Cohort Study Evaluating Glycaemic Control in Individuals with Type 2 Diabetes Mellitus Through Digital Therapeutics (DM DTx)
Phase 2 Research Study for Type 2 Diabetes Mellitus Through Digital Therapeutics
EVYD Technology
500 participants
Aug 20, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria6
- 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 Criteria15
- 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
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06810986