Study of a 16-Week Digital Program to Improve Blood Sugar Control in Adults with Type 2 Diabetes Mellitus Using BruHealth App

What this Trial Is About

Researchers are evaluating the effectiveness of Digital Therapeutics DTx in managing individuals with Type 2 Diabetes Mellitus T2DM by delivering digital lifestyle interventions through the BruHealth national health application. This single-arm, non-randomised clinical trial aims to improve glycaemic control over 16 weeks using the BALANCE Programme within the DM DTx module, supported by a healthcare professional portal for personalized care and real-time monitoring. The study also includes an optional component for Muslim participants to report fasting practices during Ramadan to assess fasting risks and experiences. Participants will take part in a 16-week digital intervention involving personalized lifestyle adjustments. They will receive online support from a personal health coach and, if needed, additional support from a dietitian or clinician. Each participant will get tailored recommendations for blood glucose monitoring, diet, and physical activity, which they will log using the BruHealth app. Regular video consultations with health coaches and a structured diabetes self-management education course are part of the program. During the study, participants will provide baseline data and complete assessment scales. They will log their blood glucose, diet, and activity while receiving ongoing monitoring through the healthcare professional portal. Researchers will measure changes in HbA1c levels to assess glycaemic control, along with secondary measures like fasting blood glucose, BMI, waist circumference, and lipid profiles. Participant feedback on the digital programs usability will also be collected. The total participation duration is 16 weeks with continuous support and assessment.

Cohort Study Evaluating Glycaemic Control in Individuals with Type 2 Diabetes Mellitus Through Digital Therapeutics (DM DTx)