Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial

? DESCRIPTION (provided by applicant): Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial In 2009 we put forward the idea that the artificial pancreas (AP) is not a single-function all-in-one device but a network encompassing the patient in a digital treatment ecosystem that can offer different treatment modalities tailored to patient preferences and signal availability. We implemented this idea in the Diabetes Assistant - DiAs - the first AP smart phone suitable for everyday use. After extensive DiAs testing in the U.S. and Europe, we can confirm that reliable technology has been developed and sufficient data have been accumulated to warrant a large-scale study aiming to establish the AP as a clinically accepted treatment for type 1 diabetes. To do so, we propose a multi-center project involving research sites in Virginia, California, New York, Minnesota, Colorado, Florida, Italy, France and Holland, all with extensive AP track record. We will execute two trials: Study 1 - the International Diabetes Closed Loop Trial - will enroll 240 patients with type 1 diabetes to test the safety and efficacy of Control-to-Range (CTR) vs. Sensor-Augmented Pump (SAP). We hypothesize that: SA1: CTR, compared to SAP, will result in: (1) Improved HbA1c without increased incidence of hypoglycemia for those with HbA1c?7.5%; (2) Lower incidence of hypoglycemia without deterioration in HbA1c for those with HbA1c