Sleep and Psychosocial Outcomes After Initiation of Advanced Hybrid Closed-Loop Insulin Delivery Systems in Youth With Type 1 Diabetes and Their Parents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Duration of Sleep
研究概览
简要总结
This study evaluates the impact of the hybrid closed-loop insulin delivery systems on sleep in youth with type 1 diabetes and their parents. Activity watches, surveys and device downloads are used to evaluate sleep in these participants.
详细描述
Sleep is important for everyone, including youth with type 1 diabetes. New technology has shown improvements in glycemic variability, especially overnight. This study evaluates the impact of advanced hybrid closed-loop insulin delivery systems on sleep for both youth with type 1 diabetes and their parents. Study measures include wearing an actigraphy watch and completing a sleep diary for 7 days and taking surveys on sleep and psychosocial measures. Study measures occur prior to starting the hybrid closed-loop system, immediately after starting the system and at 3 and 6 months after starting the system.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child diagnosed with type 1 diabetes for at least 3 months
- •Child receives clinical care at the Barbara Davis Center for Diabetes
- •Child starting an advanced HCL system as part of routine diabetes care
- •Child currently living with a parent who is willing to complete surveys for this study
- •Family able to read and speak English
- •Parent lives at home with the child with type 1 diabetes
- •Parent able to read and speak English
排除标准
- •Child has an active underlying sleep disorder, such as narcolepsy, insomnia or untreated sleep apnea
- •Child participating in an interventional research protocol
- •Child unable to complete study procedures
- •Parent has an active underlying sleep disorder, such as narcolepsy, insomnia or untreated sleep apnea
- •Parent unable to complete study procedures
结局指标
主要结局
Duration of Sleep
时间窗: End of study (6 months)
Change in duration of sleep before and after starting the advanced hybrid closed-loop system using surveys and activity watches
次要结局
- Impact on Quality of Life(End of study (6 months))
- Impact on Fear of Hypoglycemia(End of study (6 months))
- Impact on Diabetes Distress(End of study (6 months))
- Impact on Hybrid Closed-Loop System Use Perceptions(End of study (6 months))
- Impact of Sleep on Glycemic Variability(End of study (6 months))
- Impact on Perceptions of Diabetes Technology(End of study (6 months))