TRIal to slow the Progression Of Diabetes (TRIPOD): study protocol for a randomized controlled trial using wireless technology and incentives

Robyn Su May Lim, Daphne Su Lyn Gardner, Yong Mong Bee, Yin Bun Cheung, Joann Bairavi, Mihir Gandhi, Su-Yen Goh, Emily Tse Lin Ho, Xinyi Lin, Ngiap Chuan Tan, Tunn Lin Tay, Eric Andrew Finkelstein, Robyn Su May Lim, Daphne Su Lyn Gardner, Yong Mong Bee, Yin Bun Cheung, Joann Bairavi, Mihir Gandhi, Su-Yen Goh, Emily Tse Lin Ho, Xinyi Lin, Ngiap Chuan Tan, Tunn Lin Tay, Eric Andrew Finkelstein

Abstract

Background: 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.

Methods/design: TRIPOD 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.

Discussion: The 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 registration: ClinicalTrials.gov, NCT03800680. Registered on 11 January 2019.

Keywords: Behavior change; Blood glucose monitoring; Diabetes; Financial incentive; Medication adherence; Physical activity; Smartphone apps; Weight monitoring; mHealth.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
SPIRIT figure of enrollment, interventions, and assessments. DMP diabetes management package, HbA1c glycated hemoglobin, BIPQ Brief Illness Perception Questionnaire, DSMQ Diabetes Self-Management Questionnaire, EQ-5D-5 L EuroQoL 5-dimension 5-level health utility index, PSQI Pittsburgh Sleep Quality Index, WPAI:SHP Work Productivity and Activity Impairment: Specific Health Problem instrument
Fig. 2
Fig. 2
TRIPOD participant flow diagram

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