One year day-and-night home closed loop in young people with type 1 diabetes

 描述(申请人提供)：我们之前的随机临床试验评估了120多名受试者在自由生活、无人监督的家庭环境下进行的闭环式胰岛素注射，研究持续1周至3个月(总闭环式操作81,120小时/3,380天/9.3年)。所有研究均采用剑桥模型预测控制算法。在短期到中期的研究中，我们证明了闭合循环胰岛素给药的安全性、有效性和可接受性。然而，长期的表现是未知的，特别是在年轻受试者中，考虑到其他方法未能改善结果，人们对此感兴趣。本项目解决了长期闭环使用的重要问题，并将应用安卓手机闭环系统，通过下一代胰岛素泵引导胰岛素输送。该系统将配置为在闭合环路因组件连接性有限等原因暂时无法运行的情况下防止低血糖。具体地说，我们将评估在自由生活、无人监督的家庭环境下，6至18岁患有1型糖尿病的儿童和青少年12个月24/7闭环的表现。我们将使用由640G泵和Enlite 3传感器(均为美敦力)和运行剑桥模型预测控制算法的Android手机组成的闭环系统。通过使用预测性低血糖管理，集成在640G泵上，以及即使在Android驱动的闭环未运行时，在预测低血糖时暂停胰岛素输送，系统的安全性将得到增强。总共有130名参与者将随机接受24/7全天候闭环或传感器强化胰岛素泵治疗(每组65名参与者)。这项研究将比较两种研究干预措施的生物医学、心理社会和成本效益。中心实验室测量的HbA1c将成为主要终点。生物医学结果(平均血糖、达到/高于/低于目标的时间以及其他相关的血糖/胰岛素指标)将辅之以对社会心理/人为因素问题的评估(焦点小组和问卷)和成本效用分析。该项目将提供信息，以促进Pivotl研究，从而获得监管批准、商业化和24/7全天候闭环控制的补偿。

 DESCRIPTION (provided by applicant): Our previous randomized clinical trials evaluated closed loop insulin delivery in over 120 subjects under FREE-LIVING UNSUPERVISED HOME settings in studies lasting 1 WEEK to 3 MONTHS (total closed loop operation 81,120 hours/3,380days/9.3 years). All studies used CAMBRIDGE model predictive control algorithm. We demonstrated the safety, efficacy, and acceptability of closed loop insulin delivery over short to medium long investigations. However, performance over prolonged period is unknown and is of interest particularly in young subjects given failure of other approaches to improve outcomes. The present project addresses the important question of LONG TERM closed loop use and will apply an Android-phone closed loop system directing insulin delivery by a next generation insulin pump. The system will be configured to protect against HYPOGLYCAEMIA in case of closed loop not being temporarily operational for reasons such as limited component connectivity. Specifically, we will evaluate the performance of 12 MONTH 24/7 CLOSED LOOP in CHILDREN AND ADOLESCENTS aged 6 to 18 years with type 1 diabetes under FREE-LIVING UNSUPERVISED HOME SETTINGS. We will use closed loop system comprising 640G PUMP and ENLITE 3 sensor (both Medtronic) and an Android phone running CAMBRIDGE MODEL PREDICTIVE CONTROL ALGORITHM. The system SAFETY will be ENHANCED by the use of predictive low glucose management, INTEGRATED on 640G pump, and suspending insulin delivery when hypoglycaemia is predicted even when Android-driven closed loop is not operating. In total, 130 PARTICIPANTS will be randomised to undergo either 24/7 closed loop or sensor augmented insulin pump therapy (65 participants in each group). The study will compare BIOMEDICAL, PSYCHOSOCIAL, and COST-EFFECTIVENESS of the two study interventions. HbA1c measured in central laboratory will be the primary endpoint. Biomedical outcomes (mean glucose, time in/above/below target and other related glucose/insulin metrics) will be complemented by assessments of psychosocial/human factors issues (focus groups and questionnaires) and cost utility analysis. The project will provide information to facilitate pivotl studies leading to REGULATORY APPROVAL, COMMERCIALISATION, AND REIMBURSEMENT of 24/7 closed-loop control.