The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France
brief summary
This post-market surveillance study is primarily designed to demonstrate the ongoing safety of the Control-IQ system, the ongoing performance of glycemic control and quality of life with Control-IQ system use, and the rate of use of the Control-IQ system. The system will be assessed in all approved populations during the first 12 months of use.
detailed description
This post-market surveillance study is a single-arm, prospective cohort study. It is designed to:
1. Demonstrate, in the post-approval setting, the safety of the Control-IQ System for the management of type 1 diabetes by assessing the rate of severe metabolic complications (severe hypoglycemia and/or diabetic ketoacidosis). 2. Determine glycemic outcomes during real-world use of the Control-IQ System over 12 months post-initiation. 3. Demonstrate patient-reported satisfaction with the device, trust in the Control-IQ System, usability of the system, and improved quality of life. 4. Describe the real-world use of the Control-IQ System.