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

NCT ID: NCT07211126

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2027-12-31

Brief Summary

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.

Detailed Description

This post-market surveillance study is a single-arm, prospective cohort study. It is designed to:

1. 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).

2. Determine glycemic outcomes during real-world use of the Control-IQ System over 12 months post-initiation.

3. Demonstrate patient-reported satisfaction with the device, trust in the Control-IQ System, usability of the system, and improved quality of life.

4. Describe the real-world use of the Control-IQ System.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Control-IQ System

Participants will use the Control-IQ System as per standard of care.

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

Intervention Type: DEVICE

Participants enrolled in the study will start use of the t:slim X2 insulin pump with Control-IQ technology (Control-IQ System) with Dexcom G6 or Dexcom G7, and be followed for 12 months.

Interventions

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

Participants enrolled in the study will start use of the t:slim X2 insulin pump with Control-IQ technology (Control-IQ System) with Dexcom G6 or Dexcom G7, and be followed for 12 months.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tandem Diabetes Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Arthur Senigout

Role: CONTACT

record-iq@sanoia.com

+33 6 85 98 40 44

Other Identifiers

TP-0018999

Identifier Type: -

Identifier Source: org_study_id