Clinical trial NCT06810986: Cohort Study Evaluating Glycaemic Control in Individuals with Type 2 Diabetes Mellitus Through Digital Therapeutics (DM DTx)
Official title: Phase 2 Research Study for Type 2 Diabetes Mellitus Through Digital Therapeutics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: Lifestyle Intervention
Digital Therapeutics
Type 2 Diabetes Mellitus
Lead sponsor: EVYD Technology
Sponsor class: INDUSTRY
Collaborators: name: Ministry of Health, Brunei Darussalam
First posted: 2025-02-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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).

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:

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.

Eligibility 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

Primary outcomes:
measure: Reduction in HbA1c from baseline following a 16-week lifestyle intervention
timeFrame: 16 weeks
Secondary outcomes:
measure: Overall change in HbA1c
timeFrame: 16 weeks
measure: Change in fasting lipid profile
timeFrame: 16 weeks
measure: Change in fasting blood glucose
timeFrame: 16 weeks
measure: Change in BMI
timeFrame: 16 weeks
measure: Change in waist circumference
timeFrame: 16 weeks
measure: Participants' feedback on the use of DM DTx
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Bandar Seri Begawan
country: Brunei Darussalam
facility: EVYD Technology
Study officials:
affiliation: Raja Isteri Pengiran Anak Saleha (RIPAS) hospital
name: Chong Pui Lin, BM, MD
role: PRINCIPAL_INVESTIGATOR
References: