A Randomized Trial to Slow the Progression of Diabetes

NCT03800680 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 269

Last updated 2023-06-22

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

BEHAVIORAL

Diabetes Management Package (DMP)

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.

BEHAVIORAL

M-POWER Rewards

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.

Sponsors & Collaborators

  • National Medical Research Council (NMRC), Singapore

    collaborator OTHER_GOV
  • SingHealth Polyclinics

    collaborator OTHER
  • Singapore General Hospital

    collaborator OTHER
  • Changi General Hospital

    collaborator OTHER
  • Duke-NUS Graduate Medical School

    lead OTHER

Principal Investigators

  • Eric A Finkelstein, PhD, MHA · Duke-NUS Graduate Medical School

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-19
Primary Completion
2023-06-08
Completion
2023-06-11

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03800680 on ClinicalTrials.gov