Home Use of MD-Logic Automated Insulin Delivery System: Safety and Efficacy

MD-Logic 自动胰岛素输送系统的家庭使用：安全性和有效性

基本信息

批准号：
9055076
负责人：
Richard Mauritz Bergenstal
金额：
$ 199.17万
依托单位：
HEALTHPARTNERS INSTITUTE
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 2020-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9055076
关键词：
Address Adolescent Adult Adverse event Age Artificial Pancreas Behavior Blood Glucose Camping Caregivers Child Clinical Trials Data Monitoring Committees Computer software Data Device Approval Devices Diabetes Mellitus Diabetic Ketoacidosis Environment Europe Evaluation Exercise Fright Fuzzy Logic Germany Glucose Glycosylated hemoglobin A Goals Home environment Hour Hybrids Hyperglycemia Hypoglycemia Inpatients Insulin Insulin Infusion Systems Insulin-Dependent Diabetes Mellitus Israel Life Logic Measures Medical center Monitor Nutritional Outcome Pathway interactions Patients Pediatrics Performance Phase Protocols documentation Publishing Pump Quality of life Randomized Randomized Clinical Trials Reading Research Research Design Research Project Grants Risk Safety Slovenia Solutions Specific qualifier value Study Subject System Technology Testing Time United States United States Food and Drug Administration Youth age group aged arm base blood glucose regulation burden of illness clinical research site commercialization design diabetes management follow-up glucose monitor glucose sensor glycemic control improved innovation innovative technologies instrument learning ability meetings novel personalized medicine phase 3 study primary outcome public health relevance randomized trial safety testing satisfaction sensor theories treatment duration user-friendly

项目摘要

DESCRIPTION (provided by applicant): The purpose of this project, called MD2Go, is to address the challenge of testing an artificial pancreas (AP) system to develop a commercially available automated insulin-delivery solution for people living with type 1 diabetes (T1D). The MD-Logic Automated Insulin Delivery (MD-Logic) system, developed by the Diabetes Technology Center, Schneider Children's Medical Center of Israel, is an AP system that establishes glucose control by applying fuzzy logic theory to imitate lines of reasoning of diabetes caregivers. This system provides a personalized treatment approach with real-time learning ability that effectively tracks the unpredictable behavior of glucose-insulin dynamics and adjusts insulin accordingly. The MD-Logic system has been studied in a multicenter consortium in Slovenia, Germany, and Israel. It has been used in increasingly challenging settings, including overnight in an inpatient setting, a diabetes camp setting, and in the home overnight. Recently, the system was tested at home for 24 hours a day, 7 days a week (24/7); over the weekend (60 hours); and for 2 weeks. These preliminary studies demonstrate the feasibility, safety, and efficacy of MD-Logic compared with a sensor-augmented pump (SAP) system under different conditions. The software for controlling glucose levels has received a CE Mark in Europe, making it the first AP software to receive regulatory approval in the world. Commercialization will be adequately advanced only with a study designed to yield U.S. Food and drug Administration (FDA) approvable outcomes. The MD2Go study protocol is designed so that, if the hypotheses are correct, the findings will directly advance AP technology toward commercialization. Our 3-phase study incorporates FDA guidance acquired from prior pre-submission meetings with innovative technology, excellent clinical sites, and a top coordinating center. Phase 1 includes pilot testing of MD-Logic in adults to assess safety and reliability during supervised, monitored exercise and nutritional challenges with concurrent confirmation of continuous glucose monitor accuracy with Yellow Springs Instrument (YSI) equivalent comparisons. Then the pilot subjects will continue use 24/7 as a hybrid closed-loop system for 3 months. With approval from a Data Safety and Monitoring Board, the identical pilot testing will be repeated in subjects age 12 to 21 years (the FDA's recommended formal and strict definition of pediatrics). Phase 2 will be a large- scale, multicenter, multinational phase III randomized clinical trial of MD-Logic compared with SAP in 240 youth aged 12 to 21. The primary outcomes are efficacy, defined as the percentage of blood glucose sensor readings in the target range of 70-180 mg/dL, safety defined as the percentage of blood glucose sensor readings below 70 mg/dL, and a secondary efficacy outcome of change in HbA1c over 6 months of continued hybrid closed-loop use. Phase 3 is a proof-of-concept study for MD-Logic's use as a full closed-loop system in adults. In its entirety, this cutting-edge research project has potential to become a major milestone on the pathway to commercialization of a full closed-loop solution for 24/7 treatment in patients with T1D.

描述（由申请人提供）：该项目的目的称为MD2GO，是针对测试睾丸palcress（AP）TEM的挑战，以开发针对1型糖尿病患者（T1D）的MD患者的市售自动化胰岛素 - 溶解解决方案 - 糖尿病技术中心开发的遗传自动胰岛素输送（MD逻辑）系统是一种AP系统，通过添加Fuzy Logic理论来模仿糖尿病护理的推理，通过添加Fuzy Logic理论来建立葡萄糖控制。抬起能力，可以有效地跟踪Unun-Prable的行为相应地调整胰岛素。每天24个小时，每周7天（60个小时）；与在不同条件下的传感器增强泵（SAP）系统相比控制水平在欧洲获得了CE标记，这是第一个在世界范围内获得监管批准的商品，只有AS研究Desield Desield美国食品和药物管理局（FDA），如果这些假设是正确的。，调查结果将直接推进AP技术的商业化。黄色弹簧仪器（YSI）等效比较。 FDA'SRMED对儿科的正式和严格的定义），MD逻辑的跨国公司III期随机临床试验与240名12至21岁的SAP相比在70-180 mg/dL的目标范围内，由于血糖传感器读数的百分比低于70 mg/dl，并且在6个月内使用HBA1C的二次疗效结果成年人。