NCT06810986

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

Phase 2 Research Study for Type 2 Diabetes Mellitus Through Digital Therapeutics

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: EVYD Technology · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is conducted to evaluate the effectiveness of Digital therapeutics (DTx) in managing patients with Type 2 Diabetes Mellitus (T2DM) by delivering digital lifestyle interventions through a national health application (BruHealth).

Detailed description

This study is a single-arm, non-randomised clinical trial designed to evaluate the effectiveness and feasibility of an online management approach to improve glycaemic control in individuals with Type 2 Diabetes Mellitus (T2DM) through a digital lifestyle intervention (named the BALANCE Programme) over a 16-week period. The intervention leverages the Diabetes Mellitus Digital Therapeutics (DM DTx) module within the BruHealth application. Additionally, a Healthcare Professional (HCP) portal is included to facilitate ongoing monitoring and support, ensuring personalized care and real-time interactions between participants and healthcare providers. In addition, Muslim participants are offered the option of providing information in the DM DTx module about their fasting practices during Ramadan as an opportunistic way of obtaining data on the fasting risk and fasting experience in this cohort. Primary Objective: The primary objective is to assess the proportion of participants who experience a reduction in HbA1c levels by at least 0.6% by the end of the 16-week intervention period. Secondary Objectives: 1. To evaluate the overall changes in HbA1c, fasting blood glucose, Body Mass Index (BMI), waist circumference and improvements in lipid profile components (such as cholesterol and triglycerides) at week 16, compared to baseline measurements; 2. To evaluate participants' feedback on their experience with the BALANCE Programme and its usability after 16 weeks of usage; 3. to evaluate fasting experience amongst Muslims with T2DM during Ramadhan and to calculate their fasting risk using IDF-DAR score.

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
BEHAVIORAL	16-week digital intervention	Participants will be enrolled in a 16-week programme with the aim to manage T2DM through lifestyle adjustments. Participants will be given online support by their personal health coach with additional support from a dietitian or clinician in the study if required. Each participant will receive personalised recommendations for blood glucose monitoring schedule, diet and physical activity. Participants are required to log their blood glucose, diet and physical activity in the BruHealth application. Participants will review their progress with their health coach via video consultation on a regular basis. Additionally, participants will also participate in a structured diabetes self-management education course.

Timeline

• Start date: 2024-08-20
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2025-02-06
• Last updated: 2025-02-06

Locations

1 site across 1 country: Brunei