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

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.

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.

Interventions

• Device 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.

Primary outcome measures

• Rate of diabetic ketoacidosis (DKA). [Time frame: 12 months]
• Rate of severe hypoglycemia (SH) [Time frame: 12 months]

Secondary outcome measures (10)

• Time in Range 70-180 mg/dL (TIR) [Time frame: 12 months]
• Time above 180 mg/dL [Time frame: 12 months]
• Time above 250 mg/dL [Time frame: 12 months]
• Time less than 70 mg/dL [Time frame: 12 months]
• Time less than 54 mg/dL [Time frame: 12 months]
• Treatment Satisfaction [Time frame: 12 months]
• System Usability [Time frame: 12 months]
• Quality of Life Change [Time frame: 12 months]
• Fear of Hypoglycemic Events Change [Time frame: 12 months]
• Rate of use of the system [Time frame: 12 months]

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 :

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 21 centers

• CH Agen-Nérac — Agen
• CHU d'Angers — Angers
• CHU Lyon HFME — Bron
• Centre du Diabète - Diab-e-Care Hospices Civils de Lyon (HCL) — Lyon
• Hôpital Européen (APHM) — Marseille
• GHEF Meaux — Meaux
• CHR Metz-Thionville — Metz
• CHU de Montpellier — Montpellier
• … and 13 more centers

Identifiers

NCT: NCT07211126 · TP-0018999

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗