睡眠优化可改善成人 1 型糖尿病患者的血糖控制 (SOPT)
2026年8月5日 更新者：Pamela Martyn-Nemeth、University of Illinois at Chicago
多达 40% 的 1 型糖尿病成人睡眠不足，这与不良健康后果有关，包括血糖控制不佳和更严重的糖尿病并发症。
在这项研究中，睡眠干预 (Sleep-Opt) 使用可穿戴睡眠跟踪技术、电话指导和信息内容，旨在改善患有 1 型糖尿病的工作年龄成人的睡眠和血糖控制。
Sleep-Opt 可以减少糖尿病并发症的发生并改善 1 型糖尿病患者的生活质量。
研究概览
详细说明
尽管治疗方案和技术有所改进，但只有不到 20% 的成人 1 型糖尿病 (T1D) 达到血糖目标。
睡眠越来越被认为是改善血糖控制的潜在可修改目标。
糖尿病困扰、不良的自我管理行为和生活质量 (QoL) 下降也与睡眠变异性和睡眠时间不足有关。
美国糖尿病协会糖尿病医疗标准将睡眠作为糖尿病患者医学评估的重要组成部分。
但是，没有给出关于如何改善睡眠的具体建议。
关于睡眠优化对 T1D 血糖控制的影响，存在显着的知识差距。
本研究的目的是确定 T1D 特异性睡眠优化干预 (Sleep-Opt) 对睡眠变异性、睡眠持续时间和血糖控制 (A1C) 等主要结局的疗效；其他血糖参数（血糖变异性、范围内的时间）、糖尿病困扰、自我管理行为、QoL 以及其他患者报告的患有 T1D 和习惯性睡眠变异性增加或睡眠时间短的工作年龄成人的结果。
为实现这些目标，计划在 120 名患有 T1D 的工作年龄成人（18 至 65 岁）中进行随机对照试验。
将筛查参与者的习惯性睡眠变异性（> 1 小时/周）或睡眠时间不足（< 6.5 小时/晚）。
符合条件的受试者将被随机分配到 Sleep-Opt 组或健康生活注意力控制组，为期 12 周。
计划为期一周的磨合期，通过活动记录仪测量睡眠基线（睡眠变异性和持续时间）、血糖（A1C 和相关血糖测量：使用连续血糖监测的血糖变异性和范围内时间）和其他次要结果：糖尿病痛苦、自我管理行为、生活质量和其他患者报告的结果。
Sleep-Opt 是该研究团队开发的一种技术辅助行为睡眠干预，它利用了公众对消费者睡眠跟踪的兴趣迅速增长（3 年内增长了 500%）。
行为干预采用四个要素：可穿戴睡眠追踪器、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。
在中点（第 6 周）完成（第 12 周）和计划后（第 24 周），将重复基线测量以确定两组之间的差异和干预的可持续性。
研究类型
介入性
注册 (实际的)
144
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Illinois
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Chicago、Illinois、美国、60612
- University of Illinois Chicago
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 18-65岁的成年人
- 至少一年的 1 型糖尿病临床诊断
- 报告的习惯性睡眠变异性（1 小时/周或更多）或工作日或工作日的睡眠时间少于 6.5 小时/晚（通过活动记录睡眠表确认）
- 改善睡眠的愿望
- 拥有智能手机
排除标准：
- 失眠症状
- 阻塞性睡眠呼吸暂停的高风险
- 在过去 6 个月内有过严重的低血糖事件（例如 意识丧失）
- A1C 大于 10%
- 轮班或夜班工作
- 使用睡眠药物/辅助工具
- 肾功能损害（估计肾小球滤过率 < 45 毫升/分钟）
- 目前有重大疾病（如心力衰竭、肝硬化、需要氧气的慢性阻塞性肺病、癌症的积极治疗、抑郁症、中风病史和神经功能缺损
- 母乳喂养、怀孕或计划怀孕
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：睡眠选择
为期 12 周的干预，包括自我监控、目标设定、激励增强。
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12周行为干预
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有源比较器：健康生活
为期 12 周的干预，包括每周电话联系、及时的教学内容和对干预组的关注。
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健康生活
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sleep Variability Week 6
大体时间：Week 6
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Standard deviation total sleep time for one week
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Week 6
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Sleep Variability Week 12
大体时间：Week 12
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Standard deviation total sleep time for one week
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Week 12
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Sleep Variability Week 24
大体时间：Week 24
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Standard deviation total sleep time for one week
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Week 24
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Sleep Duration Week 6
大体时间：Weeks 6
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total sleep time minutes
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Weeks 6
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Sleep Duration Week 12
大体时间：Week 12
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total sleep time in minutes
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Week 12
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Sleep Duration Week 24
大体时间：Week 24
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total sleep time in minutes
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Week 24
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HbA1C Week 6
大体时间：Week 6
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Hemoglobin A1C week 6, %
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Week 6
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HbA1C Week 12
大体时间：Week 12
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HbA1c blood test
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Week 12
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HbA1C Week 24
大体时间：Week 24
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HbA1c blood test
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Week 24
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Diabetes Distress Week 6
大体时间：Week 6
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Type 1 Diabetes Distress Scale measures diabetes distress.
Item mean scores calculated (sum of scores/number of items) ranges from 1-6 Higher scores indicated greater distress Unit of measure = units on a scale
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Week 6
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Diabetes Distress Week 12
大体时间：Week 12
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Type 1 Diabetes Distress Scale measures diabetes distress.
Item mean scores calculated (sum of scores/number of items) ranges from 1-6 Higher scores indicated greater distress Unit of measure = units on a scale
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Week 12
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Diabetes Distress Week 24
大体时间：Week 24
|
Type 1 Diabetes Distress Scale measures diabetes distress.
Item mean scores calculated (sum of scores/number of items) ranges from 1-6 Higher scores indicated greater distress Unit of measure = units on a scale
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Week 24
|
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Self-management Behavior Week 6
大体时间：Week 6
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Diabetes Self Management Questionnaire-R (DSMQ-R) measures diabetes self-management Item mean scores calculated (sum of scores/maximum possible sum of items * 10).
Ranges from 0-10.
Higher numbers indicate better self-management behavior Unit of measure = units on a scale
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Week 6
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Self Management Behavior Week 12
大体时间：Week 12
|
Diabetes Self Management Questionnaire-R (DSMQ-R) measures diabetes self-management Item mean scores calculated (sum of scores/maximum possible sum of items * 10).
Scores ranges from 0-10.
Higher numbers indicate better self-management behavior Unit of measure = units on a scale
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Week 12
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Self Management Behavior Week 24
大体时间：Week 24
|
Diabetes Self Management Questionnaire-R (DSMQ-R) measures diabetes self-management Item mean scores calculated (sum of scores/maximum possible sum of items * 10).
Ranges from 0-10.
Higher numbers indicate better self-management behavior Unit of measure = units on a scale
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Week 24
|
|
Quality of Life Week 6
大体时间：Week 6
|
Diabetes Quality of Life scale measures quality of life Total quality of life score calculated as follows: (Raw total score - lowest possible score)/raw score range * 100. Scores range from 0-100. Scores are reverse coded so that higher numbers indicate better quality of life. Unit of measure = units on a scale |
Week 6
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Quality of Life Week 12
大体时间：Week 12
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Diabetes Quality of Life scale measures quality of life Total quality of life score calculated as follows: (Raw total score - lowest possible score)/raw score range * 100. Scores range from 0-100. Scores are reverse coded so that higher numbers indicate better quality of life. Unit of measure = units on a scale. |
Week 12
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Quality of Life Week 24
大体时间：Week 24
|
Diabetes Quality of Life scale measures quality of life Total quality of life score calculated as follows: (Raw total score - lowest possible score)/raw score range * 100. Scores range from 0-100. Scores are reverse coded so that higher numbers indicate better quality of life. Unit of measure = units on a scale. |
Week 24
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Fatigue Week 6
大体时间：Week 6
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Patient Reported Outcomes Measure (PROMIS) fatigue scale score measures fatigue. The total score was converted to T-scores (with T-scores, 50 indicates the population mean with a standard deviation of 10). Mean T-scores were calculated. Higher scores reflect greater fatigue. |
Week 6
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Fatigue Week 12
大体时间：Week 12
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Patient Reported Outcomes Measure (PROMIS) fatigue scale score measures fatigue. The total score was converted to T-scores (with T-scores, 50 indicates the population mean with a standard deviation of 10). Mean T-scores were calculated. Higher scores reflect greater fatigue. |
Week 12
|
|
Fatigue Week 24
大体时间：Week 24
|
Patient Reported Outcomes Measure (PROMIS) fatigue scale score measures fatigue. The total score was converted to T-scores (with T-scores, 50 indicates the population mean with a standard deviation of 10). Mean T-scores were calculated. Higher scores reflect greater fatigue. |
Week 24
|
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Mood Week 6
大体时间：Week 6
|
Center for Epidemiological Studies-Depression (CES-D) measures depressive mood.
Total summed score ranges from 0-60.
Higher scores indicate greater depressive mood.
Unit of measure = units on a scale.
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Week 6
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Mood Week 12
大体时间：Week 12
|
Center for Epidemiological Studies-Depression (CES-D) measures depressive mood.
Total summed score ranges from 0-60.
Higher scores indicate greater depressive mood.
Unit of measure = units on a scale.
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Week 12
|
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Mood Week 24
大体时间：Week 24
|
Center for Epidemiological Studies-Depression (CES-D) measures depressive mood.
Total summed score ranges from 0-60.
Higher scores indicate greater depressive mood.
Unit of measure = units on a scale.
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Week 24
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Subjective Sleep Quality Week 6
大体时间：Week 6
|
Pittsburgh Sleep Quality Index (PSQI) measures subjective sleep quality.
Total summed score ranges 0-21.
Higher score reflects poorer sleep quality.
Unit of measure = units on a scale.
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Week 6
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Subjective Sleep Quality Week 12
大体时间：Week 12
|
Pittsburgh Sleep Quality Index (PSQI) measures subjective sleep quality.
Total summed score ranges 0-21.
Higher score reflects poorer sleep quality.
Unit of measure = units on a scale.
|
Week 12
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Subjective Sleep Quality Week 24
大体时间：Week 24
|
Pittsburgh Sleep Quality Index (PSQI) measures subjective sleep quality.
Total summed score ranges 0-21.
Higher score reflects poorer sleep quality.
Unit of measure = units on a scale.
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Week 24
|
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Glycemic Variability Week 6
大体时间：Week 6
|
Coefficient of variation (CV%), continuous glucose monitoring (CGM)-derived glucose standard deviation (SD) divided by the mean and multiplied by 100.
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Week 6
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Glycemic Variability Week 12
大体时间：Week 12
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Coefficient of variation (CV%), continuous glucose monitoring (CGM)-derived glucose standard deviation (SD) divided by the mean and multiplied by 100.
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Week 12
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Glycemic Variability Week 24
大体时间：Week 24
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Coefficient of variation (CV%), continuous glucose monitoring (CGM)-derived glucose standard deviation (SD) divided by the mean and multiplied by 100.
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Week 24
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Glucose Time-in-range Week 6
大体时间：Week 6
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Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL.
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Week 6
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Glucose Time-in-range Week 12
大体时间：Week 12
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Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL.
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Week 12
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Glucose Time-in-range Week 24
大体时间：Week 24
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Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL.
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Week 24
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Tests of the Sleep Intervention Effect on A1C That is Due to the Change in Sleep Duration
大体时间：week 12
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Mediation tests of the sleep intervention effect on A1C that is due to the change in sleep duration.
It is the product of parameter estimates testing the effect of the intervention on sleep duration and the mediating effect of the change in sleep duration on A1C.
Markov chain Monte Carlo (MCMC) models were used.
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week 12
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Mediation Tests of the Sleep Intervention Effect on A1C That is Due to the Change in Sleep Variability.
大体时间：Week 12
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Results are not reported by treatment arm.
This analysis tests the sleep intervention effect on A1C that is mediated by the change in sleep variability.
The values reported are the product of parameter estimates testing the effect of the intervention on sleep variability and the effect of the change in sleep variability on A1C.
Markov chain Monte Carlo (MCMC) models were used.
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Week 12
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Pamela Martyn-Nemeth, PhD、University of Illinois at Chicago
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Martyn-Nemeth P, Duffecy J, Quinn L, Reutrakul S, Steffen AD, Burke L, Clark Withington MH, Irsheed GA, Perez R, Park M, Saleh A, Mihailescu D, Baron KG. Sleep optimization to improve glycemic control in adults with type 1 diabetes: study protocol for a randomized controlled parallel intervention trial. Trials. 2022 Aug 19;23(1):686. doi: 10.1186/s13063-022-06565-6.
- Hong SJ, Pratuangtham S, Martyn-Nemeth P, Steffen AD, Park CG, Reutrakul S. Blue Light Exposure During Sleep in Type 1 Diabetes: Impacts on Glycemic Control and Psychosocial Health. J Sleep Res. 2026 Jun 5:e70380. doi: 10.1111/jsr.70380. Online ahead of print.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年1月19日
初级完成 (实际的)
2024年12月21日
研究完成 (实际的)
2025年12月21日
研究注册日期
首次提交
2020年7月22日
首先提交符合 QC 标准的
2020年8月6日
首次发布 (实际的)
2020年8月10日
研究记录更新
最后更新发布 (实际的)
2026年8月27日
上次提交的符合 QC 标准的更新
2026年8月5日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.