Guidelines RSSDI-ESI Clinical Practice Recommendations for the Management of Type 2 Diabetes Mellitus 2020 Rajeev Chawla1, S. V. Madhu2, B. M. Makkar3, Sujoy Ghosh4, Banshi Saboo5, Sanjay Kalra6, On behalf of the RSSDI-ESI Consensus Group* 1North Delhi Diabetes Centre, Rohini, New Delhi, 2Centre for Diabetes, Endocrinology and Metabolism, UCMS-GTB Hospital, 3Dr. Makkar’s Diabetes and Obesity Centre, Paschim Vihar, New Delhi, 4Department of Endocrinology and Metabolism, Institute of Post Graduate Medical Education and Research, Kolkata, West Bengal, 5DiaCare - A Complete Diabetes Care Centre, Ahmedabad, Gujarat, 6Department of Endocrinology, Bharti Hospital, Karnal, Haryana, India *RSSDI-ESI CONSENSUS GROUP Diagnosis of Diabetes Coordinators: S. R. Aravind, Ganapathi Bantwal Members: A. H. Zargar Nihal Thomas, Alok Kanugo Prevention (Including Screening and Coordinators: S. V. Madhu, R. M. Anjana Early Detection) Members: A. Ramachandran, Eesh Bhatia, Amitesh Agarwal Treatment 1: Medical Nutrition Therapy Coordinators: Anoop Misra, Naval Vikram, and Lifestyle Modification Members: Parminder Singh, Sambit Das, Vageesh Ayyar Treatment 2: Oral Antidiabetic Agents Coordinators: Shashank Joshi, Krishna Seshadri Members: Vijay Panikar, Sameer Agarwal, V. Sringesh Treatment 3: Injectables Coordinators: A. K. Das, Sanjay Agarwal Members: Ajay Kumar, Sunil Jain, Sujit Jha Treatment 4: Individualizing Therapy Coordinators: Banshi Saboo, A. K. Singh Members: Muralidharan, Santosh Singh, Rajesh Khadgawat Post Prandial Hyperglycaemia Coordinators: Hari Kumar, Kaushik Pandit Members: S. K. Sharma, Mathew John, Pradip Mukhopadhyay Acute Metabolic Complications Coordinators: Jubin Jacob, Anil Bhansali Members: Sushil Jindal, Kamlakar Tripathi, Narsingh Verma Hypoglycaemia Coordinators: Anand Moses, Jamal Ahmed Members: D. C. Sharma, G. Vijaykumar, Dheeraj Kapoor Chronic Complications 1: Retinopathy, Coordinators: Rajeev Chawla, Rakesh Sahay Neuropathy, Diabetic Kidney Disease Members: Shalini Jaggi, R. K. Lalwani, Hitesh Punyani Chronic Complications 2: Diabetic Foot Coordinators: S. K. Singh, Vijay Vishwanathan and Peripheral Arterial Disease Members: Ashu Rastogi, Ghanshyam Goyal, Ashraf Ganie Contd... Address for correspondence: Prof. S.V. Madhu, Director-Professor and Head, Department of Endocrinology and Head, Centre for Diabetes, Endocrinology and Metabolism, UCMS-GTBHospital, New Delhi, India. E-mail: [email protected] This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution‑NonCommercial‑ShareAlike 4.0 License, which allows others to Access this article online remix, tweak, and build upon the work non‑commercially, as long as appropriate credit Quick Response Code: is given and the new creations are licensed under the identical terms. Website: www.ijem.in For reprints contact: [email protected] How to cite this article: Chawla R, Madhu SV, Makkar BM, Ghosh S, DOI: Saboo B, Kalra S. RSSDI-ESI clinical practice recommendations for the 10.4103/ijem.IJEM_225_20 management of type 2 diabetes mellitus 2020. Indian J Endocr Metab 2020;24:1-122. © 2020 Indian Journal of Endocrinology and Metabolism | Published by Wolters Kluwer - Medknow 1 Chawla, et al.: RSSDI-ESI clinical practice recommendations Diabetes and CVD Coordinators: V. Mohan, Arvind Gupta Members: Shaileja Kale, Sudhir Bhandari, R. V. Jayakumar Obesity and Type 2 Diabetes Mellitus Coordinators: B. M. Makkar, Neeta Deshpande, Members: C. L Nawal, K. A. V. Subramanian, Rucha Mehta Infections and Vaccinations Coordinators: Subhankar Chowdhary, Jayant Panda Members: Pramod Gandhi, J. K. Sharma, Vinay Dhandhania Sexual Dysfunction Coordinators: Samar Banerjee, P. K. Jabbar Members: Mithun Bhartiya, Urman Dhruv, Premlata vartakavi Glycaemic Monitoring Coordinators: Siddhartha Das, A. G. Unnikrishnan Members: Rajiv Kovil, Alok Sachan, Girish Varma Technologies Coordinators: Jothydev, Ambrish Mithal Members: K. M. Prasanna Kumar, Manoj Chawla, Ameya Joshi Special Situations Coordinators: Nikhil Tandon, Padma Menon Members: Sujoy Ghosh, Nalini Shah, Usha Sriram, Rajesh Rajput Fasting and diabetes Coordinators: Sarita Bajaj, Manas Barua Members: M. K. Garg, Sachin Chhitawar, Hemant Thacker Education Coordinators: Vasanth Kumar, Sunil Gupta Members: Meena Chhabra, Amit Gupta, G. D. Ramchandani Psychosocial Issues Coordinators: H. B. Chandalia, Sanjay Kalra Members: G. R. Sridhar, Rishi Shukla, Salam Ranabir Complementary and Alternate Therapies Coordinators: P. V. Rao, Anuj Maheshwari Members: J. P. Sai, K. R. Narsimha Setty, Saurabh Srivastava DIAGNOSIS OF DIABETES RECOMMENDATIONS Recommended Care Prediabetes can be diagnosed with any of the following criteria • Impaired fasting glucose (IFG): FPG 100 mg/dL to 125 mg/dL or • Impaired glucose tolerance (IGT): 2-h plasma glucose (2-h PG) during 75-g OGTT 140 mg/dL to 199 mg/dL or • HbA1c ≥5.7%-6.4% Diabetes can be diagnosed with any of the following criteria: • FPG ≥126 mg/dL* or • FPG ≥126 mg/dL and/or 2-h PG ≥200 mg/dL using 75-g OGTT • HbA1c≥6.5% ** or • Random plasma glucose ≥200 mg/dL in the presence of classical diabetes symptoms Asymptomatic individuals with a single abnormal test should have the test repeated to confirm the diagnosis unless the result is unequivocally abnormal. Limited Care Diabetes can be diagnosed with any of the following criteria: • FPG ≥126 mg/dL* or • FPG ≥126 mg/dL and/or 2-h plasma glucose ≥200 mg/dL using 75-g OGTT or • Random plasma glucose ≥200 mg/dL in the presence of classical diabetes symptoms Asymptomatic individuals with a single abnormal test should have the test repeated to confirm the diagnosis unless the result is unequivocally abnormal NOTE • Plasma must be separated soon after collection because • Estimation of HbA1c should be performed using NGSP the blood glucose levels drop by 5%–8% hourly if whole standardized method. blood is stored at room temperature. • Capillary glucose estimation methods are not recommended for diagnosis For more details on glucose estimation visit: http://www.ncbi. • Venous plasma is used for estimation of glucose nlm.nih.gov/books/NBK248/ 2 Indian Journal of Endocrinology and Metabolism ¦ Volume 24 ¦ Issue 1 ¦ January-February 2020 Chawla, et al.: RSSDI-ESI clinical practice recommendations *FPG is defined as glucose estimated after no caloric intake RATIONALE AND EVIDENCE for at least 8–12 hours. Glycosylated haemoglobin cut off for diagnosis of diabetes **Using a method that is National Glycohaemoglobin in Indian patients Standardization Program (NGSP) certified. For more on • The RSSDI expert panel suggests HbA1c and NGSP, please visit http://www.ngsp.org/index. ▫ HbA1c ≥6.5% as optimal level for diagnosis of asp diabetes in Indian patients ▫ HbA1c cannot be used as ‘sole’ measurement for BACKGROUND diagnosis of diabetes in Indian settings. The diagnostic criteria of diabetes have been constantly These recommendations are based on the Indian evolving. Both type 1 and type 2 Diabetes mellitus (DM) evidences are diagnosed based on the plasma glucose criteria, either • A recent study conducted in Singapore residents the fasting plasma glucose (FPG) levels or the 2-h plasma of Chinese, Malay and Indian race to assess the post-prandial glucose (2-h PPG) levels during a 75-g oral performance of HbA1c as a screening test in Asian glucose tolerance test (OGTT), or the newer glycosylated populations suggested that HbA1c is an appropriate haemoglobin (HbA1c) criteria which reflects the average alternative to FPG as a first-step screening test, and a plasma glucose concentration over the previous 8–12 combination of HbA1c with a cut-off of ≥6.1% and FPG weeks.[1,2] The International Expert Committee Report level ≥100 mg/dL would improve detection in patients recommend a cut-point of ≥6.5% for HbA1c for diagnosing with diabetes.[6] diabetes as an alternative to fasting plasma glucose (FPG • A study to assess the diagnostic accuracy and optimal [3] ≥7.0 mmol/L). HbA1c testing has some substantial HbA1c cutoffs for diabetes and prediabetes among high- advantages over FPG and OGTT, such as convenience, risk south Indians suggested that HbA1c ≥6.5% can pre-analytical stability, and less day-to-day fluctuations be defined as a cut-off for diabetes and HbA1c ≥5.9% due to stress and illness.[3] Additionally, HbA1c has is optimal for prediabetes diagnosis and value <5.6% been recognized as marker to assess secondary vascular excludes prediabetes/diabetes status.[8] complications due to metabolic derailments in susceptible • Data from a community based randomized cross sectional individuals.[2,4,5] However, given ethnic differences in sensitivity and specificity of HbA1c population-specific study in urban Chandigarh suggest that HbA1c cut point cut-offs might be necessary.[6,7] Moreover, measuring of 6.5% has optimal specificity of 88%, while cut off HbA1c is expensive as compared to FPG assessments and point of 7.0% has sensitivity of 92% for diagnosis of [10] standardization of measurement techniques and laboratories diabetes. are poorly practiced across the country.[8] Also, in several • The results of the Chennai Urban Rural Epidemiology countries including India, HbA1c demonstrated inadequate Study (CURES) demonstrated 88.0% sensitivity and predictive accuracy in the diagnosis of diabetes, there is 87.9% specificity for detection of diabetes when HbA1c no consensus on a suitable cut-off point of HbA1c for cut off point is 6.1% (based on 2-h post load plasma diagnosis of diabetes in this high-risk population.[9]