Diagnosis and Management of Uncomplicated Type 2 Diabetes

Diagnosis and Management of

Uncomplicated Type 2 Diabetes Mellitus in Family Practice

Noel L. Espallardo, MD MSc for the PAFP Research Committee

Abstract

Background

The cost of DM treatment in the Philippines is mainly shouldered by the patient. Most patients rely

on "out-of-pocket" expenses, namely, laboratory procedures and daily medications. There are

guidelines available, unfortunately its dissemination and implementation rely on passive strategies.

This clinical pathway is an attempt to operationalize these guideline recommendations in family and

community outpatient practice.

Methods

The PAFP Clinical Pathways Group reviewed the published medical literature to identify, summarize, and operationalize the evidence in clinical publication on the management of patients with type 2 diabetes mellitus in family and community practice. The recommendations are time-bound tasks on patient care processes, in terms of history and physical examination, laboratory tests, pharmacologic and non-pharmacologic interventions.

Recommendations

First Visit

• Elicit symptoms of hyperglycemia i.e. polyuria, polyphagia, polydipsia, nocturia and weight

loss (A-II)

• General physical examination focus on cardiac, renal, peripheral pulse retinopathy,

neuropathy, skin and BMI (A-II)

• Conduct risk screening for asymptomatic and BMI≥25kg/m2 or ≥45 years old (A-II)

• Request for FBS or RBS or OGTT or Hgb A1C (A-I)

• Not advisable to give routine vitamin supplementation with antioxidants, such as vitamins E

and C and carotene (A-I)

• Structured health education on lifestyle changes (alcohol and smoking), moderate weight

loss, regular physical activity, reduced calories, sugar and dietary fat intake (A-III)

• Arrange for development and implementation of family-focused and community-oriented

intervention (A-III)

• Patient is aware of diabetes type 2 and management plan (A-III)

Second Visit

• Review the laboratory results and establish the diagnosis as diabetes type 2, pre-diabetes or

non-diabetes (A-II)

• If diabetes type 2 or pre-diabetes, asses the patient and family’s dietary patterns, physical

activity habits, nutritional status and weight history, diabetes understanding, psychological,

social and community health support systems (A-III)

• Evaluate social determinants of health (SCREEM) (A_III)

• If diabetes type 2, request for laboratory tests to detect complication or target organ

damage (A-II). If normal, repeat testing every year if there are risk factors and at least at 3-

year intervals if there are no risk factors (B-III)

• First step medication is Metformin 500 mg twice a day (A-I)

• If with marked symptoms and significantly elevated blood glucose levels or A1C, consider

metformin and insulin from the outset (A-II)

• If pre-diabetes metformin 500 mg once daily may be considered if there is impaired glucose

tolerance or impaired fasting glucose or A1C of 5.7–6.4% (A-II)

• Develop and agree on the management plan (A-III)

• Provide diabetes self-management education and counselling (A-II)

• Medical nutrition therapy focusing on limitation of carbohydrate and fat intake and weight

loss (A-I)

• Emphasize increase in physical activity (A-I)

• Limit alcohol intake, smoking cessation (A-II)

• Involve a family member/caregiver in the diabetes self-management education and

counselling, medical nutrition therapy, physical activity and limitation of alcohol intake (A-II)

• Setup a telemedicine and other digital application to complement face-to-face management

of patients (A-I)

• Patient outcomes are: 1) agree on management plan and goals, 2) Aware on medications,

dose and side effects, 3) aware on what to do if hyoglycemia occur (A-III)

Continuing Care

• Review of treatment regimens (medication adherence, meal plan, physical activity patterns,

and lifestyle change) and response to treatment (self-monitoring or A1C records) (A-II)

• Check for hypoglycemic episodes and other adverse events (A-II)

• Random or fasting blood sugar testing during clinic visit may be done to guide timely

treatment changes (A-III)

• A1C test quarterly or twice a year depending on response to treatment (A-III)

• Based on initial response, titrate metformin dose for 3 months to achieve treatment goal (A-

I). If the diabetes is not controlled by metformin after 1 month add basal insulin or another

oral hypoglycemic drugs (A-I) (be aware of contraindications)

• Enhance diabetes self-management education and counselling, medical nutrition therapy,

physical activity and limitation of alcohol intake (A-II)

• Enhance the family member/caregiver’s role in the diabetes self-management education and

counselling, medical nutrition therapy, physical activity and limitation of alcohol intake (A-II)

• Coordinate referral for social and economic support for the patient if needed (A-III)

• Empower community health workers and diabetic patients for coordination and monitoring

(A-III)

• Patient outcomes should be: 1) achievement of treatment goals (A-I), 2) improved quality of

life (A-I), 3) satisfaction to management plan (A-III), 4) continuing compliance to diabetes

self-management (A-III)

Implementation

We recommend that at the clinic level, self-reviews of chart records using the recommendations of

this clinical pathway as the criteria may be done. Identification of barriers and developing

interventions to promote compliance to the clinical pathway recommendations may be more

effective.

Background

The prevalence of diabetes type 2 is increasing worldwide and in Asian countries including

the Philippines. The increase is associated with urbanization associated with change in dietary

preferences and sedentary lifestyle. The American Diabetes Association (ADA) published the 2016

Standards of Medical Care in Diabetes. This provided guidelines to clinicians, researchers, payers,

patients, and other interested parties in diabetes care. The synopsis focuses on 8 key areas that are

important to primary care providers. The recommendations emphasized individualized care to

manage the disease, prevent or delay complications, and improve outcomes.1

Although glycaemic control and reduction of micro- and macrovascular outcomes remain

essential aspects of treatment, access and cost are major limiting factors; therefore, a pragmatic

approach is required in restricted-resource settings.2 In general, the recommendations are:

• Glycemic targets and glucose-lowering therapies must be individualized.

• Diet, exercise, and education remain the foundation of any type 2 diabetes treatment

program.

• Unless there are prevalent contraindications, metformin is the optimal first-line drug.

• After metformin, there are limited data to guide us. Combination therapy with an additional

1–2 oral or injectable agents is reasonable, aiming to minimize side effects where possible.

• Ultimately, many patients will require insulin therapy alone or in combination with other

agents to maintain glucose control.

• All treatment decisions, where possible, should be made in conjunction with the patient,

focusing on his/her preferences, needs, and values.

• Comprehensive cardiovascular risk reduction must be a major focus of therapy.3

• More recent versions of these guidelines have additional recommendations for patients with

clinical cardiovascular disease, a sodium-glucose cotransporter 2 (SGLT2) inhibitor or a

glucagon-like peptide 1 (GLP-1) receptor agonist with proven cardiovascular benefit.

• For patients with chronic kidney disease or clinical heart failure and atherosclerotic

cardiovascular disease, an SGLT2 inhibitor with proven benefit is recommended. GLP-1

receptor agonists are generally recommended as the first injectable medication.4

In the Philippines the cost of treatment is mainly shouldered by the patient. PHIC does not

currently reimburse outpatient care. Thus, most patients rely on "out-of-pocket" expenses, namely,

laboratory procedures and daily medications.5 There are guidelines available like the ones discussed

previously, unfortunately its dissemination and implementation rely on passive strategies, leading to

significant variation in health care. This clinical pathway is an attempt to operationalize these

guideline recommendations in family and community outpatient practice.

Objectives

This clinical pathway was developed to guide family and community physicians on the

diagnosis and continuing management of type 2 diabetes mellitus. It provides recommendations to

the following clinical decisions: 1) clinical history and physical examination; 2) laboratory and

ancillary procedures to be requested; 3) pharmacologic interventions; 4) non-pharmacologic

interventions; and 5) patient outcomes to expect.

Methods of Development and Implementation

The PAFP Clinical Pathways Group reviewed the published medical literature to identify, summarize, and operationalize the evidence in clinical publication on the management of patients with type 2 diabetes mellitus in family and community practice. The recommendations are time-bound tasks on patient care processes, in terms of history and physical examination, laboratory tests, pharmacologic and non-pharmacologic interventions.

The group adopted several strategies in developing the recommendations. The first strategy is emphasizing on evidence-based recommendations as recommended assessments and interventions. The second strategy is recognition of potential variations between-patient and between specific practice settings. The third strategy is the recognition of "stakeholder groups" in family and community practice with careful attention to getting their opinion and support but without sacrificing the objectives of developing and implementing clinical pathways. The fourth strategy is emphasis on the commitment to establish the ultimate goal of improving the effectiveness, efficiency and quality of patient care in family and community practice.

For the first strategy, the group searched PubMed and HERDIN using the terms “diabetes mellitus”, “type 2”, “diagnosis” and “treatment”. Retrieval of articles was focused on the following type of clinical publications, clinical practice guidelines, meta-analysis, randomized controlled trials and clinical trials. Then the strongly graded recommendations were adapted and included in the clinical pathway recommendations. Each recommendation was graded based on the level of evidence. The more rigorous meta-analysis of clinical trials and observational studies were prioritized over low-quality trials in the formulation and grading of the recommendations. The evidence for the patient care processes were reviewed and summarized as notes to justify the recommendations. The second strategy was to present the clinical pathway recommendations to the QA Committee who acted as panel of experts and discussed potential variations in different setting of family practice. A panel grade on the applicability of the recommendations was obtained. As part of the third strategy, the clinical pathway was then disseminated to the selected PAFP chapters and members and other stakeholders for consensus development. Dissemination was also done by publication in the Filipino Family Physician Journal, conference presentations (PAFP Annual Convention) and focused group discussions.

As a fourth strategy, the implementation of clinical pathways to be adopted by the PAFP was utilized as quality improvement activities in a form of patient record reviews, audit and feedback. Audit and review standards used were the recommendations in the clinical pathway. Implementation of clinical pathways was encouraged at the practice level and the organizational level. Practice level was a simple count of family and community medicine practitioners using and

applying the clinical pathways. Organizational level were activities of the PAFP devoted to the promotion, development, dissemination and implementation of clinical pathways.

Grading of the Recommendations

The PAFP QA Committee met as a panel and graded the recommendations as shown in Table

1. The grading system was a mix of the strength of the reviewed published evidence and the

consensus of a panel of experts. In some cases, the published evidence may not be applicable in

Philippine family and community practice setting, so a panel grade based on the consensus of clinical

experts was also used. Thus, if the recommendation was based on a published evidence that is a well

done randomized controlled trial and the panel of expert voted unanimously for the

recommendation, it was given a grade of A-I. If the level of evidence is based on an observational

study but the panel still unanimously considered the recommendation, the grade given was A-II and

if the level of evidence is just an opinion and the panel still unanimously recommended it, the grade

was A-III.

Table 1 Grading of the Recommendations

Panel Grade Level

Evidence Grade Level

1 2 3

A A-I A-II A-III

B B-I B-II B-III

C C-I C-II C-III

Panel Grade Levels

A - All the panel members agree that the recommendation should be adopted because it is

relevant, applicable and will benefit many patients.

B - Majority of the panel members agree that the recommendation should be adopted

because it is relevant, applicable in many areas and will benefit many patients.

C - Panel members were divided that the recommendation should be adopted and is not

sure if it will be applicable in many areas or will benefit many patients.

Evidence Grade Levels

I - The best evidence cited to support the recommendation is a well-conducted randomized

controlled trial. The CONSORT standard may be used to evaluate a well-conducted

randomized controlled trial.

II - The best evidence cited to support the recommendation is a well-conducted

observational study i.e. match control or before and after clinical trial, cohort studies, case

control studies and cross-sectional studies. The STROBE statement may be used to evaluate

a well-conducted observational study.

III - The best evidence cited to support the recommendation is based on expert opinion or

observational study that did not meet the criteria for level II.

In the implementation of the clinical pathways, the PAFP QA committee recommend

adherence to guideline recommendations that are graded as either A-I, A-II or B-I. However, the

committee also recommend using sound clinical judgment and patient involvement in the decision

making before applying the recommendations.

Pathway Recommendations

Visit

Pathway Tasks Patient Outcomes History and Physical Examination Laboratory Pharmacologic

Intervention Non-pharmacologic Interventions

First Visit __Elicit symptoms of hyperglycemia i.e. polyuria, polyphagia, polydipsia, nocturia and weight loss (A-II) __General physical examination focus on cardiac, renal, peripheral pulse retinopathy, neuropathy, skin and BMI (A-II) __Conduct risk screening for asymptomatic and BMI≥25kg/m2 or ≥45 years old (A-II)

__Request for FBS or RBS or OGTT or Hgb A1C (A-I) (This can also be done in patients with classic symptoms or in asymptomatic adults with BMI≥25kg/m2 and with risk factors or in asymptomatic adults ≥45yrs old with BMI≥25kg/m2)

__Not advisable to give routine vitamin supplementation with antioxidants, such as vitamins E and C and carotene (A-I)

Patient Intervention __Structured health education on lifestyle changes (alcohol and smoking), moderate weight loss, regular physical activity, reduced calories, sugar and dietary fat intake (A-III) Family-focused and Community-oriented interventions __Arrange for development and implementation of family-focused and community-oriented intervention (A-III)

__Aware of diabetes type 2 and management plan (A-III) Follow-up Visit __In 1-2 weeks (A-III)

Variations

__If during the first visit the patient has laboratory results that fit the classification of diabetes mellitus type 2, follow the recommendations during the second visit (A-III)

__If the doctor has doubts about the accuracy of available laboratory test, the test can be repeated for confirmation (A-III)

Visit

Pathway Tasks Patient Outcomes History and Physical Examination Laboratory Pharmacologic Intervention Non-pharmacologic Interventions

Second Visit

__Review the laboratory results and establish the diagnosis as diabetes type 2, pre-diabetes or non-diabetes (A-II) __If diabetes type 2 or pre-diabetes, asses the patient and family’s dietary patterns, physical activity habits, nutritional status and weight history, diabetes understanding, psychological, social and community health support systems (A-III) __Social determinants of health (SCREEM) (A_III)

__If diabetes type 2, request for laboratory tests to detect complication or target organ damage (A-II) __If normal, repeat testing every year if there are risk factors and at least at 3-year intervals if there are no risk factors (B-III)

__ Metformin 500 mg twice a day (A-I) __If with marked symptoms and significantly elevated blood glucose levels or A1C, consider metformin and insulin from the outset (A-II) __If pre-diabetes metformin 500 mg once daily may be considered if there is impaired glucose tolerance or impaired fasting glucose or A1C of 5.7–6.4% (A-II)

Patient Intervention __Develop and agree on the management plan (A-III) __Provide diabetes self-management education and counselling (A-II) __Medical nutrition therapy focusing on limitation of carbohydrate and fat intake and weight loss (A-I) __Emphasize increase in physical activity (A-I) __Limit alcohol intake, smoking cessation (A-II) Family Intervention __Involve a family member/caregiver in the diabetes self-management education and counselling, medical nutrition therapy, physical activity and limitation of alcohol intake (A-II) Telemedicine __Setup a telemedicine and other digital application to complement face-to-face management of patients (A-I)

__Aware of diagnosis of diabetes type 2, risks and complications (A-III) __Agree on management plan and goals (A-III) __Aware on medications, dose and side effects (A-III) __Aware on what to do if hyoglycemia occur Follow-up Visit __After 1 month (A-III)

Variations

Visit

Pathway Tasks Patient Outcomes History and Physical Examination Laboratory Pharmacologic Intervention Non-pharmacologic Interventions

Continuing Visit

__Review of treatment regimens (medication adherence, meal plan, physical activity patterns, and lifestyle change) and response to treatment (self-monitoring or A1C records) (A-II) __Check for hypoglycemic episodes and other adverse events (A-II) __ Continuing evaluation of psychosocial status (A-II) __Physical examination should focus on weight monitoring and the presence of vascular complications. (retinopathy, nephropathy, neuropathy, coronary heart disease, cerebrovascular disease, peripheral artery disease) (A-II)

__Random or fasting blood sugar testing during clinic visit may be done to guide timely treatment changes (A-III) __A1C test quarterly or twice a year depending on response to treatment (A-III)

__Based on initial response, titrate metformin dose for 3 months to achieve treatment goal (A-I) or __If the diabetes is not controlled by metformin after 1 month add basal insulin or another oral hypoglycemic drugs (A-I) (be aware of contraindications) __Adjust dose of other drugs (A-II)

Patient Intervention __Enhance diabetes self-management education and counselling, medical nutrition therapy, physical activity and limitation of alcohol intake (A-II) Family Intervention __Enhance the family member/caregiver’s role in the diabetes self-management education and counselling, medical nutrition therapy, physical activity and limitation of alcohol intake (A-II) Community-level Intervention __Coordinate referral for social and economic support for the patient if needed (A-III) __Empower community health workers and diabetic patients for coordination and monitoring (A-III)

__Achievement of treatment goals (A-I) __Improved quality of life (A-I) __Satisfaction to management plan (A-III) __Continuing compliance to diabetes self-management (A-III) Follow-up Visit __Monthly or quarterly depending on blood sugar control (A-III)

Variations

__Note contraindication

Clinical Evidence of the Recommendations

The management of diabetes must be patient-centered, family focused and community

oriented. Patient-centered care is defined as “providing care that is respectful of and responsive to

individual patient preferences, needs, and values”. Patients and families should be allowed to make

the final decisions regarding lifestyle changes and the pharmaceutical interventions they will take.

To ensure adherence to this multi-faceted intervention, family cooperation is also necessary. To

ensure adequate monitoring the effect of intervention, community resources must also be tapped.

Thus, in family and community practice, diabetes is best managed by a team. They include but are

not limited to, family physicians, nurse practitioners, physician’s assistants, dietitians, pharmacists,

and mental health professionals with special interest in diabetes.6 They should also include

community social and health workers.

First Visit

Clinical History and Physical Examination

The classical symptoms of type 2 diabetes mellitus are usually associated with

hyperglycemia i.e., polyuria, polydipsia and weight loss.7 Sometimes the symptoms are noticed late

in the disease and are already associated with complications like blurring of vision, numbness or

tingling sensation and slow or non-healing wound. The classic symptoms and symptoms associated

with complications must be elicited in the clinical history.

The minimum physical examination that must be done if diabetes mellitus type 2 is being

considered must be the following:

• Height, weight, and computation of BMI

• Blood pressure determination

• Fundoscopic examination

• Thyroid palpation

• Skin examination

• Comprehensive foot examination including inspection of pulses, reflexes, vibration and

sensation.6,7

If the initial clinical evaluation did not reveal the classical symptoms of diabetes, try to elicit

the following risk factors that can justify laboratory testing:

• physical inactivity

• first-degree relative with diabetes

• women who delivered a baby weighing ≥9 lb or who were diagnosed with GDM

hypertension (blood pressure 140/90 mmHg or on therapy for hypertension)

• HDL cholesterol level ≥35 mg/dL (0.90 mmol/L) and/or a triglyceride level 250 mg/dL (2.82

mmol/L)

• women with PCOS

• other clinical conditions associated with insulin resistance (e.g., severe obesity, acanthosis

nigricans)

• history of CVD

• A1C 5.7%, IGT, or IFG on previous testing

If the patient consulted with an available laboratory tests, try to establish the diagnosis

based on the available information and proceed to the tasks listed in the second visit.

Laboratory and Ancillary Procedures

To establish the diagnosis, either fasting blood sugar, random blood sugar, oral glucose

tolerance test and/or HbA1C may be done. Most clinical trials on diabetes consider derangement in

this laboratory parameters as definition and inclusion to a clinical trial on diabetes. Once the

diagnosis is established, the following tests are suggested to be done for individuals being seen for

the first time for evaluation of diabetes mellitus type 2:

• Fasting lipid profile, including total, LDL and HDL cholesterol and triglycerides if not yet done

within the past year

• Liver enzyme/transaminase tests (AST/ALT) and creatinine7

In asymptomatic patients, consider testing if overweight or obese (BMI≥25kg/m2) and who

have one or more additional risk factors for diabetes enumerated above. In those without risk

factors, testing may be done if the patient is age 45 years and above.6 Universal screening using

laboratory tests for diabetes is not recommended as it would identify very few individuals relative to

the cost it will entail.7

Pharmacologic Treatment

If the diagnosis of diabetes mellitus type 2 is not yet established, there is no need to start

pharmacologic treatment for diabetes. Routine supplementation with multi-vitamins or antioxidants,

such as vitamins E and C and carotene, is not advised because of lack of evidence of efficacy and

concern related to long-term safety. There is also no evidence that they prevent diabetes or its

complications.6

Non-pharmacologic Intervention

Patient-centered Non-pharmacologic Intervention

Family and community practice are an important setting for disease among populations who

are at high risk of developing disease like diabetes mellitus type 2. The first point of contact with the

health care system and professionals can provide lifestyle counselling and support, as well as

monitoring outcomes. A start-up opportunity during the first visit, undiagnosed patients but obese

or overweight individuals and at high risk for developing type 2 diabetes should receive structured

health education that emphasize lifestyle changes, moderate weight loss (7% body weight), regular

physical activity (150 min/week), reduced calories, sugar and dietary fat intake.6 In a meta-analysis

of 43 studies that included 49,029 participants, lifestyle modification resulted RR reduction of 39%

(RR, 0.61; 95% CI, 0.54-0.68) for the development of diabetes. It has a better and sustained effect

than pharmacologic intervention.8

Thematic areas of preventive interventions for diabetes have been identified in some

reviews. The first theme is that the primary care setting is the place where starting lifestyle change is

necessary to prevent diabetes and its progression. The second is that various patient factors such as

the patient's motivation, perceptions and knowledge and trust in their healthcare providers play an

important role. And third, are the health care provider factors like workload, time constraints,

resources, knowledge and perception of patient motivations towards change are also important. All

these must be considered in designing patient-centered health education intervention. These are

also relevant to the PAFP and its members to understand the factors associated with the delivery

and uptake of diabetes prevention interventions.9

During the first visit, the family and community physician should start exploring the

development and implementation of a family-focused and community-oriented health care program

for the patient. Lifestyle interventions targeting weight loss may be implemented via technology-

mediated interventions. These diabetes prevention programs can result in clinically significant

amounts of weight loss and improvements in glycaemia in patients with prediabetes.10

Patient Outcome

Health literacy skills are essential to enable self-management and shared decision-making in

patients with type 2 diabetes mellitus. In a systematic review of 29 studies involving 13,457 patients

from seven countries were included, the prevalence of limited health literacy ranged from 7.3% to

82%.11 After the first visit, it is expected that the patient becomes aware of the diabetes, the risk

factors and how it is diagnosed. The patient should also agree to comply with the diagnostic and

treatment plan.

Second Visit


During the second visit, a review of the requested laboratory should be able to make a more

definite diagnosis. The criteria for the diagnosis of diabetes are the following:

• HbA1C≥6.5%. The test should be performed in a laboratory using a method that is NGSP

certified and standardized to the DCCT assay.

or

• FPG≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 h.

or

• 2-h plasma glucose≥200mg/dL (11.1mmol/L) during an OGTT. The test should be performed

as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous

glucose dissolved in water.

or

• In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random

plasma glucose≥200 mg/dL (11.1 mmol/L)6

Some patients, despite the presence of risk factors may have laboratory findings that may

not be classified as diabetes mellitus type 2 but cannot be classified as totally normal. They are

considered prediabetes. Their laboratory results may be the following:6

• FPG 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) (IFG)

or

• 2-h plasma glucose in the 75-g OGTT 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L)

(IGT)

or

• A1C 5.7–6.4%

If the patient is already classified to be type 2 diabetes mellitus, further elaboration of the

patient’s clinical history should include the following:

• Eating patterns, physical activity habits, nutritional status and weight history

• Diabetes education and understanding

• This should be used to assist in formulating a management plan and the basis for continuing

care.

It is also recommended to include assessment of the patient’s psychological and social

situation which may include attitudes about the illness, expectations for medical management and

outcomes, affect/mood, depression and diabetes-related distress, anxiety, eating disorders and

cognitive impairment, general and diabetes related quality of life, resources (financial and social).6


If the patient is already diagnosed to have diabetes type 2 based on previous laboratory

results, additional laboratory tests appropriate to the re- evaluation of the patient’s medical

condition i.e. detection of complication or target organ damage may be performed. If the previous

tests are normal, repeat testing at least at 3-year intervals if there are no risk factors.6 Repeat testing

should ideally be done annually if there are risk factors.7


Once diagnosed to have diabetes mellitus type 2, initiate metformin therapy along with

lifestyle interventions, unless metformin is contraindicated. Monotherapy with metformin will

usually lower HbA1C levels by 1.5 percentage points. It is generally well tolerated, with

gastrointestinal symptoms as the most common adverse effects. It is not usually associated with

hypoglycaemia even in patients with prediabetes.12

Metformin is preferred over sulfonylurea because of its safety profile. Accumulating

evidence suggests that patients with type 2 diabetes mellitus and hyperinsulinemia are at an

increased risk of developing malignancies. But monotherapy with metformin appears to be

associated with a lower risk of cancer incidence. A systematic review and meta-analysis of 8 cohort

studies showed that metformin was associated with a lower risk of cancer incidence (unadjusted RR

= 0.74, 95% CI: 0.55-0.99, I 2 = 97.89%, p < 0.00001; adjusted RR = 0.76, 95% CI: 0.54-1.07, I 2 =

98.12%, p < 0.00001) compared with monotherapy with sulfonylurea.13

Begin with low-dose metformin 500 mg taken twice per day with meals (before breakfast

and dinner). After 5–7 days, if gastrointestinal side effects have not occurred, increase dose to two

500 mg tablets taken twice per day (before breakfast and dinner). If gastrointestinal side effects

appear decrease to previous lower dose and try to increase the dose at a later time. The maximum

effective dose can be up to 1,000 mg twice per day. Greater effectiveness has been observed with

doses up to about 2,500 mg/day, but there is increased gastrointestinal side effects.12

If the patient is not considered diabetes mellitus type 2 but diagnosed to be prediabetes,

metformin therapy may also be considered if there is impaired glucose tolerance or impaired fasting

glucose or HbA1C of 5.7–6.4%, especially for those with BMI >35 kg/m2, age <60 years, and women

with prior GDM.6 The lifestyle modification intervention however is as effective and more sustained

in preventing diabetes than pharmacologic intervention. The economics of preventing diabetes are

complex. There is some evidence that diabetes prevention programmes are cost effective, but the

evidence base to date provides few clear answers regarding design of prevention programs because

of differences in denominator populations, definitions, interventions and modelling assumptions. In

a systematic review of economic analysis studies, lifestyle programmes and metformin appeared to

be cost effective in preventing diabetes in high-risk individuals. There is also unclear evidence to

answer the question of whether lifestyle programs are more cost effective than metformin.14 In

patients with marked symptoms due to significantly elevated blood glucose levels or HbA1C,

consider metformin and insulin therapy from the outset.6


Patient-centered Interventions

When the diagnosis of diabetes mellitus type 2 is confirmed, a program on patient education

on self-management is recommended. This is delivered as a structured program for diabetes self-

management education and counselling (DSMEC). This should address psychosocial issues since

emotional well-being is associated with positive diabetes outcomes.6 Facilitating medication

adherence should also be emphasized in the DSMEC.4 This can be achieved by emphasizing

knowledge about the medications, dose and side effects. Hypoglycemia is the most common adverse

event of diabetes treatment. Glucose (15–20 g) or any form of carbohydrate that contains glucose is

the preferred treatment for the awake patients. Once glucose returns to normal the individual

should consume a meal or snack to prevent recurrence.6

The management plan should be formulated in collaboration with the physician, patient,

family and other members of the health care team. Implementation of the management plan

requires that each aspect is understood and agreed to by the patient and other care providers and

that the goals and treatment plan are reasonable. Any plan should consider the patient’s age, work

schedule and conditions, physical activity, eating patterns, social situation and cultural factors and

presence of complications of diabetes or other medical conditions.6 This strategy has been shown to

be beneficial compared to usual care. In a meta-analysis of 9 studies involving 1,359 participants,

individual face-to-face education resulted to better glycemic control in a subgroup analysis of

involving participants with a higher mean baseline HbA1c greater than 8% (WMD -0.3% (95% CI -0.5

to -0.1, P = 0.007).15

DSMEC should be an ongoing process of improving the knowledge, skills and ability of the

patient for diabetes self-care as well as assist a family member in implementing and sustaining

patient behaviour needed to manage their diabetes on an ongoing basis. A good DSMEC must have

the following characteristics:

• Evidence-based

• Individualized to the patient’s language and educational level

• With structured format and supporting written materials that includes the following core

content; i.e., diabetes basic pathophysiology and treatment options; medication usage;

monitoring, preventing, detecting, and treating acute and chronic complications; healthy

coping with psychological issues; dealing with special situations (i.e., travel, fasting)

• Delivered by trained and competent health educators and counsellors

• Supports the person, family and community in developing attitudes, beliefs, knowledge, and

skills to self-manage diabetes

• Available to patients at critical times (i.e., at diagnosis, annually, when complications arise,

and when transitions in care occur)

• Includes monitoring of patient progress, including health status, quality of life.4

Aside from health education, all patients diagnosed to have diabetes mellitus type 2 should

be given medical nutrition therapy (MNT). Individuals who have prediabetes or diabetes should

receive individualized MNT as needed to achieve treatment goals.6 MNT must be directed towards

the objective of maintaining energy balance and correction of overweight and obesity. For energy

balance, the mix of carbohydrate, protein, and fat may be adjusted to meet the metabolic goals and

individual preferences of the person with diabetes. Monitoring carbohydrate, whether by

carbohydrate counting, choices, or experience-based estimation, remains a key strategy in achieving

glycemic control. Saturated fat intake should be <7% of total calories. Individualized meal planning

includes optimization of food choices to meet recommended daily allowance by a dietician may be

done.6 For weight loss, either low-carbohydrate or low-fat calorie-restricted, or Mediterranean diets

may be effective in the short term. Other nutrition and lifestyle recommendation include advice on

smoking cessation and alcohol drinking. Alcohol intake should be limited to a moderate amount (one

drink per day or less for adult women and two drinks per day or less for adult men) and should take

extra precautions to prevent hypoglycemia. Routine supplementation with antioxidants, such as

vitamins E and C and carotene, is not advised because of the lack of evidence of effectiveness.6

Exercise and increased physical activity are also important components of weight loss

program. People with diabetes should be advised to perform at least 150 min/week of moderate-

intensity aerobic physical activity (50–70% of maximum heart rate), spread over at least 3 days per

week with no more than 2 consecutive days without exercise. In the absence of contraindications,

people with type 2 diabetes should be encouraged to perform resistance training at least twice per

week.6

Family-focused interventions in patients with diabetes are important part of the overall

management of diabetes mellitus type 2. Diabetes in biologically related individuals increases

diabetes risk. A spousal history of diabetes is associated with a 26% diabetes risk increase.

Recognizing shared risk between spouses may improve diabetes detection and motivate couples to

increase collaborative efforts to optimize eating and physical activity habits.16 There is also evidence

on the impact of the marital relationship on health as well as the negative impact of illness on the

partner. Targeting both patient and partner may enhance the efficacy of psychosocial or behavioral

interventions for chronic illness. In a review of couple interventions on patients with chronic

diseases, couple-oriented interventions have small effects that may be strengthened by targeting

partners' influence on patient health behaviors.17

Aside from couple-directed intervention, another family-focused intervention can be

identification of an informal caregiver within the family. This will result to increased level of social

support to the patient and are associated with better diabetes self-care among adults with poorly

controlled diabetes. In a cross-sectional study, participants who reported receiving assistance with

their diabetes from a friend or family member in the past month were classified as having a

caregiver. Compared to participants with no informal caregiver, those with an informal caregiver

were significantly more likely to report moderate or high medication adherence (OR = 1.93, 95% CI:

1.07-3.49, p = 0.028), a key self-care target to improve diabetes control.18

Family-focused Interventions.

Lifestyle modification by persons who are at high risk can be implemented with the help of

the family and the community. Family support is crucial for lifestyle management, but it is often

overlooked when designing behavioral interventions in diabetes mellitus type 2. At risk persons

receive support from family members mostly from their spouses and children. Their relatives can

also encourage them and motivate them to fight for their health, they also provide instrumental

support by preparing healthy meals, reminding them to take medications, and sharing physical

activity. Thus, any intervention supporting self-management practices need to work with key family

members.19

Community-Oriented Interventions

Community-oriented programs addressing diet, physical activity, and health behaviors have

shown significant benefits on the prevention and management of diabetes mellitus type 2. Even in

low-middle income countries, community-oriented programs potentially reduced the risk of

developing diabetes by more than 40%, RR (0.57 [0.30, 1.06]) though it was not statistically

significant. However, there were significant reductions observed in weight, body mass index, and

waist circumference change in favor of community-oriented programs from baseline.20

PAFP FACETS

Information technology should also be used in family practice in enhancing the intervention

or monitoring the patient. The PAFP has launch the program “Family and Community Engagement in

Telemedicine Services” (FACETS). This internet-based platform can be used to enhance the care of

diabetes mellitus type 2 in family practice. Internet-based interventions seem to offer a promising

option to ameliorate huge burdens brought by type 2 diabetes mellitus. In a meta-analysis of 492

studies, internet-based interventions resulted to better glycemic control with weighted mean

difference (WMD) between usual care and internet-based interventions at endpoint was -0.426%

(95% CI -0.540 to -0.312; P<.001).21 Smartphone applications for health interventions are promising

tools as well. In another meta-analysis of 6 studies with 1,022 patients, there was a moderate effect

on glycemic control after the app-based interventions. The overall effect on HbA1c shown as mean

difference (MD) was -0.40% (-4.37 mmol/mol) (95% confidence interval [CI] -0.69 to -0.11% [-7.54 to

-1.20 mmol/mol]; p = 0.007) and standardized mean differences (SMD) was -0.40% (-4.37 mmol/mol)

(95% confidence interval [CI] -0.69 to -0.10% [-7.54 to -1.09 mmol/mol]; p = 0.008).22

Patient Outcome

During the second visit, a definite diagnosis of diabetes may already be available. At this

stage the patient should already be acquiring some knowledge and skills on self-management,

medical nutrition, exercise and other lifestyle intervention. The patient should also be aware of the

medications, dose and side effects. Since the interventions and complex and the lifestyle goals may

be difficult, the patient should also be able to access telemedicine services from their family doctors.

The patient should also know what to do when side effects to treatment occur.

Third and Continuing Visit


During the continuing visits, further elaboration of the patient’s clinical history should

include the following:

• Review of treatment regimens and response to therapy (self-monitoring or HbA1C records)

• Current treatment plan, including medications and medication adherence, meal plan,

physical activity patterns, and lifestyle change

• Hypoglycemic episodes, frequency, severity and predisposing condition

• Physical examination should focus on weight monitoring and the presence of vascular

complications.

o Microvascular: retinopathy, nephropathy, neuropathy

o Macrovascular: coronary heart disease, cerebrovascular disease, peripheral artery

disease

• Continuing evaluation of psychosocial status.6,7


Use of point-of-care testing with FBS or RBS provides the opportunity for more timely

treatment changes. Perform the A1C test at least two times a year in patients who are meeting

treatment goals (and who have stable glycemic control). Perform the A1C test quarterly in patients

whose therapy has changed or who are not meeting glycemic goals.6


During the continuing visits, titration of pharmacologic treatment to achieve glycemic

control is essential. If the diabetes is not controlled by metformin after 1-3 months of dose titration,

a well validated approach is to consider adding basal insulin or other oral hypoglycemic drugs.12 If

noninsulin monotherapy at maximal tolerated dose does not achieve or maintain the A1C target

over 3–6 months, add a second oral agent or insulin.6 The effect of other oral hypoglycemic drugs on

the cardiovascular risk must be considered on the choice of metformin add-on treatment.

Figure 1 Algorithm for Pharmacologic Management

Insulin is most effective at lowering blood glucose. It can decrease any level of elevated A1C

close to treatment goal. The initial therapy is aimed at increasing basal insulin supply (intermediate-

or long-acting insulins) The long-acting insulin analogues have not been shown to lower A1C levels

more effectively than intermediate-acting formulations. Insulin therapy has also beneficial effects on

triacylglycerol and HDL cholesterol levels but is also associated with weight gain of 2–4 kg.12

Sulfonylureas lower blood sugar by enhancing insulin secretion. They are similar to

metformin in lowering A1C levels by 1.5 percentage points. The major adverse side effect is

hypoglycaemia with severe episodes more common among the elderly. The first generation

chlorpropamide and glibenclamide (glyburide) are associated with greater hypoglycemia than

second-generation sulfonylureas (gliclazide, glimepiride, glipizide and their extended-release

formulations). Weight gain of 2 kg is also common with sulfonylurea therapy.12

Thiazolidinediones (glitazones) lower blood sugar by increasing the sensitivity of muscle, fat,

and liver to insulin (“insulin sensitizers”). It provides 0.5–1.4 percentage point decrease in A1C. They

have a more durable effect on glycemic control compared with sulfonylureas. The most common

adverse effects are weight gain, fluid retention and increased risk for congestive heart failure.12

Table 1 Pharmacologic Options for Management of Type 2 Diabetes Mellitus

Drug Dose Expected Effect Precaution and Side Effects

Metformin 500 mg BID Glycemic control Hypoglycemia

Glibenclamide 5-20 mg daily Glycemic control Hypoglycemia, difficulty of swallowing, dizziness, allergy

Glimepiride 1-2 mg daily Glycemic control Hypoglycemia, difficulty of swallowing, dizziness, tachycardia

Glipizide 2.5-5 mg daily Glycemic control Hypoglycemia, anxiety, blurred vision


DSMEC should be an ongoing process of improving the knowledge, skills and ability of the

patient for diabetes self-care as well as assist a family member in implementing and sustaining

patient behavior needed to manage their diabetes on an ongoing basis. This includes monitoring of

patient progress, health status and quality of life.4

The increasing prevalence of diabetes type 2 and costs associated with treatment and its

complications are of increasing concern. There is a need to enhance community-oriented

recommendations aimed at primary and secondary prevention. The activities can be:

• organizing to empower communities and diabetic patients

• improve coordination and standardization of care

• improve access to care by removing barriers to care

• subsidize preventive treatment costs

• Implementation of these activities require a cooperative partnership between hospital,

general practitioner and the community.23

Patient Outcome

During continuing care, the expected patient outcome should be glycemic control,

adherence to DSMEC, avoidance of side effects and complications and improved quality of life.

Lowering HbA1C to below or around 7% has been shown to reduce microvascular complications of

diabetes, and if implemented soon after the diagnosis of diabetes is associated with long-term

reduction in macrovascular disease. This corresponds to pre-prandial capillary blood glucose of 70-

130 mg/dl (3.8-7.2 mmol/L) or peak post-prandial capillary blood glucose of <180 mg/dl (<10

mmol/L). Less-stringent HbA1C goals (such as <8%) may be appropriate for patients with a history of

severe hypoglycemia, limited life expectancy, advanced microvascular or macrovascular

complications, extensive comorbid conditions, and those with longstanding diabetes in whom the

general goal is difficult to attain despite DSME, appropriate glucose monitoring, and effective doses

of multiple glucose lowering agents including insulin.6 Other patient outcomes should include

monitoring of patient progress, including patient satisfaction, health status and quality of life.4

Recommendations for Implementation

Clinic Level

The recommendations for implementation of this clinical pathway is similar to the

recommended implementation of the other clinical pathways developed by the PAFP QA

Committee. The committee will disseminate the clinical pathways in a form of lectures and

publications. However, passively delivered had little effect in changing practice.24 We recommend

that at the clinic level, self-reviews of chart records using the recommendations of this clinical

pathway as the criteria may be done. Identification of barriers and developing interventions to

promote compliance to the clinical pathway recommendations may be more effective.

Organizational Level

Similarly, at the organizational level the PAFP should establish a new model of quality

improvement initiative where self-practice reviews are included as part of the program. Within PAFP

chapters, peer group discussions, individual feedback and quality improvement reports are the main

components. This model has been shown to improve the care process for urinary problems in one

randomized clinical trial.25

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Documents

Diagnosis and Management of Uncomplicated Type 2 Diabetes