philippine clinical practice guidelines for the diagnosis and management of type 2 diabetes mellitus

Philippine Practice Guidelines for the Diagnosis & Management of

Type 2 Diabetes Mellitus

Iris Thiele Isip Tan MD, MSc, FPCP, FPSEMChief, Medical Informatics Unit

Associate Professor IV, UP College of Medicine

Adapted from the presentation of Dr. Cecilia Jimeno

Tuesday, April 23, 13

UNITE FOR DIABETES PHILIPPINESDiabetes Philippines

Institute for Studies on Diabetes Foundation, Inc.Philippine Society of Endocrinology & Metabolism

Philippine Center for Diabetes Education Foundation, Inc.


Goals & Areas of Collaboration

Establishment of a national diabetes

database

Encourage best diabetes practices - development of a unified CPG

Spearhead the fight for patients’ rights & safety - vigilance on

false claims

UNITE FOR DIABETES PHILIPPINES


Objectives for the Clinical Practice

Guideline


To develop clinical practice guidelines on the screening, diagnosis and management of diabetes which reflect the current best evidence and

which incorporate local data into the recommendations, in view of aiding clinical decision making for the benefit of the

Filipino patient

GUIDELINES THAT ARE SUITED FOR LOCAL REALITIES


Organizations in the Consensus Panel

Diabetes PhilippinesInstitute for Studies on Diabetes Foundation, Inc.Philippine Society of Endocrinology & Metabolism

Philippine Center for Diabetes Education Foundation, Inc.

23 other specialty, subspecialty organizationslay representatives of persons with diabetes



Scope of the Philippine CPG development

Outpatient setting

Screening and diagnosisScreening for complications

Prevention and treatmentSpecial groups: GDM, elderly


Philippine Clinical Practice Guideline for

Diabetes Mellitus

Part 1:SCREENING & DIAGNOSIS


UNITE PHILIPPINE CPGFOR DIABETES MELLITUS

Statement 2.1 All individuals being seen at any physician’s

clinic or by any healthcare provider should be evaluated annually for risk factors

for type 2 diabetes. (Table 1) [Grade D, Level 5]



Statement 2.2 Universal screening using laboratory

tests is NOT recommended as it would identify very few individuals who are at risk.

[Grade D, Level 5]



Table 1. Demographic and Clinical Risk Factors for Type 2 Diabetes

Testing should be considered in all adults >40 years old.



Consider earlier testing if with at least one other risk factor as follows:

•history of IGT or IFG•history of GDM or delivery of a baby weighing 8 lbs

or above•polycystic ovary syndrome (PCOS)•overweight (BMI >23 kg/m2) or obese (BMI >25

kg/m2)•waist circumference >80 cm (♀) and >90 cm (♂)

or waist-hip ratio (WHR) >1 (♂) and >0.85 (♀)



Consider earlier testing if with at least one other risk factor as follows (con’t):

•first-degree relative with type 2 diabetes•sedentary lifestyle•hypertension (BP >140/90 mm Hg)•diagnosis or history of any vascular diseases including

stroke, peripheral arterial occlusive disease, coronary artery disease



Consider earlier testing if with at least one other risk factor as follows (con’t):

•acanthosis nigricans•schizophrenia•serum HDL <35 mg/dL (0.9 mmol/L) and/or•serum triglycerides >250 mg/dL (2.82 mmol/L)


Which of the following will you NOT screen for diabetes?

a.42/F on follow-up for hypertension

b.35/M consulting for cough

c.45/M with tuberculosis

d.28/F diagnosed with PCOS


Why 40?Recommendation

from other guidelines

ADA2010

CDA2008

AACE2007 IDF 2005

All >45 y (B)

Earlier if BMI >25 kg/m2 and with >1 risk factor(s)

(B)

All > 40 y

Earlier if with risk factors

>30 y with risk factor

(B)

Target high risk people

by risk factor

assessment


Why 40?NNHeS 2008

Age (y)Prevalence of Diabetes MellitusPrevalence of Diabetes MellitusPrevalence of Diabetes MellitusPrevalence of Diabetes Mellitus

Age (y) Based on FBSa

Based on 2h postprandial

glucose

Based on DM questionnaire

True Diabetes

20-29 0.4 0.4 0.5 0.930-39 3.2 1.1 1.4 3.8

40-49 5.7 3.9 4.2 8.250-59 9.0 5.0 8.1 13.060-69 9.1 5.9 9.5 15.9>70 4.4 5.5 7.1 11.8

Overall 4.8 3.0 4.0 7.2a Based on FBS >125 mg/dLb Based on 2h-PPG > 200 mg/dLc Based on DM questionnaire (previous diagnosis by nurse or physician or on medication)d True diabetes (positive in any of the three assessment methods


You screen the 42 y.o. hypertensive. FBS is 5.2 mmol/L. What next?

a.Reassure patient she is not diabetic. There is no need to repeat the test.

b.Repeat FBS after 1 year.

c.Order an OGTT after 6 months.

d.Ask for an HbA1c after 3 months.


If initial test(s) are negative, when should repeat testing be done?

Repeat testing should ideally be done annually for Filipinos with risk factors owing to the significant prevalence and burden of diabetes in our

country. (Level 5, Grade D)


CANDI ManilaFojas MC, Lantion-Ang FL, Jimeno CA, Santiago D, Arroyo M, Laurel A, Sy H, See J.

Complications and cardiovascular risk factors among newly-diagnosed type 2 diabetics in Manila. Phil. J. Internal Medicine, 47: 99-105, May-June, 2009

Local study: newly-diagnosed diabetics in Manila20% peripheral neuropathy

42% proteinuria2% diabetic retinopathy

COMPLICATIONS FOUND AT DIAGNOSIS!



Recommended tests for diagnosing diabetes:

•Fasting plasma glucose (FPG) - 8-14 hours•Random plasma glucose (RPG)•2-h plasma glucose in 75-g OGTT



Criteria for diagnosis of diabetes (Level 2, Grade B)

•FPG >126 mg/dL (7.0 mmol/L)•Random plasma glucose >200 mg/dL (11.1 mmol/L)

in a patient with classic symptoms of hyperglycemia (weight loss, polyuria, polyphagia, polydipsia) or with signs and symptoms of hyperglycemic crisis

•2-h plasma glucose in 75-g OGTT >200 mg/dL (11.1 mmol/L)



Fasting plasma glucose (FPG) is the preferred test due to its wide availability, lower cost and better reproducibility (Level 3, Grade B)

•If the FPG falls within the impaired fasting glucose range (5.6-6.9 mmol/L) then a 75-g OGTT is recommended (Level 3, Grade B)

•Symptomatic patients - random or FPG



Among asymptomatic individuals with positive results, any of the three tests should be

repeated within two weeks for confirmation (Level 4, Grade C).



Diabetes can be diagnosed when any of the three tests are positive in a symptomatic patient (weight loss, polyuria, polyphagia, polydipsia).



A 75-g OGTT is preferred as the first test for the following (Level 3, Grade B):

•Previous FBS showing IFG 100-125 mg/dL (5.6-6.9 mmol/L)

•Previous diagnosis of CVD (CAD, stroke, peripheral arteriovascular disease) or who are at high risk of CVD

•A diagnosis of Metabolic Syndrome



At the present time, we cannot recommend the routine use of the following tests in the diagnosis of diabetes (Level 3, Grade C):

•HbA1c•Capillary blood glucose•Fructosamine•Urinalysis (Level 3, Grade B)• Plasma insulin (Level 3, Grade B)



•HbA1c•Capillary blood glucose•Fructosamine•Urinalysis

Interpret an available result with caution and confirm with any of the three standard tests (Level 2, Grade B).


Why NOT Hba1C?

Until standardization has been done in the Philippines, use HbA1c only as a tool for monitoring control among those with established DM.

•HbA1c not readily available in some areas•NGSP certification not easily verified in laboratories•Studies needed to determine effect of ethnicity


You screen the 42 y.o. hypertensive. FBS is 5.2 mmol/L. What next?

a.Reassure patient she is not diabetic. There is no need to repeat the test.

b.Repeat FBS after 1 year.

c.Order an OGTT after 6 months.

d.Ask for an HbA1c after 3 months.


Screen for risk factors for DM, prediabetes and MetS

Algorithm for Screening Diabetes Among Asymptomatic Individuals




Risk factors (Table 1)

YES





YES

Lab testing using FBS, RBS, OGTT (Fig 3)

YES





YES


YES

Age >40 y

NO

YES





YES


YES

Age >40 y

NO

YES

No further testing; re-evaluate annually

for risk factors

NO


Age >40 yAge <40 y with risk factors for DM

No 3 P’s or weight loss (asymptomatic)

No known CAD, PAD, CVD, No MetS

Diagnosed CAD, PAD, CVD or with MetS

Symptomatic (polyuria, polydipsia, polyphagia,

weight loss)







weight loss)

Fasting plasma glucose

<100 mg/dL

100-125 mg/dL

>126 mg/dL

No diabetesRepeat testing

after 1 y

75-g OGTT

Diabetes







weight loss)


<100 mg/dL

100-125 mg/dL

>126 mg/dL


after 1 y

75-g OGTT

Diabetes

75-g oral glucose tolerance test

(OGTT)

FBS <100 & 2h <140 mg/dL

FBS 100-125

or 2h 140-199mg/dL

FBS >126 mg/dL or 2h >200


after 1 y

IFG or IGT

Repeat after 6

mosDiabetes







weight loss)


<100 mg/dL

100-125 mg/dL

>126 mg/dL


after 1 y

75-g OGTT

Diabetes

75-g oral glucose tolerance test

(OGTT)

FBS <100 & 2h <140 mg/dL

FBS 100-125

or 2h 140-199mg/dL

FBS >126 mg/dL or 2h >200


after 1 y

IFG or IGT

Repeat after 6

mosDiabetes

Random plasma glucose

<140 mg/dL

140-199 mg/dL

>200 mg/dL


after 1 y

75-g OGTT

Diabetes


Philippine Clinical Practice Guideline for

Diabetes Mellitus

Part 2:MANAGEMENT & MONITORING



Initial evaluation - comprehensive medical history and PE

•Coronary heart disease risk assessment•Foot evaluation: assess risk for foot ulcer (identify

high-risk feet)•Eye exam: fundoscopy on diagnosis•Dental history or oral health history


RED FLAGSof dental disease

tooth achepain when chewing

sensitivity to cold/hot drinks

badly broken teethswelling of gums

bad breath


Prevalence among T2DM 68% (SLMC, n =192)

Bitong et al PJIM 2010

PERIODONTITIS

gum bleeding on brushingswelling and

redness of gumslooseness or

mobility of teethteeth that fall

off in adults


Which of the following will you NOT request as initial tests for a person with diabetes?

a.Fasting blood glucose, HbA1c

b.Complete lipid profile

c.Blood uric acid, 12-lead ECG

d.ALT, AST, serum creatinine



Minimal initial tests to be requested

• Fasting blood glucose, complete lipid profile• HbA1c• Liver function tests• Urinalysis; spot urine albumin-to-creatinine ratio• Serum creatinine and calculated GFR



Optional tests

• ECG and TET• TSH in type 1 diabetes, dyslipidemia or women

over age 50 y


Which of the following will you NOT request as initial tests for a person with diabetes?

a.Fasting blood glucose, HbA1c

b.Complete lipid profile

c.Blood uric acid, 12-lead ECG

d.ALT, AST, serum creatinine


Which of the following statements is true about monitoring diabetes?

a. Monitor Hba1c ideally twice a year.

b. Check FBS and postprandial blood sugar every 2-4 weeks.

c. Estimate trends in blood sugar control by checking CBGs once a week.

d. Achieve glycemic goals within three months.


Glycemic targets

Individualize targets.

FBS <4-7 mmol/L (72-126 mg/dL)

2h PPG <5-10 mmol/L (90-180 mg/dL)

Capillary (ADA) fasting 90-130 mg/dL

PPBG <180 mg/dL

HbA1c <7%


Glycemic targets

Individualize targets.

FBS <6 mmol/L

2h PPG <8 mmol/L

Newly diagnosed Relatively young (age <60 y)

No complications No risk factors for hypoglycemia

HbA1c <6.5%


Ideally, HbA1c every 3-6 months; 2x a year if controlled on stable therapy

FBS, postprandial sugar every 2-4 weeks

Capillary blood glucose 2x a week to estimate trends


Glycemic targets should be achieved within 6 months of diagnosis or first prescription.


Which of the following statements is true about monitoring diabetes?

a. Monitor Hba1c ideally twice a year.

b.Check FBS and postprandial blood sugar every 2-4 weeks.

c. Estimate trends in blood sugar control by checking CBGs once a week.

d. Achieve glycemic goals within three months.


Targets to Decrease CV Risk

BP controlLipid control ASA


Which of the following statements is true about reducing CV risk in diabetes?

a. Statins should be given regardless of baseline lipid levels.

b. There is insufficient evidence to recommend aspirin for primary prevention in men <60 y.

c. Give clopidogrel 75 mg/day for those with diabetes and a history of CVD.

d. The goal BP for most persons with diabetes is <140/80 mm Hg.



The goal BP for most persons with diabetes is <140/80 mm Hg.

•Lifestyle therapy alone for 3 months if pre-hypertensive (SBP 130-139 mm Hg or DBP 80-89 mm Hg)

•Pharmacologic + lifestyle therapy if SBP>140 mm Hg or DBP >90 mm Hg, or pre-hypertensive uncontrolled with lifestyle therapy alone


Weight loss if overweightDASH-style dietary pattern

(reduce Na, increase K, moderation of alcohol,

increased physical activity).

Lifestyle therapy



Statement 7.3 ACE inhibitors & ARBs are generally recommended

as initial therapy. If one class is not tolerated, the other should be substituted.

Multiple drug therapy (>2 agents at maximal doses) is generally required to achieve BP targets.

Thiazide-type diuretics, calcium channel blockers and B-blockers may be given as additional agents.



Recommendations are consistent with Philippine Practice Guidelines for the Treatment of Dyslipidemia.

•LDL is the primary target for dyslipidemia management in persons with diabetes.



Statement 8.1.1Statin therapy should be added to lifestyle therapy, regardless of baseline levels for diabetics

•with overt CVD (A)•without CVD who are >40 y and have >1more

other CVD risk factors (A)



Statement 8.1.2For patients at lower risk (e.g. without overt CVD and <40 y), statin therapy should be considered in addition to lifestyle therapy if -

•LDL-C remains >100 mg/dL•those with multiple risk factors (hypertension, familial

hypercholesterolemia, LVH, smoking, family history of premature CAD, male sex, age >55 y, proteinuria, albuminuria, BMI>25)



The 100-70 rule•Without overt CVD, goal is LDL-C <100 mg/

dL (2.6 mmol/L) [A]•With overt CVD, goal is LDL-C <70 mg/dL

(1.8 mmol/L). Use of high dose statin is an option. [B]



Recommendation 9.2Insufficient evidence to recommend aspirin for primary prevention in lower risk individuals

•Men < 50 y•Women <60 y * Clinical judgement if with multiple risk factors



Recommendation 9.3Use aspirin therapy for secondary prevention strategy in those with DM and a history of CVD [A].

•For patients with CVD and documented aspirin allergy, clopidogrel (75 mg/day) should be used.



Recommendation 9.4Combination therapy of ASA (75-162 mg/day) and clopidogrel (75 mg/day) is reasonable up to a year after an acute coronary syndrome [B].


Which of the following statements is true about reducing CV risk in diabetes?

a. Statins should be given regardless of baseline lipid levels.

b. There is insufficient evidence to recommend aspirin for primary prevention in men <60 y.

c. Give clopidogrel 75 mg/day for those with diabetes and a history of CVD.

d.The goal BP for most persons with diabetes is <140/80 mm Hg.


Newly diagnosed T2DM

Initiation of Drug Therapy among Newly Diagnosed Type 2 Diabetes Patients




HbA1c <9%FBS < 250

HbA1c >9%FBS > 250




HbA1c <9%FBS < 250

HbA1c >9%FBS > 250

Mono-therapy

Option for combination

therapy




HbA1c <9%FBS < 250

HbA1c >9%FBS > 250

Mono-therapy

Option for combination

therapy

Combination therapy

Insulin therapy



Statement 10.1Initiate treatment with metformin for monotherapy unless with contraindications or intolerance of its ADE’s -• diarrhea• severe nausea• abdominal pain



When optimization of therapy is needed, choose the second drug according to the following -

•degree of HbA1c lowering•hypoglycemia risk•weight gain•patient profile (dosing complexity, renal/hepatic

problems, other contraindications and age)


Adapted from AACE Diabetes Mellitus Guidelines Endocr Pract 2007

Drug Therapy HbA1c reduction (%) MONOTHERAPYMONOTHERAPY

Sulfonylureas 0.9 to 2.5Biguanide (Metformin) 1.1 to 3.0Thiazolidinedione 1.5 to 1.6Alpha-glucosidase inhibitors 0.6 to 1.3DPP-4 inhibitors 0.8

NON-INSULIN INJECTABLENON-INSULIN INJECTABLEExenatide 0.8 to 0.9

COMBINATION THERAPYCOMBINATION THERAPYSU + Metformin 1.7SU + Pioglitazone 1.2SU + Acarbose 1.3Repaglinide + Metformin 1.4Pioglitazone + Metformin 0.7DPP-4 inhibitor + Metformin 0.7DPP-4 inhibitor + Pioglitazone 0.7


Safety and Tolerability

Insulin secretagogues Metformin alpha-glucosidase

inhibitors TZDs Insulin

Risk of hypoglycemia ✔ ✔

Weight gain ✔ ✔ ✔GI side effects ✔ ✔Lactic acidosis ✔Edema ✔

1DeFronzo RA. Ann Intern Med 1999; 131:281–303. 2UKPDS. Lancet 1998; 352:837–853.3Nesto RW, et al. Circulation 2003; 108:2941–2948.


Contraindications

Sulfonylurea Meglitinide Biguanide AGI TZD

Renal insufficiency ✔ ✔ ✔

Liver disease ✔ ✔ ✔ ✔ ✔Inflammatory bowel disease ✔

Congestive heart failure ✔ ✔

Known hypersensitivity ✔ ✔ ✔ ✔ ✔



Since HbA1c reduction is the overriding goal, the precise combination used may not be as important as the glucose level achieved.

•There is no evidence that a specific combination is any more effective in lowering glucose levels or preventing complications than another.SU + Pio = SU + Metformin (Hanefield et al, 2004 & Nagasaka et al, 2004)

SU + Met = SU + DPP-IV inhibitors (?)



Statement 10.4.2The following patients must be referred to internists or diabetes specialists (endocrinologists or diabetologists) -• Type 1 diabetes• Moderate to severe hyperglycemia• Co-morbid conditions (infections, acute CV events i.e. CHF or

acute MI)• Significant hepatic and renal impairment• Women with diabetes who are pregnant


Clinical practice guidelines aim to help physicians and patients reach the best healthcare decisions.

Steinbrook R. NEJM 2007


“If you write it, and it is good, then they will follow.”

Keefer JH. Clin Chem 2001


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philippine clinical practice guidelines for the diagnosis and management of type 2 diabetes mellitus

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