Evaluating a digital intervention for prevention of type 2 diabetes: protocol for a cluster-randomised controlled trial in urban and rural India.

BACKGROUND: The rising prevalence of diabetes, particularly in low- and middle-income countries, highlights an urgent need for innovative approaches to prevention. India faces a growing burden of type 2 diabetes (T2D), placing considerable strain on affected individuals and healthcare systems. This study aims to evaluate the effectiveness of a digital intervention designed to prevent T2D in individuals with pre-diabetes in India. METHODS: A total of 3,240 individuals with pre-diabetes will be recruited across urban and rural settings in Tamil Nadu and Delhi. Participants will be cluster randomised to either the digital intervention group or the control group (usual standard of care). Clusters will comprise of wards in urban areas and villages in rural areas. Initial screening will be conducted using the Indian Diabetes Risk Score (IDRS) ≥ 30 and/or a random capillary blood glucose level ≥ 110 mg/dL. Final recruitment into the study will be based on capillary oral glucose tolerance testing (OGTT) and/or HbA1c levels. The primary outcome is incidence of T2D at 24 months, and secondary outcomes are cardiometabolic events, lifestyle and behavioural factors, and cost effectiveness of digital interventions. The study is registered with the Central Trials Registry of India (CTRI/2022/02/040650). DISCUSSION: This protocol paper details the comprehensive study design aimed at evaluating the effectiveness of a digital intervention to prevent T2D in India. If effective, the study will provide important insights into the use of technology in resource-constrained settings and offer a scalable solution for diabetes prevention. The findings could also inform future interventions and policies aimed at curbing the rising burden of diabetes in low- and middle-income countries. TRIAL REGISTRATION: CTRI/2022/02/040650 (registration date: 28.02.2022).  https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NjE2NzE=&Enc=&userName=.