Evaluating digital lifestyle interventions for managing Type 2 Diabetes
Phase 2 Research Study for Type 2 Diabetes Mellitus Through Digital Therapeutics
NA · EVYD Technology · NCT06810986
This study is testing a digital program to help people with Type 2 Diabetes manage their blood sugar levels better over 16 weeks, with support from healthcare professionals.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | EVYD Technology (industry) |
| Locations | 1 site (Bandar Seri Begawan) |
| Trial ID | NCT06810986 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a digital therapeutic approach to improve glycaemic control in individuals with Type 2 Diabetes Mellitus (T2DM) using the BALANCE Programme delivered through the BruHealth application. It is a single-arm, non-randomised clinical trial that spans 16 weeks, focusing on the reduction of HbA1c levels among participants. The intervention includes ongoing support from healthcare professionals via a dedicated portal, ensuring personalized care and real-time interactions. Additionally, the study collects data on fasting practices during Ramadan for Muslim participants to assess fasting risks.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 diagnosed with Type 2 Diabetes Mellitus who are on specific glucose-lowering treatments.
Not a fit: Patients with Type 1 Diabetes Mellitus, those on more than two insulin injections a day, or with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve glycaemic control and overall health outcomes for patients with Type 2 Diabetes Mellitus.
How similar studies have performed: Other studies have shown promise in using digital therapeutics for diabetes management, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bandar Seri Begawan
- EVYD Technology — Bandar Seri Begawan, Brunei (RECRUITING)
Study contacts
- Principal investigator: Chong Pui Lin, BM, MD — Raja Isteri Pengiran Anak Saleha (RIPAS) hospital
- Study coordinator: Jane Tey, Msc Immunology
- Email: jane.tey@evydtech.com
- Phone: +673 7430790
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes Mellitus, Lifestyle Intervention, Digital Therapeutics