-ical activity can reduce the rate of progres-sion of IGT to type 2 diabetes (6–8). Drugtherapy (metformin [8], acarbose [9], andorlistat [10] and troglitazone [no longerclinically available] [11]) has been shownto be effective in reducing progression todiabetes, though generally not as effec-tively as intensive lifestyle interventions.

ScreeningGenerally, people with type 1 diabetespresent with acute symptoms of diabetesand markedly elevated blood glucose lev-els. Type 2 diabetes is frequently not di-agnosed until complications appear, andapproximately one-third of all peoplewith diabetes may be undiagnosed. Al-though the burden and natural history ofdiabetes is well known and although thereis good evidence for benefit from treatingcases diagnosed in the context of usualclinical care, there are no randomized tri-als demonstrating the benefits of earlydiagnosis through screening of asymp-tomatic individuals (12). Nevertheless,there is sufficient indirect evidence to jus-

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

The recommendations in this paper are based on the evidence reviewed in the following publication:Standards of care for diabetes (Technical Review). Diabetes Care 17:1514–1522, 1994.

Originally approved 1988. Most recent review/revision, October 2003.Abbreviations: ABI, ankle-brachial index; ARB, angiotensin receptor blocker; CAD, coronary artery

disease; CHD, coronary heart disease; CSII, continuous subcutaneous insulin injection; CVD, cardiovasculardisease; FPG, fasting plasma glucose; GCT, glucose challenge test; DCCB, dihydropyridine calcium channelblocker; DCCT, Diabetes Control and Complications Trial; DKA, diabetic ketoacidosis; DRS, DiabeticRetinopathy Study; ECG, electrocardiogram; eGFR, estimated GFR; ESRD, end-stage renal disease; ETDRS,Early Treatment Diabetic Retinopathy Study; GDM, gestational diabetes mellitus; GFR, glomerular filtrationrate; HRC, high-risk characteristic; IFG, impaired fasting glucose; IGT, impaired glucose tolerance; MNT,medical nutrition therapy; NPDR, nonproliferative diabetic retinopathy; OGTT, oral glucose tolerance test;PAD, peripheral arterial disease; PDR, proliferative diabetic retinopathy; PPG, postprandidial plasma glu-cose; SMBG, self-monitoring of blood glucose; UKPDS, U.K. Prospective Diabetes Study.

© 2004 by the American Diabetes Association.

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

DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004 S15

tify opportunistic screening in a clinicalsetting of individuals at high risk. Criteriafor testing for diabetes in asymptomatic,undiagnosed adults are listed in Table 3.The recommended screening test for non-pregnant adults is the FPG. The OGTT ismore sensitive for the diagnosis of diabe-tes and pre-diabetes, but is impracticaland expensive as a screening procedure.

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 (13) (Table 4).

Detection and diagnosis of GDMRisk assessment for GDM should be un-dertaken at the first prenatal visit. Women

with 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 or

serum glucose concentration 1 h after a50-g oral glucose load (glucose chal-lenge test [GCT]) and perform a diag-nostic 100-g OGTT on that subset ofwomen exceeding the glucose thresh-old value on the GCT. When the two-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,�180 mg/dl at 1 h, �155 mg/dl at 2 h,and �140 mg/dl at 3 h. Two or more ofthe plasma glucose values must be metor exceeded for a positive diagnosis.The test should be done in the morningafter an overnight fast of 8–14 h. Thediagnosis can be made using a 75-g glu-cose load, but that test is not as well

Table 1—ADA evidence grading system for clinical practice recommendations

Level ofevidence Description

A Clear evidence from well-conducted, generalizable, randomized controlled trials that 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 analysis

B Supportive evidence from well-conducted cohort studies● Evidence from a well-conducted prospective cohort study or registry● Evidence from a well-conducted prospective cohort study● Evidence from a well-conducted meta-analysis of cohort studiesSupportive evidence from a well-conducted case-control study

C Supportive evidence from poorly controlled or uncontrolled studies● Evidence from randomized clinical trials with one or more major or three or more minor methodological flaws that could

invalidate the results● Evidence from observational studies with high potential for bias (such as

case series with comparison to historical controls)● Evidence from case series or case reportsConflicting evidence with the weight of evidence supporting the recommendation

E 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 timesince last meal. The classic symptoms of diabetes include polyuria, polydipsia, and unexplained weight loss.

OR2. FPG 126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for at least 8 h.

OR3. 2-h PG 200 mg/dl (11.1 mmol/l) during an OGTT. The test should be performed as described by the World Health Organization (4a),

using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water.

In the absence of unequivocal hyperglycemia, these criteria should be confirmed by repeat testing on a different day. The OGTT is not recommended for routineclinical use, but may be required in the evaluation of patients with IFG (see text) or when diabetes is still suspected despite a normal FPG.

Position Statement

S16 DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004

validated for detection of at-risk infantsor mothers as the 100-g OGTT.

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

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

low prevalence of GDM.• No known diabetes in first-degree

relatives.• No history of abnormal glucose tol-

erance.• No history of poor obstetric out-

come.

Recommendations● The FPG is the preferred test to screen

for and diagnose diabetes in childrenand nonpregnant adults. (E)

● Screen for diabetes in high-risk, asymp-tomatic, undiagnosed adults and chil-dren within the health care setting. (E)

● In those with pre-diabetes (IFG/IGT),lifestyle modification should be

strongly recommended and progres-sion of glycemic abnormalities followedby screening at least yearly. (A)

● Screen for diabetes in pregnancy usingrisk factor analysis and screening testsas noted; the OGTT is the preferredscreening test in pregnancy. (E)

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.

MANAGEMENTPeople with diabetes should receivemedical care from a physician-coordi-nated team. Such teams may include,but are not limited to, physicians,nurse practitioners, physician’s assis-tants, nurses, dietitians, pharmacists, andmental health professionals with exper-tise and a special interest in diabetes. It isessential in this collaborative and inte-grated team approach that individualswith diabetes assume an active role intheir care.

The management plan should be for-mulated as an individualized therapeuticalliance among the patient and family, thephysician, and other members of thehealth care team. Any plan should recog-nize diabetes self-management educationas an integral component of care. In de-veloping the plan, consideration shouldbe given to the patient’s age, school orwork schedule and conditions, physicalactivity, eating patterns, social situationand personality, cultural factors, andpresence of complications of diabetes or

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, ifnormal, should be repeated at 3-year intervals.

2. Testing should be considered at a younger age or be carried out more frequently in individuals who are overweight (BMI 25 kg/m2*) andhave 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 children

● CriteriaOverweight (BMI �85th percentile for age and sex, weight for height �85th percentile, or weight �120% of ideal for height)

PlusAny two of the following risk factors:

Family history of type 2 diabetes in first- or second-degree relativeRace/ethnicity (Native American, African American, Latino, Asian American, Pacific Islander)Signs of insulin resistance or conditions associated with insulin resistance (acanthosis nigricans, hypertension, dyslipidemia, or PCOS)

● Age of initiation: age 10 years or at onset of puberty, if puberty occurs at a younger age● Frequency: every 2 years● Test: FPG preferred

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

Standards of Medical Care


other medical conditions. A variety ofstrategies 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.

Glycemic controlGlycemic control is fundamental to themanagement of diabetes. Prospective ran-domized clinical trials such as the Diabe-tes Control and Complications Trial

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 AIC 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 complications associated withdiabetes

● 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● 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 in adults (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

Position Statement


(DCCT) (15) and the U.K. Prospective Di-abetes Study (UKPDS) (16,17) haveshown that improved glycemic control isassociated with sustained decreased ratesof retinopathy, nephropathy, and neu-ropathy (18). 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 (19,20). Epidemiologicalstudies support the potential of intensiveglycemic control in the reduction of CVD(15–20).

Recommended glycemic goals fornonpregnant individuals are shown in Ta-ble 6. A major limitation to the availabledata are that they do not identify the op-timum 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, and pharmacologicalagents) contribute to the reduction of

complications. 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%) can be considered in individ-ual patients based on epidemiologicalanalyses that suggest that there is no lowerlimit of A1C at which further loweringdoes not reduce risk of complications, atthe risk of increased hypoglycemia (par-ticularly in those with type 1 diabetes).However, the absolute risks and benefitsof lower targets are unknown. The risksand benefits of an A1C goal of �6% arecurrently being tested in an ongoing study(ACCORD [Action to Control Cardiovas-cular Risk in Diabetes]) in type 2 diabetes(21). Elevated postchallenge (2-h OGTT)glucose values have been associated with

increased 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 (22).

For information on glycemic controlfor women with GDM, refer to the ADAposition statement “Gestational DiabetesMellitus” (14). For information on glyce-mic control during pregnancy in womenwith preexisting diabetes, refer to MedicalManagement of Pregnancy Complicated byDiabetes (3rd ed.) (23).

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). In such instances, addi-t ional act ions suggested includeenhanced diabetes self-management edu-cation, comanagement with a diabetesteam, change in pharmacological therapy,initiation of or increase in self-monitoringof blood glucose (SMBG), more frequentcontact with the patient, and referral to anendocrinologist.

Intercurrent illnessThe stress of illness frequently aggravatesglycemic control and necessitates morefrequent monitoring of blood glucose andurine or blood ketones. A vomiting illnessaccompanied by ketosis may indicate di-abetic ketoacidosis (DKA), a life-threatening condition that requiresimmediate medical care to prevent com-plications and death; the possibility ofDKA should always be considered (24).Marked hyperglycemia requires tempo-rary adjustment of the treatment programand, if accompanied by ketosis, frequentinteraction with the diabetes care team.The patient treated with oral glucose-lowering agents or medical nutrition ther-apy (MNT) alone may temporarily require

Table 6—Summary of recommendations for adults with diabetes

Glycemic controlAIC �7.0%*Preprandial plasma glucose 90–130 mg/dl (5.0–7.2 mmol/l)Postprandial plasma glucose† �180 mg/dl (�10.0 mmol/l)

Blood pressure �130/80 mmHgLipids‡

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:● Goals should be individualized● Certain populations (children, pregnant women,

and elderly) require special considerations● Less intensive glycemic goals may be indicated

in patients with severe or frequenthypoglycemia

● More stringent glycemic goals (i.e. a normalA1C, �6%) may further reduce complicationsat the cost of increased risk of hypoglycemia(particularly in those with type 1 diabetes)

● Postprandial glucose may be targeted if AICgoals are not met despite reaching preprandialglucose 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 (61). §For women,it has been suggested that the HDL goal be increased by 10 mg/dl.



insulin. 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 (25).Aggressive glycemic management withinsulin may reduce morbidity in patientswith severe acute illness (26).

For information on management ofpatients in the hospital, refer to the ADAposition statement titled “HyperglycemicCrises in Diabetes ” (24).

Recommendations● Lowering A1C has been associated with

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

● Develop or adjust the managementplan to achieve normal or near-normalglycemia with an A1C goal of �7%. (B)

● More stringent goals (i.e., a normalA1C, �6%) can be considered in indi-vidual patients. (B)

● Lowering A1C may lower the risk ofmyocardial infarction and cardiovascu-lar death. (B)

● Aggressive glycemic management withinsulin may reduce morbidity in pa-tients with severe acute illness, periop-eratively and following myocardialinfarction. (B)

● 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)

ASSESSMENT OF GLYCEMICCONTROLTechniques are available for health pro-viders and patients to assess the effective-ness of the management plan on glycemiccontrol.

SMBGThe ADA’s consensus statements onSMBG provide a comprehensive review ofthe subject (27,28). 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 allows

patients 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. For mostpatients with type 1 diabetes and preg-nant women taking insulin, SMBG is rec-ommended three or more times daily. Theoptimal frequency and timing of SMBGfor patients with type 2 diabetes is notknown but should be sufficient to facili-tate reaching glucose goals. When addingto or 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 (29), 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.

Recommendations● SMBG is an integral component of dia-

betes therapy. (B)● Include SMBG in the management

plan. (E)● Instruct the patient in SMBG and rou-

tinely evaluate the patient’s techniqueand ability to use data to adjust therapy.(E)

A1CBy performing an A1C test, health provid-ers can measure a patient’s average glyce-mia over the preceding 2–3 months (29)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 2–3

months, 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.

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 DCCT (30).

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) and quarterly in patientswhose therapy has changed or who arenot meeting glycemic goals. (E)

MNTMNT is an integral component of diabetesmanagement and diabetes self-manage-ment education. A review of the evidenceand detailed information can be found inthe ADA technical review and positionstatement in this area (31,32). Peoplewith diabetes should receive individual-ized MNT as needed to achieve treatmentgoals, preferably provided by a registereddietitian familiar with the components of

Table 7—Correlation between A1C level andmean plasma glucose levels (30)

AIC (%)

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

Position Statement


diabetes MNT. Goals of MNT that applyto all persons with diabetes are as follows:

● Attain and maintain recommendedmetabolic outcomes, including glucoseand A1C levels; LDL cholesterol, HDLcholesterol, and triglyceride levels;blood pressure; and body weight (seeTable 6).

● Prevent and treat the chronic complica-tions and comorbidities of diabetes.Modify nutrient intake and lifestyle asappropriate for the prevention andtreatment of obesity, dyslipidemia,CVD, hypertension, and nephropathy.

● Improve health through healthy foodchoices and physical activity.

● Address individual nutritional needs,taking into consideration personal andcultural preferences and lifestyle whilerespecting the individual’s wishes andwillingness to change.

Goals of MNT that apply to specific situ-ations include the following:

● For youth with type 1 diabetes, provideadequate energy to ensure normalgrowth and development; integrate in-sulin regimens into usual eating andphysical activity habits.

● For youth with type 2 diabetes, facilitatechanges in eating and physical activityhabits that reduce insulin resistance andimprove metabolic status.

● For pregnant and lactating women,provide adequate energy and nutrientsneeded for optimal outcomes.

● For older adults, provide for the nutri-tional and psychosocial needs of an ag-ing individual.

● For individuals treated with insulin orinsulin secretagogues, provide self-management education for treatment(and prevention) of hypoglycemia,acute illnesses, and exercise-relatedblood glucose problems.

● For individuals at risk for diabetes, de-crease risk by encouraging physical ac-tivity and promoting foods choices thatfacilitate moderate weight loss or atleast prevent weight gain.

Achieving nutrition-related goals requiresa coordinated team effort that includesthe person with diabetes. Because of thecomplexity of nutrition issues, it is recom-mended that a registered dietitian, knowl-edgeable and skilled in implementingnutrition therapy into diabetes manage-

ment and education, is the team memberwho provides MNT. However, it is essen-tial that all team members are knowledge-able about nutrition therapy and aresupportive of the person with diabeteswho needs to make lifestyle changes.

MNT involves a nutrition assessmentto evaluate the patient’s food intake, met-abolic status, lifestyle and readiness tomake changes, goal setting, dietaryinstruction, and evaluation. To facilitateadherence, the plan should be individu-alized and take into account cultural, life-style, and financial considerations.Monitoring of glucose and A1C, lipids,blood pressure, and renal status is essen-tial to evaluate nutrition-related out-comes. If goals are not met (Table 6),changes must be made in the overall dia-betes care and management plan.

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)

PHYSICAL ACTIVITYADA technical reviews on exercise in pa-tients with diabetes have summarized thevalue of exercise in the diabetes manage-ment plan (33,34). 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 (6–8).

Before beginning a physical activityprogram, the patient with diabetes shouldhave a detailed medical evaluation withappropriate diagnostic studies. This ex-amination should screen for the presenceof macro- and microvascular complica-tions that may be worsened by the phys-ical activity program (see next sectionregarding coronary heart disease [CHD]screening). Identification of areas of con-cern will allow the design of an individu-alized physical activity plan that canminimize risk to the patient.

All levels of physical activity, includ-ing leisure activities, recreational sports,and competitive professional perfor-mance, can be performed by people withdiabetes who do not have complicationsand have good glycemic control. The abil-ity to adjust the therapeutic regimen (in-sulin therapy and MNT) to allow safe

participation is an important manage-ment strategy.

Recommendations● A regular physical activity program,

adapted to the presence of complica-tions, is recommended for all patientswith diabetes who are capable of partic-ipating. (B)

PREVENTION ANDMANAGEMENT OFDIABETES COMPLICATIONS

I. CVD: management of risk factorsand screening for coronary arterydiseaseCVD is the major cause of mortality forpersons with diabetes. It is also a majorcontributor to morbidity and direct andindirect costs of diabetes. Type 2 diabetesis an independent risk factor for macro-vascular disease, and its common coexist-ing conditions (e.g., hypertension anddyslipidemia) 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 (35), dyslipide-mia (36), aspirin therapy (37), and smok-ing cessation (38) and in the consensusstatement on CHD in people with diabe-tes (39). Emphasis should be placed onreducing cardiovascular risk factors,when possible, and clinicians should bealert for signs and symptoms of athero-sclerosis.

A. Blood pressure controlHypertension (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, dyslipidemia) that isaccompanied 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 in persons



with diabetes (40 – 43). Epidemiologicanalyses show that blood pressures�115/75 mmHg are associated with in-creased cardiovascular event rates andmortality in persons with diabetes(40,44,45). 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 persons with di-abetes, reducing sodium intake and bodyweight (when indicated), increasing con-sumption of fruits, vegetables, and low-fatdairy products, avoiding excessive alco-hol consumption, and increasing activitylevels have been shown to be effective inreducing blood pressure in nondiabeticindividuals (46a). These nonpharmaco-logical strategies may also positively affectglycemia and lipid control. Their effectson cardiovascular events have not beenwell 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 (47,48). Additionally, recentdata in people with diabetic nephropathyindicate that ARBs may be superior to DC-CBs for reducing cardiovascular events(49). Conversely, in the recently com-pleted International Verapamil Study(INVEST) of more than 22,000 peoplewith coronary artery disease and hyper-tension, the nondihydropyridine calciumchannel blocker, verapamil, demon-strated a similar reduction in cardiovascu-lar mortality to a �-blocker. Moreover,this relationship held true in the diabeticsubgroup (49a).

ACE inhibitors have been shown toimprove cardiovascular outcomes inhigh-cardiovascular-risk patients with orwithout hypertension (50,51). In patientswith congestive heart failure, ACE inhib-itors are associated with better outcomeswhen compared with ARBs. ARBs also im-prove cardiovascular outcomes in thesubset of patients with hypertension, dia-betes, and end-organ injury (52). Thecompelling effect of ACE inhibitors orARBs in patients with albuminuria or re-nal insufficiency provide additional ratio-

nale for use of these agents (see section IIbelow).

The ALLHAT (Antihypertensive andLipid-Lowering Treatment to PreventHeart Attack Trial), 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 (53). The�-blocker arm of the ALLHAT was termi-nated after interim analysis showed thatdoxazosin was substantially less effectivein reducing congestive heart failure thandiuretic therapy (54).

Before beginning treatment, patientswith elevated blood pressures shouldhave their blood pressure reexaminedwithin 1 month to confirm the presence ofhypertension. A systolic blood pressure�160 mmHg or a diastolic blood pres-sure �100 mmHg, however, mandatesthat immediate pharmacological therapybe initiated. Patients with hypertensionshould be seen as often as needed untilthe recommended blood pressure goal isobtained and then seen as necessary (40).In these patients, other cardiovascularrisk factors, including obesity, hyperlip-idemia, smoking, presence of microalbu-minuria (assessed before initiation oftreatment), and glycemic control, shouldbe carefully assessed and treated. Manypatients will require three or more drugsto reach target goals.

Recommendations

Screening and diagnosis● Blood pressure should be measured at

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

Goals● Patients with diabetes should be treated

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

● 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 receive

drug 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 bloodpressure 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 ARB. If one class is not tol-erated, the other should be substituted.If needed to achieve blood pressure tar-gets, a thiazide diuretic should beadded. (E)

● If ACE inhibitors, ARBs, or diuretics areused, monitor renal function and se-rum potassium levels. (E)

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

● In patients with type 2 diabetes, hyper-tension, and microalbuminuria, ACEinhibitors and ARBs have been shownto delay the progression to macroalbu-minuria. (A)

● In those with type 2 diabetes, hyperten-sion, macroalbuminuria, and renal in-sufficiency, ARBs have been shown todelay the progression of nephropathy.(A)

● 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-

Position Statement


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)

B. Lipid managementPatients 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 those who have hadprior cardiovascular events.

In studies using HMG (hydroxymeth-ylglutaryl) CoA reductase inhibitors (st-atins), patients with diabetes achievedsignificant reductions in coronary and ce-rebrovascular events (55–58). In twostudies using the fibric acid derivativegemfibrozil, reductions in cardiovascularend points were also achieved (59,60).

Target lipid levels are shown in Table6. Lifestyle intervention including MNT,increased physical activity, weight loss,and smoking cessation should allow somepatients to reach these lipid levels. Nutri-tion intervention should be tailored ac-cording 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 maybe necessary to con-trol hypertriglyceridemia.

Pharmacological treatment is indi-cated if there is an inadequate response tolifestyle modifications and improved glu-cose control. However, in patients withclinical CVD and LDL �100 mg/dl, phar-macological therapy should be initiated atthe same time that lifestyle intervention isstarted.

The first priority of pharmacologicaltherapy is to lower LDL cholesterol to atarget goal of �100 mg/dl (2.60 mmol/l).For LDL lowering, statins are the drugs ofchoice (61).

The Heart Protection Study demon-strated that in people with diabetes overthe age of 40 with a total cholesterol�135 mg/dl, LDL reduction of �30%

from baseline with the statin, simvastatinwas associated with an �25% reductionin the first event rate for major coronaryartery events independent of baselineLDL, preexisting vascular disease, type orduration of diabetes, or adequacy of gly-cemic control (58). Therefore, in patientsover the age of 40, statin therapy shouldbe routinely considered. In patients withLDL �130 mg/dl, initial therapy withboth lifestyle intervention and a statin isindicated. In patients with LDL between100 mg/dl (2.60 mmol/l) and 129 mg/dl(3.30 mmol/l), a variety of treatmentstrategies are available, including moreaggressive nutrition intervention or phar-macological treatment with a statin. If theHDL is �40 mg/dl and the LDL is be-tween 100 and 129 mg/dl, a fibric acidderivative or niacin might be used.

Niacin is the most effective drug forraising HDL but can significantly increaseblood glucose at a high dose. 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 modestchanges in glucose that are generally ame-nable to adjustment of diabetes therapy(62,63).

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.

In children and adolescentswith dia-betes, LDL cholesterol should be loweredto �100 mg/dl (2.60 mmol/l) using dietand medications based on LDL level andother cardiovascular risk factors in addi-tion to diabetes (64,65).

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), repeat lipid assessmentsevery 2 years. (E)

● In children �2 years of age, perform alipid profile after diagnosis of diabetesand when glucose control has been es-

tablished.• Type 1 diabetes: Begin prior to pu-

berty, if positive family history ofCVD (or if family history is un-known), and at puberty, if familyhistory is known and is negative.

• Type 2 diabetes: Begin at diagnosis,regardless of pubertal status.

• If lipid values are considered lowrisk, repeat lipid profile every 2–5years based on CVD risk status.

Treatment recommendations andgoals● Lifestyle modification focusing on the

reduction of saturated fat and choles-terol intake, weight loss, increasedphysical activity, and smoking cessa-tion has been shown to improve thelipid profile in patients with diabetes.(A)

● Patients who do not achieve lipid goalswith lifestyle modifications requirepharmacological therapy. (A)

● Lower LDL cholesterol to �100 mg/dl(2.6 mmol/l) as the primary goal oftherapy for adults. (B)

● Lowering LDL cholesterol with a statinis associated with a reduction in cardio-vascular events. (A)

● In people with diabetes over the age of40 with a total cholesterol �135 mg/dl,statin therapy to achieve an LDL reduc-tion of �30% regardless of baselineLDL levels may be appropriate. (A)

● In children and adolescents with diabe-tes, LDL cholesterol should be loweredto �100 mg/dl (2.60 mmol/l) usingdiet as well as medications based onLDL level and other cardiovascular riskfactors in addition to diabetes. (E)

● 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 may beappropriate. (C)

● Lowering triglycerides and increasingHDL cholesterol with a fibrate are asso-ciated with a reduction in cardiovascu-lar events in patients with clinical CVD,low HDL and near-normal levels ofLDL. (A)

● Combination therapy employing st-atins and fibrates or niacin may be nec-essary to achieve lipid targets, but havenot been evaluated in outcomes studiesfor either event reduction or safety. (E)



C. Anti-platelet agents in diabetesThe use of aspirin in diabetes is reviewedin detail in the ADA technical review (37)and position statement (66) on aspirintherapy. Aspirin has been recommendedas a primary (66a,66b) and secondarytherapy to prevent cardiovascular eventsin diabetic and nondiabetic individuals.One large meta-analysis and several clin-ical trials demonstrate the efficacy of us-ing aspirin as a preventive measure forcardiovascular events, including strokeand myocardial infarction. Many trialshave shown an �30% decrease in myo-cardial infarction and a 20% decrease instroke in a wide range of patients, includ-ing young and middle-aged patients, pa-tients with and without a history of CVD,males and females, and patients with hy-pertension.

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 below 30 years, aspirinhas not been studied.

Clopidogrel has been demonstratedto reduce CVD rates in diabetic individu-als (67). Adjunctive therapy in very high-risk patients or as alternative therapy inaspirin-intolerant patients should be con-sidered.

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

as a secondary prevention strategy inthose with diabetes with a history ofmyocardial infarction, vascular bypassprocedure, stroke or transient ischemicattack, peripheral vascular disease,claudication, and/or angina. (A)

● Use aspirin therapy (75–162 mg/day)as a primary prevention strategy inthose with type 2 diabetes at increasedcardiovascular risk, including thosewho are over 40 years of age or whohave additional risk factors (family his-tory of CVD, hypertension, smoking,dyslipidemia, albuminuria). (A)

● Use aspirin therapy (75–162 mg/day)as a primary prevention strategy inthose with type 1 diabetes at increasedcardiovascular risk, including thosewho are over 40 years of age or whohave additional risk factors (family his-tory of CVD, hypertension, smoking,dyslipidemia, albuminuria). (C)

● People with aspirin allergy, bleeding

tendency, receiving anticoagulant ther-apy, recent gastrointestinal bleeding,and clinically active hepatic disease arenot candidates for aspirin therapy.Other antiplatelet agents may be a rea-sonable alternative for patients withhigh risk. (E)

● Aspirin therapy should not be recom-mended for patients under the age of 21years because of the increased risk ofReye’s syndrome associated with aspi-rin use in this population. People underthe age of 30 have not been studied. (E)

D. Smoking cessationIssues of smoking in diabetes are re-viewed in detail in the ADA technical re-view (38) and position statement (68) onsmoking cessation. A large body of evi-dence 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 (69,70).

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.

Recommendations● Advise all patients not to smoke. (A)

● Include smoking cessation counselingand other forms of treatment as a rou-tine component of diabetes care. (B)

E. CHD screening and treatmentCHD screening and treatment are re-viewed in detail in the ADA consensusstatement on CHD in people with diabe-tes (39). To identify the presence of CHDin diabetic patients without clear or sug-gestive symptoms of coronary artery dis-ease (CAD), a risk factor–based approachto the initial diagnostic evaluation andsubsequent follow-up is recommended.At least annually, cardiovascular risk fac-tors should be assessed. These risk factorsinclude 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 ACE in-hibitor.

Candidates for a diagnostic cardiacstress test include those with 1) typical oratypical cardiac symptoms and 2) an ab-normal resting electrocardiogram (ECG).Candidates for a screening cardiac stresstest include those with 1) a history of pe-ripheral or carotid occlusive disease; 2)sedentary lifestyle, age �35 years, andplans to begin a vigorous exercise pro-gram; and 3) two or more of the risk fac-tors noted above.

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.

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 cardiologistis recommended regarding further work-up.

Recommendations● Perform exercise stress testing in

asymptomatic diabetic patients basedon the criteria outlined above. Considera risk factor–based strategy for the di-agnosis of CAD that might include

Position Statement


stress ECG and/or stress echocardiogra-phy and/or perfusion imaging. (E)

● Refer patients with signs and symptomsof CVD or with positive noninvasivetest for CAD to a cardiologist for furtherevaluation. (E)

● In patients with treated congestiveheart failure, metformin use is contra-indicated. The thiazolidinediones areassociated with fluid retention, andtheir use can be complicated by the de-velopment of congestive heart failure.Caution in prescribing thiazolidinedio-nes in the setting of known congestiveheart failure or other heart diseases aswell as in patients with preexistingedema or concurrent insulin therapy isrequired. (E)

● In patients �55 years of age, with orwithout hypertension but with anothercardiovascular risk factor (history ofCVD, dyslipidemia, microalbuminuria,smoking), an ACE inhibitor (if not con-traindicated) should be considered toreduce 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)

II. Nephropathy screening andtreatmentDiabetic 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 (71).

Patients with microalbuminuria whoprogress to macroalbuminuria (�300mg/24 h) are likely to progress to ESRDover a period of years (72,73). 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 (74,75) and type 2 diabetes

(16). The UKPDS provided strong evi-dence that control of blood pressure canreduce the development of nephropathy(41). 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 progres-sion from micro- to macroalbuminuriaand can slow the decline in glomerularfiltration rate (GFR) in patients with mac-roalbuminuria (41,76–78).

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 (50).ARBs have also been shown to reduce therate of progression from micro- to mac-roalbuminuria as well as ESRD in patientswith type 2 diabetes (79–81). Some evi-dence suggests that ARBs have a smallermagnitude of rise in potassium comparedwith ACE inhibitors in people with ne-phropathy (82). 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 (49). In the set-ting of albuminuria or nephropathy, inpatients unable to tolerate ACE inhibitorsand/or ARBs, consider the use of non-DCCBs, �-blockers, or diuretics for themanagement of blood pressure (83,84).

A meta-analysis of several small stud-ies has shown that protein restriction maybe of benefit in some patients whose ne-phropathy seems to be progressing de-spite optimal glucose and blood pressurecontrol (85).

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(86,87). The other two alternatives (24-hcollection and a timed specimen) arerarely necessary. Measurement of a spot

urine microalbumin by immunoassay orby using a dipstick test specific for mi-croalbumin without simultaneously mea-suring urine creatinine is less expensivethan the recommended methods, but issusceptible to false-negative and false-positive determinations as a result of vari-ation in urine concentration due tohydration and other factors.

At least two of three tests measuredwithin a 6-month period should show el-evated levels before a patient is designatedas having microalbuminuria. Abnormali-ties of albumin excretion are defined inTable 8.

Physicians may use the Levey modifi-cation of the Cockcroft and Gault equa-tion to calculate estimated GFR (eGFR)from serum creatinine and to stage thepatient’s renal disease (87,88). The eGFRcan easily be calculated by going to www.kidney.org/professionals/dogi/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. Many experts suggest thatmanaging urine microalbuminuria to re-duce it to the normal or near-normalrange may improve renal and cardiovas-cular prognosis; this approach has notbeen formally evaluated in prospectivetrials.

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�1 � 1.73 m�2 or if difficul-ties occur in the management of hyper-

Table 8—Definitions of abnormalities in al-bumin excretion

CategorySpot collection

(�g/mg creatinine)

Normal �30Microalbuminuria 30–299Macro (clinical)

albuminuria300

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,congestive heart failure, marked hyperglycemia, andmarked hypertension may elevate urinary albuminexcretion over baseline values.



tension or hyperkalemia. It is suggestedthat consultation with a nephrologist beobtained when the GFR is �30 ml �min�1 � 1.73 m�2. Early referral of suchpatients has been found to reduce costand improve quality of care and keep peo-ple off dialysis longer (89). For a completediscussion on the treatment of nephropa-thy, see the ADA’s position statement “Di-abetic Nephropathy” (90).

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)

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. (E)

Treatment● In the treatment of both micro- and

macroalbuminuria, either ACE inhibi-tors or ARBs should be used. (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, withhypertension and any degree of albu-minuria, ACE inhibitors have beenshown to delay the progression ofnephropathy. (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�1

body wt�1 � day�1 (�10% of daily cal-

ories), the current adult-recommendeddietary allowance for protein. Furtherrestriction may be useful in slowing thedecline of GFR in selected patients. (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. (E)

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

● Consider referral to a physician experi-enced in the care of diabetic renal dis-ease when the eGFR has fallen to �60ml � min�1 � 1.73 m�2 or if difficultiesoccur in the management of hyperten-sion or hyperkalemia. (B)

III. Diabetic retinopathy screeningand treatmentDiabetic 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.

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 (15,16).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 of pro-liferative diabetic retinopathy (PDR).Lowering blood pressure, as demon-strated by the UKPDS, has been shown todecrease the progression of retinopathy.Several case series and a controlled pro-spective study suggest that pregnancy intype 1 diabetic patients may aggravate ret-inopathy (91). During pregnancy and 1year postpartum, retinopathy may be

transiently aggravated; laser photocoagu-lation surgery can minimize this risk (92).

Patients with type 1 diabetes shouldhave an initial dilated and comprehensiveeye examination by an ophthalmologist oroptometrist within 3–5 years after the on-set of diabetes. Patients with type 2 diabe-tes should have an initial dilated andcomprehensive eye examination by anophthalmologist or optometrist shortlyafter the diagnosis of diabetes. Subse-quent examinations for type 1 and type 2diabetic patients should be repeated an-nually by an ophthalmologist or optome-t r i s t who is knowledgeab le andexperienced in diagnosing the presence ofdiabetic retinopathy and is aware of itsmanagement. Less frequent exams (every2–3 years) may be considered with theadvice of an eye care professional in thesetting of a normal eye exam (93–95). Ex-aminations will be required more fre-quently if retinopathy is progressing.

One of the main motivations forscreening for diabetic retinopathy is theestablished efficacy of laser photocoagu-lation surgery in preventing visual loss.Two large National Institutes of Health–sponsored trials, the Diabetic Retinopa-thy Study (DRS) (96–100) and the EarlyTreatment Diabetic Retinopathy Study(ETDRS), provide the strongest supportfor the therapeutic benefit of photocoag-ulation surgery (101–107).

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 high-riskcharacteristics (HRCs) (chiefly disc neo-vascularization or vitreous hemorrhagewith any retinal neovascularization). Ofcontrol eyes with HRCs, 26% progressedto severe visual loss vs. 11% of treatedeyes. Given the risk of a modest loss ofvisual acuity and of contraction of visualfield from panretinal laser surgery, suchtherapy has been primarily recommendedfor eyes approaching 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% ofuntreated eyes had a doubling of the vi-sual angle (e.g., 20/50 to 20/100) com-

Position Statement


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 nonproliferative diabetic reti-nopathy (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 benefi-cial in reducing the risk of further visualloss, but generally not beneficial in revers-ing already diminished acuity. This pre-ventive effect and the fact that patientswith PDR or macular edema may beasymptomatic provide strong support fora screening program to detect diabetic ret-inopathy.

For a detailed review of the evidenceand further discussion, see the ADA’stechnical review and position statementon this subject (91,108,109).

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 who is knowledge-

able and experienced in diagnosing thepresence of diabetic retinopathy and isaware of its management. Less frequentexams (every 2–3 years) may be consid-ered with the advice of an eye care pro-fessional in the setting of a normal eyeexam. Examinations will be requiredmore frequently if retinopathy is pro-gressing. (B)

● When planning pregnancy, womenwith preexisting diabetes should have acomprehensive eye examination andshould be counseled on the risk of de-velopment and/or progression of dia-betic retinopathy. Women withdiabetes who become pregnant shouldhave a comprehensive eye examinationin the first trimester and close fol-low-up throughout pregnancy and for1 year postpartum. This guideline doesnot apply to women who develop GDMbecause such individuals are not at in-creased risk for diabetic retinopathy.(B)

Treatment● Laser therapy can reduce the risk of vi-

sion loss in patients with HRCs. (A)● Promptly refer patients with any level of

macular edema, severe NPDR, or anyPDR to an ophthalmologist who isknowledgeable and experienced in themanagement and treatment of diabeticretinopathy. (A)

IV. Foot careAmputation 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 (decreasedor 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 conditions 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,bunions) 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 peripheral arte-rial disease (PAD) should include a his-tory for claudication and an assessment ofthe pedal pulses. Consider obtaining anankle-brachial index (ABI), as many pa-tients with PAD are asymptomatic. Refer



patients with significant or a positive ABIfor further vascular assessment and con-sider exercise, medications, and surgicaloptions (110).

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 offoot 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 area (111,112).

Problems involving the feet, espe-cially ulcers and wound care, may requirecare by a podiatrist, orthopedic surgeon,or rehabilitation specialist experienced inthe management of persons with diabetes.For a complete discussion on wound care,see the ADA’s consensus statement on di-abetic foot wound care (113).

Recommendations● A multidisciplinary approach is recom-

mended for persons with foot ulcersand high-risk feet, especially those witha history of prior ulcer or amputation.(A)

● The foot examination can be accom-plished in a primary care setting andshould include the use of a Semmes-Weinstein monofilament, tuning fork,palpation, and a visual examination. (B)

● Educate all patients, especially thosewith risk factors, including smoking, orprior lower-extremity complications,about the risk and prevention of footproblems and reinforce self-care behav-ior. (B)

● Refer high-risk patients to foot care spe-cialists for ongoing preventive care andlife-long surveillance. (C)

● Initial screening for PAD should in-clude a history for claudication and an

assessment of the pedal pulses. Con-sider obtaining an 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)

● Perform a comprehensive foot exami-nation annually on patients with diabe-tes to identify risk factors predictive ofulcers and amputations. Perform a vi-sual inspection of patients’ feet at eachroutine visit. (E)

PREVENTIVE CARE

I. Preconception careMajor 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 tri-mester 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 (114–118). 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 patients

rather 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 malformationsassociated 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 and position statementon this subject (119,120).

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 evaluated

Position Statement


and, 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)

II. ImmunizationInfluenza 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 (121). People withdiabetes may be at increased risk of thebacteremic form of pneumococcal infec-tion and have been reported to have ahigh risk of nosocomial bacteremia,which has a mortality rate as high as 50%.

Safe and effective vaccines are avail-able that can greatly reduce the risk ofserious complications from these diseases(122,123). 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 persons over 65 years

of age as well as for all persons of any agewith 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 (124,125).

Recommendations● Annually provide an influenza vaccine

to all diabetic patients 6 months of ageor older. (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)

SPECIAL CONSIDERATIONS

I. Care of older adults with diabetesDiabetes 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 persons withdiabetes can be expected to grow rapidlyover the coming decades. A recent publi-cation, “Guidelines for improving the careof the older person with diabetes,” con-tains evidence-based guidelines pro-duced in conjunction with the AmericanGeriatric Society. This document containsan excellent discussion of this area, andspecific guidelines and language from ithave been incorporated below (126). Un-fortunately, there are no long-term stud-ies in persons over 65 years of agedemonstrating the benefits of tight glyce-mic control, blood pressure, and lipidcontrol. Older persons with diabetes havehigher rates of premature death, func-tional disability, and coexisting illnessessuch as hypertension, CHD, and strokethan those without diabetes. Older adultswith diabetes are also at greater risk thanother older persons for several commongeriatric syndromes, such as polyphar-macy, depression, cognitive impairment,urinary incontinence, injurious falls, andpersistent pain.

The care of older adults with diabetesis complicated by their clinical and func-tional heterogeneity. Some older personsdeveloped diabetes in middle age and face

years of comorbidity; others who arenewly diagnosed may have had years ofundiagnosed 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 persons with diabeteshave little comorbidity and are active. Lifeexpectancies are also highly variable forthis population. Clinicians caring forolder adults with diabetes must take thisheterogeneity into consideration whensetting and prioritizing treatment goals.

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 per-sons with diabetes, greater reductions inmorbidity and mortality may result fromcontrol of all cardiovascular risk factorsrather than from tight glycemic controlalone. There is strong evidence from clin-ical trials of the value of treating hyper-tension in the elderly. There is lessevidence 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 special



care 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. Thiazo-lidinediones should not be used in pa-tients with congestive heart failure (NewYork Heart Association [NYHA] Class IIIand IV). Drugs should be started at thelowest dose and titrated up gradually un-til targets are reached or side effects de-velop. As well as regards blood pressureand lipid management, the potential ben-efits must always be weighed against po-tential risks.

II. Children and adolescentsApproximately three-quarters of all newlydiagnosed cases of type 1 diabetes occurin individuals younger than 18 years ofage. Care of this group requires integra-tion of diabetes management with thecomplicated physical and emotionalgrowth needs of children, adolescents,and their families.

Diabetes care for children of this age-group should be provided by a team thatcan deal with these special medical, edu-cational, nutritional, and behavioral is-sues.

At the time of initial diagnosis, it isextremely important to establish the goalsof care and to begin diabetes self-management education. A firm educa-tional base should be provided so that theindividual and family can become in-creasingly independent in the self-management of diabetes. Glycemic goalsmay need to be modified to take into ac-count the fact that most children youngerthan 6 or 7 years of age have a form of“hypoglycemic unawareness,” in that theylack the cognitive capacity to recognizeand respond to hypoglycemic symptomsand may be at greater risk for the sequelaeof hypoglycemia.

Intercurrent illnesses are more fre-quent in young children. Sick-day man-agement rules, including assessment forketosis with every illness, must be estab-lished and taught to prevent severe hyper-g lycemia and DKA that requireshospitalization and may lead to severemorbidity and even death (24). MNTshould be provided at diagnosis, and atleast annually thereafter, by an individual

experienced with the nutritional needs ofthe growing child and the behavioral is-sues that have an impact on adolescentdiets. Caution must be exercised to avoidoveraggressive dietary manipulation inthe very young. Assessment of lifestyleneeds should be accompanied by possiblemodifications of the diabetes regimen.For example, an adolescent who requiresmore flexibility might be switched to abasal/bolus insulin program with pre-prandial rapidly acting insulin adminis-tration or continuous subcutaneousinsulin injection (CSII).

A major issue deserving emphasis inthis age-group is that of “adherence.” Nomatter how sound the medical regimen, itcan only be as good as the ability of thefamily and/or individual to implement it.Family involvement in diabetes remainsan important component of optimal dia-betes management throughout childhoodand into adolescence. Health care provid-ers who care for children and adolescents,therefore, must be capable of evaluatingthe behavioral, emotional, and psychoso-cial factors that interfere with implemen-tation and then must work with theindividual and family to resolve problemsthat occur and/or to modify goals as ap-propriate.

The incidence of type 2 diabetes inchildren and adolescents has been shownto be increasing, especially in ethnic mi-nority populations (127,128). Althoughthere are insufficient data to make definiterecommendations, a recent ADA consen-sus statement provides guidance to theprevention, screening, and treatment oftype 2 diabetes in young people. The idealgoal of treatment is normalization ofblood glucose and A1C values. Accuratediagnosis and classification of diabetes iscrucial in determining appropriate treat-ment for these patients. Medical manage-ment should include MNT, exercise, andlifestyle interventions, but drug therapy,including insulin in many cases, isrequired. Successful control of comor-bidities, such as hypertension and hyper-lipidemia, is also important. For furtherdiscussion, see the ADA consensus state-ment “Type 2 Diabetes in Children andAdolescents” (13).

Information should be supplied tothe school or day care setting so thatschool personnel are aware of the diagno-sis of diabetes in the student and of thesigns, symptoms, and treatment of hypo-glycemia. It is desirable that blood glu-

cose testing be performed at the school orday care setting before lunch and whensigns or symptoms of abnormal bloodglucose levels are present. Many childrenmay require support for insulin adminis-tration by either injection or CSII beforelunch at school or in day care.

For further discussion, see the ADA’sposition statement “The Care of ChildrenWith Diabetes in the School and Day CareSetting” (129) and the NDEP publication“Helping the Student with Diabetes Succeed:A Guide for School Personnel” (National Di-abetes Education Program, 2003, ww-w.ndep.nih.gov).

Strategies for improving diabetescareThe implementation of the standards ofcare for diabetes is suboptimal in thehealth care system. The challenge of pro-viding effective diabetes care has thus fardefied a simple solution, yet numerousinterventions have been implementedwith strategies to improve adherence tothe recommended standards. Successfulprograms have published results showingimprovement in important outcomessuch as A1C measurements as well as pro-cess measures such as provision of eyeexams. The interventions have been fo-cused at this level of providers, the sys-tem, and patients. Features of successfulprograms reported in the literature in-clude:

● Improving provider education regard-ing the standards of care through for-mal and informal provider educationprogram.

● Adoption of practice guidelines, withparticipation of the providers in theprocess. Guidelines should be readilyaccessible at the point of service, suchas on patient charts, in examiningrooms, or on office computer systems.

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

● Systems changes, such as provision ofautomated reminders to providers andpatients, profiling or reporting of datato providers, and identification of pa-tients at risk because of abnormal targetvalues or a lack of reported values.

● Quality improvement programs com-bining CQI or other cycles of analysisand intervention with provider perfor-mance data.

● Practice changes, such as clustering of

Position Statement


dedicated diabetes visits and group vis-its.

● Tracking systems either with an elec-tronic medical record or patient regis-try have been helpful at increasingadherence to standards of care.

● Delivery of diabetes self-managementeducation has been shown to increaseadherence to standard of care.

● Availability of case management ser-vices, usually by a nurse. Nurses usingdetailed protocols working under thesupervision of physicians. Nurse edu-cation calls have been helpful.

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

● Clustering patients with diabetes intospecific times within a primary carepractice schedule.

● Other nonautomated systems such asmailing reminders to patients, chartstickers, and flow sheets have been use-ful to prompt both providers and pa-tients.

Because these interventions are generallyprovided as components of a multifacto-rial intervention, it is difficult to assess thecontribution of each component; how-ever, it is clear that optimal diabetes man-agement requ i re s an organ ized ,systematic approach and involvement of ahealth care team. Further research toidentify improved mechanisms to trans-late research into practice is necessary.Successful translation will require a mul-tidiscipline approach utilizing a variety ofbehavioral and technological approaches.

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 as well as process measuressuch as provision of eye exams. Featuresof successful programs reported in the lit-erature include:

● Adoption of practice guidelines, withparticipation of the providers in theprocess. Guidelines should be readilyaccessible at the point of service, suchas on patient charts, in examiningrooms, or on office computer systems.

● Systems changes, such as provision ofautomated reminders to providers and

patients, profiling or reporting of datato providers, and identification of pa-tients at risk because of abnormal targetvalues or a lack of reported values.

● Practice changes, such as scheduling ofdedicated diabetes visits and group vis-its.

● Delivery of diabetes self-managementeducation.

● Availability of case management ser-vices, usually by a nurse.

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

● Because these interventions are gener-ally provided as components of a mul-tifactorial intervention, it is difficult toassess the contribution of each compo-nent; however, it is clear that optimaldiabetes management requires an orga-nized, systematic approach and in-volvement of a health care team.

● Simple tools such as flow charts may beuseful in smaller practices.

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Documents

Standards of Medical Care in Diabetes · IGT 2-h plasma glucose 140 mg/dl (7.8 mmol/l) to 199 mg/dl (11.0 mmol/l) Recently, IFG and IGT have been ofﬁ-cially termed “pre-diabetes.”