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Government of West Bengal

State NCD Cell


Health & Family Welfare Department
National Health Mission
GN-29, 4th Floor, Swasthya Sathi Building, Swasthya Bhawan Premises, Sector - V
Salt-Lake, Bidhannagar, Kolkata - 700091

Memo no. HFW-27024/12/2019-NCD SEC-Dept. of H&FW/ 4 2120Jj Dt. () J, Q J, 2 02 f


To,

The Principal & MSVP of all Medical Colleges & Teaching Institution
The Chief Medical Officer of Health of all Districts & Health District
Superintendents/BMOHs of all hospitals and health centres

Madam/Sir,

In recent decades, India has witnessed a rapidly exploding epidemic of type II diabetes. Indeed,
India today has the second largest number of people with diabetes in the world. The
International Diabetes Federation (IDF) estimates that there are 72.9 million people with
diabetes in India in 2017, which is projected to rise to 134.3 million by the year 2045. The
prevalence of diabetes in urban India, especially in large metropolitan cities has increased from
2% in the 1970s to over 20% at present and the rural areas are also fast catching up. West
Bengal has 22% prevalence of diabetes (NFHS 5) and approximately one crore adults with type II
diabetes.

India has adopted National Program for Prevention and Control of Cancer, Diabetes, CVD and
Stroke (NPCDCS) focuses on the achievement of various goals e.g. 25% relative reduction in the
Premature mortality from NCO (diabetes, cardiovascular disease, cancer etc.) by 2025 within
the existing healthcare system. Diabetes being a silent killer, controlling that with un-
interrupted drug and lifestyle modification is a major challenge. Adopting a simple standard
treatment protocol for management of type II diabetes is the first step to ensure treatment
compliance and archive >75% control of patients suffering from diabetes.

THUS A STATE SPECIFIC STANDARD TREATMENT PROTOCOL FOR DIABETS is hereby prepared
(Annexed) adopted from WHO, other state protocols and international standard with necessary
inputs and modifications from eminent subject specialists and medical teachers of West Bengal,
considering evidenced based safety, efficacy and cost benefit issues. Strict adherence of the
protocol is desirable for put on treatment of all new type II diabetic patients until complication
and other co-morbid situation arises (also included in protocol) in life saving condition.

tvvJoi~f\_}~'V\
Director of Medical Education
q-/~l.2-1
tor of Health Services
Govt. of West Bengal Govt. of West Bengal
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TREATMENT PROTOCOL FOR TYPE 2 DIABETES MELLITUS
Life Style Modifications:
Screen: (any 1)
• Age ≥30 years 1. Avoid tobacco and alcohol.
2. Exercise regularly 150 minutes per week.
• BMI ≥23 kg/m 2
3. If overweight/ obese, lose weight.
• H/O Prediabetes (annually) 4. Diet- decrease quantity of cereals
• H/O GDM (every 3 years) by 25%, encourage fruits and
vegetables.
• Symptoms of DM: polyuria, 5. Eat less than one teaspoon of salt
polydipsia, polyphagia, per day.
unexplained weight loss 6. Reduce fat intake by changing how
• Any other NCD you cook – remove fatty part of
meat, boil, limit reuse of oil for
frying.
Advise Life Style Modifications & assess for complications.
7. Avoid packed and stored foods.
……………………….Primary Tier…………………………
If Initial FPG 200-250mg/dl or PPPG 300-350mg/dl, consider 8. Avoid excess sugar, carbonated/
starting dual drug therapy (Metformin + Teneligliptin) packaged drinks.

1 Start T. Metformin 500 mg OD or BD


Monitor FPG/ PPPG monthly. Glycemic Goals for most patients:
• Pre Prandial Plasma Glucose- 80-130
Review in 1 month, if FPG/ PPBG values are high. mg/dl
• 2 hour Post Prandial Plasma
1A Intensify T. Metformin 1000 mg BD Glucose-<140-150 mg/ dl
Along with LSM (up titrate to maximally tolerated • HbA1c- <7% (to be checked atleast
gastrointestinal side effects). twice a year)

Review in 1 month, if FPG/ PPBG values are high.

2 Add T. Teneligliptin 20 mg OD Screen for co-morbidities and


complications: (atleast annually)
Along with LSM, T. Metformin 1000 mg BID. Hypertension- Blood pressure
(preferably every visit)
………………………Secondary tier…………………..........
Dyslipidemia- Fasting lipid profile
3 Add third drug* Cardiovascular disorders- ECG
DRUG INDICATIONS CAUTION Retinopathy- Dilated Fundus
examination
Glimepiride Robust glucose Weight gain, Nephropathy- Serum creatinine,
lowering hypoglycemia urinary albumin: creatinine ratio
Dapagliflozin Heart failure or at risk Catabolic state, recurrent Neuropathy- Monofilament test
(generic) of heart failure, reno- genitourinary tract Peripheral arterial disease- Distal
protection, established infection, H/O upper pulses ± ABI (Ankle Brachial Index)
atherosclerotic urinary tract infections,
cardiovascular disease severely insulinopaenic
Pioglitazone Atherosclerotic Heart failure, oedema
cardiovascular disease
Hypoglycemia
Voglibose Prandial glucose Gastrointestinal side
regulator at any stage effects • Symptoms:
Cold sweat, trembling of hands,
*Priority of choice of third line drug, to be decided based on
associated compelling co-morbidities hunger, palpitation, confusion.
If initial FPG>250mg/dl or PPPG>350 mg/dl, especially • Treatment:
with severe osmotic symptoms or co-existent infection or Give 15 gms of glucose and
presence of any complications or uncontrolled glucose with consume complex carbohydrate
three drug therapy consider referring to District (starchy food). Recheck blood
Hospital/SDH for consideration of insulin initiation. glucose after 15 minutes and
repeat if hypoglycemia continues.
If plasma glucose is under control by any of these steps and no
• Review: Current anti-
complications are identified, same treatment should be continued.
diabetic medication.
Follow-up should be done every 1-3 monthly on the basis of FBG
and 2 hour PPBG.
GUIDELINES FOR MANAGEMENT OF TYPE 2 DIABETES MELUTUS IN PRIMARY CARE SETTING

I. SCREENING FOR TYPE 2 DIABETES MELUTUS

Whom to screen? (if no symptoms)


1. Age ~30 years without other risk factors
2. All overweight or obese adults (BMI ~23 kg/m 2) and children older than 10 years
(BMl>85th centile)
3. Patients with prediabetes (AlC ~5.7%, IGT, or IFG) should be tested yearly
4. Women who were diagnosed with GDM should have lifelong testing at least every 3
years
If results are normal, testing should be repeated at a minimum of 3-year intervals, with
consideration of more frequent testing depending on initial results and risk status

IGT - Impaired Glucose Tolerance; IFG - Impaired Fasting Glucose

Criteria for the Screening and Diagnosis of Diabetes*

Indicators Pre-diabetes Diabetes


Fasting plasma glucose 100-125 mg/di (IFG) ~ 126 mg/di
2hr post 75 gm Glucose load
140-199 mg/di (IGT) ~ 200mg/dl
plasma glucose
HbAlc 5.7-6.4 % ~6.5%
Random plasma glucose ~ 200 mg/di **

IFG - Impaired Fasting Glucose; IGT - Impaired Glucose Tolerance

*If asymptomatic, single abnormal test report needs reconfirmation as soon as possible

**Only diagnostic in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis

II. PRINCIPLES OF THERAPY


Ill. Alleviate symptoms, prevent acute and chronic complications, improve quality of life

1. Screen for comorbidities

What to screen for? How to screen?


Hypertension Blood pressure
Dyslipidemia Fasting lipid profile (preferably after glycemic control)
Cardiovascular ECG
Retinopathy Dilated Fundus examination/ Fundus photography
Nephropathy Serum creatinine
Urinary albumin (spot urinary albumin-to creatinine ratio) { after

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W hat to screen fo r? How to screen?
glycemic control}
Neuropathy i. pinprick sensation
ii. 10-g monofilament
iii. Vibration perception threshold
Peripheral arterial Distal pulses± ABI*
disease
* ABI: Ankle Brachia! (systolic BP) Index

2. Lifestyle changes

Nutrition ./ Calorie restriction (if BMI is increased)


./ Balanced diet
./ Adequate fruits & vegetables
./ Avoid deep fried foods, soft drinks, processed foods
Physical activity ./ 150 min/week moderate exertion, spread over at least 3
days/week, with no more than 2 consecutive days without
activity± Resistance exercise
Sleep ./ About 7 hours per night
Tobacco avoidance ./ No tobacco products
Moderation of ./ No more than 1 drink per day for adult women and no more than
alcohol intake 2 drinks per day for adult men

3. Pharmacological therapy

Whom to treat?

./ All patients with diabetes not responding to lifestyle therapy for a period of 3 months should be
started on pharmacological therapy
./ If initial HbAlc ~ 7.5%, pharmacological treatment should be started along with lifestyle
changes

Which drug to choose?

i. Oral antidiabetic drugs

1st line agent

Metformin is recommended as the first line treatment for all patients with type 2 diabetes mellitus
unless not tolerated or contraindicated (eGFR<30ml/min/l.73m2), lactic acidosis, any acute illness or,
hypoxaemic states)

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2nd line agent

Add Teneligliptin to Metformin if blood glucose is not controlled with Metformin alone or if Metformin
is contraindicated

3n1 line agent (to be decided by specialist) *

DRUG INDICATIONS CAUTION

Glimepiride Robust glucose lowering Weight gain, hypoglycemia

Heart failure or at risk of heart Catabolic state, recurrent


Da pagliflozi n
failure, reno-protection, genitourinary tract infection, H/0
(generic) established atherosclerotic upper urinary tract infections,
cardiovascular disease severely insulinopaenic

Atherosclerotic cardiovascular
Pioglitazone Heart failure, oedema
disease

Prandial glucose regulator at


Voglibose Gastrointestinal side effects
any stage

*Priority of choice of these drugs to be decided based on associated compelling co-morbidities

Doses of Oral Anti-hyperglycaemic agents:

Drug Initial dose Maximum Frequency of dose


dose
Metformin SOOmgto 1 gm 2.Sgm o.d., bid, tid
(depending on
preparation and total
dose)
Sulphonylureas
Glimepiride 1 to 4 mg 8mg 0.0., 8.1.D

Teneligliptin 20mg 20mg OD


AGI
Voglibose 0.2mgwith 0.3mgwith With meals
each meal each meal

Pioglitazone 15mg 30mg OD


Dapagliflozin
5-lOmg 10mg OD

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ii. Insulin (Specialist initiation)

Indications of insulin?
1. Catabolic state/ Uncontrolled hyperglycemia
2. Preconception & Pregnancy
3. Major surgery/ Acute metabolic/ infective complications

./ Consider insulin if at the time of diagnosis, patient is symptomatic and have one of the
following: Fasting plasma glucose> 250mg/dl or Postprandial glucose> 300mg/dl or
HbAlc >10%
./ Insulin can be considered at any stage in type 2 diabetes mellitus. However, it is
recommended to consider insulin after failure of 3 oral antidiabetic drugs

Which insulin to initiate?

./ If fasting blood glucose is predominantly raised - consider Basal insulin


./ If postprandial blood glucose is predominantly raised - consider premixed insulin
./ Human insulins are generally preferred over analog insulins, especially because of price
advantage
./ Rapid acting analogs may be preferred in sick patients with unreliable food intake
./ long acting analogs may be preferred in patients particularly experiencing recurrent nocturnal
hypoglycemia
./ SMBG (Self Monitoring of Blood Glucose) to be strongly encouraged, whenever insulin is
inititiated

How to initiate insulin?

• Basal insulin: 0.1-0.2 units/ kg/ day or, lOUnits/day; generally at a fixed time at night. Titrate
every 3rd day (after monitoring fasting glucose) to achieve glycaemic targets
• Pre-mixed insulin: 0.4-0.5 units/ kg/ day; administer 2;3rd of the total daily dose with morning
meal and 1;3rd with evening meal; analogue pre-mixed insulin to be injected within 10 min of
onset of meal, while human pre-mixed insulin needs to be injected about 30 min pre-meal
• For Basal bolus: 50% dose as basal, rest 50% in three divided doses as prandial insulin

1\,-Jo ~°'\'IA>V\
Director of Medical Education
Govt. of West Bengal
Director of Heal] lt:c
Govt. of West Bengal

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Memo no. HFW-27024/12/2019-NCD SEC-Dept. of H&FW / q 2,Q.,/Lo.fJ._ Dt. 0 J. 0 J o ? D21.
Copy forwarded for information to the :-

1. The Mission Director, (NHM) West Bengal,


2. The Addi. Mission Director, (NHM) West Bengal,
3. The Principal & MSVP, All Medical Colleges
4. Jt. DHS, NCD
5. Dy. DHS, NCD-1 & II
6. Programme Officer - I & II, NHM
7. The Chief Medical Officer of Health, All Districts & Health Districts
8. Coordinator, LT cell, Swsathya Bhawan, for web posting
9. Office copy

~Tl"J/2-1
Asst. D.H.S, NCO - II
Govt. of West Bengal

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