A Cognitive Behavioral Sleep Self-Management Intervention for Young Adults with Type 1 Diabetes

针对年轻 1 型糖尿病患者的认知行为睡眠自我管理干预

• 批准号: 10713232
• 负责人: Stephanie Alisha Griggs
• 金额: $ 75.4万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10713232
• 关键词: Achievement; Acute; Adolescent; Adult; Affect; Age; American; Behavior Therapy; Behavioral; Blindness; Blood Glucose Self-Monitoring; Body Weight; Caring; Chronic; Clinical; Clinical and Translational Science Awards; Cognition; Cognitive; Continuous Glucose Monitor; Coronary Arteriosclerosis; Data; Diabetes Mellitus; Dimensions; Distress; Drowsiness; Economic Burden; Enrollment; Ensure; Environment; Female; General Population; Glucose; Glycosylated Hemoglobin; Glycosylated hemoglobin A; Goals; Health; Hour; Impairment; Information Systems; Insulin; Insulin-Dependent Diabetes Mellitus; Intervention; Kidney Diseases; Laboratories; Leptin; Life; Measurement; Measures; Mediating; Modeling; Ohio; Outcome; Patient Outcomes Assessments; Patient Self-Report; Phase; Population; Provider; Randomized; Regulation; Research Personnel; Risk; Science; Self Management; Sleep; Sleep Deprivation; Sleep disturbances; Stroke; Subgroup; Symptoms; Target Populations; Techniques; Theoretical model; Time; United States National Institutes of Health; Universities; University Hospitals; actigraphy; alertness; arm; attentional control; behavior change; burden of illness; career; clinical decision-making; cohort; college; comparison intervention; diabetes distress; diabetes self-management; efficacy evaluation; ghrelin; glucose tolerance; high risk; impaired glucose tolerance; improved; improvement on sleep; innovation; insulin sensitivity; macrovascular disease; middle age; motivational enhancement therapy; nerve damage; novel; poor sleep; post intervention; premature; primary outcome; recruit; response; satisfaction; sleep health; therapeutic target; tool; treatment as usual; wearable device; young adult

PROJECT SUMMARY/ABSTRACT Only 2 in 8 young adults (age 18-30 years) with type 1 diabetes (T1D) achieve glycemic targets (A1C < 7.0%). In well-controlled lab studies sleep deprivation impairs glucose tolerance and insulin sensitivity, a reduces acute insulin response to glucose, impairs body weight regulation (lower leptin, higher ghrelin), and impairs alertness in young adults without chronic conditions and decreases insulin sensitivity in middle-aged adults with T1D. Using cognitive-behavioral approaches to sleep by 1 hour over 6 weeks to 12 months in natural environments is feasible and contributes to improvements in insulin sensitivity, glucose tolerance, and general distress symptoms in young adults without chronic conditions and improved time in glucose range in adolescents with T1D. Sleep duration, regularity, and timing are modifiable targets that may improve glycemia and other important diabetes self-management outcomes in young adults with T1D. Here we leverage our preliminary findings in the proposed study to advance cognitive-behavioral sleep self-management for T1D (K99/R00NR018886). We propose to enroll 248 young adults ages 18-30 years with T1D (50% female, 40% underrepresented) who are not achieving glycemic targets (A1C ≥ 7%). The goals of this study are two-fold: (1) to compare the immediate and short-term effects of a 3-month cognitive-behavioral sleep self-management intervention (CB-sleep) versus enhanced usual care (time-balanced attention control) on sleep health dimensions and glycemia and (2) to determine whether sleep health mediates the associations between the intervention and control condition over 9 months (baseline to 3 months and 6 and 9 months post baseline). We will randomize 1:1 to the CB-sleep or enhanced usual care condition (time balanced attention control). Sleep health dimensions will be rigorously measured using validated tools: regularity (actigraphy and self-report), satisfaction (Patient-Reported Outcomes Measurement Information System Sleep Disturbance), alertness (Epworth Sleepiness), timing, efficiency, and duration (actigraphy and self-report). Glycemia will be determined by A1C (primary outcome) with subgroup analyses of glucose variability/glucose percentage time in range 70-180 mg/dL (via continuous glucose monitors or self-monitored blood glucose six times daily). Data will be analyzed using multivariate techniques, and efficacy will be determined.

项目摘要/摘要 1型糖尿病（T1D）中只有8名年轻人（18-30岁）实现了血糖靶标（A1C <7.0％）。 在控制良好的实验室研究中，睡眠剥夺会损害葡萄糖耐受性和胰岛素敏感性，降低了急性 胰岛素对葡萄糖的反应，会损害体重调节（较低的瘦素，较高的生长素），并损害机敏 在没有慢性疾病的年轻人中，T1D的中年成年人的胰岛素敏感性降低。 在自然环境中，在6周到12个月内使用认知行为的睡眠方法是 可行并有助于提高胰岛素敏感性，葡萄糖耐量和一般困扰症状 在没有慢性条件的年轻人中，T1D青少年的葡萄糖范围有所改善。睡觉 持续时间，规律性和时机是可修改的靶标，可以改善血糖和其他重要糖尿病 T1D的年轻人的自我管理结果。在这里，我们利用提议的初步发现 促进T1D（K99/R00NR018886）的认知行为睡眠自我管理的研究。我们建议 未能实现的248名年轻人（女性为50％，女性为40％）18-30岁的年轻人（40％） 血糖靶标（A1C≥7％）。这项研究的目标是两个方面：（1）比较立即和短期的 3个月的认知行为睡眠自我管理干预（CB-Sleep）的影响与增强 在睡眠健康维度和血糖上的护理（时间平衡的注意力控制）以及（2）确定是否是否 睡眠健康介导了9个月内干预与控制状况之间的关联（基线） 基线后至3个月，6个月和9个月）。我们将将1：1随机分配到CB-Sleep或增强的常规护理 条件（时间平衡注意力控制）。睡眠健康维度将使用经过验证的 工具：规律性（行动学和自我报告），满意度（患者报告的结果测量信息 系统睡眠障碍），机敏性（Epworth嗜睡），时机，效率和持续时间（行动学和 自我报告）。血糖将由A1C（主要结果）确定，并通过亚组分析葡萄糖来确定 范围70-180 mg/dl的可变性/葡萄糖百分比（通过连续葡萄糖监测器或自我监测 血糖每天六次）。数据将使用多元技术进行分析，有效性将是 决定。