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| ID | Type | Description | Link |
|---|---|---|---|
| BALANCE Programme | Other Identifier | EVYD Technology |
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| Name | Class |
|---|---|
| Ministry of Health, Brunei Darussalam | UNKNOWN |
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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Therapeutics for Type 2 Diabetes Mellitus | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 16-week digital intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in HbA1c from baseline following a 16-week lifestyle intervention | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall change in HbA1c | Evaluation of overall changes in HbA1c | 16 weeks |
| Change in fasting lipid profile | Evaluation of overall changes in fasting lipid profile |
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Inclusion Criteria:
Age 18 to 70 years
Diagnosed with T2DM who are on any one or more of the following treatments:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jane Tey, Msc Immunology | Contact | +673 7430790 | jane.tey@evydtech.com | |
| Joshua Lam, MBBS | Contact | +65 97309276 | joshua.lam@evydtech.com |
| Name | Affiliation | Role |
|---|---|---|
| Chong Pui Lin, BM, MD | Raja Isteri Pengiran Anak Saleha (RIPAS) hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EVYD Technology | Recruiting | Bandar Seri Begawan | BG3122 | Brunei |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 16 weeks |
| Change in fasting blood glucose | Evaluation of overall changes in fasting blood glucose | 16 weeks |
| Change in BMI | Evaluation of overall changes in BMI | 16 weeks |
| Change in waist circumference | Evaluation of overall changes in waist circumference | 16 weeks |
| Participants' feedback on the use of DM DTx | Evaluation of participants' feedback of DM DTx through a series of questionnaires completed on end line | 16 weeks |
| D004700 | Endocrine System Diseases |