The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6+
SponsorTandem Diabetes Care, Inc.

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)

Treatment groups

350 Participants
are divided into 1 treatment group

Sponsors and collaborators