A Summary of the Malaysian Clinical Practice Guidelines: Management of Type 2 Diabetes Mellitus (4th Edition) 2009
Feisul Idzwan Mustapha,1 Rohana Abdul Ghani,2 Alexander Tan,3 Wan Mohd Izani Wan Mohamed,4 Winnie Chee Siew Swee5 on behalf of the CPG Secretariat, Health Technology Assessment Section, Medical Development Division, Ministry of Health, Malaysia
2 Faculty of Medicine, National University of Malaysia
3 Faculty of Medicine, University of Malaya
4 Faculty of Medicine, University of Science, Malaysia
5 International Medical University, Malaysia
Feisul Idzwan Mustapha, MD
Disease Control Division (NCD Section), Ministry of Health, Malaysia,
Level 6, Block E10, Parcel E, 62590 Putrajaya, Malaysia
Email: dr.feisul@moh.gov.my
There were three previous Clinical Practice Guidelines
(CPG) on the Management of Type 2 Diabetes Mellitus, the 1st edition
published in 1992, followed by the 2nd edition (1996) and the 3rd
edition (2004). This 4th edition was deemed necessary due to the tremendous
body of new evidence that has become available in the last 4 to 5 years that has major
impact on the management of Type 2 Diabetes, including new targets for control, new
classes of pharmacological agents targeting novel pathways, as well as major outcome
studies. The main objective of this guideline is to provide
evidence-based recommendations to assist health care providers in the identification,
diagnosis and management of people with type 2 diabetes mellitus (T2DM). It seeks to
answer four main clinical questions i.e., (i) How can diabetes be prevented? (ii) How
to screen for glucose intolerance? (iii) How is diabetes diagnosed? and (iv) How can
people with diabetes be managed? This guideline is divided into six main sections as
follows: Section 1 - Diabetes: The Disease; Section 2 - Screening and Diagnosis;
Section 3 - Management of Type 2 Diabetes Mellitus; Section 4 - Metabolic Syndrome;
Section 5 - Management of Chronic Complications; and lastly, Section 6 - Prevention of
Type 2 Diabetes Mellitus. In addition, the appendices contain the following information
(i) carbohydrate content of common Malaysian foods; (ii) glycaemic index of foods;
(iii) examples of physical activity; (iv) food exchange list; (v) the 5-item version of
the International Index of Erectile Function; (vi) dosage of anti-diabetic agents in
renal failure; and lastly (vii) clinical monitoring protocol. In Malaysia, the development of clinical practice
guidelines is coordinated by the CPG Secretariat, Health Technology Assessment Section,
Medical Development Division, Ministry of Health (MOH). Malaysia already has in place
standard operating procedures (SOPs) for the development of new CPGs or the revision of
existing CPGs. For this guideline, the Guideline Development Task Force was formed in
2008, consisting of endocrinologists, a nephrologist, an ophthalmologist, two family
medicine specialists, a general physician, a neurologist, a paediatric endocrinologist,
two public health specialists, a dietician and a diabetic nurse educator. The clinical questions were divided into major subgroups
and members of the CPG Task Force were assigned individual topics within these
subgroups. Literature search was carried out on PUBMED, Medline, Cochrane Databases of
Systemic Reviews, and via the OVID search engine. References were also made on existing
guidelines on the management of Type 2 diabetes, including American Diabetes
Association (ADA) Position Statement on Standards of Medical Care in Diabetes 2008;
American Association of Clinical Endocrinologists (AACE) Medical Guidelines for
Clinical Practice for the Management of Diabetes Mellitus 2007; International Diabetes
Federation (IDF) Global Guideline for Type 2 Diabetes 2005; American Diabetes
Association (ADA) and European Association for the Study of Diabetes (EASD) Management
of Hyperglycaemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and
Adjustment of Therapy 2006; Malaysian CPG on Management of Obesity 2004; Canadian
Clinical Practice Guidelines 2003; and Medical Nutrition Therapy Guidelines for Type 2
Diabetes, Malaysian Dietitian Association 2005. All literature retrieved were critically appraised,
presented and discussed during group meetings. The articles were graded using the
criteria used by the United States/Canadian Preventive Services Task Force, while the
grading of recommendation in this guideline was modified from the Scottish
Intercollegiate Guidelines Network (SIGN). All statements and recommendations
formulated were agreed by the CPG Task Force members. Where the evidence was
insufficient, the recommendations were derived by group consensus. The draft guideline was submitted to external reviewers
consisting of senior consultants of various relevant specialties. In addition, the
draft guideline was also posted on the MOH website for comments and feedback. Finally
in May 2009, the final guideline received the approval of the Health Technology
Assessment and Clinical Practice Guidelines Council, MOH. It was officially launched by
the Director General of Health Malaysia in Putrajaya, Malaysia in August
2009. The guideline recommendations on screening are divided
into four main categories: (i) for symptomatic individuals; (ii) asymptomatic adults;
(iii) pregnant women; and (iv) children and adolescents. The indications for screening
are consistent with current international guidelines and were mostly adapted from ADA
recommendations.1 One major exception is the age cut-off point of 30 years
for screening in the general population. The decision was based on the results of the
Third National Health and Morbidity Survey (NMHS III) 2006,2 which showed a
sharp increase in age-specific prevalence after the age of 30 years. (Figure 1) The screening algorithm for symptomatic individuals is
shown in Figure 2, while for asymptomatic individuals in Figure 3. Screening for
diabetes using fasting plasma glucose (FPG) should be performed annually in those with
risk factors and those ≥30 years. For children and adolescents at
risk of developing diabetes, screening every 2 years should be initiated at 10 years
old or at onset of puberty if puberty occurs at a younger age. In addition, more
frequent or earlier testing with either a FPG or 2-hour plasma glucose in a 75g oral
glucose tolerance test (OGTT) should be considered in people with additional risk
factors for diabetes. For diagnosis using OGTT, Malaysia used 6.1 mmol/L as the cut-off
point at 0-hour, instead of ADA’s 5.6 mmol/L (Table 1), consistent
with IDF recommendations.3 The CPG Task Force has created a unique treatment
algorithm for Malaysia for the management of T2DM in relation to diagnosis and
glycaemic targets. (Figure 4) The initial treatment regime is determined by the
HbA1c level at diagnosis. However, taking into account that the coverage of
HbA 1c testing in Malaysia is not universal, particularly within the public
health sector where over 70% of diabetes patients are on active follow-up, the CPG Task
Force also included the corresponding fasting plasma glucose levels as well. The
treatment targets are modified from the IDF Western Pacific Region (IDF-WPR) Type 2
Diabetes Practical Targets and Treatment as shown in Table 2.3 In
particular, the CPG Task Force has adopted HbA1c of <6.5% as optimum
glycaemic control. Targets for control are applicable for all age
groups. However, in patients with co-morbidities or elderly patients, targets should be
individualised. Click here to download Table
1 Table 1. Values for Oral Glucose
Tolerance Test (OGTT) Click here to download Table2 Table 2. Treatment Targets Click here to download Figure
1 Figure 1. Prevalence of diabetes in
Malaysia by age group, 2006 All T2DM patients are started on pharmacological
treatment. As first-line therapy, metformin is the preferred choice; however other oral
anti-diabetic (OAD) agents are acceptable alternatives. The algorithm also specifically
states that sulphonylureas should preferably not be used as first-line. Second-line
therapy after metformin is open to all classes of drugs. The CPG included references to
five classes of OAD which are (i) a-glucosidase inhibitors; (ii) biguanides; (iii)
dipeptidyl peptidase-4 inhibitors; (iv) insulin secretagogues; and (v)
thiazolidinediones. When indicated, start with a minimal dose of OAD agent, while
re-emphasising diet and physical activity. An appropriate duration of time (2 to 16
weeks, depending on the OAD agent used) between increments are given to allow
achievement of steady state blood glucose control. Click here to download Figure
2 Figure 2. Screening algorithm for
symptomatic individuals Insulin may be used as initial therapy in T2DM
particularly in marked hyperglycaemia or if targets have not been reached despite
optimal OAD therapy. The CPG recommends starting with either pre-bed
intermediate-acting, or pre-bed long-acting insulin or pre-dinner premixed insulin. The
‘fix the fasting first’ principle is applied in
optimising the insulin dose. In children and adolescents, long-acting or
intermediate-acting insulin may be added at a dose of 0.5u/kg at bed-time. In addition,
short-term insulin therapy should be considered in (i) acute illness, surgery, stress
and emergencies; (ii) pregnancy; (iii) breast-feeding; and (iv) severe metabolic
decompensation. Upon diagnosis, all patients are advised on lifestyle modification,
medication and patient education to encourage self-care. It is recommended that all
individuals with diabetes receive diet counseling by a dietitian. Diet counseling
should be individualised according to nutrient needs, severity of disease, cultural
preferences and willingness to change. The primary strategy recommended is monitoring
of carbohydrate intake by carbohydrate exchanges. Total carbohydrate intake should be
consistent and evenly distributed throughout the day with regular meal timings and
synchronised with medication time actions. Glycemic index (GI) may be used to guide
food choices while keeping to calories and carbohydrate prescription. Excessive intake
of sucrose is discouraged as it may lead to weight gain and sucrose intake must be
counted as part of the total carbohydrate allowance for the day. Artificial sweeteners
such as aspartame are allowed. Other dietary recommendations include reducing saturated
fat and cholesterol intake and limiting sodium intake.4 For physical activity, it is recommended that individuals
should exercise 5 days a week and brisk walking is recommended for all. The duration of
exercise should be at least 150 mins/week of moderate intensity activities. For
overweight and obese individuals, physical activity should gradually be increased to 60
to 90 minutes per day for long term weight loss. Any increase in daily energy
expenditure such as gardening, walking up stairs, or washing the car is beneficial. Click here to download Figure
3 Figure 3. Screening algorithm for
asymptomatic individuals Click here to download Figure
4 Figure 4. Treatment algorithm The recommendations for this section are mostly adapted
from the National Institute for Health and Clinical Excellence (NICE), Diabetes in
Pregnancy. 5 The CPG emphasises on pre-pregnancy euglycaemia with
early referral to physician or endocrinologist, counselling and target HbA
1c <6.5% with insulin therapy if necessary. The glycaemic
targets during pregnancy are shown in Table 3, with individualised monitoring
recommended as follows: Click here to download Table
3 Table 3. Glycaemic Targets During
Pregnancy All insulin including rapid acting insulin is safe.
Metformin and glibenclamide are not recommended during pregnancy. In addition,
Glucose-Insulin-Potassium (GIK) regimen can be used during delivery or caesarean
section. During post-partum period, insulin dosage must be reduced as insulin
requirement drops immediately after delivery by 60-75%. For breast-feeding patients
insulin therapy should be continued at a lower dose if necessary. In non-breast-feeding
patients, OAD agents can be continued. The CPG recommends initiation of treatment in diabetics
with blood pressure (BP) >130/80 mmHg and they should be screened for proteinuria or
microalbuminuria.6 Tight BP control (<130/80 mmHg) should take precedence
over the class of anti-hypertensive drug used. In the presence of proteinuria of
>1g/24 hours, the target BP is ≤125/75 mmHg. The treatment of
hypertension in diabetes is recommended based on the Malaysian Clinical Practice
Guidelines for the Management of Hypertension 2008.7 This includes dietary
counselling targeting optimal body weight and dietary sodium restriction. Angiotensin converting enzyme inhibitors (ACEI) are the
drug of choice for patients with diabetes, both with and without microalbuminuria or
proteinuria, with angiotensin receptor blocker (ARBs) recommended for ACEI intolerant
patients. Diuretics, calcium channel blockers (CCBs), beta-blockers and peripheral
alpha blockers may be used as add-on therapy. A table which illustrates the choice of
anti-hypertensive drugs in diabetes patients with concomitant conditions, adapted from
the Malaysian Hypertension CPG is also included in the guideline.7 The guideline emphasises LDL-C as the primary target.
Without overt CVD patients >40 years old should be treated with a statin regardless
of baseline LDL cholesterol levels. With overt CVD, all patients should be treated with
a statin to a target LDL-C of 1.8mmol/L. The secondary targets are non-HDL-C, HDL-C and
TG. The recommended medications are as follows: · Increase HDL-C: Fibrate +/- Nicotinic
Acid · Combined Hyperlipidaemia: Statins +/-
Fibrate or Resin +Fibrate or Nicotinic Acid Statin therapy is contraindicated in pregnancy. In
children and adolescents lipid lowering medications should only be initiated in those
>10 years old. The CPG recognises the metabolic syndrome based on the
IDF definition, which includes central obesity (waist circumference of 90 cm for men
and 80 cm for women) plus any two of the following: (i) raised TG level >1.7 mmol/L;
(ii) low HDL-C (<1.0 mmol/L in men and <1.3 mmol/L in women); (iii) high BP
≥130/85 mm Hg; (iv) raised FPG ≥5.6 mmol/L or
previously diagnosed T2DM. The main aim of therapy is to reduce the risk of
cardiovascular disease and the development of T2DM. Management includes lifestyle
modification with pharmacological treatment of the individual components of the
syndrome to target values as shown in Table 2. The recommended optimal weight loss is 1
to 2 kg/month in adults. The recommended anti-obesity agents in diabetics include
orlistat and sibutramine. Bariatric surgery may be an option in patients with BMI
>35 kg/m2. Anti-obesity agents and bariatric surgery are not recommended
in children. People with T2DM should be screened for complications at
diagnosis and thereafter at yearly intervals. The screening schedule is shown in Table
4. Achieving as well as maintaining tight glycaemic and blood pressure control is
reiterated repeatedly for prevention of complications. For retinopathy, health care professionals should refer
patients to an ophthalmologist for (i) unexplained poor vision; (ii) diabetic
retinopathy greater than occasional microaneurysms; and (iii) macular oedema or hard
exudates within the macula. Urgent referral is required if there is (i) sudden visual
deterioration; (ii) new vessels on fundoscopy; (iii) rubeosisiridis; (iv) vitreous
haemorrhage; and (v) retinal detachment. Annual screening for microalbuminuria is advocated as
essential. Microalbuminuria is defined as a urinary albumin:creatinine ratio (ACR)
>2.5 mg/mmol in men and >3.5 mg/mmol in women, or a urinary albumin concentration
>20mg/l. Screening can be done initially with conventional dipstick on an early
morning urine specimen if urine dipstick for proteinuria is negative. Two further tests
within 3 to 6 months is required to confirm a positive microalbuminuria. In patients
with proteinuria of >1 gram a day, the target BP is ≤125/75
mmHg. ACEI or ARB should be started unless contraindicated. Referral to a nephrologist
should be made if (i) serum creatinine >200 μmol/L; (ii) haematuria;
(iii) nephritic syndrome; (iv) absence of retinopathy (where the diagnosis of diabetic
nephropathy may be in doubt); (v) difficult to control blood pressure; and (vi)
worsening renal function. Click here to download Table
4 Table 4. Schedule for Screening for
Complications Diabetic peripheral neuropathy may be diagnosed by 10-g
monofilament pressure sensation, 128 Hz tuning fork, ankle jerks (deep tendon reflexes)
and pin prick test. Medical treatment for sensory symptoms of painful peripheral
neuropathy includes: gabapentin, lamotrigine, carbamazepine or amitriptyline. To reduce the risk of coronary heart disease (CHD),
patients with atypical symptoms or who are asymptomatic should be screened using a
resting ECG and by applying an established cardiovascular risk assessment tool such as
Framingham Risk Score or UKPDS Risk Engine.8,9 Patients with an abnormal
resting ECG or those having high risk should be referred to a cardiologist for further
evaluation. Primary prevention with low dose aspirin is not generally recommended
unless patients have high risk of developing CHD based on the Framingham Risk
Assessment Score (>10% risk over a 10 year period). All adult male T2DM patients over the age of 40 should be
asked about erectile dysfunction (ED) and screened for ED by using the International
Index of Erectile Function (IIEF) questionnaire. Medications which cause ED should be
avoided if possible. Phosphodiesterase-5 (PDE-5) inhibitors can be used to treat ED in
patients without contraindications. Urology referral may be necessary for those not
responding; or for those with contraindications to PDE-5 inhibitors. In addition to lifestyle modification to decrease the
risk of conversion of IFG or IGT to frank T2DM, metformin should be considered as
off-label use for those at very high risk (combined IFG and IGT plus other risk
factors) or for those who fail lifestyle therapy after 6 months. The use of other
agents like ACEIs, ARBs and statins are not recommended solely for the purpose of
primary prevention. For prevention of diabetes, weight loss (5-10% of initial
body weight), regular physical activity (150 min/week), with dietary strategies
including reduced calories and behavior modification are recommended. A high fibre diet
(20-30g/day with 5 to 7 servings/day) consisting of vegetables, fruits, legumes and
whole grains is encouraged.4 To support the dissemination of the recommendations
contained in the CPG, the CPG Task Force also developed and published two supporting
documents. The first document is the 'Quick Reference for Health
Care Providers,' an 8-page pocket-size booklet which provides key
messages and a summary of the main recommendations in the CPG Management of T2DM
(4th edition) 2009. The main objective of this booklet is to provide an easy
and quick reference for doctors, assistant medical officers and nurses involved in the
management of T2DM patients, particularly at the primary care level. The second document published is the 'Training Module for Health Care Providers.' This is a comprehensive document which also includes a CD containing powerpoint presentations of the various topics contained in the T2DM CPG together with relevant case studies. The main objective of this document is to provide a standardised training package to assist trainers in conducting training to disseminate the recommendations contained in the CPG to all health care providers involved in the management of T2DM particularly at the primary care level. The CPG Task Force also undertook a series of
training-of-trainers (TOT) workshops held in five different regions throughout Malaysia
which was held from October 2009 until January 2010. A total 169 family medicine
specialists, physicians and medical officers from various MOH health care facilities
underwent this 2-full day training, which was conducted mostly by members of the CPG
Task Force. The Training Module developed was used as the training material during the
TOT and subsequent echo trainings held at the state, district and hospital level
throughout 2010. Publication of the T2DM CPG was only the first step in
the process of disseminating the latest recommendations to further improve the quality
of care of T2DM patients. It is an important tool, but it will only prove useful if
health care providers are aware of its existence, have easy access, ease of retrieving
the required information and have the opportunity to undergo training on the practical
aspects of implementation. All of the documents mentioned in this article were printed
and distributed throughout Malaysia. They are also downloadable in pdf format from the
MOH website, together with the powerpoint slides for the Training Module. For the public primary health care facilities, Malaysia
has in place an audit mechanism called the ‘Diabetes Clinical
Audit,’ together with a National Quality Assurance (QA) Program
entitled ‘Quality of Diabetes Care at MOH Health Care Facilities:
Glycaemic Control’ which are implemented in all MOH health clinics
throughout Malaysia involved in the management of T2DM patients since 2009. For the QA
program, the current set optimum standard is ≥30% of T2DM patients
achieving HbA1c<6.5% for each health clinic. Compliance to the current
T2DM CPG forms part of the shortfall in quality (SIQ) investigation within the QA
program. Over the coming years, the CPG Task Force hopes to see a positive impact of
the implementation of the recommendations contained in the CPG. Members of the CPG Task Force: Prof. Dr. Wan Mohamad Wan
Bebakar, Prof. Dr. Amir Sharifuddin Khir, Dr. Andrew Lim Keat Eu, Prof. Dr. Anuar Zaini
Md. Zain, Dr. Arlene Ngan, Prof. Dr. Chan Siew Pheng, Dr. Fatanah Ismail, Dr. Feisul
Idzwan Mustapha, Dr. G.R. Letchuman Ramanathan, Dr. Haniffah Abdul Gafoor, Dr. Hew Fen
Lee, Dr. Husni Hussain, Prof. Dr. Ikram Shah Ismail, Prof. Dr. Khalid Abdul Kadir,
Prof. Dr. KhooEe Ming, Prof. Dr. Mafauzy Mohamed, Dr. Malik Mumtaz, Dr. Mastura Ismail,
Prof. Dr. Nor Azmi Kamaruddin, Prof. Dr. Rokiah Pendek, Dr. Rozina Mohd. Ghazalli, Dr.
Tan Ming Yeong, Prof. Dr. Wu Loo Ling and Dr. Zanariah Hussein. The full document is available at the Malaysia
Ministry of Health website at http://www.moh.gov.my/v/ed . 1. American Diabetes Association (ADA). Position
Statement on Standards of Medical Care in Diabetes-2009. Diabetes
Care. 2009;32:S13-S61. 2. Ministry of Health, Malaysia. The Third National
Health and Morbidity Survey (NHMS III) 2006. 2008. 3. International Diabetes Federation (IDF). Global
Guidelines for Type 2 Diabetes 2005. http://www.idf.org. Accessed May 4, 2009. 4. Malaysian Dietitian's Association.
Medical Nutrition Therapy Guidelines for Type 2 Diabetes. 2005. 5. National Institute for Health and Clinical Excellence
(NICE). Diabetes in Prenancy (revised reprint July 2008). Accessed May 4, 2008. 6. Guidelines Subcommittee. World Health Organization
– International Society of Hypertension: Guidelines for the
Management of Hypertension. Journal of Hypertension. 1999;17:151-183. 7. Malaysian Clinical Practice Guidelines for the
Management of Hypertension 2008. http://www.moh.gov.my/MohPortal/
cpgDetail.jsp?action=view&id=51. Accessed May 4, 2009. 8. National Cholesterol Education Program. Third Report
of the Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in
Adults (Adults Treatment Panel III). Risk Assessment Tool for Estimating Your 10-year
Risk of Having a Heart Attack. http://hp2010.nhlbihin.net/atpiii/calculator.asp?usertype%20_20prof. Accessed May 4, 2009. 9. Diabetes Trial Unit, The Expert Centre for Diabetes,
Endocrinology and Metabolism. UKPDS Risk Engine. http://www.dtu.ox.ac.uk/riskengine. Accessed May 4, 2009.
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Copyright© 2011 by the JAFES
Received March 17, 2011. Accepted May 3, 2011.
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