University of Colorado School of Medicine, Department of Pediatrics, Barbara Davis Center for Diabetes, 1775 Aurora Ct., Aurora, CO 80045, United States.
Florida State University, College of Medicine, Department of Clinical Sciences, 1115 W. Call Street, Tallahassee, FL 32306, United States.
Contemp Clin Trials. 2021 Mar;102:106279. doi: 10.1016/j.cct.2021.106279. Epub 2021 Jan 11.
Individuals with type 1 diabetes (T1D) must engage in a variety of complex and burdensome self-management behaviors daily to maintain near normal blood glucose levels and prevent complications. There is a need for interventions to improve use of sophisticated diabetes technologies, such as insulin pumps, during adolescence - a very high-risk developmental period for individuals with T1D. All diabetes devices, including insulin pumps, store large amounts of behavioral data that can be downloaded and analyzed to evaluate adherence to recommended T1D self-management behaviors. The overall objective of the present study, Pump it Up!, was to use objectively downloaded insulin pump data to inform and test two interventions to optimize insulin pump use in adolescents with T1D and their caregivers. Multiphase Optimization Strategy (MOST) was used to achieve the overall goal of this study - to separately test the main effect of the Pump It Up! Personalized T1D Self-Management Behaviors Feedback Report and the main effect of Pump It Up! Problem-Solving Skills intervention to improve T1D self-management behaviors using a 2 × 2 factorial design. The purpose of this paper is to describe the Pump It Up! study design and rationale, and participant baseline characteristics. Longitudinal data analyses will be conducted, and moderating effects of psychosocial factors will be examined in relation to primary (insulin pump self-management behaviors) and secondary (A1C) outcomes.
1 型糖尿病（T1D）患者必须每天进行各种复杂且繁琐的自我管理行为，以维持接近正常的血糖水平并预防并发症。需要干预措施来改善青少年时期（T1D 患者非常高风险的发育阶段）对复杂糖尿病技术（如胰岛素泵）的使用。所有糖尿病设备，包括胰岛素泵，都会存储大量行为数据，这些数据可以下载并进行分析，以评估对推荐的 T1D 自我管理行为的依从性。本研究的总体目标是利用客观下载的胰岛素泵数据，为优化青少年 T1D 患者及其照顾者使用胰岛素泵的两种干预措施提供信息和测试。多阶段优化策略（MOST）用于实现本研究的总体目标，即分别测试 Pump It Up！个性化 T1D 自我管理行为反馈报告和 Pump It Up！解决问题技能干预的主要效果，以改善 T1D 自我管理行为，采用 2×2 析因设计。本文旨在描述 Pump It Up！研究设计和原理，以及参与者的基线特征。将进行纵向数据分析，并检查心理社会因素对主要（胰岛素泵自我管理行为）和次要（A1C）结果的调节作用。
