The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France
RECORD-IQ
1 other identifier
observational
350
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2026
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2025
CompletedFirst Posted
Study publicly available on registry
October 7, 2025
CompletedStudy Start
First participant enrolled
March 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
May 1, 2026
April 1, 2026
1.7 years
September 29, 2025
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of diabetic ketoacidosis (DKA).
The incidence rate of diabetic ketoacidosis (DKA) will be calculated by dividing the total number of events observed in the entire cohort over the 12-month follow-up period. Results will be expressed as the number of events per 100 patient-years.
12 months
Rate of severe hypoglycemia (SH)
The incidence rate of severe hypoglycemia (SH) will be calculated by dividing the total number of events observed in the entire cohort over the 12-month follow-up period. Results will be expressed as the number of events per 100 patient-years.
12 months
Secondary Outcomes (10)
Time in Range 70-180 mg/dL (TIR)
12 months
Time above 180 mg/dL
12 months
Time above 250 mg/dL
12 months
Time less than 70 mg/dL
12 months
Time less than 54 mg/dL
12 months
- +5 more secondary outcomes
Study Arms (1)
Control-IQ System
Participants will use the Control-IQ System as per standard of care.
Interventions
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.
Eligibility Criteria
All individuals with Type 1 Diabetes age 6+, who start therapy with the t:slim X2 insulin pump with Control-IQ technology (Control-IQ System) with a Dexcom G6 or Dexcom G7 and meet eligibility criteria.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
CH Agen-Nérac
Agen, 47923, France
CHU d'Angers
Angers, 49100, France
CHU Lyon HFME
Bron, 69677, France
Centre du Diabète - Diab-e-Care Hospices Civils de Lyon (HCL)
Lyon, 69003, France
Hôpital Européen (APHM)
Marseille, 13003, France
GHEF Meaux
Meaux, 77100, France
CHR Metz-Thionville
Metz, 57000, France
CHU de Montpellier
Montpellier, 34090, France
Clinique Saint Jean de Védas
Montpellier, 34430, France
CHU Nîmes
Nîmes, 30029, France
Institut St-Pierre
Palavas-les-Flots, 34250, France
Hôpital Lariboisière
Paris, 75010, France
Hôpital St-Antoine (APHP)
Paris, 75012, France
GH Paris Saint-Joseph
Paris, 75014, France
Hôpital Européen Georges Pompidou (APHP)
Paris, 75015, France
Hôpital Robert Debré
Paris, 75019, France
CH de Périgueux
Périgueux, 24000, France
MSP Les Belles Fleurs
Saint-Cyr-sur-Loire, 37540, France
Clinique Pasteur Toulouse
Toulouse, 31300, France
CHU Toulouse
Toulouse, 31403, France
CHU Tours
Tours, 37000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Pierre Riveline, MD, PhD
Centre Universitaire du diabète et de ses complications, APHP, Hôpital Lariboisière, Paris, France
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2025
First Posted
October 7, 2025
Study Start
March 3, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share