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.

项目总结/摘要 只有2/8的1型糖尿病（T1 D）年轻人（18-30岁）达到血糖目标（A1 C < 7.0%）。 在严格控制的实验室研究中，睡眠剥夺会损害葡萄糖耐量和胰岛素敏感性， 胰岛素对葡萄糖的反应，损害体重调节（瘦素降低，胃饥饿素升高），并损害警觉性 在没有慢性疾病的年轻人中，降低了T1 D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周到12个月内睡眠1小时， 可行，有助于改善胰岛素敏感性、葡萄糖耐量和一般痛苦症状 在无慢性疾病的年轻人中，T1 D青少年血糖范围内的时间有所改善。睡眠 持续时间、规律性和时机是可以改变的目标，可以改善糖尿病和其他重要的糖尿病 T1 D年轻成人的自我管理结果。在这里，我们利用我们的初步调查结果，在拟议的 一项旨在促进T1 D患者认知行为睡眠自我管理的研究（K99/R 00 NR 018886）。我们建议 入组248名年龄在18-30岁之间的T1 D年轻人（50%为女性，40%代表性不足），这些人没有达到 血糖目标（A1 C ≥ 7%）。本研究的目的有两个：（1）比较即时和短期 3个月认知行为睡眠自我管理干预（CB睡眠）与增强常规睡眠的效果 护理（时间平衡的注意力控制）对睡眠健康的影响和（2）确定是否 睡眠健康在9个月的干预和控制条件（基线）之间起中介作用 至基线后3个月以及6和9个月）。我们将1：1随机分配至CB睡眠或增强常规护理组 时间平衡注意力控制（Time Balanced Attention Control）睡眠健康方面将严格衡量使用验证 工具：规律性（体动记录和自我报告）、满意度（患者报告结局测量信息 系统睡眠障碍）、警觉性（埃普沃思嗜睡）、时间、效率和持续时间（活动记录仪和 自我报告）。将通过A1 C（主要结局）和葡萄糖亚组分析确定血糖 变异性/葡萄糖百分比时间在70-180 mg/dL范围内（通过连续葡萄糖监测仪或自我监测 每日6次血糖）。将使用多变量技术分析数据， 测定