Sleep optimization to improve glycemic control in adults with type 1 diabetes: study protocol for a randomized controlled parallel intervention trial.
Sleep optimization to improve glycemic control in adults with type 1 diabetes: study protocol for a randomized controlled parallel intervention trial.
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尽管治疗方案和技术有所改进，但只有不到20%的1型糖尿病（T1 D）成人达到血糖目标。睡眠越来越被认为是改善血糖控制的一个潜在的可改变的目标。糖尿病困扰，自我管理行为差，生活质量下降也与睡眠变异性和睡眠时间不足有关。关于改善睡眠的干预措施以及睡眠优化对T1 D血糖控制的影响，存在显著的知识缺口。本研究的目的是确定T1 D特异性睡眠优化干预的疗效（Sleep-Opt）对睡眠变异性、睡眠持续时间和血糖控制（A1 C）的主要结局;其他血糖参数（血糖变异性，时间范围[TIR]）;糖尿病痛苦;自我管理行为;生活质量;以及T1 D和习惯性睡眠变异性增加或睡眠持续时间短的成人患者报告的其他结局。将在120名T1 D成人（年龄18 - 65岁）中开展一项随机对照平行组研究。将对参与者进行习惯性睡眠变异性（> 1小时/周）或睡眠持续时间不足（< 6.5小时/晚）的筛选。合格受试者将随机分配至Sleep-Opt干预组或健康生活关注对照组，持续12周。计划一个为期1周的导入期，通过活动记录仪（睡眠变异性和持续时间）、A1 C（A1 C和相关血糖测量：血糖变异性和TIR，使用连续血糖监测）和其他次要结局（糖尿病困扰、自我管理行为、生活质量和其他患者报告的结局）进行基线睡眠测量。Sleep-Opt是我们最近开发的一种技术辅助的行为睡眠干预，它利用了公众对睡眠跟踪的兴趣。我们的行为干预采用四个要素：可穿戴睡眠跟踪器，教学内容，交互式智能手机应用程序和简短的电话咨询。注意力控制组将参加健康生活信息计划。基线测量将在中点、项目完成和项目后（分别为第6、12和24周）重复进行，以确定两组之间的差异和干预的可持续性。更好地了解改善T1 D患者睡眠的策略有可能成为糖尿病的重要组成部分。临床试验注册：NCT 04506151。
Despite improvements in treatment regimens and technology, less than 20% of adults with type 1 diabetes (T1D) achieve glycemic targets. Sleep is increasingly recognized as a potentially modifiable target for improving glycemic control. Diabetes distress, poor self-management behaviors, and reduced quality of life have also been linked to sleep variability and insufficient sleep duration. A significant gap of knowledge exists regarding interventions to improve sleep and the effects of sleep optimization on glycemic control in T1D. The purpose of this study is to determine the efficacy of a T1D-specific sleep optimization intervention (Sleep-Opt) on the primary outcomes of sleep variability, sleep duration, and glycemic control (A1C); other glycemic parameters (glycemic variability, time-in-range [TIR]); diabetes distress; self-management behaviors; quality of life; and other patient-reported outcomes in adults with T1D and habitual increased sleep variability or short sleep duration. A randomized controlled parallel-arm study will be employed in 120 adults (aged 18 to 65 years) with T1D. Participants will be screened for habitual sleep variability (> 1 h/week) or insufficient sleep duration (< 6.5 h per night). Eligible subjects will be randomized to the Sleep-Opt intervention group or healthy living attention control group for 12 weeks. A 1-week run-in period is planned, with baseline measures of sleep by actigraphy (sleep variability and duration), glycemia (A1C and related glycemic measures: glycemic variability and TIR using continuous glucose monitoring), and other secondary outcomes: diabetes distress, self-management behaviors, quality of life, and additional patient-reported outcomes. Sleep-Opt is a technology-assisted behavioral sleep intervention that we recently developed that leverages the rapidly increasing public interest in sleep tracking. Our behavioral intervention employs four elements: a wearable sleep tracker, didactic content, an interactive smartphone application, and brief telephone counseling. The attention control group will participate in a healthy living information program. Baseline measures will be repeated at midpoint, program completion, and post-program (weeks 6, 12, and 24, respectively) to determine differences between the two groups and sustainability of the intervention. A better understanding of strategies to improve sleep in persons with T1D has the potential to be an important component of diabetes. Clinical Trial Registration: NCT04506151.
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影响因子：
3
作者：
Fisher L;Hessler D;Polonsky W;Strycker L;Masharani U;Peters A
通讯作者：
Peters A
影响因子：
3.7
作者：
Bouhassira D;Letanoux M;Hartemann A
通讯作者：
Hartemann A
影响因子：
5.4
作者：
Bailey T;Bode BW;Christiansen MP;Klaff LJ;Alva S
通讯作者：
Alva S
影响因子：
16.2
作者：
Borel, Anne-Laure;Pepin, Jean-Louis;Benhamou, Pierre-Yves
通讯作者：
Benhamou, Pierre-Yves
影响因子：
44.5
作者：
Bell, Kirstine J.;Barclay, Alan W.;Brand-Miller, Jennie C.
通讯作者：
Brand-Miller, Jennie C.