Malone Susan Kohl, Peleckis Amy J, Grunin Laura, Yu Gary, Jang Sooyong, Weimer James, Lee Insup, Rickels Michael R, Goel Namni
Rory Meyers College of Nursing, New York University, New York, NY 10010, USA.
Institute for Diabetes, Obesity, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.
J Diabetes Res. 2021 Feb 12;2021:6611064. doi: 10.1155/2021/6611064. eCollection 2021.
Nocturnal hypoglycemia is life threatening for individuals with type 1 diabetes (T1D) due to loss of hypoglycemia symptom recognition (hypoglycemia unawareness) and impaired glucose counter regulation. These individuals also show disturbed sleep, which may result from glycemic dysregulation. Whether use of a hybrid closed loop (HCL) insulin delivery system with integrated continuous glucose monitoring (CGM) designed for improving glycemic control, relates to better sleep across time in this population remains unknown. The purpose of this study was to describe long-term changes in glycemic control and objective sleep after initiating hybrid closed loop (HCL) insulin delivery in adults with type 1 diabetes and hypoglycemia unawareness. To accomplish this, six adults (median age = 58 y) participated in an 18-month ongoing trial assessing HCL effectiveness. Glycemic control and sleep were measured using continuous glucose monitoring and wrist accelerometers every 3 months. Paired sample -tests and Cohen's effect sizes modeled glycemic and sleep changes and the magnitude of these changes from baseline to 9 months. Reduced hypoglycemia ( = 0.47-0.79), reduced basal insulin requirements ( = 0.48), and a smaller glucose coefficient of variation ( = 0.47) occurred with medium-large effect sizes from baseline to 9 months. Hypoglycemia awareness improved from baseline to 6 months with medium-large effect sizes (Clarke score ( = 0.60), lability index ( = 0.50), HYPO score ( = 1.06)). Shorter sleep onset latency ( = 1.53; < 0.01), shorter sleep duration ( = 0.79), fewer total activity counts ( = 1.32), shorter average awakening length ( = 0.46), and delays in sleep onset ( = 1.06) and sleep midpoint ( = 0.72) occurred with medium-large effect sizes from baseline to 9 months. HCL led to clinically significant reductions in hypoglycemia and improved hypoglycemia awareness. Sleep showed a delayed onset, reduced awakening length and onset latency, and maintenance of high sleep efficiency after initiating HCL. Our findings add to the limited evidence on the relationships between diabetes therapeutic technologies and sleep health. This trial is registered with ClinicalTrials.gov (NCT03215914).
夜间低血糖对1型糖尿病（T1D）患者来说是危及生命的，这是由于低血糖症状识别丧失（低血糖无意识）和葡萄糖反向调节受损所致。这些患者还表现出睡眠紊乱，这可能是血糖调节异常导致的。对于这群人，使用旨在改善血糖控制的集成连续血糖监测（CGM）的混合闭环（HCL）胰岛素输送系统是否会随着时间推移带来更好的睡眠，目前尚不清楚。本研究的目的是描述1型糖尿病合并低血糖无意识的成年人开始使用混合闭环（HCL）胰岛素输送后血糖控制和客观睡眠的长期变化。为实现这一目的，六名成年人（中位年龄 = 58岁）参与了一项为期18个月的正在进行的评估HCL有效性的试验。每3个月使用连续血糖监测和手腕加速计测量血糖控制和睡眠情况。配对样本检验和科恩效应量对血糖和睡眠变化以及从基线到9个月这些变化的幅度进行了建模。从基线到9个月，低血糖减少（效应量 = 0.47 - 0.79），基础胰岛素需求减少（效应量 = 0.48），葡萄糖变异系数变小（效应量 = 0.47），效应量为中等至大。从基线到6个月，低血糖意识有所改善，效应量为中等至大（克拉克评分（效应量 = 0.60）、不稳定性指数（效应量 = 0.50）、低血糖评分（效应量 = 1.06））。从基线到9个月，睡眠开始潜伏期缩短（效应量 = 1.53；P < 0.01），睡眠时间缩短（效应量 = 0.79），总活动计数减少（效应量 = 1.32），平均觉醒时长缩短（效应量 = 0.46），睡眠开始延迟（效应量 = 1.06）和睡眠中点延迟（效应量 = 0.72），效应量为中等至大。HCL导致低血糖在临床上显著减少，并改善了低血糖意识。开始使用HCL后，睡眠出现延迟开始、觉醒时长和开始潜伏期减少，以及高睡眠效率得以维持。我们的研究结果补充了关于糖尿病治疗技术与睡眠健康之间关系的有限证据。本试验已在ClinicalTrials.gov（NCT03215914）注册。
