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估24/7闭环在1型糖尿病儿童和青少年中的表现。传统上，胰岛素是根据血糖水平注射的，每天最多注射六次。然而，胰岛素需要更精确的滴定，以达到接近正常的血糖水平，并降低低血糖水平的风险。这可以通过胰岛素闭环输送来实现。葡萄糖是用连续血糖监测仪每分钟测量一次。信号被无线传输到一个手持设备，该设备计算给定葡萄糖水平下合适的胰岛素量。然后，胰岛素率的信息通过无线传输到胰岛素泵。利用我们的知识和在夜间胰岛素闭环递送测试中获得的结果，我们将开发和测试一个24/7闭环胰岛素递送闭环系统的原型。临床工作将首先在受控的实验室环境中测试一个原型闭环系统。众所周知，儿童和青少年的胰岛素需求比成人有更大的波动，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、错过餐后和未通知的用餐后。我们将继续测试在30天的家庭环境中24/7闭环胰岛素输注，并与持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医学、社会和监管机构接受闭环控制，并为其商业开发和24/7闭环系统的广泛使用铺平道路。

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.