04 Diabetes

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SPECIAL THEME

Diagnosis and Management of Uncomplicated Type 2


Diabetes Mellitus in Family Practice

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

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 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, assess 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)

146 THE FILIPINO FAMILY PHYSICIAN


• 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)
• Set up 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.

Introduction • Ultimately, many patients will require insulin therapy alone or in


combination with other agents to maintain glucose control.
The prevalence of diabetes type 2 is increasing worldwide and • All treatment decisions, where possible, should be made in
in Asian countries including the Philippines. The increase is associated conjunction with the patient, focusing on his/her preferences,
with urbanization associated with change in dietary preferences needs, and values.
and sedentary lifestyle. The American Diabetes Association (ADA) • Comprehensive cardiovascular risk reduction must be a major
published the 2016 Standards of Medical Care in Diabetes. This provided focus of therapy.3
guidelines to clinicians, researchers, payers, patients, and other • More recent versions of these guidelines have additional
interested parties in diabetes care. The synopsis focuses on 8 key areas recommendations for patients with clinical cardiovascular disease,
that are important to primary care providers. The recommendations a sodium-glucose cotransporter 2 (SGLT2) inhibitor or a glucagon-
emphasized individualized care to manage the disease, prevent or delay like peptide 1 (GLP-1) receptor agonist with proven cardiovascular
complications, and improve outcomes.1 benefit.
Although glycaemic control and reduction of micro- and • For patients with chronic kidney disease or clinical heart failure
macrovascular outcomes remain essential aspects of treatment, and atherosclerotic cardiovascular disease, an SGLT2 inhibitor
access and cost are major limiting factors; therefore, a pragmatic with proven benefit is recommended. GLP-1 receptor agonists are
approach is required in restricted-resource settings.2 In general, the generally recommended as the first injectable medication.4
recommendations are:
• Glycemic targets and glucose-lowering therapies must be In the Philippines the cost of treatment is mainly shouldered by
individualized. the patient. PHIC does not currently reimburse outpatient care. Thus,
• Diet, exercise, and education remain the foundation of any type 2 most patients rely on “out-of-pocket” expenses, namely, laboratory
diabetes treatment program. procedures and daily medications.5 There are guidelines available
• Unless there are prevalent contraindications, metformin is the like the ones discussed previously, unfortunately its dissemination
optimal first-line drug. and implementation rely on passive strategies, leading to significant
• After metformin, there are limited data to guide us. Combination variation in health care. This clinical pathway is an attempt to
therapy with an additional 1–2 oral or injectable agents is operationalize these guideline recommendations in family and
reasonable, aiming to minimize side effects where possible. community outpatient practice.

VOL. 59 NO. 2 DECEMBER, 2021 147


Objectives pathway. Implementation of clinical pathways was encouraged at the
practice level and the organizational level. Practice level was a simple
This clinical pathway was developed to guide family and count of family and community medicine practitioners using and
community physicians on the diagnosis and continuing management of applying the clinical pathways. Organizational level were activities of
type 2 diabetes mellitus. It provides recommendations to the following the PAFP devoted to the promotion, development, dissemination and
clinical decisions: 1) clinical history and physical examination; implementation of clinical pathways.
2) laboratory and ancillary procedures to be requested; 3) pharmacologic
interventions; 4) non-pharmacologic interventions; and 5) patient Grading of the Recommendations
outcomes to expect.
The PAFP QA Committee met as a panel and graded the
Methods of Development and Implementation recommendations as shown in Table 1. The grading system was a mix
of the strength of the reviewed published evidence and the consensus
The PAFP Clinical Pathways Group reviewed the published medical of a panel of experts. In some cases, the published evidence may not
literature to identify, summarize, and operationalize the evidence in be applicable in Philippine family and community practice setting, so
clinical publication on the management of patients with type 2 diabetes a panel grade based on the consensus of clinical experts was also used.
mellitus in family and community practice. The recommendations Thus, if the recommendation was based on a published evidence that is
are time-bound tasks on patient care processes, in terms of history a well done randomized controlled trial and the panel of expert voted
and physical examination, laboratory tests, pharmacologic and non- unanimously for the recommendation, it was given a grade of A-I. If
pharmacologic interventions. the level of evidence is based on an observational study but the panel
The group adopted several strategies in developing the still unanimously considered the recommendation, the grade given was
recommendations. The first strategy is emphasizing on evidence-based A-II and if the level of evidence is just an opinion and the panel still
recommendations as recommended assessments and interventions. unanimously recommended it, the grade was A-III.
The second strategy is recognition of potential variations between-
patient and between specific practice settings. The third strategy is the Table 1. Grading of the recommendations.
recognition of “stakeholder groups” in family and community practice
Panel Grade Level Evidence Grade Level
with careful attention to getting their opinion and support but without
1 2 3
sacrificing the objectives of developing and implementing clinical
pathways. The fourth strategy is emphasis on the commitment to A A-I A-II A-III
establish the ultimate goal of improving the effectiveness, efficiency B B-I B-II B-III
and quality of patient care in family and community practice. C C-I C-II C-III
For the first strategy, the group searched PubMed and HERDIN
using the terms “diabetes mellitus”, “type 2”, “diagnosis” and Panel Grade Levels
“treatment”. Retrieval of articles was focused on the following type A - All the panel members agree that the recommendation should be
of clinical publications, clinical practice guidelines, meta-analysis, adopted because it is relevant, applicable and will benefit many
randomized controlled trials and clinical trials. Then the strongly graded patients.
recommendations were adapted and included in the clinical pathway B - Majority of the panel members agree that the recommendation
recommendations. Each recommendation was graded based on the should be adopted because it is relevant, applicable in many areas
level of evidence. The more rigorous meta-analysis of clinical trials and and will benefit many patients.
observational studies were prioritized over low-quality trials in the C - Panel members were divided that the recommendation should be
formulation and grading of the recommendations. The evidence for the adopted and is not sure if it will be applicable in many areas or will
patient care processes were reviewed and summarized as notes to justify benefit many patients.
the recommendations. The second strategy was to present the clinical
pathway recommendations to the QA Committee who acted as panel of Evidence Grade Levels
experts and discussed potential variations in different setting of family I - The best evidence cited to support the recommendation is a well-
practice. A panel grade on the applicability of the recommendations conducted randomized controlled trial. The CONSORT standard may
was obtained. As part of the third strategy, the clinical pathway was be used to evaluate a well-conducted randomized controlled trial.
then disseminated to the selected PAFP chapters and members and II - The best evidence cited to support the recommendation is a well-
other stakeholders for consensus development. Dissemination was also conducted observational study i.e. match control or before and
done by publication in the Filipino Family Physician Journal, conference after clinical trial, cohort studies, case control studies and cross-
presentations (PAFP Annual Convention) and focused group discussions. sectional studies. The STROBE statement may be used to evaluate
As a fourth strategy, the implementation of clinical pathways to a well-conducted observational study.
be adopted by the PAFP was utilized as quality improvement activities III - The best evidence cited to support the recommendation is based
in a form of patient record reviews, audit and feedback. Audit and on expert opinion or observational study that did not meet the
review standards used were the recommendations in the clinical criteria for level II.

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In the implementation of the clinical pathways, the PAFP QA recommend using sound clinical judgment and patient involvement in
committee recommend adherence to guideline recommendations the decision making before applying the recommendations.
that are graded as either A-I, A-II or B-I. However, the committee also

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

First Visit __Elicit symptoms of __Request for FBS or RBS or OGTT __Not advisable to give routine Patient Intervention __Aware of
hyperglycemia i.e. polyuria, or Hgb A1C (A-I) vitamin supplementation with __Structured health education diabetes type 2 and
polyphagia, polydipsia, nocturia antioxidants, such as vitamins E on lifestyle changes (alcohol and management plan
and weight loss (A-II) (This can also be done in and C and carotene (A-I) smoking), moderate weight loss, (A-III)
patients with classic symptoms regular physical activity, reduced
__General physical examination or in asymptomatic adults with calories, sugar and dietary fat intake Follow-up Visit
focus on cardiac, renal, peripheral BMI≥25kg/m2 and with risk (A-III) __In 1-2 weeks (A-III)
pulse retinopathy, neuropathy, skin factors or in asymptomatic adults
and BMI (A-II) ≥45yrs old with BMI≥25kg/m2) Family-focused and Community-
oriented interventions
__Conduct risk screening for __If the doctor has doubts __Arrange for development
asymptomatic and BMI≥25kg/m2 about the accuracy of available and implementation of family-
or ≥45 years old (A-II) laboratory test, the test can be focused and community-oriented
repeated for confirmation (A-III) intervention (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)

Second Visit __Review the laboratory results If diabetes type 2, request __ Metformin 500 mg twice Patient Intervention __Aware of diagnosis
and establish the diagnosis as for laboratory tests to detect a day (A-I) __Develop and agree on the of diabetes type 2,
diabetes type 2, pre-diabetes or complication or target organ management plan (A-III) risks and complications
non-diabetes (A-II) damage (A-II) __If with marked symptoms (A-III)
and significantly elevated __Provide diabetes self-
__If diabetes type 2 or pre- __If normal, repeat testing every blood glucose levels or A1C, management education and __Agree on
diabetes, asses the patient and year if there are risk factors and consider metformin and insulin counselling (A-II) management plan and
family’s dietary patterns, physical at least at 3-year intervals if there from the outset (A-II) goals (A-III)
activity habits, nutritional status are no risk factors (B-III) __Medical nutrition therapy
and weight history, diabetes __If pre-diabetes metformin focusing on limitation of __Aware on
understanding, psychological, 500 mg once daily may be carbohydrate and fat intake and medications, dose and
social and community health considered if there is impaired weight loss (A-I) side effects (A-III)
support systems (A-III) glucose tolerance or impaired
fasting glucose or A1C of __Emphasize increase in physical __Aware on what to
__Social determinants of health 5.7–6.4% (A-II) activity (A-I) do if hyoglycemia occur
(SCREEM) (A_III)
__Limit alcohol intake, smoking Follow-up Visit
cessation (A-II) __After 1 month
(A-III)
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)

Variations

VOL. 59 NO. 2 DECEMBER, 2021 149


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

Continuing __Review of treatment regimens __Random or fasting blood sugar __Based on initial response, Patient Intervention __Achievement of
Visit (medication adherence, meal plan, testing during clinic visit may be titrate metformin dose for 3 __Enhance diabetes self- treatment goals (A-I)
physical activity patterns, and done to guide timely treatment months to achieve treatment management education and
lifestyle change) and response to changes (A-III) goal (A-I) counselling, medical nutrition __Improved quality of
treatment (self-monitoring or A1C therapy, physical activity and life (A-I)
records) (A-II) __A1C test quarterly or twice a or limitation of alcohol intake (A-II)
year depending on response to __Satisfaction to
__Check for hypoglycemic treatment (A-III) __If the diabetes is not Family Intervention management plan
episodes and other adverse events controlled by metformin after __Enhance the family member/ (A-III)
(A-II) 1 month add basal insulin or caregiver’s role in the diabetes
another oral hypoglycemic self-management education and __Continuing
__ Continuing evaluation of drugs (A-I) (be aware of counselling, medical nutrition compliance to diabetes
psychosocial status (A-II) contraindications) therapy, physical activity and self-management
limitation of alcohol intake (A-II) (A-III)
__Physical examination should __Adjust dose of other drugs
focus on weight monitoring (A-II) Community-level Intervention Follow-up Visit
and the presence of vascular __Coordinate referral for social and __Monthly or
complications. (retinopathy, economic support for the patient if quarterly depending
nephropathy, neuropathy, coronary needed (A-III) on blood sugar control
heart disease, cerebrovascular (A-III)
disease, peripheral artery disease) __Empower community health
(A-II) workers and diabetic patients for
coordination and monitoring (A-III)

Variations __Note contraindication

Clinical Evidence of the Recommendations classic symptoms and symptoms associated with complications must be
elicited in the clinical history.
The management of diabetes must be patient-centered, family The minimum physical examination that must be done if diabetes
focused and community oriented. Patient-centered care is defined mellitus type 2 is being considered must be the following:
as “providing care that is respectful of and responsive to individual • Height, weight, and computation of BMI
patient preferences, needs, and values”. Patients and families should • Blood pressure determination
be allowed to make the final decisions regarding lifestyle changes and • Fundoscopic examination
the pharmaceutical interventions they will take. To ensure adherence • Thyroid palpation
to this multi-faceted intervention, family cooperation is also necessary. • Skin examination
To ensure adequate monitoring the effect of intervention, community • Comprehensive foot examination including inspection of pulses,
resources must also be tapped. Thus, in family and community practice, reflexes, vibration and sensation.6,7
diabetes is best managed by a team. They include but are not limited to,
family physicians, nurse practitioners, physician’s assistants, dietitians, If the initial clinical evaluation did not reveal the classical
pharmacists, and mental health professionals with special interest symptoms of diabetes, try to elicit the following risk factors that can
in diabetes.6 They should also include community social and health justify laboratory testing:
workers. • physical inactivity
• first-degree relative with diabetes
First Visit • women who delivered a baby weighing ≥9 lb or who were
diagnosed with GDM hypertension (blood pressure 140/90 mmHg
Clinical History and Physical Examination or on therapy for hypertension)
• HDL cholesterol level ≥35 mg/dL (0.90 mmol/L) and/or a
The classical symptoms of type 2 diabetes mellitus are usually triglyceride level 250 mg/dL (2.82 mmol/L)
associated with hyperglycemia i.e., polyuria, polydipsia and weight • women with PCOS
loss.7 Sometimes the symptoms are noticed late in the disease and • other clinical conditions associated with insulin resistance (e.g.,
are already associated with complications like blurring of vision, severe obesity, acanthosis nigricans)
numbness or tingling sensation and slow or non-healing wound. The • history of CVD

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• A1C 5.7%, IGT, or IFG on previous testing Thematic areas of preventive interventions for diabetes have been
identified in some reviews. The first theme is that the primary care
If the patient consulted with an available laboratory tests, try to setting is the place where starting lifestyle change is necessary to
establish the diagnosis based on the available information and proceed prevent diabetes and its progression. The second is that various patient
to the tasks listed in the second visit. factors such as the patient’s motivation, perceptions and knowledge
and trust in their healthcare providers play an important role. And third,
Laboratory and Ancillary Procedures are the health care provider factors like workload, time constraints,
resources, knowledge and perception of patient motivations towards
To establish the diagnosis, either fasting blood sugar, random change are also important. All these must be considered in designing
blood sugar, oral glucose tolerance test and/or HbA1C may be done. patient-centered health education intervention. These are also relevant
Most clinical trials on diabetes consider derangement in this laboratory to the PAFP and its members to understand the factors associated with
parameters as definition and inclusion to a clinical trial on diabetes. the delivery and uptake of diabetes prevention interventions.9
Once the diagnosis is established, the following tests are suggested to During the first visit, the family and community physician should
be done for individuals being seen for the first time for evaluation of start exploring the development and implementation of a family-
diabetes mellitus type 2: focused and community-oriented health care program for the patient.
Lifestyle interventions targeting weight loss may be implemented
• Fasting lipid profile, including total, LDL and HDL cholesterol and via technology-mediated interventions. These diabetes prevention
triglycerides if not yet done within the past year programs can result in clinically significant amounts of weight loss and
• Liver enzyme/transaminase tests (AST/ALT) and creatinine7 improvements in glycaemia in patients with prediabetes.10

In asymptomatic patients, consider testing if overweight or obese Patient Outcome


(BMI≥25kg/m2) and who have one or more additional risk factors for
diabetes enumerated above. In those without risk factors, testing may Health literacy skills are essential to enable self-management and
be done if the patient is age 45 years and above.6 Universal screening shared decision-making in patients with type 2 diabetes mellitus. In a
using laboratory tests for diabetes is not recommended as it would systematic review of 29 studies involving 13,457 patients from seven
identify very few individuals relative to the cost it will entail.7 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
Pharmacologic Treatment patient becomes aware of the diabetes, the risk factors and how it is
diagnosed. The patient should also agree to comply with the diagnostic
If the diagnosis of diabetes mellitus type 2 is not yet established, and treatment plan.
there is no need to start pharmacologic treatment for diabetes. Routine
supplementation with multi-vitamins or antioxidants, such as vitamins Second Visit
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 Clinical History and Physical Examination
evidence that they prevent diabetes or its complications.6
During the second visit, a review of the requested laboratory
Non-pharmacologic Intervention should be able to make a more definite diagnosis. The criteria for the
diagnosis of diabetes are the following:
Patient-centered Non-pharmacologic Intervention
• HbA1C≥6.5%. The test should be performed in a laboratory using
Family and community practice are an important setting for a method that is NGSP certified and standardized to the DCCT
disease among populations who are at high risk of developing disease assay.
like diabetes mellitus type 2. The first point of contact with the health or
care system and professionals can provide lifestyle counselling and • FPG≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric
support, as well as monitoring outcomes. A start-up opportunity intake for at least 8 h.
during the first visit, undiagnosed patients but obese or overweight or
individuals and at high risk for developing type 2 diabetes should • 2-h plasma glucose≥200mg/dL (11.1mmol/L) during an OGTT.
receive structured health education that emphasize lifestyle changes, The test should be performed as described by the WHO, using a
moderate weight loss (7% body weight), regular physical activity glucose load containing the equivalent of 75 g anhydrous glucose
(150 min/week), reduced calories, sugar and dietary fat intake.6 In a dissolved in water.
meta-analysis of 43 studies that included 49,029 participants, lifestyle or
modification resulted RR reduction of 39% (RR, 0.61; 95% CI, 0.54-0.68) • In a patient with classic symptoms of hyperglycemia or
for the development of diabetes. It has a better and sustained effect hyperglycemic crisis, a random plasma glucose≥200 mg/dL (11.1
than pharmacologic intervention.8 mmol/L)6

VOL. 59 NO. 2 DECEMBER, 2021 151


Some patients, despite the presence of risk factors may have laboratory associated with a lower risk of cancer incidence (unadjusted RR = 0.74,
findings that may not be classified as diabetes mellitus type 2 but 95% CI: 0.55-0.99, I2 = 97.89%, p < 0.00001; adjusted RR = 0.76, 95%
cannot be classified as totally normal. They are considered prediabetes. CI: 0.54-1.07, I2 = 98.12%, p < 0.00001) compared with monotherapy
Their laboratory results may be the following:6 with sulfonylurea.13
Begin with low-dose metformin 500 mg taken twice per day with
• FPG 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) (IFG) meals (before breakfast and dinner). After 5–7 days, if gastrointestinal
or side effects have not occurred, increase dose to two 500 mg tablets
• 2-h plasma glucose in the 75-g OGTT 140 mg/dL (7.8 mmol/L) to taken twice per day (before breakfast and dinner). If gastrointestinal
199 mg/dL (11.0 mmol/L) (IGT) side effects appear decrease to previous lower dose and try to increase
or the dose at a later time. The maximum effective dose can be up to 1,000
• A1C 5.7–6.4% mg twice per day. Greater effectiveness has been observed with doses
up to about 2,500 mg/day, but there is increased gastrointestinal side
If the patient is already classified to be type 2 diabetes mellitus, effects.12
further elaboration of the patient’s clinical history should include the If the patient is not considered diabetes mellitus type 2 but
following: diagnosed to be prediabetes, metformin therapy may also be considered
if there is impaired glucose tolerance or impaired fasting glucose or
• Eating patterns, physical activity habits, nutritional status and HbA1C of 5.7–6.4%, especially for those with BMI >35 kg/m2, age
weight history <60 years, and women with prior GDM.6 The lifestyle modification
• Diabetes education and understanding intervention however is as effective and more sustained in preventing
• This should be used to assist in formulating a management plan diabetes than pharmacologic intervention. The economics of preventing
and the basis for continuing care. diabetes are complex. There is some evidence that diabetes prevention
programmes are cost effective, but the evidence base to date provides
It is also recommended to include assessment of the patient’s few clear answers regarding design of prevention programs because of
psychological and social situation which may include attitudes about differences in denominator populations, definitions, interventions and
the illness, expectations for medical management and outcomes, modelling assumptions. In a systematic review of economic analysis
affect/mood, depression and diabetes-related distress, anxiety, eating studies, lifestyle programmes and metformin appeared to be cost
disorders and cognitive impairment, general and diabetes related effective in preventing diabetes in high-risk individuals. There is also
quality of life, resources (financial and social).6 unclear evidence to answer the question of whether lifestyle programs
are more cost effective than metformin.14 In patients with marked
Laboratory and Ancillary Procedures symptoms due to significantly elevated blood glucose levels or HbA1C,
consider metformin and insulin therapy from the outset.6
If the patient is already diagnosed to have diabetes type 2 based
on previous laboratory results, additional laboratory tests appropriate Non-pharmacologic Intervention
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 Patient-centered Interventions
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 When the diagnosis of diabetes mellitus type 2 is confirmed, a
are risk factors.7 program on patient education on self-management is recommended.
This is delivered as a structured program for diabetes self-management
Pharmacologic Treatment education and counselling (DSMEC). This should address psychosocial
issues since emotional well-being is associated with positive
Once diagnosed to have diabetes mellitus type 2, initiate diabetes outcomes.6 Facilitating medication adherence should also
metformin therapy along with lifestyle interventions, unless metformin be emphasized in the DSMEC.4 This can be achieved by emphasizing
is contraindicated. Monotherapy with metformin will usually lower knowledge about the medications, dose and side effects. Hypoglycemia
HbA1C levels by 1.5 percentage points. It is generally well tolerated, is the most common adverse event of diabetes treatment. Glucose (15–
with gastrointestinal symptoms as the most common adverse effects. 20 g) or any form of carbohydrate that contains glucose is the preferred
It is not usually associated with hypoglycaemia even in patients with treatment for the awake patients. Once glucose returns to normal the
prediabetes.12 individual should consume a meal or snack to prevent recurrence.6
Metformin is preferred over sulfonylurea because of its safety The management plan should be formulated in collaboration
profile. Accumulating evidence suggests that patients with type 2 with the physician, patient, family and other members of the health
diabetes mellitus and hyperinsulinemia are at an increased risk of care team. Implementation of the management plan requires that
developing malignancies. But monotherapy with metformin appears to each aspect is understood and agreed to by the patient and other care
be associated with a lower risk of cancer incidence. A systematic review providers and that the goals and treatment plan are reasonable. Any
and meta-analysis of 8 cohort studies showed that metformin was plan should consider the patient’s age, work schedule and conditions,

152 THE FILIPINO FAMILY PHYSICIAN


physical activity, eating patterns, social situation and cultural factors advised to perform at least 150 min/week of moderate-intensity aerobic
and presence of complications of diabetes or other medical conditions.6 physical activity (50–70% of maximum heart rate), spread over at least
This strategy has been shown to be beneficial compared to usual care. 3 days per week with no more than 2 consecutive days without exercise.
In a meta-analysis of 9 studies involving 1,359 participants, individual In the absence of contraindications, people with type 2 diabetes should
face-to-face education resulted to better glycemic control in a subgroup be encouraged to perform resistance training at least twice per week.6
analysis of involving participants with a higher mean baseline HbA1c Family-focused interventions in patients with diabetes are important
greater than 8% (WMD -0.3% (95% CI -0.5 to -0.1, p = 0.007).15 part of the overall management of diabetes mellitus type 2. Diabetes
DSMEC should be an ongoing process of improving the knowledge, in biologically related individuals increases diabetes risk. A spousal
skills and ability of the patient for diabetes self-care as well as assist history of diabetes is associated with a 26% diabetes risk increase.
a family member in implementing and sustaining patient behaviour Recognizing shared risk between spouses may improve diabetes
needed to manage their diabetes on an ongoing basis. A good DSMEC detection and motivate couples to increase collaborative efforts to
must have the following characteristics: 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
• Evidence-based impact of illness on the partner. Targeting both patient and partner
• Individualized to the patient’s language and educational level may enhance the efficacy of psychosocial or behavioral interventions
• With structured format and supporting written materials for chronic illness. In a review of couple interventions on patients with
that includes the following core content; i.e., diabetes basic chronic diseases, couple-oriented interventions have small effects that
pathophysiology and treatment options; medication usage; may be strengthened by targeting partners’ influence on patient health
monitoring, preventing, detecting, and treating acute and chronic behaviors.17
complications; healthy coping with psychological issues; dealing Aside from couple-directed intervention, another family-focused
with special situations (i.e., travel, fasting) intervention can be identification of an informal caregiver within the
• Delivered by trained and competent health educators and family. This will result to increased level of social support to the patient
counsellors and are associated with better diabetes self-care among adults with
• Supports the person, family and community in developing poorly controlled diabetes. In a cross-sectional study, participants
attitudes, beliefs, knowledge, and skills to self-manage diabetes who reported receiving assistance with their diabetes from a friend or
• Available to patients at critical times (i.e., at diagnosis, annually, family member in the past month were classified as having a caregiver.
when complications arise, and when transitions in care occur) Compared to participants with no informal caregiver, those with an
• Includes monitoring of patient progress, including health status, informal caregiver were significantly more likely to report moderate or
quality of life.4 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
Aside from health education, all patients diagnosed to have
diabetes mellitus type 2 should be given medical nutrition therapy Family-focused Interventions
(MNT). Individuals who have prediabetes or diabetes should receive
individualized MNT as needed to achieve treatment goals.6 MNT must Lifestyle modification by persons who are at high risk can be
be directed towards the objective of maintaining energy balance implemented with the help of the family and the community. Family
and correction of overweight and obesity. For energy balance, the support is crucial for lifestyle management, but it is often overlooked
mix of carbohydrate, protein, and fat may be adjusted to meet the when designing behavioral interventions in diabetes mellitus type
metabolic goals and individual preferences of the person with diabetes. 2. At risk persons receive support from family members mostly
Monitoring carbohydrate, whether by carbohydrate counting, choices, from their spouses and children. Their relatives can also encourage
or experience-based estimation, remains a key strategy in achieving them and motivate them to fight for their health, they also provide
glycemic control. Saturated fat intake should be <7% of total calories. instrumental support by preparing healthy meals, reminding them to
Individualized meal planning includes optimization of food choices to take medications, and sharing physical activity. Thus, any intervention
meet recommended daily allowance by a dietician may be done.6 For supporting self-management practices need to work with key family
weight loss, either low-carbohydrate or low-fat calorie-restricted, or members.19
Mediterranean diets may be effective in the short term. Other nutrition
and lifestyle recommendation include advice on smoking cessation Community-Oriented Interventions
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 Community-oriented programs addressing diet, physical activity,
day or less for adult men) and should take extra precautions to prevent and health behaviors have shown significant benefits on the prevention
hypoglycemia. Routine supplementation with antioxidants, such as and management of diabetes mellitus type 2. Even in low-middle
vitamins E and C and carotene, is not advised because of the lack of income countries, community-oriented programs potentially reduced
evidence of effectiveness.6 the risk of developing diabetes by more than 40%, RR (0.57 [0.30,
Exercise and increased physical activity are also important 1.06]) though it was not statistically significant. However, there were
components of weight loss program. People with diabetes should be significant reductions observed in weight, body mass index, and waist

VOL. 59 NO. 2 DECEMBER, 2021 153


circumference change in favor of community-oriented programs from • Review of treatment regimens and response to therapy (self-
baseline.20 monitoring or HbA1C records)
• Current treatment plan, including medications and medication
PAFP FACETS adherence, meal plan, physical activity patterns, and lifestyle
change
Information technology should also be used in family practice • Hypoglycemic episodes, frequency, severity and predisposing
in enhancing the intervention or monitoring the patient. The PAFP condition
has launch the program “Family and Community Engagement in • Physical examination should focus on weight monitoring and the
Telemedicine Services” (FACETS). This internet-based platform can be presence of vascular complications.
used to enhance the care of diabetes mellitus type 2 in family practice. o Microvascular: retinopathy, nephropathy, neuropathy
Internet-based interventions seem to offer a promising option to o Macrovascular: coronary heart disease, cerebrovascular
ameliorate huge burdens brought by type 2 diabetes mellitus. In a disease, peripheral artery disease
meta-analysis of 492 studies, internet-based interventions resulted • Continuing evaluation of psychosocial status.6,7
to better glycemic control with weighted mean difference (WMD)
between usual care and internet-based interventions at endpoint was Laboratory and Ancillary Procedures
-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- Use of point-of-care testing with FBS or RBS provides the opportunity
analysis of 6 studies with 1,022 patients, there was a moderate effect on for more timely treatment changes. Perform the A1C test at least two
glycemic control after the app-based interventions. The overall effect on times a year in patients who are meeting treatment goals (and who have
HbA1c shown as mean difference (MD) was -0.40% (-4.37 mmol/mol) stable glycemic control). Perform the A1C test quarterly in patients whose
(95% confidence interval [CI] -0.69 to -0.11% [-7.54 to -1.20 mmol/ therapy has changed or who are not meeting glycemic goals.6
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 Pharmacologic Treatment

Patient Outcome During the continuing visits, titration of pharmacologic treatment to


achieve glycemic control is essential. If the diabetes is not controlled
During the second visit, a definite diagnosis of diabetes may already by metformin after 1-3 months of dose titration, a well validated
be available. At this stage the patient should already be acquiring some approach is to consider adding basal insulin or other oral hypoglycemic
knowledge and skills on self-management, medical nutrition, exercise drugs.12 If noninsulin monotherapy at maximal tolerated dose does not
and other lifestyle intervention. The patient should also be aware of the achieve or maintain the A1C target over 3–6 months, add a second oral
medications, dose and side effects. Since the interventions and complex agent or insulin.6 The effect of other oral hypoglycemic drugs on the
and the lifestyle goals may be difficult, the patient should also be able cardiovascular risk must be considered on the choice of metformin add-
to access telemedicine services from their family doctors. The patient on treatment.
should also know what to do when side effects to treatment occur. Insulin is most effective at lowering blood glucose. It can
decrease any level of elevated A1C close to treatment goal. The initial
Third and Continuing Visit therapy is aimed at increasing basal insulin supply (intermediate- or
long-acting insulins) The long-acting insulin analogues have not
Clinical History and Physical Examination been shown to lower A1C levels more effectively than intermediate-
acting formulations. Insulin therapy has also beneficial effects on
During the continuing visits, further elaboration of the patient’s triacylglycerol and HDL cholesterol levels but is also associated with
clinical history should include the following: weight gain of 2–4 kg.12

Tier: Well-validated core therapies

Figure 1. Algorithm for pharmacologic management

154 THE FILIPINO FAMILY PHYSICIAN


Sulfonylureas lower blood sugar by enhancing insulin secretion. They complications and improved quality of life. Lowering HbA1C to below
are similar to metformin in lowering A1C levels by 1.5 percentage points. or around 7% has been shown to reduce microvascular complications
The major adverse side effect is hypoglycaemia with severe episodes of diabetes, and if implemented soon after the diagnosis of diabetes
more common among the elderly. The first generation chlorpropamide is associated with long-term reduction in macrovascular disease.
and glibenclamide (glyburide) are associated with greater hypoglycemia This corresponds to pre-prandial capillary blood glucose of 70-130
than second-generation sulfonylureas (gliclazide, glimepiride, glipizide mg/dl (3.8-7.2 mmol/L) or peak post-prandial capillary blood glucose of
and their extended-release formulations). Weight gain of 2 kg is also <180 mg/dl (<10 mmol/L). Less-stringent HbA1C goals (such as <8%)
common with sulfonylurea therapy.12 may be appropriate for patients with a history of severe hypoglycemia,
Thiazolidinediones (glitazones) lower blood sugar by increasing limited life expectancy, advanced microvascular or macrovascular
the sensitivity of muscle, fat, and liver to insulin (“insulin sensitizers”). complications, extensive comorbid conditions, and those with
It provides 0.5–1.4 percentage point decrease in A1C. They have a longstanding diabetes in whom the general goal is difficult to attain
more durable effect on glycemic control compared with sulfonylureas. despite DSME, appropriate glucose monitoring, and effective doses
The most common adverse effects are weight gain, fluid retention and of multiple glucose lowering agents including insulin.6 Other patient
increased risk for congestive heart failure.12 outcomes should include monitoring of patient progress, including
patient satisfaction, health status and quality of life.4

Table 1. Pharmacologic options for management of type 2 diabetes mellitus. Recommendations for Implementation
Drug Dose Expected Effect Precaution and Side Effects
Clinic Level
Metformin 500 mg BID Glycemic control Hypoglycemia
The recommendations for implementation of this clinical pathway
Glibenclamide 5-20 mg daily Glycemic control Hypoglycemia, difficulty of is similar to the recommended implementation of the other clinical
swallowing, dizziness, allergy pathways developed by the PAFP QA Committee. The committee will
disseminate the clinical pathways in a form of lectures and publications.
Glimepiride 1-2 mg daily Glycemic control Hypoglycemia, difficulty of
swallowing, dizziness, tachycardia However, passively delivered had little effect in changing practice.24
We recommend that at the clinic level, self-reviews of chart records
Glipizide 2.5-5 mg daily Glycemic control Hypoglycemia, anxiety, using the recommendations of this clinical pathway as the criteria may
blurred vision be done. Identification of barriers and developing interventions to
promote compliance to the clinical pathway recommendations may be
more effective.
Non-pharmacologic Intervention
Organizational Level
DSMEC should be an ongoing process of improving the knowledge,
skills and ability of the patient for diabetes self-care as well as assist Similarly, at the organizational level the PAFP should establish
a family member in implementing and sustaining patient behavior a new model of quality improvement initiative where self-practice
needed to manage their diabetes on an ongoing basis. This includes reviews are included as part of the program. Within PAFP chapters, peer
monitoring of patient progress, health status and quality of life.4 group discussions, individual feedback and quality improvement reports
The increasing prevalence of diabetes type 2 and costs associated are the main components. This model has been shown to improve the
with treatment and its complications are of increasing concern. There care process for urinary problems in one randomized clinical trial.25
is a need to enhance community-oriented recommendations aimed at
primary and secondary prevention. The activities can be: References

• organizing to empower communities and diabetic patients 1. Chamberlain JJ, et al. Diagnosis and management of diabetes: Synopsis of the
• improve coordination and standardization of care 2016 American Diabetes Association Standards of Medical Care in Diabetes.
• improve access to care by removing barriers to care Ann Intern Med 2016 Apr 19;164(8):542-52.
• subsidize preventive treatment costs 2. Mohan V, et al. Management of type 2 diabetes in developing countries:
balancing optimal glycaemic control and outcomes with affordability and
• Implementation of these activities require a cooperative
accessibility to treatment. Diab Ther 2020 Jan;11(1):15-35.
partnership between hospital, general practitioner and the 3. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia
community.23 in type 2 diabetes: a patient-centered approach: position statement of the
American Diabetes Association (ADA) and the European Association for the
Patient Outcome Study of Diabetes (EASD). Diabetes Care 2012 Jun;35(6):1364-79.
4. Davies MJ, et al. Management of hyperglycemia in type 2 diabetes, 2018.
A consensus report by the American Diabetes Association (ADA) and the
During continuing care, the expected patient outcome should be European Association for the Study of Diabetes (EASD). Diabetes Care 2018
glycemic control, adherence to DSMEC, avoidance of side effects and Dec;41(12):2669-701.

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