Real-World Study of Omnipod 5 Automated Insulin Delivery System Use in People Aged 2 Years and Older with Type 1 Diabetes in France

What this Trial Is About

Researchers are evaluating the Omnipod 5 Automated Insulin Delivery System in people with type 1 diabetes aged 2 years and older. This study aims to observe real-world use of the device over 12 months, focusing on blood sugar control, quality of life, patient satisfaction, and rates of acute diabetes complications. The study is non-interventional and prospective, involving multiple centers in France. Participants use the Omnipod 5 System, a tubeless automated insulin pump designed to deliver insulin under the skin and used with compatible continuous glucose monitors such as the FreeStyle Libre 2 Plus sensor. The study follows patients for 12 months after they start using the system in automated mode. During this time, researchers collect data on how well blood sugar levels are controlled and how participants use the device. Throughout the study, participants complete quality-of-life questionnaires and treatment satisfaction surveys at the start, 6 months, and 12 months. Data on glucose levels, insulin delivery, and diabetes complications are collected continuously during the 12-month period. Safety, device usage patterns, and reasons for stopping the system are also monitored. Participants remain under their usual medical care while contributing data to this observational study.

Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)