NCT06028139

Brief Summary

Lifestyle change is key to diabetes management but there are limited resources and time to support patients in improving lifestyle behaviour in the current healthcare system. Currently, health coaching for behavioural chance guided by continuous glucose data, wearable and lifestyle data is not available in primary and tertiary care management of diabetes. This parallel-group randomised controlled trial (RCT) aims to investigate the effectiveness of a novel multi-component model of care comprising interventions including the mobile app EMPOWER and smartwatch, health coaching, and continuous glucose monitoring (CGM).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

3 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 24, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

1.1 years

First QC Date

August 28, 2023

Last Update Submit

April 16, 2024

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    HbA1c over 6 months

    6 months

Secondary Outcomes (10)

  • Physical activity as measured by number of steps

    6 months

  • Physical activity as measured by moderate to vigorous active minutes

    6 months

  • Physical activity as measured by GPAQ

    6 months

  • Diet as measured by DASH

    6 months

  • Sugar sweetened beverages intake

    6 months

  • +5 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: Continuous glucose monitoring and health coachingBehavioral: EMPOWER mobile app

Control

OTHER
Behavioral: EMPOWER mobile app

Interventions

Continuous glucose monitoring and health coachingBEHAVIORAL

Each CGM device will work for 14 days. The participants will use the CGM devices for the first two-week period in the first three months of the trial, and the first two-week period of the second three months of the trial. Participants will interact with health coach throughout the study duration.

Intervention
EMPOWER mobile appBEHAVIORAL

Nudges will be delivered through the EMPOWER mobile app. Participants will log lifestyle information such as diet and physical activity, and clinical information such as medication and HbA1c levels through the EMPOWER mobile app.

ControlIntervention

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 21 years and above
  • Have diagnosis of type 2 diabetes mellitus
  • Provided informed consent
  • Have near-field communication (NFC) compatible phones
  • Able to engage in light physical activity (e.g., walking)

You may not qualify if:

  • Significant cognitive impairment
  • Other conditions that may preclude participants from wearing CGM devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Singapore General Hospital

Singapore, 486838, Singapore

RECRUITING

National Heart Centre Singapore

Singapore, Singapore

RECRUITING

Sengkang General Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Central Study Contacts

Lian Leng Low

CONTACT

63265872low.lian.leng@singhealth.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2023

First Posted

September 8, 2023

Study Start

October 24, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04

Locations

SG(3)