NCT03800680

Brief Summary

The research objective of this one-year study is to test whether an evidence-based, low-cost mobile diabetes management package (DMP), with or without an incentive program grounded in economic theory (M-POWER Rewards), can effectively and cost-effectively improve health outcomes for adults with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
269

participants targeted

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

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

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

January 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

October 19, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

3.6 years

First QC Date

January 9, 2019

Last Update Submit

June 21, 2023

Conditions

Diabetes Mellitus, Type 2

Keywords

DiabetesSmartphone applicationBehavior changeWeight monitoringPhysical activityBlood glucose monitoringMedication adherenceFinancial incentiveCost-effectiveness analysis

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c levels at Month 12

    HbA1c or glycated hemoglobin is a measure of blood glucose levels. HbA1c blood tests will be conducted at baseline and Month 12 and the difference will be calculated.

    Baseline, Month 12

Secondary Outcomes (14)

  • Change in HbA1c levels at Month 6

    Baseline, Month 6

  • Change in weight at Months 6 and 12

    Baseline, Month 6, Month 12

  • Change in blood pressure at Months 6 and 12

    Baseline, Month 6, Month 12

  • Proportion of participants that had insulin treatment initiated by Months 6 and 12

    Baseline, Month 6, Month 12

  • Change in self-reported physical activity at Months 6 and 12

    Baseline, Month 6, Month 12

  • +9 more secondary outcomes

Study Arms (3)

Usual Care (Arm 1)

NO INTERVENTION

Participants will receive usual care by their diabetes clinics.

DMP (Arm 2)

EXPERIMENTAL

Participants will receive usual care by their diabetes clinics and the Diabetes Management Package (DMP).

Behavioral: Diabetes Management Package (DMP)

DMP + M-POWER Rewards (Arm 3)

EXPERIMENTAL

Participants will receive usual care by their diabetes clinics, the Diabetes Management Package (DMP), and the financial incentive program, M-POWER Rewards.

Behavioral: Diabetes Management Package (DMP)Behavioral: M-POWER Rewards

Interventions

Diabetes Management Package (DMP)BEHAVIORAL

M-POWER app: A one-stop portal to monitor diabetes self-management activities and progress. The app syncs and displays relevant data from study devices and apps. GlycoLeap: A 24-week, digitally-delivered education and behavior change program for T2DM patients. 4 study devices with accompanying apps to aid in diabetes self-management: weighing scale, pedometer, glucometer, and pill tracker. Recommended activities: * Complete all 24 GlycoLeap lessons and quizzes * Weight Monitoring: Weigh at least once a week. * Physical Activity: At least 150 minutes of moderate-to-vigorous activity per week, targeting at least 420 Fitbit active minutes per week. * Blood Glucose Monitoring: At least three post-meal measurements within 4.0-10.0 mmol/L per week, with each reading taken on different days. * Medication: Take medications as prescribed.

DMP (Arm 2)DMP + M-POWER Rewards (Arm 3)
M-POWER RewardsBEHAVIORAL

A financial incentive program were participants can earn up to 516 M-Points (1 M-Point is equivalent to S$1) over the one-year study period for performing specific activities according to recommendations that are meant to improve glycemic control and for achieving HbA1c and weight loss goals. M-Points can be reimbursed in the form of financial rebates for approved non-inpatient healthcare-related expenses incurred during the study period.

DMP + M-POWER Rewards (Arm 3)

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Not on insulin.
  • On at least one oral glucose-lowering drug.
  • Singapore Citizen or Permanent Resident with no plans to relocate during the study period.
  • Able to read, write, and communicate in English.
  • Own a personal smartphone and be able to use it.

You may not qualify if:

  • Pregnant or lactating.
  • Diagnosed with chronic kidney disease (stage 3B with eGFR \<45mL/min) or undergoing dialysis for end-stage kidney failure.
  • Diagnosed with liver cirrhosis.
  • Diagnosed with cancer that required treatment in the past five years.
  • Diagnosed with heart attack (i.e., acute myocardial infarction) within the past one year.
  • Diagnosed with heart failure (i.e., congestive heart failure)
  • Diagnosed with stroke or transient ischemic attacks.
  • Undergone whole blood or red blood cell transfusion within the past three months.
  • Diagnosed with severe anaemia (Haemoglobin \<10g/dL)
  • Diagnosed with sickle-cell disease
  • Diagnosed with Thalassemia major
  • Undergone bariatric surgery or extensive bowel resection.
  • Undergone lower limb amputation (including toe amputation).
  • Taking systemic corticosteroids (including Traditional Chinese or Malay medicine).
  • Currently on doctor's advice against engaging in moderate-to-vigorous physical activity (i.e., brisk walking or more intense).
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke-NUS Medical School

Singapore, 169857, Singapore

Location

Related Publications (2)

  • Bairavi J, Gardner DS, Yeoh E, Tham KW, Gandhi M, Tan NC, Lee PC, Lim RSM, Adamjee T, Cheung YB, Bee YM, Finkelstein EA. Protocol update and baseline characteristics for the TRIal to slow the Progression of Diabetes (TRIPOD) randomized controlled trial. Trials. 2023 Nov 14;24(1):728. doi: 10.1186/s13063-023-07770-7.

    PMID: 37964330DERIVED

  • Lim RSM, Gardner DSL, Bee YM, Cheung YB, Bairavi J, Gandhi M, Goh SY, Ho ETL, Lin X, Tan NC, Tay TL, Finkelstein EA. TRIal to slow the Progression Of Diabetes (TRIPOD): study protocol for a randomized controlled trial using wireless technology and incentives. Trials. 2019 Nov 28;20(1):650. doi: 10.1186/s13063-019-3749-x.

    PMID: 31779678DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusMotor ActivityMedication Adherence

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehaviorPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Eric A Finkelstein, PhD, MHA

    Duke-NUS Graduate Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 11, 2019

Study Start

October 19, 2019

Primary Completion

June 8, 2023

Study Completion

June 11, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations

SG(1)