Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, University of Cambridge School of Clinical Medicine, Cambridge, UK.
Department of Paediatrics, University of Cambridge School of Clinical Medicine, Cambridge, UK.
BMJ Open. 2021 Feb 12;11(2):e042790. doi: 10.1136/bmjopen-2020-042790.
Diabetes management in very young children remains challenging. Glycaemic targets are achieved at the expense of high parental diabetes management burden and frequent hypoglycaemia, impacting quality of life for the whole family. Our objective is to assess whether automated insulin delivery can improve glycaemic control and alleviate the burden of diabetes management in this particular age group.
The study adopts an open-label, multinational, multicentre, randomised, crossover design and aims to randomise 72 children aged 1-7 years with type 1 diabetes on insulin pump therapy. Following screening, participants will receive training on study insulin pump and study continuous glucose monitoring devices. Participants will be randomised to 16-week use of the hybrid closed-loop system (intervention period) or to 16-week use of sensor-augmented pump therapy (control period) with 1-4 weeks washout period before crossing over to the other arm. The order of the two study periods will be random. The primary endpoint is the between-group difference in time spent in the target glucose range from 3.9 to 10.0 mmol/L based on sensor glucose readings during the 16-week study periods. Analyses will be conducted on an intention-to-treat basis. Key secondary endpoints are between group differences in time spent above and below target glucose range, glycated haemoglobin and average sensor glucose. Participants' and caregivers' experiences will be evaluated using questionnaires and qualitative interviews, and sleep quality will be assessed. A health economic analysis will be performed.
Ethics approval has been obtained from Cambridge East Research Ethics Committee (UK), Ethics Committees of the University of Innsbruck, the University of Vienna and the University of Graz (Austria), Ethics Committee of the Medical Faculty of the University of Leipzig (Germany) and Comité National d'Ethique de Recherche (Luxembourg). The results will be disseminated by peer-reviewed publications and conference presentations.
NCT03784027.
对非常年幼的儿童进行糖尿病管理仍然具有挑战性。血糖目标是通过增加父母的糖尿病管理负担和频繁发生低血糖来实现的，这会影响整个家庭的生活质量。我们的目的是评估自动胰岛素输送是否可以改善血糖控制并减轻该特定年龄段的糖尿病管理负担。
该研究采用开放标签、多国、多中心、随机、交叉设计，旨在将 72 名年龄在 1-7 岁、接受胰岛素泵治疗的 1 型糖尿病儿童随机分组。筛选后，参与者将接受有关研究胰岛素泵和研究连续血糖监测设备的培训。参与者将随机接受 16 周的混合闭环系统（干预期）或 16 周的传感器增强型泵治疗（对照组），在交叉到另一臂之前有 1-4 周的洗脱期。两个研究期的顺序是随机的。主要终点是基于传感器血糖读数，在 16 周研究期间目标血糖范围内的时间，两组之间的差异。分析将基于意向治疗进行。次要终点是两组之间目标血糖范围内和血糖范围之外的时间、糖化血红蛋白和平均传感器血糖的差异。将使用问卷和定性访谈评估参与者和护理人员的经验，并评估睡眠质量。将进行健康经济学分析。
剑桥东部研究伦理委员会（英国）、因斯布鲁克大学、维也纳大学和格拉茨大学（奥地利）伦理委员会、莱比锡大学医学系伦理委员会（德国）和卢森堡国家伦理研究委员会已获得伦理批准。结果将通过同行评审出版物和会议报告进行传播。
NCT03784027。
