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

优化睡眠可改善成人 1 型糖尿病患者的血糖控制

• 批准号: 10206127
• 负责人: Pamela Ann Martyn-Nemeth
• 金额: $ 61.37万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10206127
• 关键词: Adult; Affect; Aftercare; Age; American; Attention; Behavior; Behavior Therapy; Behavioral; Blood Glucose; Caring; Circadian desynchrony; Clinical Trials; Complications of Diabetes Mellitus; Control Groups; Cross-Sectional Studies; Data; Development; Diabetes Mellitus; Disease; Distress; Elements; Evaluation; Fasting; Fatigue; Glucose; Goals; Health; Hour; Individual; Insulin Resistance; Insulin-Dependent Diabetes Mellitus; Intervention; Knowledge; Lead; Link; Measures; Medical; Mission; Monitor; Moods; Motivation; National Institute of Diabetes and Digestive and Kidney Diseases; Outcome; Participant; Patient Outcomes Assessments; Patient Self-Report; Patients; Persons; Pilot Projects; Prevention; Quality of life; Randomized; Randomized Controlled Trials; Recommendation; Research; Research Personnel; Research Support; Running; Self Management; Sleep; Sleep Deprivation; Strategic Planning; Technology; Time; Treatment Protocols; actigraphy; attentional control; base; behavior change; behavioral outcome; blood glucose regulation; design; diabetes distress; diabetes self-management; glucose monitor; glycemic control; improved; insulin sensitivity; interest; novel; primary outcome; programs; psychological outcomes; secondary outcome; sleep quality; sleep regulation; smartphone Application; telephone coaching

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.

摘要 尽管治疗方案和技术有所改进，但只有不到20%的1型糖尿病成年人 (T1D)实现血糖目标。睡眠越来越被认为是一个潜在的可改变的目标， 改善血糖控制。糖尿病困扰，自我管理行为差，生活质量下降 (QoL)也与睡眠变异性和睡眠时间不足有关。美国糖尿病 糖尿病医疗标准协会将睡眠作为糖尿病治疗的重要组成部分。 糖尿病患者的医学评估。但是，没有就如何 改善睡眠。关于睡眠优化对血糖的影响， T1 D的控制。本研究的目的是确定T1 D特异性睡眠优化的功效 干预（Sleep-Opt）对睡眠变异性、睡眠持续时间和血糖控制的主要结局 (A1C);其他血糖参数（血糖变异性、范围内时间）、糖尿病痛苦、自我管理 T1 D和习惯性增加的工作年龄成人的行为、QoL和其他患者报告的结局 睡眠波动性或睡眠持续时间短。为了实现这些目标，我们提出了一项随机对照试验， 120名工作年龄成人（18至65岁）T1 D患者。将对参与者进行习惯性睡眠变异性筛查（> 1小时/周）或睡眠时间不足（每晚< 6.5小时）。合格受试者将随机分配至 Sleep-Opt组或健康生活注意对照组12周。一周的磨合期 计划，通过体动记录仪（睡眠变异性和持续时间）、睡眠质量（A1 C和 相关血糖测量：血糖变异性和使用连续血糖监测的范围内时间），以及 其他次要结局：糖尿病痛苦、自我管理行为、生活质量和其他患者- 报告结果。Sleep-Opt是一种技术辅助的行为睡眠干预， 开发了一种利用消费者对睡眠跟踪的快速增长的公众兴趣（3年内增长500%）的方法。 年）。我们的行为干预采用四个要素：可穿戴睡眠跟踪器，教学内容， 互动式智能手机应用程序和简短的电话咨询。注意力控制组将参与 健康生活信息项目在中点（第6周）完成（第12周）和程序后（第12周） 24），将重复基线测量，以确定两组之间的差异和 干预。