Status:

COMPLETED

A Randomized Trial to Slow the Progression of Diabetes

Lead Sponsor:

Duke-NUS Graduate Medical School

Collaborating Sponsors:

National Medical Research Council (NMRC), Singapore

SingHealth Polyclinics

Conditions:

Diabetes Mellitus, Type 2

Eligibility:

All Genders

21-70 years

Phase:

NA

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 ...

Detailed Description

Technological and economic advancement have created a major challenge to public health agencies in Singapore and other first world countries: the challenge being how to get individuals to maintain a h...

Eligibility Criteria

Inclusion

  • All eligibility criteria will be self-declared.
  • Diagnosed with T2DM with suboptimal diabetes control as defined by a HbA1c level of between 7.5% and 11.0% (inclusive) at their most recent test taken within the past six calendar months. This HbA1c inclusion criterion will be based on the patients' self-reported HbA1c levels and test dates.
  • 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.

Exclusion

  • 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).
  • Currently have a condition(s) that restricts engaging in moderate-to-vigorous physical activity (i.e., brisk walking or more intense).

Key Trial Info

Start Date :

October 19 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 11 2023

Estimated Enrollment :

269 Patients enrolled

Trial Details

Trial ID

NCT03800680

Start Date

October 19 2019

End Date

June 11 2023

Last Update

June 22 2023

Active Locations (1)

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Duke-NUS Medical School

Singapore, Singapore, 169857