LeBlanc Erin S, Smith Ning, Hwang Dennis, Young Deborah R, Oshiro Caryn, Mayhew Meghan, Massimino Stefan, Catlin Chris, Clarke Gregory
Kaiser Permanente Center for Health Research, Portland, OR, USA.
Kaiser Permanente Center for Health Research, Portland, OR, USA.
Contemp Clin Trials. 2025 Feb;149:107796. doi: 10.1016/j.cct.2024.107796. Epub 2024 Dec 25.
Insomnia is a modifiable risk factor for type 2 diabetes.
Describe the methodology for the Sleep for Health study, a randomized clinical trial examining the effectiveness of digital cognitive behavioral therapy for insomnia (dCBT-I) in reducing hyperglycemia in 300 people with both insomnia and prediabetes.
Primary outcome is glucose level 2 h after a 75-g glucose load. Secondary outcomes include fasting glucose, hemoglobin A1c, insulin resistance score, mean glucose from continuous glucose monitoring (CGM), standard deviation of CGM values, and number of CGM values >140 mg/d.
Participants with a hemoglobin A1c in the prediabetes range (5.7 % to 6.4 %) and clinically significant insomnia are randomized to a dCBT-I program or patient education control program. dCBT-I includes six sessions that focus on changing sleep habits and scheduling factors that affect sleep and addresses misconceptions about sleep and insomnia, utilizing interactive components and goal-setting. Those in the control arm receive access to a sleep-education website, which presents informational content in a simple, static form, without interactive components or active skills training, and all content is provided at once, rather than in modules that unlock over time. At baseline, 11 weeks and 33 weeks after randomization, participants undergo laboratory testing with a 2-h oral glucose tolerance test, hemoglobin A1c, and insulin resistance score. They also undertake 10 days of CGM and actigraphy wear and complete two dietary recalls.
This trial is testing whether a program to improve sleep will positively impact glycemia among those with prediabetes. Registration with clinicaltrials.gov on October 3, 2023: NCT06067139.
失眠是2型糖尿病的一个可改变的风险因素。
描述“健康睡眠研究”的方法，这是一项随机临床试验，旨在研究数字认知行为疗法治疗失眠（dCBT-I）对300名患有失眠和糖尿病前期的患者降低高血糖的有效性。
主要结果是75克葡萄糖负荷后2小时的血糖水平。次要结果包括空腹血糖、糖化血红蛋白、胰岛素抵抗评分、连续血糖监测（CGM）的平均血糖、CGM值的标准差以及CGM值>140mg/d的数量。
糖化血红蛋白处于糖尿病前期范围（5.7%至6.4%）且有临床意义的失眠患者被随机分配到dCBT-I项目或患者教育对照项目。dCBT-I包括六个疗程，重点是改变睡眠习惯和影响睡眠的时间安排因素，并解决有关睡眠和失眠的误解，利用互动组件和设定目标。对照组的患者可以访问一个睡眠教育网站，该网站以简单、静态的形式呈现信息内容，没有互动组件或主动技能培训，所有内容一次性提供，而不是随着时间逐步解锁的模块。在基线、随机分组后11周和33周，参与者接受实验室检测，包括2小时口服葡萄糖耐量试验、糖化血红蛋白和胰岛素抵抗评分。他们还进行10天的CGM和活动记录仪佩戴，并完成两次饮食回顾。
该试验正在测试一项改善睡眠的项目是否会对糖尿病前期患者的血糖产生积极影响。于2023年10月3日在clinicaltrials.gov注册：NCT06067139。
