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Diabetes Mellitus, Type 2TRIPODNCT03800680

A Randomized Trial to Slow the Progression of Diabetes

A study testing Diabetes Management Package (DMP) and M-POWER Rewards in people with Diabetes Mellitus, Type 2, run by Duke-NUS Graduate Medical School at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 70 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Diabetes Management Package (DMP) and M-POWER Rewards
Could I receive a placebo?
No, everyone receives an active treatment
How many people
269 participants
Where
1 siteSingapore
Study dates
19 Oct 2019to 11 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
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  • 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).

Trial locations and contacts

1 site in 1 country.

Singapore1 site
  • Duke-NUS Medical School

    Singapore, 169857

Other trials in Singapore

About this study

Official title: A Randomized Trial to Slow the Progression of Diabetes (The TRIPOD Study)

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.

Read the 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 healthy lifestyle when that is no longer a requirement for economic prosperity (and in fact may be a hindrance). What is required is a low cost strategy that effectively manages risk factors for chronic disease without overwhelming the public healthcare infrastructure. Although technology and economic advancement are clearly part of the problem, they may also be part of the solution.

For patients with type 2 diabetes mellitus (T2DM), lifestyle modification can be highly effective at stemming the progression of the disease. Effective interventions include modules that teach appropriate strategies for weight management, increased physical activity, better diet, routine glucose monitoring, and strict compliance to prescribed diabetes medications. These components can now be effectively delivered electronically. A recent review and meta-analysis of 13 smartphone applications for diabetes management found that these applications offered modest benefits, with a mean difference in HbA1c of -0.40%.

Because of the high costs involved in treating people with chronic conditions, employers, insurers, and governments all have a financial incentive to contain the chronic disease epidemic. Therefore, each has shown a willingness to invest in some level of prevention and treatment efforts. It is our contention that contingent rewards may be necessary to help people overcome their preferences for current over future consumption, often called present bias. Behavioral economists recommend that, to overcome present bias, rewards should be tied to both short-term and long-term outcomes or behaviors, such as monitoring blood glucose and taking medications as prescribed (short term) and pre-defined outcomes such as achieving a target HbA1c level over a specified duration (long term). Based on a recent systematic review of incentive studies conducted by members of our team, an optimal rewards strategy has the potential to greatly increase the effectiveness of existing mobile diabetes applications. If shown to be effective and cost effective, the investigators also believe payers will subsidize such a strategy.

Specifically, the investigators propose to conduct a 52-week, three-arm randomized controlled trial to evaluate whether an evidence-based, low-cost mobile diabetes management package (DMP), with or without an incentive program grounded in economic theory, can effectively and cost-effectively improve outcomes for adults with diabetes. The control arm (Arm 1) will receive usual care, whereas participants in the intervention arms will receive the DMP alone (Arm 2) or the DMP with the M-POWER Rewards incentive program (Arm 3) in addition to their usual care. The investigators hypothesize that participants in Arms 2 and 3 will show improved glycemic control, as measured by HbA1c levels, at the Month 12 primary endpoint compared to participants in the Arm 1 control group. The investigators also hypothesize that Arm 3 will have improved HbA1c levels compared to Arm 2 at Month 12. Similar hypotheses will be tested for secondary outcomes measured at Month 6.

In addition, the investigators will quantify the incremental cost-effectiveness of DMP with M-POWER Rewards and the net cost implications of both from a third party payer's perspective. The investigators hypothesize that despite its higher implementation cost, effectiveness will be greater and net cost will be lower for Arm 3 relative to the Arm 1 control group due to the reduction in medical expenditures that result from improved glycaemic control.

Being tested
Diabetes Management Package (DMP), M-POWER Rewards
Keywords
Diabetes, Smartphone application, Behavior change, Weight monitoring, Physical activity, Blood glucose monitoring, Medication adherence, Financial incentive, Cost-effectiveness analysis
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus, Motor Activity, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diabetes Management Package (DMP)Behavioural

    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.
  • M-POWER RewardsBehavioural

    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.

Study groups in NCT03800680
Study groupRoleWhat they receive
Usual Care (Arm 1)No interventionParticipants will receive usual care by their diabetes clinics.
DMP (Arm 2)ExperimentalParticipants will receive usual care by their diabetes clinics and the Diabetes Management Package (DMP).
Receives: Behavioral: Diabetes Management Package (DMP)
DMP + M-POWER Rewards (Arm 3)ExperimentalParticipants will receive usual care by their diabetes clinics, the Diabetes Management Package (DMP), and the financial incentive program, M-POWER Rewards.
Receives: Behavioral: Diabetes Management Package (DMP); Behavioral: M-POWER Rewards

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Month 12

Secondary outcomes (14)
  1. Change in HbA1c levels at Month 6

    HbA1c or glycated hemoglobin is a measure of blood glucose levels. HbA1c blood tests will be conducted at baseline and Month 6 and the difference between the follow-up assessment (Months 6) and baseline will be calculated.

    Measured: Baseline, Month 6

  2. Change in weight at Months 6 and 12

    Weight will be measured at baseline, Month 6, and Month 12. The difference in weight between each follow-up assessment (Months 6 and 12) and baseline will be calculated.

    Measured: Baseline, Month 6, Month 12

  3. Change in blood pressure at Months 6 and 12

    Blood pressure will be measured at baseline, Month 6, and Month 12. The difference in blood pressure between each follow-up assessment (Months 6 and 12) and baseline will be calculated.

    Measured: Baseline, Month 6, Month 12

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

    Percentage of participants that had insulin treatment initiated by their diabetes care physician by each follow-up assessment (Months 6 and 12).

    Measured: Baseline, Month 6, Month 12

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

    Self-reported physical activity data will be collected at baseline, Month 6, and Month 12 via the Global Physical Activity Questionnaire (GPAQ). The difference in self-reported physical activity between each follow-up assessment (Months 6 and 12) and baseline will be calculated.

    Measured: Baseline, Month 6, Month 12

  6. Change in self-reported weight monitoring at Months 6 and 12

    Self-reported weight monitoring data will be collected at baseline, Month 6, and Month 12. The difference in self-reported weight monitoring between each follow-up assessment (Months 6 and 12) and baseline will be calculated.

    Measured: Baseline, Month 6, Month 12

  7. Change in self-reported blood glucose monitoring at Months 6 and 12

    Self-reported blood glucose monitoring data will be collected at baseline, Month 6, and Month 12. The difference in self-reported blood glucose monitoring between each follow-up assessment (Months 6 and 12) and baseline will be calculated.

    Measured: Baseline, Month 6, Month 12

  8. Change in self-reported medication adherence at Months 6 and 12

    Self-reported medication adherence data will be collected at baseline, Month 6, and Month 12. The difference in self-reported medication adherence between each follow-up assessment (Months 6 and 12) and baseline will be calculated.

    Measured: Baseline, Month 6, Month 12

  9. Change in self-reported diabetes self-management at Months 6 and 12

    Self-reported diabetes self-management data will be collected at baseline, Month 6, and Month 12 via the Diabetes Self-Management Questionnaire (DSMQ). The difference in self-reported diabetes self-management between each follow-up assessment (Months 6 and 12) and baseline will be calculated.

    Measured: Baseline, Month 6, Month 12

  10. Change in self-reported sleep quality at Months 6 and 12

    Self-reported sleep quality data will be collected at baseline, Month 6, and Month 12 via the Pittsburgh Sleep Quality Index (PSQI). The difference in self-reported sleep quality between each follow-up assessment (Months 6 and 12) and baseline will be calculated.

    Measured: Baseline, Month 6, Month 12

  11. Change in self-reported work productivity and daily activity impairment at Months 6 and 12

    Self-reported work productivity and daily activity impairment data will be collected at baseline, Month 6, and Month 12 via a modified Work Productivity and Activity Impairment: Specific Health Problem instrument (WPAI:SHP). The difference in self-reported work productivity and daily activity impairment between each follow-up assessment (Months 6 and 12) and baseline will be calculated.

    Measured: Baseline, Month 6, Month 12

  12. Change in self-reported health utility index at Months 6 and 12

    Self-reported health utility index data will be collected at baseline, Month 6, and Month 12 via the EQ-5D-5L questionnaire. The difference in self-reported health utility index between each follow-up assessment (Months 6 and 12) and baseline will be calculated.

    Measured: Baseline, Month 6, Month 12

  13. Incremental cost-effectiveness ratios based on HbA1c at Month 12

    Incremental cost-effectiveness ratios will be determined by calculating the incremental cost per unit reduction in HbA1c at Month 12 (primary endpoint) compared to baseline.

    Measured: Baseline, Month 12

  14. Incremental cost-effectiveness ratios based on QALY at Month 12

    Incremental cost-effectiveness ratios will be determined by calculating the incremental cost per quality adjusted life year (QALY) gained at Month 12 (primary endpoint) compared to baseline.

    Measured: Baseline, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2019
  2. Study start19 Oct 2019
  3. Primary completion8 Jun 2023
  4. Study completion11 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
269 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03800680
Sponsor's protocol ID
HSRGDB16Dec003
Acronym
TRIPOD
Status last verified
Jun 2023
First submitted
9 Jan 2019
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37964330
  • 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.

    PubMed 31779678

Questions about this trial

What is this clinical trial studying?

A study testing Diabetes Management Package (DMP) and M-POWER Rewards in people with Diabetes Mellitus, Type 2, run by Duke-NUS Graduate Medical School at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c levels at Month 12 (time frame: Baseline, Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03800680, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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