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SMART- India Study (Statistical Modelling And Risk assessment of Type 2 diabetes complications in India)

Current diagnoses of diabetes and its complications such as retinopathy (eye problems), diabetic kidney disease, stroke and ischaemic heart disease and diabetic foot are based on expensive tools and laboratory tests. Therefore, these are not accessible to many people around the world, meaning that we have a lack of data on the prevalence of diabetic retinopathy or a diabetic care pathway that is cost-effective in low and medium income countries. Non-laboratory tests may be more cost-effective than laboratory tests, and therefore may be more accessible in these countries.

This UK-India collaborative study will test whether non-laboratory tests could be used to accurately diagnose pre-diabetes, diabetes and each complication of diabetes. The aim is to find the most cost-effective test, or tests that include questionnaires and demographic data that could accurately be used, instead of the current standard tests that are not accessible to several people around the world because of the costs. The study will also allow us to report the overall prevalence and regional prevalence of diabetic retinopathy and sight-threatening retinopathy in India using a point of care retinal camera. By conducting a national study, we will also be able to evaluate the feasibility of a diabetic care pathway in India. The longer term aim is to translate these models and risk scores to many countries globally.

The study will be conducted by healthcare workers across at 20 sites in India and each site will have three clusters stratified into urban, rural and certain populations that have presumed poor access to healthcare.  It is expected that each cluster will screen 800 – 2,000 consenting participants > 40 years, facilitating a total sample size of a minimum of 48,000 and ideally 120,000 participants.

The healthcare workers will do door-to-door surveys to collect data including demographics, point of care tests to detect pre diabetes and diabetes, retinal photographs taken using hand-held cameras if diabetes is detected, EQ5D, an instrument to measure of health-related quality of life, with vision bolt-on data, where data is available, and detailed cost data.

An application has been developed to collect the data onto a tablet that is linked to a newly developed cloud based electronic database. The retinal photographs will also be uploaded to this platform and sent for grading.

Location of the 20 sites across India involved in the SMART India study

Ophthalmologists at four main sites namely Aravind Medical Research Foundation, Vision Research Foundation, Madras Diabetic Research Foundation and Hyderabad Eye Research Foundation will co-ordinate the study across the 20 sites and will be responsible for the training of healthcare workers doing the surveys, point of care testing and taking retinal images.

 

Dr Kim Ramasamy, Aravind Medical Research Foundation,

Madurai, Tamil Nadu

Dr Rajiv Raman, Vision Research Foundation, Chennai

Dr Viswananthan Mohan, Madras Diabetic Research Foundation, Chennai

Dr Taraprasad Das, Hyderabad Eye Research Foundation, Hyderabad

SMART-India Study Flow

 

 

Last updated: 22nd November 2018