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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要患有 1 型糖尿病 (T1D) 的 8 名年轻人（18-30 岁）中只有 2 人达到血糖目标 (A1C < 7.0%)。在控制良好的实验室研究中，睡眠不足会损害葡萄糖耐量和胰岛素敏感性，从而降低急性胰岛素对葡萄糖的反应，损害体重调节（瘦素降低，生长素释放肽升高），并损害警觉性在没有慢性病的年轻人中，胰岛素敏感性降低，并降低患有 T1D 的中年人的胰岛素敏感性。在自然环境中使用认知行为方法在 6 周至 12 个月内睡眠 1 小时是可能并有助于改善胰岛素敏感性、葡萄糖耐量和一般痛苦症状在没有慢性病的年轻人中，改善了患有 T1D 的青少年的血糖范围时间。持续时间、规律性和时间安排是可以改善血糖和其他重要糖尿病的可修改目标在此，我们利用了拟议中的初步研究结果。推进 T1D 认知行为睡眠自我管理的研究 (K99/R00NR018886)。招募 248 名 18-30 岁患有 T1D 的年轻人（50% 为女性，40% 代表性不足），但未取得成绩血糖目标（A1C≥7%）本研究的目标有两个：（1）比较近期和短期。 3 个月认知行为睡眠自我管理干预 (CB-sleep) 与增强常规干预的效果对睡眠健康维度和血糖进行护理（时间平衡注意力控制），以及 (2) 确定是否睡眠健康在 9 个月内调节干预和控制条件之间的关联（基线基线后 3 个月、6 个月和 9 个月）我们将按 1:1 随机分配至 CB 睡眠或强化常规护理。将使用经过验证的方法严格测量睡眠健康状况（时间平衡注意力控制）。工具：规律性（体动记录和自我报告）、满意度（患者报告的结果测量信息系统睡眠障碍）、警觉性（Epworth 嗜睡）、计时、效率和持续时间（体动记录仪和自我报告）。血糖将通过 A1C（主要结果）和葡萄糖亚组分析来确定。变异性/血糖百分比时间在 70-180 mg/dL 范围内（通过连续血糖监测仪或自我监测每天六次血糖）将使用多变量技术分析数据，并评估疗效。决定。