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

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes Mellitus (T2DM)

• Registration Number: NCT06810986
• Lead Sponsor: EVYD Technology

Brief 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.

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-20
• Study First Submitted: 2025-01-31
• Study First Submitted QC: 2025-01-31
• Last Update Submitted: 2025-01-31
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Age 18 to 70 years

• Diagnosed with T2DM who are on any one or more of the following treatments:

  1. oral glucose lowering medication(s)
  2. any type of insulin treatment (up to 2 injections a day only)
  3. on diet control only
  4. GLP-1 receptor agonist established at least 6 months prior to enrolment

Exclusion Criteria

• Diagnosed with T2DM on more than 2 insulin injections a day
• Diagnosed with Type 1 Diabetes Mellitus (T1DM)
• Pregnant / Breast-feeding
• Recent Myocardial Infarction (MI) or Stroke / Cerebrovascular Accidents (CVA) in the past 6 months
• Heart failure
• Liver failure
• Active cancer
• Undergoing active treatment for active foot disease
• Undergoing active treatment for active diabetes-related eye disease
• CKD stage 4 and 5 (eGFR < 30ml/min)
• Hospitalisation for any reason in the past 6 months
• Advised by doctor to not participate in intense physical activity
• Physical disability and/or unable to perform Activities of Daily Living (ADL) independently
• Unable to use Youtube on mobile devices
• Unable to use BruHealth independently

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Reduction in HbA1c from baseline following a 16-week lifestyle intervention	16 weeks	The proportion of participants who achieve at least 0.6% reduction in HbA1c from baseline following a 16-week lifestyle intervention provided by DM DTx

Secondary Outcome Measures

Name	Time	Method
Overall change in HbA1c	16 weeks	Evaluation of overall changes in HbA1c
Change in fasting lipid profile	16 weeks	Evaluation of overall changes in fasting lipid profile
Change in fasting blood glucose	16 weeks	Evaluation of overall changes in fasting blood glucose
Change in BMI	16 weeks	Evaluation of overall changes in BMI
Change in waist circumference	16 weeks	Evaluation of overall changes in waist circumference
Participants' feedback on the use of DM DTx	16 weeks	Evaluation of participants' feedback of DM DTx through a series of questionnaires completed on end line

Trial Locations

Locations (1)

EVYD Technology; 🇧🇳 Bandar Seri Begawan, Brunei Darussalam