PMID- 33310798 OWN - NLM STAT- MEDLINE DCOM- 20210519 LR - 20221207 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 10 IP - 12 DP - 2020 Dec 12 TI - Protocol on a multicentre statistical and economic modelling study of risk-based stratified and personalised screening for diabetes and its complications in India (SMART India). PG - e039657 LID - 10.1136/bmjopen-2020-039657 [doi] LID - e039657 AB - INTRODUCTION: The aim of this study is to develop practical and affordable models to (a) diagnose people with diabetes and prediabetes and (b) identify those at risk of diabetes complications so that these models can be applied to the population in low-income and middle-income countries (LMIC) where laboratory tests are unaffordable. METHODS AND ANALYSIS: This statistical and economic modelling study will be done on at least 48 000 prospectively recruited participants aged 40 years or above through community screening across 20 predefined regions in India. Each participant will be tested for capillary random blood glucose (RBG) and complete a detailed health-related questionnaire. People with known diabetes and all participants with predefined levels of RBG will undergo further tests, including point-of-care (POC) glycated haemoglobin (HbA1c), POC lipid profile and POC urine test for microalbuminuria, retinal photography using non-mydriatic hand-held retinal camera, visual acuity assessment in both eyes and complete quality of life questionnaires. The primary aim of the study is to develop a model and assess its diagnostic performance to predict HbA1c diagnosed diabetes from simple tests that can be applied in resource-limited settings; secondary outcomes include RBG cut-off for definition of prediabetes, diagnostic accuracy of cost-effective risk stratification models for diabetic retinopathy and models for identifying those at risk of complications of diabetes. Diagnostic accuracy inter-tests agreement, statistical and economic modelling will be performed, accounting for clustering effects. ETHICS AND DISSEMINATION: The Indian Council of Medical Research/Health Ministry Screening Committee (HMSC/2018-0494 dated 17 December 2018 and institutional ethics committees of all the participating institutions approved the study. Results will be published in peer-reviewed journals and will be presented at national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN57962668 V1.0 24/09/2018. CI - (c) Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. FAU - Sivaprasad, Sobha AU - Sivaprasad S AUID- ORCID: 0000-0001-8952-0659 AD - NIHR Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK s.sivaprasad@ucl.ac.uk. AD - Vision Sciences, UCL Institute of Ophthalmology, London, UK. FAU - Raman, Rajiv AU - Raman R AUID- ORCID: 0000-0001-5842-0233 AD - Retina Department, Vision Research Foundation, Sankara Nethralaya, Chennai, India. FAU - Rajalakshmi, Ramachandran AU - Rajalakshmi R AD - Deaprtment of Diabetes, Madras Diabetes Research Foundation, Dr Mohan's Diabetes Specialities Centre, Chennai, India. FAU - Mohan, Viswanathan AU - Mohan V AD - Deaprtment of Diabetes, Madras Diabetes Research Foundation, Dr Mohan's Diabetes Specialities Centre, Chennai, India. FAU - Deepa, Mohan AU - Deepa M AD - Deaprtment of Diabetes, Madras Diabetes Research Foundation, Dr Mohan's Diabetes Specialities Centre, Chennai, India. FAU - Das, Taraprasad AU - Das T AD - Retina Department, Hyderabad Eye Research Foundation, LV Prasad Eye Institute, Hyderabad, India. FAU - Ramasamy, Kim AU - Ramasamy K AD - Retina Department, Aravind Medical Research Foundation, Madurai, India. FAU - Prevost, A Toby AU - Prevost AT AUID- ORCID: 0000-0003-1723-0796 AD - Nightingale-Saunders Clinical Trials and Epidemiology Unit, King's College London, London, UK. FAU - Wittenberg, Raphael AU - Wittenberg R AD - Centre for Health Service Economics and Organisation, University of Oxford, Oxford, UK. FAU - Netuveli, Gopalakrishnan AU - Netuveli G AD - Institute for Connected Communities, University of East London, London, UK. FAU - Lingam, Gopal AU - Lingam G AD - Department of Ophthalmology, National University Hospital, Singapore. FAU - Hanif, Wasim AU - Hanif W AD - Department of Diabetes, University Hospital, Birmingham, UK. FAU - Ramakrishnan, Radha AU - Ramakrishnan R AD - Vision Sciences, UCL Institute of Ophthalmology, London, UK. FAU - Ramu, Jayashree AU - Ramu J AD - NIHR Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK. FAU - Surya, Janani AU - Surya J AD - Retina Department, Vision Research Foundation, Sankara Nethralaya, Chennai, India. FAU - Conroy, Dolores AU - Conroy D AD - Vision Sciences, UCL Institute of Ophthalmology, London, UK. CN - SMART India Study Collaborators LA - eng SI - ISRCTN/ISRCTN57962668 GR - MR/P027881/1/MRC_/Medical Research Council/United Kingdom PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20201212 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 RN - 0 (Glycated Hemoglobin A) SB - IM MH - Adult MH - *Diabetic Retinopathy/diagnosis MH - Glycated Hemoglobin/analysis MH - Humans MH - India MH - Multicenter Studies as Topic MH - *Prediabetic State/diagnosis MH - Quality of Life PMC - PMC7735124 OTO - NOTNLM OT - diabetic retinopathy OT - epidemiology OT - general diabetes OT - health economics OT - medical retina OT - public health COIS- Competing interests: None declared. EDAT- 2020/12/15 06:00 MHDA- 2021/05/20 06:00 PMCR- 2020/12/12 CRDT- 2020/12/14 10:43 PHST- 2020/12/14 10:43 [entrez] PHST- 2020/12/15 06:00 [pubmed] PHST- 2021/05/20 06:00 [medline] PHST- 2020/12/12 00:00 [pmc-release] AID - bmjopen-2020-039657 [pii] AID - 10.1136/bmjopen-2020-039657 [doi] PST - epublish SO - BMJ Open. 2020 Dec 12;10(12):e039657. doi: 10.1136/bmjopen-2020-039657.