Abstract
BackgroundThe outcomes for those with type 2 diabetes mellitus (T2DM) in Singapore are poor. In this TRIal to slow the Progression Of Diabetes (TRIPOD), we will evaluate the effectiveness and cost-effectiveness of a comprehensive diabetes management package (DMP), with or without a financial incentives program, M-POWER Rewards, in efforts to improve HbA1c levels for individuals with T2DM.Methods/designTRIPOD is a randomized, open-label, controlled, multi-center, superiority trial with three parallel arms: (1) usual care only, (2) usual care with DMP, and (3) usual care with DMP plus M-POWER Rewards. A total of 339 adults with sub-optimally controlled T2DM (self-reported HbA1c 7.5–11.0%) will be block randomized according to a 1:1:1 allocation ratio to the three arms. The primary outcome is mean change in HbA1c level at Month 12 from baseline. Secondary outcomes include mean change in HbA1c level at Months 6, 18, and 24; mean changes at Months 6, 12, 18, and 24 in weight, blood pressure, and self-reported physical activity, weight monitoring, blood glucose monitoring, medication adherence, diabetes self-management, sleep quality, work productivity and daily activity impairment, and health utility index; and proportion of participants initiating insulin treatment by Months 6, 12, 18, and 24. Incremental cost-effectiveness ratios will be computed based on costs per improvement in HbA1c at Month 12 and converted to cost per quality-adjusted life year gained.DiscussionThe TRIPOD study will present insights about the long-term cost-effectiveness and financial viability of the interventions and the potential for integrating within usual care.Trial registrationClinicalTrials.gov, NCT03800680. Registered on 11 January 2019.
Highlights
The outcomes for those with type 2 diabetes mellitus (T2DM) in Singapore are poor
Systematic reviews and meta-analyses strongly support the effectiveness of various lifestyle interventions in reducing blood sugar levels—as measured by glycated hemoglobin (HbA1c)—and body weight, two key outcomes that have been associated with lowering diabetesassociated health risks [5, 6], especially among patients with sub-optimal glycemic control [7]
We hypothesize that between baseline and Month 12, mean improvements in Glycated hemoglobin (HbA1c) level will be greatest in the diabetes management package (DMP) plus M-POWER Rewards arm, followed by DMP alone, followed by usual care
Summary
The outcomes for those with type 2 diabetes mellitus (T2DM) in Singapore are poor. In this TRIal to slow the Progression Of Diabetes (TRIPOD), we will evaluate the effectiveness and cost-effectiveness of a comprehensive diabetes management package (DMP), with or without a financial incentives program, M-POWER Rewards, in efforts to improve HbA1c levels for individuals with T2DM. We hypothesize that a comprehensive mHealth program incorporating key lifestyle intervention strategies, with or without financial incentives for healthy behaviors, could offer a scalable, cost-effective, and potentially cost-saving approach to address Singapore’s diabetes epidemic
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