Sleep and Chronotype in Children With Type 1 Diabetes
Determination of Sleep Disorder and Chronotype in Children and Adolescents With Type 1 Diabetes; Observation of the Impact on Glycemic Control and Treatment
Type 1 diabetes is the most common metabolic disorder in children and adolescents. Sleep is important for prognosis and several sleep parameters are related to metabolic control. However, limited number of studies in children and adolescents showed mixed results and recommendations about how to address sleep in the clinical care of diabetes in children are still lacking. There is a need to examine the potential role of sleep in developing preventive interventions for diabetes management in children and adolescents.
The authors aimed to describe sleep/wake patterns ,sleep problems, and chronotype of children and adolescents with type 1 diabetes, and to assess the relation of sleep measures with metabolic control and treatment.
The study has a prospective observational cross-sectional design. An estimated sample size is calculated as 83. Children diagnosed with type 1 diabetes between 6 to 18 years of age will be recruited from two pediatric endocrinology centers specialized in diabetes. Sleep/wake pattern will be assessed by actigraphy, and sleep diaries. Sleep disorder will be assessed by the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) Sleep Disorder Scale, and Chronotype Questionnaire will be used to determine the chronotype.
研究概览
地位
条件
详细说明
Type 1 diabetes is the most common metabolic disorder in children and adolescents. Sleep is important for prognosis and several sleep parameters are related to metabolic control. However, limited number of studies in children and adolescents showed mixed results and recommendations about how to address sleep in the clinical care of diabetes in children are still lacking. There is a need to examine the potential role of sleep in preventive interventions.
The authors aimed to describe sleep/wake patterns ,sleep problems, and chronotype of children and adolescents with type 1 diabetes, and to assess the relation of sleep measures with metabolic control and treatment.
The study has a prospective observational cross-sectional design. An estimated sample size is calculated as 83. Children diagnosed with type 1 diabetes between 6 to 18 years of age will be recruited from two pediatric endocrinology centers specialized in diabetes. Sleep/wake pattern will be assessed by actigraphy, and sleep diaries. Sleep wake patterns will be assessed by Philips Respironics Mini-Mitter Actiwatch-2 for at least 3 days at home environment and sleep diaries within 5-minute intervals will be filled out by parents. Actigraphy is a validated wristwatch-like device that distinguishes sleep from wakefulness based on accelerometer measured movement.
Sleep disorder will be assessed by the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) Sleep Disorder Scale, and Chronotype Questionnaire will be used to determine the chronotype.
For metabolic control, targeted standard values will be used for continuous glucose measurement. (Target daily blood glucose ranges 70-180 mg/dl, <4% <70 mg/dl, <1% <54 mg/dl, <25% >180 mg/dl, <5% rate >250 mg/dl). The latest Hemoglobin A1c level will also be evaluated.
A questionnaire developed by the investigators including sociodemographic characteristics, and diabetes related information will be gathered from the patient records.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Istanbul、火鸡
- Marmara University School of Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- aged between 6 to 18 years
- use of continuous glucose monitoring system
Exclusion Criteria:
- acute medical condition that can impact sleep (diabetes keto acidosis, cold, influenza)
- diagnosed neurodevelopmental or behavioral condition like autism spectrum disorder or Attention Deficit/Hyperactivity Disorder
- diagnosed sleep disorder (Obstructive Sleep Apnea)
- Current use of medications that can impact sleep (diphenhydramine)
学习计划
研究是如何设计的？
设计细节
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 wake patterns measured by actigraphy
大体时间：baseline
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sleep wake patterns
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baseline
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sleep disorder
大体时间：Baseline
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sleep disorder measured with the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) Sleep Disorder Scale.
The scale has an 8-item parent form, that could be filled up by parents or legal guardians of children aged between 6-17 years, and a 9-item self report form to be filled up by adolescents aged between 11-17 years.
For each item, the caregiver is asked to rate the severity of symptoms related to sleep disorders that occurred within the past 7 days, she/he had observed in his/her child.
The scale has a 5-point Likert type rating (1=never, 2=very little/rarely, 3=sometimes, 4=most of the time, 5=almost all the time).
Total scores range between 8-40 and higher scores indicate presence of much more severe sleep-related problems.
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Baseline
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chronotype
大体时间：baseline
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chronotype measured with Chronotype Questionnaire.Children's Chronotype Questionnaire (CCTQ) is a parent report, 27-item mixed format questionnaire measuring chronotype of children in multiple domains : the midsleep point on free days (MSF), a morningness/eveningness scale(M/E) score, and a five-point chronotype (CT) score.
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baseline
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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metabolic control
大体时间：baseline
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metabolic control measured by number of hypo and hyperglycemic episodes over the past month
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baseline
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metabolic control
大体时间：baseline
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metabolic control measured by the most recent hemoglobin A1c
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baseline
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treatment
大体时间：baseline
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treatment measured by insulin dose per kilogram
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baseline
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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