Clinical trials of a closed-loop control system for type 1 diabetes management

1 型糖尿病管理闭环控制系统的临床试验

• 批准号: 8326110
• 负责人: EDWARD DAMIANO
• 金额: $ 136.58万
• 依托单位: BOSTON UNIVERSITY (CHARLES RIVER CAMPUS)
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8326110
• 关键词: 18 year old; Adult; Algorithms; Anus; Back; Bicycling; Blood Glucose; Blood capillaries; Blood specimen; Bolus Infusion; Carbohydrates; Caring; Clinical Research; Clinical Trials; Companions; Data; Devices; Diabetes Mellitus; Dose; Eating; Effectiveness; Engineering; Exercise; Family suidae; Frequencies; General Hospitals; Glucagon; Glucose; Goals; Health; Hospitals; Hour; Human; Infusion Pumps; Infusion procedures; Insulin; Insulin Infusion Systems; Insulin-Dependent Diabetes Mellitus; Intercellular Fluid; International; Left; Link; Massachusetts; Measures; Monitor; Nurses; Patients; Persons; Pharmaceutical Preparations; Plasma; Protocols documentation; Pump; Randomized; Reading; Running; Schedule; Signal Transduction; Stream; Structure; System; Testing; Therapeutic; Time; Venous; base; blood glucose regulation; capillary; computer program; design; diabetes management; diabetic; feeding; glucose monitor; human subject; laptop; meetings; pre-clinical; prevent; research study; response; safety testing; sensor; subcutaneous; volunteer

The ultimate embodiment of an extracorporeal closed-loop blood-glucose control system will be a portable de- vice consisting of three components: a continuous glucose monitor (CGM), a continuous subcutaneous (SC) drug infusion device (e.g. an insulin pump), and a control algorithm. The control algorithm links the other two com- ponents by receiving the glucose data stream from the CGM, making a therapeutic decision based on that data stream, and issuing commands to the drug infusion device. We have designed and tested closed-loop control systems that safely and effectively regulate blood-glucose (BG) levels based on either a venous BG data stream (in diabetic pigs and in people with type 1 diabetes) or a CGM data stream (in diabetic pigs). We have further tested our CGM-based closed-loop control system in diabetic pigs using both an insulin-only configuration and a bihormonal (insulin and glucagon) configuration. Based on our positive preclinical results, we hypothesize that our CGM-based closed-loop glucose-control system can provide safe and effective BG control in people with type 1 diabetes. Our objective is to test this hypothesis and optimize our closed-loop system by conducting human trials in the Mallinckrodt Clinical Research Center at the Massachusetts General Hospital on healthy adult vol- unteers (18 years and older) with type 1 diabetes. We propose to achieve this objective with the following three specific aims: (1) to test the safety and efficacy of our control system (in both the bihormonal and insulin-only configurations) in regulating BG in adults with type 1 diabetes based on interstitial-fluid (ISF) glucose data from a CGM, (2) to repeat the study of Aim 1 using the same control system with the addition of periods of structured exercise in the study protocol, and (3) to conduct 5-day continuous closed-loop in-patient studies using a fully integrated PDA-based portable control system in adults with type 1 diabetes.

体外循环血糖控制系统的最终体现将是一种便携式降糖装置。 由三部分组成：连续血糖监测仪(CGM)、连续皮下给药(SC) 输液装置(例如胰岛素泵)和控制算法。控制算法将另外两个串口连接起来。 通过接收来自CGM的血糖数据流，根据该数据做出治疗决定 流，并向药物输注装置发出命令。我们已经设计并测试了闭环控制。 基于静脉血糖数据流安全而有效地调节血糖(BG)水平的系统 (在糖尿病猪和1型糖尿病患者中)或CGM数据流(在糖尿病猪中)。我们还有更多 在糖尿病猪身上测试了我们基于CGM的闭环控制系统，使用了仅使用胰岛素的配置和 一种双激素(胰岛素和胰升糖素)的配置。基于我们积极的临床前研究结果，我们假设 我们基于CGM的闭环血糖控制系统可以为类风湿性心脏病患者提供安全有效的血糖控制 糖尿病1例。我们的目标是测试这一假设，并通过引导人类来优化我们的闭环系统 在马萨诸塞州总医院的Mallinckrodt临床研究中心进行的关于健康成人的试验 1型糖尿病患者(18岁及以上)。我们建议通过以下三个方面来实现这一目标 具体目标：(1)测试我们的控制系统的安全性和有效性(在双激素和仅使用胰岛素的情况下 配置)在成人1型糖尿病患者中调节BG，基于来自 CGM，(2)重复目标1的研究，使用相同的控制系统，增加结构化的周期 在研究方案中进行练习，以及(3)进行为期5天的连续闭环住院研究 成人1型糖尿病患者的基于PDA的集成便携式控制系统。