Madrid-Valero Juan J, Ware Julia, Allen Janet M, Boughton Charlotte K, Hartnell Sara, Wilinska Malgorzata E, Thankamony Ajay, de Beaufort Carine, Schierloh Ulrike, Campbell Fiona M, Sibayan Judy, Bocchino Laura E, Kollman Craig, Hovorka Roman, Gregory Alice M, Consortium KidsAP
Department of Health Psychology, Faculty of Health Sciences, University of Alicante, San Vicente del Raspeig, Spain.
Wellcome-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Pediatr Diabetes. 2023 Jun 13;2023:7937007. doi: 10.1155/2023/7937007. eCollection 2023.
Parents of children living with type 1 diabetes (T1D) often report short and/or poor quality sleep. The development of closed-loop systems promises to transform the management of T1D. This study compared sleep quality and quantity in caregivers of children using a closed-loop system (CL) or sensor-augmented pump (SAP) therapy.
Data from sleep diaries, accelerometers, and questionnaires were provided by forty parents (classified as caregiver 1 (main analyses) or 2 (supplementary analyses) based on their contribution towards treatment management) of 21 very young children aged 1 to 7 years living with T1D (mean age: 4.7 (SD = 1.7)). Assessments were made at a single post-randomisation time point when the child was completing either the 16-week CL arm ( = 10) or the 16-week SAP arm ( = 11) of the main study.
Overall, there was a mixed pattern of results and group differences were not statistically significant at the < 0.05 level. However, when we consider the direction of results and results from caregiver 1, sleep diary data showed that parents of the CL (as compared to the SAP) group reported a shorter sleep duration but better sleep quality, fewer awakenings, and less wake after sleep onset (WASO). Actiwatch data showed that caregiver 1 of the CL (as compared to the SAP) group had a shorter sleep latency; greater sleep efficiency; and less wake after sleep onset. Results from the Pittsburgh Sleep Quality Index also showed better sleep quality for caregiver 1 of the CL group as compared to the SAP group.
Results from this study suggest that sleep quality and quantity in parents of children using CL were not significantly different to those using SAP. Considering effect sizes and the direction of the non-significant results, CL treatment could be associated with better sleep quality in the primary caregiver. However, further research is needed to confirm these findings. This trial is registered with NCT05158816.
1型糖尿病（T1D）患儿的父母经常报告孩子睡眠短和/或质量差。闭环系统的发展有望改变T1D的管理方式。本研究比较了使用闭环系统（CL）或传感器增强泵（SAP）治疗的儿童的照顾者的睡眠质量和睡眠时间。
40名父母（根据他们对治疗管理的贡献分为照顾者1（主要分析）或照顾者2（补充分析））提供了21名1至7岁患有T1D的幼儿（平均年龄：4.7（标准差=1.7））的睡眠日记、加速度计和问卷调查数据。评估是在主要研究的16周CL组（n = 10）或16周SAP组（n = 11）的儿童完成随机分组后的单个时间点进行的。
总体而言，结果呈现混合模式，组间差异在<0.05水平上无统计学意义。然而，当我们考虑结果的方向和照顾者1的结果时，睡眠日记数据显示，CL组（与SAP组相比）的父母报告睡眠时间较短，但睡眠质量较好，觉醒次数较少，睡眠后觉醒时间（WASO）较短。Actiwatch数据显示，CL组（与SAP组相比）的照顾者1睡眠潜伏期较短；睡眠效率较高；睡眠后觉醒时间较短。匹兹堡睡眠质量指数的结果也显示，与SAP组相比，CL组照顾者1的睡眠质量更好。
本研究结果表明，使用CL的儿童的父母的睡眠质量和睡眠时间与使用SAP的父母没有显著差异。考虑到效应大小和无显著结果的方向，CL治疗可能与主要照顾者更好的睡眠质量相关。然而，需要进一步的研究来证实这些发现。本试验已在ClinicalTrials.gov上注册，注册号为NCT05158816。
