Study of Safety and Use of Next-Generation Omnipod Automated Insulin Delivery Systems in People With Type 1 Diabetes Aged 2 to 70 Years

What this Trial Is About

Researchers are evaluating the safety and feasibility of new automated insulin delivery algorithms using the Omnipod devices in people with type 1 diabetes. This study aims to enroll up to 80 participants, including both adults and children aged 2 to 70 years, who have been diagnosed with type 1 diabetes for varying durations depending on age. The study includes both hotel and outpatient evaluation periods to assess glucose control in different settings. Participants will use the Omnipod M System and Omnipod S System, which are automated insulin delivery devices designed to help manage blood glucose levels. The study involves a 72-hour hotel period using the Omnipod M system and outpatient periods of 4 weeks with the Omnipod M and a final 3 weeks with the Omnipod S. These devices will be worn continuously throughout the study to monitor blood glucose and insulin delivery. During the study, participants will have their glucose levels monitored extensively, including measurements of time spent below and above specific glucose thresholds during both hotel and outpatient periods. Researchers will also assess mean glucose levels, insulin usage, and the incidence of severe hypoglycemia and diabetic ketoacidosis. Participants will be assessed for safety and device usability over the course of the study, which runs until early 2027.

Evaluating Glucose Control Using a Next-Generation AID Algorithm in Individuals With T1D