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)

Abstract

IntroductionThe 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 analysisThis 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 disseminationThe 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 numberISRCTN57962668 V1.0 24/09/2018.