The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France
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.
• Clinician-confirmed type 1 diabetes and for whom the site has initiated the t:slim X2 insulin pump with Control-IQ technology (Control-IQ System) with a Dexcom G6 or G7 CGM sensor.
• Age ≥ 6 years at enrollment.
• Using an insulin approved for use in the pump.
• Ability for patient or parent/guardian to respond to alerts and alarms, and to provide basic diabetes self-management.
• Reside full-time in mainland France.
• Have an email address and mobile phone number
• Participant or participant's parent/guardian has read and understood the information notice and has agreed to participate in the study. This includes agreeing to :
‣ use Control-IQ technology, and to continue use for at least 12 consecutive months after study enrollment.
⁃ the reuse of their clinical data including HbA1c results, obtained at most 4 months prior to enrollment, and as available according to the standard of care during the next 12 months.
⁃ complete questionnaires per the study protocol.