The Importance of Sleep for Diabetes Associated Tasks and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Sleep quality
研究概览
简要总结
Adolescents with type 1 diabetes (T1D) experience more disturbed sleep compared to their healthy peers, especially because they tend to spend less time in deep sleep, the most restoring part of sleep, potentially impacting diabetes management. Disturbed sleep may adversely affect diabetes management which requires day-to-day decision-making, emotional and behavioural regulation, attention, and planning. Despite a massive increase in new technology, more than 50% of adolescents do not reach their glycaemic target. Lack of sleep impairing diabetes management including blood glucose monitoring may play an important role in reaching the goal. For approximately 4000 children and adolescents in Denmark living with T1D, sleep disturbances may therefore account for short and long-term diabetes complications.
Our overall aims are to investigate: (1) If and how glycaemic variability (GV) influences sleep quality and sleep stages and (2) if and how poor sleep quality influences time-in-range (TIR), time-above-range (TAR) and time-below-range (TBR) the following day.
详细描述
Background: Sleep distrubances are increasing among adolescents in Denmark. In 2017, a large health survey reported that 14.9 % of the 16-24 year-olds ( n= 7,627) had sleep problems over the last two weeks-an alarmingly high increase of 33.3% since the first survey in 2010. Adolescents with type 1 diabetes (T1D) experience more disturbed sleep compared to their healthy peers, especially because they tend to spend less time in deep sleep, the most restoring part of sleep. Disturbed sleep may adversely affect diabetes management which requires daily blood glucose monitoring (BGM), day-to-day decision-making, emotional and behavioural regulation, attention and planning (behavioural pathway). Diabetes management plays an important role in reaching glycemic targets and the worsening glycemic outcome may impact sleep and start a vicious circle. Currently, >50% of adolescents do not reach the glycemic target. Furthermore, the disturbance of circadian rhythmicity may in itself have metabolic consequences (metabolic pathway). Disturbed sleep may contribute to the 40% increased risk of psychiatric disease (anxiety, depression and eating disorders) associated with childhood diabetes. A link between psychiatric disease, stress and sleep has been confirmed. For the approximately 4000 children and adolescents in Denmark living with T1D, this means sleep problems may contribute negatively and increase the risk of short and long-term diabetes complications.
Over the past decades, the use of technology such as insulin pumps and continuous glucose monitors (CGM) in T1D treatment has increased dramatically, but still far from all reaches glycemic targets. This may, in part, be explained by the vicious circle and the additional disturbances from alarms and difficulties in initiating sleep due to itching or irritation from having devices attached to the body. The more beneficial effect on sleep from advanced insulin pumps like hybrid closed loop systems with less glycemic variability and fewer alarms overnight, has yet to be proved in children and adolescents.
The term sleep is defined as sleep quality and duration. Disturbed sleep is defined as too short or long duration for age based on guidelines from the American Academy of Sleep Medicine (AASM) and/or poor quality sleep. The ability to be more resilient, have better coping strategies and more self-compassion may impact your sleep through the influence on rumination, reducing sleep latency (period from going to bed to falling asleep) and duration of wake-up periods, why resilience, coping and compassion are potentially modifiable factors. Other factors like social activities and media uses are important factors associated with changes in circadian rhythmicity, sleep length, sleep disturbances and poorer daytime performance. Furthermore, poor glycemic control is associated with sleep disorders like obstructive sleep apnea.
The golden standard for sleep assessment is polysomnography (PSG), but it is limited because it (1) typically provides only 1-2 nights of information about a child's sleep, (2) requires in some cases observation outside the natural environment in a sleep lab and (3) has significant financial costs. We have access to a new home sleep test with eye movement detection (HST REM+) from Somnomedics GmbH which is validated against PSG in adults. The HST REM+ is a simplified PSG which measures sleep architecture (sleep stages) with three electrodes in the forehead and one behind the ear. The HST REM+ can make measurements for up to 5 nights at home with a tablet showing how to apply the electrodes. The HST REM+ is combined with ActiGraph wGT3X-BT (AG), a small wristwatch measuring movements and validated against PSG in adolescents. With the majority of children being treated with continuous glucose monitoring (CGM) and insulin pumps, we have the unique opportunity to combine data from these different objective sleep measures and thorough diabetes management data from downloads from insulin pump and CGM. This opens for the opportunity to study 24/7 variation in diabetes management and glycemic outcome including device alarm frequency and relate this to the current and previous night sleep. Additionally, we are able to study how advanced insulin pumps including hybrids closed loop systems impact sleep parameters such as sleep duration, sleep stages, sleep efficiency and sleep latency.
Our overall aims are to investigate: (1) If and how glycaemic variability influences sleep quality and sleep stages and (2) if and how poor sleep quality influences time-in-range (TIR), time-above-range (TAR) and time-below-range (TBR) the following day.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes for > 6 months
- •Use of both insulin pump and continuous glucose monitor
排除标准
- •Severe psychiatric diseases using ICD-10 codes (e.g. ADHD, autism spectrum disorder, eating disorders, retarded mental development)
- •Unwillingness to participate and inability to read and understand Danish or English.
结局指标
主要结局
Sleep quality
时间窗: In the the study periode (one to maksimum five nights)
% of total sleep time in deep sleep (stage N3 and N4)
Daytime time-in-range (TIR)
时间窗: In the study periode (7 days)
3,9-10 mmol/L
次要结局
未报告次要终点
