Cohort Study Evaluating Glycaemic Control in Individuals with Type 2 Diabetes Mellitus Through Digital Therapeutics (DM DTx)
Recruiting · NCT06810986 · Interventional (participants receive a specific treatment) · Lead sponsor: EVYD Technology
View the official record on ClinicalTrials.gov →Interventions studied
16-week digital intervention
What this trial is about
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).
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- EVYD Technology - Bandar Seri Begawan, Brunei