Translation of the UVA Advanced Automated Insulin Delivery Systems to Clinical Care in Young Children: Glycemic Control, Regulatory Acceptance and Optimization of Day to Day Use

UVA 先进自动胰岛素输送系统在幼儿临床护理中的应用：血糖控制、监管接受和日常使用优化

基本信息

批准号：
10474818
负责人：
MARC D BRETON
金额：
$ 1.94万
依托单位：
UNIVERSITY OF VIRGINIA
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-01 至 2023-06-30
项目状态：
已结题

项目摘要

In 2011 we put forward the idea that Artificial Pancreas (AP) systems is a digital treatment ecosystem that can offer different treatment modalities tailored to patient/families' preferences and signal availability. After extensive testing around the world, our CLC algorithm and AP components were implemented in commercial systems (Dexcom, formerly TypeZero, InControl and Tandem t:slim X2 with ControlIQ) available to patients since the end of 2019 following more than 30 clinical trials and 1.2 million hours of use. We propose now, in collaboration with Tandem Diabetes Care and Dexcom, to introduce the next generation of algorithm technology insulin pump, and continuous glucose sensors. Making the system smaller, easy to use, and with a user interface perfectly suitable for children 2-6 years old and their parents/caregivers. At this point we can confirm that reliable technology has been developed and sufficient data have been accumulated to warrant a large-scale study aiming to establish this new state-of-the-art technology as a clinically accepted treatment for children (2-6 years old) with type 1 diabetes (T1D) and their families. We propose a large-scale multi-center clinical trial at 3 research sites around the United States that will enroll 102 2-6 years old children with T1D and at least 1 of their parents/caregivers, to use the system for 3 months in a 2:1 randomized, control parallel study comparing AP vs. Standard of Care (SoC). In addition, the study will conclude with a 3-month extension in which the SoC group will transition to use AP and the experimental group will continue with more relaxing follow up visits. All study sites are pediatric centers with extensive expertise in clinical trials in children and AP track record. We will show: (1) that glycemic control achieved by CLC will be superior to SoC therapy in terms of: (i) Reduced incidence of hypoglycemia without deterioration in HbA1c; (ii) Improved time within the target ranges of 70-180 mg/dl during the day and 70-140 mg/dl overnight; (iii) Improved HbA1c without increased risk of hypoglycemia, notably for those with HbA1c 7.5% at the baseline, and (iv) Reduced extreme glycemic events below 54 mg/dl and above 300 mg/dl, and fewer episodes of severe hypoglycemia, episodes of DKA, or other serious adverse events. (2) and that use of AP with real-time monitoring and cloud features will reduce diabetes distress and will result in: (i) Reduced fear of hypoglycemia, in both parent and child and better quality of life among parents/caregivers and children as compared to SoC; (ii) System acceptance and positive evaluation of the AP user interface and of the real-time remote monitoring/automated notification system; the latter will be particularly useful for parents when children are at pre-school/day care, and (iii) System reliability and usability meeting regulatory acceptance criteria. We therefore expect to test and validate an AP system that includes interacting Local (AP, near the child) and Global (Cloud/Real-time remote monitoring, available to parents) components, which in concert provide both optimal glucose control for 2-6 years old children with type 1 diabetes and peace of mind for their families.

在2011年，我们提出了人工胰腺（AP）系统是一个数字处理生态系统的想法提供针对患者/家庭的偏好和信号可用性量身定制的不同治疗方式。大量之后在世界各地测试，我们的CLC算法和AP组件在商业系统中实施（dexcom，以前是typezero，Incontrol和Tandem t：带有控制性的Slim X2）以来可用于患者。在30多次临床试验和120万小时的使用之后，2019年的使用。我们现在建议与串联糖尿病护理和Dexcom，介绍下一代算法技术胰岛素泵，以及连续的葡萄糖传感器。使系统较小，易于使用，并且使用用户界面非常合适适用于2-6岁的儿童及其父母/照顾者。在这一点上，我们可以确认可靠的技术已经已开发并积累了足够的数据，以保证一项旨在建立的大规模研究这项新的最先进技术是针对1型儿童（2-6岁）的临床接受治疗糖尿病（T1D）及其家人。我们在3个研究地点提出了一项大规模的多中心临床试验美国将注册102个2-6岁的T1D儿童，至少有1名父母/照顾者，在2：1随机，控制平行研究中使用该系统3个月，比较AP与护理标准（SOC）。此外，该研究将以3个月的扩展为结束，SOC组将过渡到使用 AP和实验组将继续进行更多放松的后续访问。所有研究地点都是小儿在儿童临床试验和AP往绩记录中具有广泛专业知识的中心。我们将显示：（1）CLC实现的血糖控制将优于SOC治疗：（i）降低的发病率 HBA1C中没有恶化的低血糖；（ii）在目标范围内提高了70-180 mg/dl的时间。一天和70-140 mg/dl隔夜；（iii）改善了HBA1C而没有增加血糖风险，尤其是基线时HBA1C 7.5％的人，（iv）极端血糖事件降低到54 mg/dl及以上 300 mg/dl，严重低血糖，DKA发作或其他严重的不良事件的发作更少。（2）使用AP与实时监控和云功能的使用将减少糖尿病的困扰，并将导致在以下和儿童与SOC相比；（ii）AP用户界面的系统接受和正面评估实时远程监视/自动通知系统的；后者对父母特别有用当孩子在学前/日托和（iii）系统可靠性和可用性会议时标准。因此，我们期望测试和验证包括本地互动（AP，附近）和全球（云/实时远程监视，可用于父母）组件，共同提供两者 2-6岁的1型糖尿病儿童的最佳葡萄糖控制，并为家人安心。