Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in France / NCT07211126
Recruiting Observational

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

NCT07211126 · tracked via the Priya Life Science France tracker
Sponsor
Tandem Diabetes Care, Inc
Phase
Observational
Started
2026-03-03
Last updated
2026-10-08

Condition(s) studied

Diabetes Mellitus, Type 1

Investigational drug(s) / intervention(s)

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

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.

Study 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Rate of diabetic ketoacidosis (DKA). — 12 months
    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.
  • Rate of severe hypoglycemia (SH) — 12 months
    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.

Trial sites (23)

FacilityCityRegionStatus
CH Agen-Nérac Agen France Recruiting
CHU d'Angers Angers France Recruiting
CHU Lyon HFME Bron France Recruiting
Centre du Diabète - Diab-e-Care Hospices Civils de Lyon (HCL) Lyon France Recruiting
Hôpital Européen (APHM) Marseille France Recruiting
GHEF Meaux Meaux France Recruiting
CHR Metz-Thionville Metz France Recruiting
CHU de Montpellier Montpellier France Recruiting
Clinique Saint Jean de Védas Montpellier France Recruiting
Hôpitaux Pédiatriques de Nice CHU Lenval Nice France Recruiting
CHU Nîmes Nîmes France Recruiting
Institut St-Pierre Palavas-les-Flots France Recruiting
Hôpital Lariboisière Paris France Recruiting
Hôpital St-Antoine (APHP) Paris France Recruiting
GH Paris Saint-Joseph Paris France Recruiting
Hôpital Européen Georges Pompidou (APHP) Paris France Recruiting
Hôpital Robert Debré Paris France Recruiting
CH de Périgueux Périgueux France Recruiting
MSP Les Belles Fleurs Saint-Cyr-sur-Loire France Recruiting
CHRU Strasbourg Strasbourg France Recruiting
Clinique Pasteur Toulouse Toulouse France Recruiting
CHU Toulouse Toulouse France Recruiting
CHU Tours Tours France Recruiting

Other trials for the same condition

A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE) Recruiting
Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop. Recruiting
Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension) Active, not recruiting
Impact of Dietary Intervention Within an Interprofessional Cooperative Protocol for Prandial Insulin Dose Adjustment in People Living With Type 1 Diabetes Starting soon
A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07211126 on ClinicalTrials.gov ↗ ← All trials in France