Thinking Outside the Clinic: A Digital Health Approach for Young Adults with Type 1 Diabetes

摘要 许多患有1型糖尿病(T1D)的年轻人在复杂的日常需求中挣扎，坚持 他们的医疗方案和未能实现良好的血糖控制。然而，几乎没有干预措施 专门为这个年龄段开发的。在拟议的研究中，我们将向所有人提供一款应用程序(SweetGoals) 参与者作为“核心”干预。这款应用程序会提示参与者每周将他们的糖尿病设备上传到 与设备无关的上传程序(Glooko)，将自动检索上传的数据并应用决策规则 每天和每周的自我管理目标，并将生成关于实现目标的反馈信息。 此外，拟议的研究将测试两个独特的干预组件，旨在支持和优化 数字自我监控、目标设定和目标实现。这些组成部分包括：(1)激励措施 促进日常对目标的始终如一的坚持，以及(2)网络健康辅导，教授有效解决问题 专注于自我管理的个性化障碍。我们将使用一种新的数字直接面向患者的招聘 超越临床的方法和干预交付模式。而不是依靠诊所来转变 它的护理系统，我们的干预将直接帮助青年患者发展技能，以提高他们的 卫生保健系统的利用。一项先前的试点随机对照试验(N=61)，将这种干预方法与通常的方法进行比较 青少年的护理显示对糖化血红蛋白有显著和持续的影响。这些结果是非常有希望的， 我们认为，这种干预措施非常适合年轻人。在这项拟议的研究中，300名年轻人年龄 19-25名T1D及以上目标(HB)A1C(≥8.0%)将通过社交媒体招聘。所有参与者将 接收基于开源干预平台MobileCoach(www.Mobile- Coach.eu)。该应用程序自动化了我们的试点干预的许多功能，极大地提高了传播性。 这些功能包括自动检索Glooko“消化”的糖尿病设备数据，并提示和提供 关于遵守目标的反馈。遵守目标包括(A)每日血糖监测；(B)进餐时间 行为。将使用22个析因设计来检验(1)适度金融的主要和交互效应 达到遵守目标的激励措施和(2)网络健康指导。教练会教你如何解决问题 生成针对遵从性挑战的个性化解决方案的方法。干预将持续6个月。 主要结果将是A1c的减少。我们假设A1c有更大的持续改善 接受指导和奖励的参与者。此外，我们假设了一种协同效应 这些组成部分之间的相互作用，使接受这两个组成部分的人产生更大的积极成果。我们 还将测试四个关键的自我监管机制和应用程序参与度指标，作为结果的预测指标。 这些目标的成功实现将支持这一干预措施的传播和有效性研究 这旨在改善这一高危和未被充分研究的T1D青年人群的血糖控制。

Abstract Many young adults with type 1 diabetes (T1D) struggle with the complex daily demands of adherence to their medical regimen and fail to achieve good glycemic control. However, few interventions have been developed specifically for this age group. In the proposed study, we will provide an app (SweetGoals) to all participants as a “core” intervention. The app prompts participants to upload their diabetes devices weekly to a device-agnostic uploader (Glooko), will automatically retrieve uploaded data and apply decision rules about daily and weekly self-management goals, and will generate feedback messages about goal attainment. Further, the proposed study will test two unique intervention components designed to support and optimize digital self-monitoring, goal setting, and goal achievement. These components include (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. Instead of relying on the clinic to transform its system of care, our intervention will directly assist young adult patients in developing skills to improve their utilization of the health care system. A prior pilot RCT (N=61) comparing this intervention approach to usual care among adolescents showed significant and sustained impact on A1c. These results were very promising, and we believe this intervention is well suited to young adults. In the proposed study, 300 young adults ages 19-25 with T1D and above target (Hb)A1c (≥ 8.0%) will be recruited via social media. All participants will receive the SweetGoals app built on an open-source intervention platform MobileCoach (www.Mobile- Coach.eu). The app automates many features of our piloted intervention, greatly increasing disseminability. These include automatic retrieval of diabetes device data “digested” by Glooko and prompting and providing feedback on adherence goals. Adherence targets include (a) daily glucose monitoring; and (b) mealtime behaviors. A 22 factorial design will be used to test the main and interactive effects of (1) modest financial incentives for meeting adherence targets and (2) web health coaching. Coaches will teach a problem-solving approach that generates personalized solutions to adherence challenges. The intervention will last 6 months. The primary outcome will be reduction in A1c. We hypothesize greater sustained A1c improvements in participants who receive coaching and who receive incentives. Further, we hypothesize a synergistic interaction between these components, resulting in greater positive outcomes among those receiving both. We will also test four key self-regulation mechanisms and app engagement metrics as predictors of outcomes. 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.