一项针对 1 型糖尿病青年成年人的数字健康干预措施（SweetGoals）：析因随机试验方案。
A Digital Health Intervention (SweetGoals) for Young Adults With Type 1 Diabetes: Protocol for a Factorial Randomized Trial.
作者信息
Stanger Catherine, Kowatsch Tobias, Xie Haiyi, Nahum-Shani Inbal, Lim-Liberty Frances, Anderson Molly, Santhanam Prabhakaran, Kaden Sarah, Rosenberg Briana
机构信息
Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, Lebanon, NH, United States.
Centre for Digital Health Interventions, Department of Management, Technology, and Economics, ETH Zurich, Zurich, Switzerland.
出版信息
JMIR Res Protoc. 2021 Feb 23;10(2):e27109. doi: 10.2196/27109.
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)A ≥ 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 A. 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 A 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://clinicaltrials.gov/ct2/show/NCT04646473.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/27109.
背景
许多1型糖尿病（T1D）的年轻成年人在坚持日常复杂的医疗方案方面存在困难，无法实现目标范围的血糖控制。然而，专门针对这个年龄组开发的干预措施很少。
目的
在这项随机试验中，我们将向所有参与者提供一款移动应用程序（SweetGoals）作为“核心”干预措施。该应用程序提示参与者每周将糖尿病设备的数据上传到一个与设备无关的上传器（Glooko），自动检索上传的数据，评估每日和每周的自我管理目标，并生成关于目标达成情况的反馈信息。此外，该试验将测试两个独特的干预组成部分：（1）激励措施以促进每日持续坚持目标；（2）网络健康指导，教授以针对自我管理的个性化障碍为重点的有效问题解决方法。我们将使用一种新颖的数字直接面向患者的招募方法和超越诊所的干预交付模式。
方法
将对300名年龄在19 - 25岁、1型糖尿病且糖化血红蛋白（Hb）A≥8.0%的年轻成年人进行2×2析因随机试验。所有参与者将收到SweetGoals应用程序，该应用程序跟踪并提供关于两个依从性目标的反馈：（a）每日血糖监测；（b）进餐时间行为。参与者将被随机分配到激励措施和健康指导的析因组合中。干预将持续6个月。主要结局将是糖化血红蛋白（A）的降低。次要结局包括纵向中介模型中的自我调节机制以及作为结局预测指标的参与度指标。参与者将完成6个月和12个月的随访评估。我们假设与未接受这些组成部分的参与者相比，接受指导和接受激励措施的参与者在糖化血红蛋白（A）方面有更大的持续改善。
结果
预计数据收集将于2025年2月完成。主要和次要结局的分析预计将于2025年12月完成。
结论
这些目标的成功完成将支持对该干预措施的传播和有效性研究，该干预措施旨在改善这一高风险且研究不足的1型糖尿病年轻成年人人群的血糖控制。
试验注册
ClinicalTrials.gov NCT04646473；https://clinicaltrials.gov/ct2/show/NCT04646473。
国际注册报告识别号（IRRID）：PRR1-10.2196/27109。
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