Cohort Study Evaluating Glycaemic Control in Individuals with Type 2 Diabetes Mellitus Through Digital Therapeutics (DM DTx)
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
-
Age 18 to 70 years
-
Diagnosed with T2DM who are on any one or more of the following treatments:
- oral glucose lowering medication(s)
- any type of insulin treatment (up to 2 injections a day only)
- on diet control only
- GLP-1 receptor agonist established at least 6 months prior to enrolment
- 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
Related Research Topics
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Trial Locations
- Locations (1)
EVYD Technology
🇧🇳Bandar Seri Begawan, Brunei Darussalam
EVYD Technology🇧🇳Bandar Seri Begawan, Brunei DarussalamJoshua Lam, MBBSContact+65 97309276joshua.lam@evydtech.comJane Tey, Msc ImmunologyContact+673 7430790jane.tey@evydtech.com