A pilot randomised controlled trial comparing telephonic message based follow up versus standard of care in patients with uncontrolled Type 2 Diabetes Mellitus in Medicine OPD

Diabetes mellitus is a complex metabolic illness marked by elevated blood sugar levels due to issues with insulin secretion or action. It affects around 422 million people worldwide, particularly impacting low- and middle-income countries and causing 1.5 million deaths annually. The cases of Diabetes in India have been steadily increasing and rural Tamil Nadu experiencing a nearly threefold increase.

Studies indicate that digital tools for health coaching and education can help improve diabetes control measures, such as HbA1c, weight loss, and blood glucose levels. One effective intervention is telephone follow-up after a hospital visit, as phones are widely used and do not require additional equipment. This method involves health-related messages and motivational calls to encourage medication adherence and lifestyle changes. The study aims to show that such telephonic follow-up interventions can improve HbA1c levels and reduce LDL cholesterol, blood pressure, and depression within three months.

The study focuses on general medicine outpatients in Tamil Nadu with HbA1c levels exceeding 8, comparing the effectiveness of standard treatment alone versus standard treatment supplemented with telephonic follow-up. The intervention group receives six weekly messages and a phone call at six weeks from the principal investigator, with messages provided in Tamil or English based on patient preference. Patients must be over 18, easily reachable by phone, and consent to participate. Exclusion criteria are not specified. The comparator group receives standard treatment following department practices.

The main goal of this study is to see if telemedicine follow-up for patients is as effective as standard care in managing HbA1c levels (a measure of blood sugar) at 3 months. Secondary goals include comparing HbA1c levels at 6 months, assessing patient satisfaction with telemedicine at 3 months, quality of life and comparing the prevalence of depression at 3 months between the telemedicine and standard care groups.