Home testing of 24/7 closed-loop control in children and adolescents with type 1

描述（由申请人提供）：本项目将在实验室和家庭环境中评价24/7闭环治疗1型糖尿病儿童和青少年的性能。传统上，胰岛素是根据用点式血糖仪测量的血糖水平注射的，每天最多注射六次。然而，需要更准确地滴定胰岛素以达到接近正常的血糖水平并降低低血糖水平的风险。这可以通过闭环胰岛素输注来实现。通过连续葡萄糖监测仪逐分钟测量葡萄糖。该信号被无线传输到手持设备，该设备计算出给定葡萄糖水平下的正确胰岛素量。然后，将关于胰岛素速率的信息无线传输到胰岛素泵。利用我们在夜间闭环胰岛素输注测试期间获得的知识和结果，我们将开发和测试用于24/7闭环胰岛素输注的闭环系统原型。临床工作将从在受控实验室环境中测试原型闭环系统开始。众所周知，儿童和青少年的胰岛素需求波动比成人大，需要实验室经验来确定闭环的可行性和安全性，特别是在餐后、运动期间以及错过餐时大剂量和未经通知的餐后。我们将继续在30天内在家庭环境中测试24/7闭环胰岛素输注，并与连续皮下胰岛素输注治疗进行比较。预计我们的研究结果将有助于创造医疗，社会和监管机构对闭环控制的接受，并为其商业开发和24/7闭环系统的广泛使用铺平道路。 公共卫生相关性：由于强化胰岛素治疗相关的低血糖风险增加，1型糖尿病受试者的治疗目标难以实现。本项目的总体目标是评估在1型糖尿病儿童和青少年中进行24/7闭环控制和膳食通知的安全性、有效性和实用性。在此之前，将在临床研究中心环境中对依从性和不依从性受试者进行24/7闭环控制评价，以收集支持家庭检测监管提交的数据。

DESCRIPTION (provided by applicant): This project will evaluate performance of 24/7 closed-loop in children and adolescents with type 1 diabetes in the laboratory and home settings. Traditionally, insulin is injected according to blood glucose levels measured with a spot glucose meter up to six times a day. However, insulin needs to be more accurately titrated to attain near-normal blood glucose levels and to reduce the risk of low blood glucose levels. This can be achieved by closed-loop insulin delivery. Glucose is measured on a minute-to-minute basis by a continuous glucose monitor. The signal is transmitted wirelessly to a handheld device, which calculates the right amount of insulin for a given glucose level. The information on the insulin rate is then transmitted wirelessly to an insulin pump. Utilising our knowledge and results obtained during testing of overnight closed-loop insulin delivery, we will develop and test a prototype of closed-loop system for 24/7 closed-loop insulin delivery. The clinical work will start by testing a prototype closed-loop system in controlled laboratory settings. Children and adolescents are known to have larger swings in insulin need than adults and laboratory experience is required to establish the feasibility and safety of closed-loop particularly after meals, during exercise, and following missed meal boluses and unannounced meals. We will proceed to testing 24/7 closed-loop insulin delivery at home settings over 30 days and compare with treatment by the continuous subcutaneous insulin infusion. It is anticipated that our results will contribute to the creation of medical, social, and regulatory acceptance of closed-loop control and will pave the way for its commercial exploitation and a widespread use of 24/7 closed-loop system. PUBLIC HEALTH RELEVANCE: Treatment goals for subjects with type 1 diabetes are difficult to achieve due to an increased risk of hypoglycaemia associated with intensive insulin therapy. The overall objective of this project is to evaluate safety, efficacy, and utility of 24/7 closed-loop control with meal announcement in home settings in children and adolescents with type 1 diabetes. This will be preceded by evaluating 24/7 closed-loop control in compliant and non-compliant subjects in clinical research centre settings to collect data supporting regulatory submission for home testing.