Cohort Study Evaluating Glycaemic Control in Individuals with Type 2 Diabetes Mellitus Through Digital Therapeutics (DM DTx) (DM DTx)
Phase 2 Research Study for Type 2 Diabetes Mellitus Through Digital Therapeutics
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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;
- To evaluate participants' feedback on their experience with the BALANCE Programme and its usability after 16 weeks of usage;
- to evaluate fasting experience amongst Muslims with T2DM during Ramadhan and to calculate their fasting risk using IDF-DAR score.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jane Tey, Msc Immunology
- Phone Number: +673 7430790
- Email: jane.tey@evydtech.com
Study Contact Backup
- Name: Joshua Lam, MBBS
- Phone Number: +65 97309276
- Email: joshua.lam@evydtech.com
Study Locations
-
-
-
Bandar Seri Begawan, Brunei Darussalam, BG3122
- Recruiting
- EVYD Technology
-
Contact:
- Jane Tey, Msc Immunology
- Phone Number: +673 7430790
- Email: jane.tey@evydtech.com
-
Contact:
- Joshua Lam, MBBS
- Phone Number: +65 97309276
- Email: joshua.lam@evydtech.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Digital Therapeutics for Type 2 Diabetes Mellitus
16 weeks digital intervention with online support This study is a single-arm, non-randomised clinical trial, which will collect participant's baseline data, apply relevant assessment scales, collect data using a comprehensive digital intervention in 16 weeks to evaluate the improvement of relevant markers post 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction in HbA1c from baseline following a 16-week lifestyle intervention
Time Frame: 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
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall change in HbA1c
Time Frame: 16 weeks
|
Evaluation of overall changes in HbA1c
|
16 weeks
|
|
Change in fasting lipid profile
Time Frame: 16 weeks
|
Evaluation of overall changes in fasting lipid profile
|
16 weeks
|
|
Change in fasting blood glucose
Time Frame: 16 weeks
|
Evaluation of overall changes in fasting blood glucose
|
16 weeks
|
|
Change in BMI
Time Frame: 16 weeks
|
Evaluation of overall changes in BMI
|
16 weeks
|
|
Change in waist circumference
Time Frame: 16 weeks
|
Evaluation of overall changes in waist circumference
|
16 weeks
|
|
Participants' feedback on the use of DM DTx
Time Frame: 16 weeks
|
Evaluation of participants' feedback of DM DTx through a series of questionnaires completed on end line
|
16 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chong Pui Lin, BM, MD, Raja Isteri Pengiran Anak Saleha (RIPAS) hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MHREC/MOH/2024/11
- BALANCE Programme (Other Identifier: EVYD Technology)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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