Sleep optimization to improve glycemic control in adults with type 1 diabetes

摘要 尽管治疗方案和技术有所改进，但只有不到20%的成年人患有1型糖尿病 (T1D)达到血糖目标。越来越多的人认识到睡眠是一种潜在的可修改的目标 改善血糖控制。糖尿病痛苦、不良的自我管理行为和降低的生活质量 (生活质量)也与睡眠变异性和睡眠持续时间不足有关。美国的糖尿病 糖尿病医疗护理协会标准将睡眠作为糖尿病的一个重要组成部分 糖尿病患者的医学评估。然而，没有就如何做到这一点提出具体建议 改善睡眠。关于优化睡眠对血糖的影响，人们的认识存在很大差距。 T1D中的对照。这项研究的目的是确定针对T1D的睡眠优化的有效性 对睡眠变异性、睡眠时间和血糖控制的主要结果的干预(睡眠-OPT) (A1C)；其他血糖参数(血糖变异性、在范围内的时间)、糖尿病痛苦、自我管理 有T1D和习惯性增加的工作年龄成年人的行为、生活质量和其他患者报告的结果 睡眠变化性或睡眠持续时间短。为了达到这些目的，我们提出了一项随机对照试验 120名工作年龄成人(18-65岁)患有T1D。参与者将接受习惯性睡眠变异性筛查(&gt； 每周1小时)或睡眠时间不足(每晚6.5小时)。符合条件的受试者将被随机分配到 睡眠选择组或健康生活注意对照组，为期12周。为期一周的磨合期是 有计划的，通过活动描记(睡眠变异性和持续时间)、血糖(A1C和 相关的血糖测量：使用连续血糖监测的血糖变异性和范围内的时间)，以及 其他次要结果：糖尿病痛苦、自我管理行为、生活质量和额外的患者- 报告结果。Slear-Opt是一种技术辅助的行为睡眠干预，我们最近 利用消费者对睡眠跟踪的快速增长的公众兴趣(3年增长500%) 年)。我们的行为干预使用了四个元素：可穿戴式睡眠跟踪器、教学内容和 交互式智能手机应用程序，以及简短的电话咨询。注意控制组将参加 在一个健康生活信息项目中。在中点(第6周)完成(第12周)和计划后(周 24)，将重复基线措施，以确定两组之间的差异和 干预行动。

Abstract Despite improvements in treatment regimens and technology, less than 20% of adults with type 1 diabetes (T1D) achieve glycemic targets. Sleep is increasingly recognized as a potentially modifiable target for improving glycemic control. Diabetes distress, poor self-management behaviors, and reduced quality of life (QoL) have also been linked to sleep variability and insufficient sleep duration. The American Diabetes Association Standards of Medical Care in Diabetes incorporated sleep as an important component of the medical evaluation in persons with diabetes. However, no specific recommendation was given as to how to improve sleep. A significant gap of knowledge exists regarding the effects of sleep optimization on glycemic control in T1D. The purpose of this study is to determine the efficacy of a T1D-specific sleep optimization intervention (Sleep-Opt) on the primary outcomes of sleep variability, sleep duration and glycemic control (A1C); other glycemic parameters (glycemic variability, time in range), diabetes distress, self-management behavior, QoL, and other patient reported outcomes in working-age adults with T1D and habitual increased sleep variability or short sleep duration. To achieve these aims, we propose a randomized controlled trial in 120 working age adults (18 to 65 years) with T1D. Participants will be screened for habitual sleep variability (> 1 hour/week) or insufficient sleep duration (< 6.5 hours per night). Eligible subjects will be randomized to the Sleep-Opt group or healthy living attention control group for twelve weeks. A one-week run-in period is planned, with baseline measures of sleep by actigraphy (sleep variability and duration), glycemia (A1C and related glycemic measures: glycemic variability and time in range using continuous glucose monitoring), and other secondary outcomes: diabetes distress, self-management behaviors, quality of life and additional patient- reported outcomes. Sleep-Opt is a technology-assisted behavioral sleep intervention that we recently developed that leverages the rapidly increasing public interest in sleep tracking by consumers (+500% in 3 years). Our behavioral intervention employs four elements: a wearable sleep tracker, didactic content, an interactive smartphone application, and brief telephone counseling. The attention control group will participate in a healthy living information program. At midpoint (Week 6) completion (Week 12) and post-program (Week 24), baseline measures will be repeated to determine differences between the two groups and sustainability of the intervention.