Overview
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.
Description
This post-market surveillance study is a single-arm, prospective cohort study. It is designed to:
- 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).
- Determine glycemic outcomes during real-world use of the Control-IQ System over 12 months post-initiation.
- Demonstrate patient-reported satisfaction with the device, trust in the Control-IQ System, usability of the system, and improved quality of life.
- Describe the real-world use of the Control-IQ System.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- A medical or other condition, or medications being taken that, in the investigator's judgement would be a safety concern for participation in the study.
- Patients considered vulnerable under French law.
