睡眠健康研究：失眠治疗对糖尿病前期患者血糖影响的随机临床试验。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-02-01 DOI:10.1016/j.cct.2024.107796

Erin S. LeBlanc , Ning Smith , Dennis Hwang , Deborah R. Young , Caryn Oshiro , Meghan Mayhew , Stefan Massimino , Chris Catlin , Gregory Clarke

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引用次数: 0

摘要

背景：失眠是2型糖尿病的一个可改变的危险因素。目的：描述睡眠健康研究的方法，该研究是一项随机临床试验，旨在检测数字认知行为疗法（dCBT-I）在300名失眠和前驱糖尿病患者中降低高血糖的有效性。结果：主要结果是75克葡萄糖负荷后的血糖水平2 h。次要结局包括空腹血糖、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值的标准差和CGM值的数量>140 mg/d。方法：糖化血红蛋白在糖尿病前期范围（5.7 %至6.4 %）和临床显著失眠的参与者被随机分配到dCBT-I计划或患者教育控制计划。dCBT-I包括六个部分，重点关注改变睡眠习惯和影响睡眠的时间安排因素，并利用互动组件和目标设定解决关于睡眠和失眠的误解。控制组的人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，所有内容都是一次性提供的，而不是以模块的形式随着时间的推移解锁。在基线，随机分组后11 周和33 周，参与者接受2小时口服葡萄糖耐量试验、血红蛋白A1c和胰岛素抵抗评分的实验室测试。他们还进行10 天的CGM和活动记录仪磨损，并完成两次饮食召回。摘要：这项试验是为了测试一个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。2023年10月3日在clinicaltrials.gov注册：NCT06067139。

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The sleep for health study: A randomized clinical trial of the impact of insomnia treatment on glycemia in people with prediabetes

Background

Insomnia is a modifiable risk factor for type 2 diabetes.

Objective

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.

Outcomes

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.

Methods

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.

Summary

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.

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.