About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- t:slim X2 insulin pump with Control-IQ technology (Control-IQ System)