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

描述(由申请人提供)：该项目将在实验室和家庭环境中评估1型糖尿病儿童和青少年全天候闭环的表现。传统上，胰岛素的注射是根据Spot血糖仪测量的血糖水平进行的，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。这可以通过闭环式胰岛素输送来实现。血糖由连续的血糖监测仪每分钟测量一次。信号被无线传输到手持设备，该设备根据给定的血糖水平计算出合适的胰岛素含量。然后，关于胰岛素比率的信息被无线传输到胰岛素泵。利用我们在隔夜胰岛素闭环给药测试中获得的知识和结果，我们将开发和测试一种24/7闭环胰岛素给药系统的原型。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年人更大，需要实验室经验来确定闭环系统的可行性和安全性，特别是在饭后、运动期间、错过饭团和突如其来的饭后。我们将在30天内在家中测试全天候的闭环胰岛素输送，并与持续皮下注射胰岛素的治疗进行比较。预计我们的成果将有助于创建医疗、社会和监管机构对闭环系统控制的接受，并将为其商业开发和24/7全天候闭环系统的广泛使用铺平道路。 公共卫生相关性：1型糖尿病患者的治疗目标很难实现，因为强化胰岛素治疗会增加低血糖风险。该项目的总体目标是评估在家庭环境中对1型糖尿病儿童和青少年进行24/7全天候食物通告闭环控制的安全性、有效性和实用性。在此之前，将评估临床研究中心环境中符合和不符合的受试者的全天候闭环控制，以收集支持监管提交的家庭测试的数据。

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.