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

Tandem Diabetes Care

Status

Not yet enrolling

Conditions

Diabetes Mellitus, Type 1

Treatments

Device: t:slim X2 insulin pump with Control-IQ technology (Control-IQ System)

Study type

Observational

Funder types

Industry

Identifiers

NCT07211126

TP-0018999

Details and patient eligibility

About

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.

Full 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.

Enrollment

350 estimated patients

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

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 :
1. use Control-IQ technology, and to continue use for at least 12 consecutive months after study enrollment.
2. 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.
3. 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.