Evaluation of Multifaceted Patient-Peer Delivered Intervention for Type-2 Diabetes Control and Remission in Rural Locations in India: Open-Label Cluster Randomised Pilot Study

ABSTRACT Objective To evaluate the effectiveness of a multifaceted lifestyle intervention delivered by patient peers and supported by healthcare workers and technology to achieve control and remission of type 2 diabetes. Methods Open-label, cluster-randomised controlled trial conducted in rural Assam, India. Type 2 diabetes patients identified through a screening program in 25 villages (clusters) were randomly assigned to intervention or standard care. At baseline, all participants underwent assessment of diet, physical activity, quality of life, medicine intake, physical measurements and biochemical evaluation. The intervention was a contextually designed package, delivered during fortnightly group counselling by patient-peers and healthcare workers, focusing on carbohydrate-restricted healthy diet, physical activity, diabetes management, and medication de-escalation. Nutrition data were transferred to the study management for suggestions and modifications on smartphones. Intervention was implemented for 3 months, when anthropometric and biochemical parameters were reassessed. Primary outcomes were diabetes control (HbA1c, fasting glucose) and remission (HbA1c <6.5% without medications). Modified intention-to-treat analysis has been performed. Results 353 patients in rural locations (intervention=193, standard care=160) were enrolled. Baseline sociodemographic, lifestyle, clinical and biochemical parameters were not different in intervention and standard-care groups. At 3 months, in the intervention vs standard-care group there was significantly lower median (interquartile range) HbA1c 7.9% (7.0-8.7) vs 8.6% (7.6-9.8), p<0.001; and fasting glucose 188.0 mg/dl (146.2-253.5) vs 210.0 mg/dl (166.0-282.0), p=0.001. Diabetes remission was in 9 participants (5.0%) in intervention vs 4 (2.7%) in standard care (p=0.249). Conclusions Patient-peers delivered and healthcare worker- and technology-supported diet and lifestyle intervention for type 2 diabetes led to significant improvement in diabetes control in rural patients in India. Diabetes remission was observed in a low proportion. Trial registration Registered with Clinical Trials Registry of India at www.ctri.nic.in ; registration number CTRI/2022/03/041302 dated 22 March 2022. STRENGTHS AND LIMITATIONS OF THE STUDY Multifaceted diet and lifestyle intervention for type-2 diabetes control and remission, delivered by patient-peers with health worker and technology support, is feasible in rural populations in India. This cluster-randomised trial shows that the intervention led to significantly better diabetes control. Diabetes remission occurred in a small proportion. Larger and longer prospective studies are required to confirm the effectiveness of such lifestyle strategies for diabetes control and remission in India, lower-middle, and low-income countries.