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

1型糖尿病青少年一年昼夜居家闭环

基本信息

批准号：
9053630
负责人：
BRUCE A BUCKINGHAM
金额：
$ 634.49万
依托单位：
UNIVERSITY OF CAMBRIDGE
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-09-30 至 2021-08-31
项目状态：
已结题

项目摘要

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.

描述（由申请人提供）：我们之前的随机临床试验在持续1周至3个月的研究中，在120多名受试者的自由生活无监督家庭环境中评价了闭环胰岛素输注（总闭环操作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。我们通过短期至中长期研究证明了闭环胰岛素输注的安全性、有效性和可接受性。然而，长期的性能是未知的，特别是在年轻受试者中，考虑到其他方法无法改善结局，这是值得关注的。本项目解决了长期闭环使用的重要问题，并将应用Android手机闭环系统，通过下一代胰岛素泵指导胰岛素输注。系统将被配置为在闭环因组件连接受限等原因暂时无法运行的情况下防止低血糖。具体而言，我们将评估12个月24/7闭环治疗在自由生活无监督家庭环境下6至18岁1型糖尿病儿童和青少年中的性能。我们将使用闭环系统，包括640 G传感器和ENLITE 3传感器（均为Medtronic）以及运行剑桥模型预测控制算法的Android手机。系统安全性将通过使用预测性低血糖管理、集成在640 G胰岛素泵上以及在预测低血糖时暂停胰岛素输注（即使Android驱动的闭环未运行）来增强。总共有130名受试者将随机接受24/7闭环或传感器增强胰岛素泵治疗（每组65名受试者）。本研究将比较两种研究干预措施的生物医学、心理社会和成本承受能力。中心实验室测量的HbA 1c将作为主要终点。生物医学结局（平均血糖、达到/高于/低于目标的时间和其他相关血糖/胰岛素指标）将通过社会心理/人为因素问题（焦点小组和问卷）评估和成本效用分析进行补充。该项目将提供信息，以促进24/7闭环控制的监管批准、商业化和补偿的可行性研究。