Effects of primary-care led self-management and low carbohydrate diet on glycaemic control in individuals with type 2 diabetes mellitus: study protocol of a cluster randomised controlled trial

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Introduction Type 2 diabetes mellitus (T2D) poses a significant global health burden, contributing to mortality and morbidity primarily through its complications such as renal failure, cardiovascular events, and others. Dietary patterns, particularly low carbohydrate diet and diabetes self-management education (DSME) have shown promise in improving glycaemic control and other metabolic parameters. However, evidence on the safety and long-term efficacy of such diets including health education, especially in populations like India with a high carbohydrate dietary tradition, is limited. This paper outlines a randomised controlled trial to determine the effectiveness of adopting a low carbohydrate diet in addition to standard care for T2D patients compared to those following standard care alone. Methods and analysis This is a cluster randomized controlled trial that adheres to the Recommendations for Interventional Trials as outlined by the Standard Protocol Items. The study will be conducted in 16 urban primary health centres (UPHCs). UPHCs randomized to either standard care or low carbohydrate diet intervention. Outcome: generating evidence on improving HbA1c levels without increasing anti-hyperglycaemic medication. This will be achieved through the use of CGM technology and personalized nutrition counselling, which will focus on dietary carbohydrate restriction for patients with T2DM. Discussion Results of this study will be published in peer-reviewed journals. The trial will provide insights into the efficacy and feasibility of implementing low carbohydrate diets and DSME in T2D management within public health settings. This protocol is registered on Clinical Trials Registry-India. The registration number for this trial is CTRI/2024/02/062202.