Impact of the Mylife CamAPS FX System With the DEXCOM G6 Sensor on T1D Patients in France
Condition(s) studied
Investigational drug(s) / intervention(s)
No Intervention: Observational Cohort: No intervention
Study summary
This is a non-interventional, longitudinal, prospective, multicenter, post market-registration and national study conducted in France. The study is conducted among participants with type 1 diabetes (T1D) using the mylife CamAPS FX hybrid closed-loop insulin delivery system combined with the DEXCOM G6 Continuous Glucose Monitoring (CGM) sensor (the System).
The main objective of the study is to evaluate, under real-life conditions, the impact of the System on glycemic control in participants with T1D after one year of use.
Secondary objectives include assessing participant-reported outcomes, such as quality-of-life, treatment satisfaction, fear of hypoglycemia, and sleep quality, describing complications related to the system, the rate of hybrid closed-loop usage over one year, and analyzing system usage parameters.
The study will involve approximately 125 participants (including 100 adults and 25 minors) across 22 centers in France. Patients will be followed up for 12 months.
Eligibility
Primary outcome measure(s)
- Change in Time in Range (TIR) — Baseline and 3 months
Change in Time in Range (TIR, 70-180 mg/dL; for pregnant women: TIR, 63-140 mg/dL) (%)
Trial sites (22)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU Amiens | Amiens | France | Recruiting |
| Hôtel Dieu-Pédiatrie | Angers | France | Recruiting |
| CH Victor Dupouy | Argenteuil | France | Recruiting |
| Hôpital Bois Guillaume | Bois-Guillaume | France | Recruiting |
| CHU de Bordeaux | Bordeaux | France | Recruiting |
| CHU Brest - Hôpital La Cavale Blanche | Brest | France | Recruiting |
| Hôpital Femme Mère Enfant Lyon | Bron | France | Recruiting |
| CHU Grenoble Alpes | Grenoble | France | Recruiting |
| Groupe Hospitalier de la Rochelle Ré Aunis | La Rochelle | France | Recruiting |
| Hospices Civils de Lyon DIAB-Ecare | Lyon | France | Recruiting |
| Hôpital Européen | Marseille | France | Recruiting |
| Hôpital Europeen Georges Pompidou | Paris | France | Recruiting |
| Hôpital Universitaire Necker Enfants Malades | Paris | France | Recruiting |
| Groupe hospitalier Bichat Claude Bernard | Paris | France | Recruiting |
| CH Périgueux | Périgueux | France | Recruiting |
| CHU Poitiers | Poitiers | France | Recruiting |
| Hôpital NOVO, Site Pontoise | Pontoise | France | Recruiting |
| CHU Toulouse | Toulouse | France | Recruiting |
| Clinique Pasteur | Toulouse | France | Recruiting |
| CHRU Nancy-Hôpitaux de Brabois Adultes | Vandœuvre-lès-Nancy | France | Recruiting |
| CH Bretagne Atlantique | Vannes | France | Recruiting |
| Hôpital Robert Schuman-UNEOS | Vantoux | France | Recruiting |
Other trials for the same condition
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 NCT07048795 on ClinicalTrials.gov ↗ ← All trials in France