Evaluating a digital intervention for prevention of type 2 diabetes: protocol for a cluster-randomised controlled trial in urban and rural India
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Published version
Author(s)
Type
Journal Article
Abstract
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).
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).
Date Issued
2025-10-01
Date Acceptance
2025-08-07
Citation
BMC Public Health, 2025, 25
ISSN
1471-2458
Publisher
BMC
Journal / Book Title
BMC Public Health
Volume
25
Copyright Statement
© The Author(s) 2025. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
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Publication Status
Published
Article Number
3247
Date Publish Online
2025-10-01