NCT06810986

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

February 6, 2025

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

January 31, 2025

Last Update Submit

January 31, 2025

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Lifestyle InterventionDigital TherapeuticsType 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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

    16 weeks

Secondary Outcomes (6)

  • Overall change in HbA1c

    16 weeks

  • Change in fasting lipid profile

    16 weeks

  • Change in fasting blood glucose

    16 weeks

  • Change in BMI

    16 weeks

  • Change in waist circumference

    16 weeks

  • +1 more secondary outcomes

Study Arms (1)

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.

Behavioral: 16-week digital intervention

Interventions

16-week digital interventionBEHAVIORAL

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.

Also known as: Lifestyle Intervention
Digital Therapeutics for Type 2 Diabetes Mellitus

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EVYD Technology

Bandar Seri Begawan, BG3122, Brunei

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Chong Pui Lin, BM, MD

    Raja Isteri Pengiran Anak Saleha (RIPAS) hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Tey, Msc Immunology

CONTACT

+673 7430790jane.tey@evydtech.com

Joshua Lam, MBBS

CONTACT

+65 97309276joshua.lam@evydtech.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2025

First Posted

February 6, 2025

Study Start

August 20, 2024

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

February 6, 2025

Record last verified: 2024-08

Locations

BR(1)