Cohort Study Evaluating Glycaemic Control in Individuals with Type 2 Diabetes Mellitus Through Digital Therapeutics (DM DTx)
NCT ID: NCT06810986
Last Updated: 2025-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
500 participants
INTERVENTIONAL
2024-08-20
2025-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Development and Exploration of the Effectiveness and Feasbility of a Digital Intervention for Type 2 Diabetes Mellitus
NCT05364476
Digital Diabetes Self Management Education and Support for Patients With Type 2 Diabetes
NCT05026528
A 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With T2DM
NCT03090464
Assessing Effectiveness of a Diabetes Navigator in Increasing Progression of Advanced Diabetes Technologies
NCT06229236
Diabetes Self-Management & Support LIVE
NCT02040038
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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:
1. 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;
2. To evaluate participants' feedback on their experience with the BALANCE Programme and its usability after 16 weeks of usage;
3. to evaluate fasting experience amongst Muslims with T2DM during Ramadhan and to calculate their fasting risk using IDF-DAR score.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
16-week digital 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
16-week digital 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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ministry of Health, Brunei Darussalam
UNKNOWN
EVYD Technology
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chong Pui Lin, BM, MD
Role: PRINCIPAL_INVESTIGATOR
Raja Isteri Pengiran Anak Saleha (RIPAS) hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
EVYD Technology
Bandar Seri Begawan, , Brunei
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BALANCE Programme
Identifier Type: OTHER
Identifier Source: secondary_id
MHREC/MOH/2024/11
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.