Type 2 Diabetes Mellitus (T2DM)DM DTxNCT06810986
Cohort Study Evaluating Glycaemic Control in Individuals with Type 2 Diabetes Mellitus Through Digital Therapeutics (DM DTx)
A study testing 16-week digital intervention in people with Type 2 Diabetes Mellitus (T2DM), run by EVYD Technology at 1 site in Brunei.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- 16-week digital intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteBrunei
- Study dates
- 20 Aug 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Brunei1 site, 1 recruiting
- Recruiting
EVYD Technology
Bandar Seri Begawan, BG3122
Joshua Lam, MBBS, +65 97309276, joshua.lam@evydtech.com
Jane Tey, Msc Immunology, +673 7430790, jane.tey@evydtech.com
About this study
Official title: Phase 2 Research Study for Type 2 Diabetes Mellitus Through Digital Therapeutics
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).
Read the detailed description
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:
- 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;
- To evaluate participants' feedback on their experience with the BALANCE Programme and its usability after 16 weeks of usage;
- to evaluate fasting experience amongst Muslims with T2DM during Ramadhan and to calculate their fasting risk using IDF-DAR score.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- 16-week digital intervention
- Keywords
- Lifestyle Intervention, Digital Therapeutics, Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16-week digital interventionBehavioural
Also called Lifestyle 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: 16-week digital intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks
Secondary outcomes (6)
Overall change in HbA1c
Evaluation of overall changes in HbA1c
Measured: 16 weeks
Change in fasting lipid profile
Evaluation of overall changes in fasting lipid profile
Measured: 16 weeks
Change in fasting blood glucose
Evaluation of overall changes in fasting blood glucose
Measured: 16 weeks
Change in BMI
Evaluation of overall changes in BMI
Measured: 16 weeks
Change in waist circumference
Evaluation of overall changes in waist circumference
Measured: 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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start20 Aug 2024
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EVYD Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ministry of Health, Brunei Darussalam
- Responsible party
- Sponsor
- Investigators
- Chong Pui Lin, BM, MD, Principal investigator, Raja Isteri Pengiran Anak Saleha (RIPAS) hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810986
- Sponsor's protocol ID
- MHREC/MOH/2024/11
- Other IDs
- BALANCE Programme
- Acronym
- DM DTx
- Status last verified
- Aug 2024
- First submitted
- 31 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Research Study for Type 2 Diabetes Mellitus Through Digital Therapeutics
- ClinicalTrials.gov ID
- NCT06810986
- Acronym / sponsor ID
- DM DTx / MHREC/MOH/2024/11
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Lifestyle Intervention, Digital Therapeutics, Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- EVYD TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Ministry of Health, Brunei Darussalam
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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:
- 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;
- To evaluate participants' feedback on their experience with the BALANCE Programme and its usability after 16 weeks of usage;
- to evaluate fasting experience amongst Muslims with T2DM during Ramadhan and to calculate their fasting risk using IDF-DAR score.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital Therapeutics for Type 2 Diabetes Mellitus | Experimental | Behavioral: 16-week digital intervention16 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 70 years
- Diagnosed with T2DM who are on any one or more of the following treatments:
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 16-week digital interventionAlso: Lifestyle InterventionParticipants 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. | Behavioural | Digital Therapeutics for Type 2 Diabetes Mellitus |
Primary outcome
Reduction in HbA1c from baseline following a 16-week lifestyle intervention
Time frame: 16 weeks
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
6 secondary outcomes
Overall change in HbA1c
Time frame: 16 weeks
Change in fasting lipid profile
Time frame: 16 weeks
Change in fasting blood glucose
Time frame: 16 weeks
Change in BMI
Time frame: 16 weeks
Change in waist circumference
Time frame: 16 weeks
Participants' feedback on the use of DM DTx
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chong Pui Lin, BM, MD principal investigator
Raja Isteri Pengiran Anak Saleha (RIPAS) hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 16-week digital intervention in people with Type 2 Diabetes Mellitus (T2DM), run by EVYD Technology at 1 site in Brunei.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brunei. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jane Tey, Msc Immunology (+673 7430790, jane.tey@evydtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in HbA1c from baseline following a 16-week lifestyle intervention (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.