A Digital Health Intervention (SweetGoals) for Young Adults With Type 1 Diabetes: Protocol for a Factorial Randomized Trial

Catherine Stanger, Tobias Kowatsch, Haiyi Xie, Inbal Nahum-Shani, Frances Lim-Liberty, Molly Anderson, Prabhakaran Santhanam, Sarah Kaden, Briana Rosenberg, Catherine Stanger, Tobias Kowatsch, Haiyi Xie, Inbal Nahum-Shani, Frances Lim-Liberty, Molly Anderson, Prabhakaran Santhanam, Sarah Kaden, Briana Rosenberg

Abstract

Background: Many young adults with type 1 diabetes (T1D) struggle with the complex daily demands of adherence to their medical regimen and fail to achieve target range glycemic control. Few interventions, however, have been developed specifically for this age group.

Objective: In this randomized trial, we will provide a mobile app (SweetGoals) to all participants as a "core" intervention. The app prompts participants to upload data from their diabetes devices weekly to a device-agnostic uploader (Glooko), automatically retrieves uploaded data, assesses daily and weekly self-management goals, and generates feedback messages about goal attainment. Further, the trial will test two unique intervention components: (1) incentives to promote consistent daily adherence to goals, and (2) web health coaching to teach effective problem solving focused on personalized barriers to self-management. We will use a novel digital direct-to-patient recruitment method and intervention delivery model that transcends the clinic.

Methods: A 2x2 factorial randomized trial will be conducted with 300 young adults ages 19-25 with type 1 diabetes and (Hb)A1c ≥ 8.0%. All participants will receive the SweetGoals app that tracks and provides feedback about two adherence targets: (a) daily glucose monitoring; and (b) mealtime behaviors. Participants will be randomized to the factorial combination of incentives and health coaching. The intervention will last 6 months. The primary outcome will be reduction in A1c. Secondary outcomes include self-regulation mechanisms in longitudinal mediation models and engagement metrics as a predictor of outcomes. Participants will complete 6- and 12-month follow-up assessments. We hypothesize greater sustained A1c improvements in participants who receive coaching and who receive incentives compared to those who do not receive those components.

Results: Data collection is expected to be complete by February 2025. Analyses of primary and secondary outcomes are expected by December 2025.

Conclusions: Successful completion of these aims will support dissemination and effectiveness studies of this intervention that seeks to improve glycemic control in this high-risk and understudied population of young adults with T1D.

Trial registration: ClinicalTrials.gov NCT04646473; https://ichgcp.net/clinical-trials-registry/NCT04646473.

International registered report identifier (irrid): PRR1-10.2196/27109.

Keywords: health coaching; incentives; mhealth; type 1 diabetes; young adults.

Conflict of interest statement

Conflicts of Interest: TK and PS are affiliated with the Center for Digital Health Interventions [134], a joint initiative of the Department of Management, Technology, and Economics at ETH Zurich and the Institute of Technology Management at the University of St. Gallen, which is funded in part by the Swiss health insurer CSS (Christian Social Health Insurance Company of Switzerland). TK is a founder of Pathmate Technologies, a university spin-off company that creates and delivers digital clinical pathways. Neither CSS nor Pathmate Technologies were involved in any way in this manuscript.

©Catherine Stanger, Tobias Kowatsch, Haiyi Xie, Inbal Nahum-Shani, Frances Lim-Liberty, Molly Anderson, Prabhakaran Santhanam, Sarah Kaden, Briana Rosenberg. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 23.02.2021.

Figures

Figure 1
Figure 1
Conceptual model of intervention effects on hemoglobin A1c.
Figure 2
Figure 2
Screening, recruitment, and randomization process.
Figure 3
Figure 3
Study design.
Figure 4
Figure 4
SweetGoals dialogue with digital coach Taylor.
Figure 5
Figure 5
SweetGoals goal feedback graphs—continuous glucose monitor user.
Figure 6
Figure 6
SweetGoals incentives feedback graphs.

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Source: PubMed

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