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

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 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.