Clinical Research Directory
Browse clinical research sites, groups, and studies.
Impact of the Mylife CamAPS FX System With the DEXCOM G6 Sensor on T1D Patients in France
Sponsor: mylife Diabetes Care AG
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 (e.g., Boost/Ease-Off mode use, insulin-to-carbohydrate ratios, alarms). The study will involve approximately 125 participants (including 100 adults and 25 minors) across 20 centers in France. Endocrinologists / diabetes specialists will monitor participants over the 12-month period after they start using the system and collect data at the three data collection time points.
Official title: Impact de l'Utilisation du système Mylife CamAPS FX associé au Capteur DEXCOM G6 Sur le contrôle glycémique et la qualité de Vie de Patients DT1, en Vie réelle, en France
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
125
Start Date
2025-12-11
Completion Date
2027-12
Last Updated
2026-03-03
Healthy Volunteers
No
Conditions
Interventions
No Intervention: Observational Cohort
No intervention
Locations (20)
CHU Amiens
Amiens, France
Hôtel Dieu-Pédiatrie
Angers, France
CH Victor Dupouy
Argenteuil, France
Hôpital Bois Guillaume
Bois-Guillaume, France
CHU Brest - Hôpital La Cavale Blanche
Brest, France
Hôpital Femme Mère Enfant Lyon
Bron, France
CHU Grenoble Alpes
Grenoble, France
Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle, France
Hospices Civils de Lyon DIAB-Ecare
Lyon, France
Hôpital Européen
Marseille, France
Hôpital Europeen Georges Pompidou
Paris, France
Hôpital Universitaire Necker Enfants Malades
Paris, France
Groupe hospitalier Bichat Claude Bernard
Paris, France
CH Périgueux
Périgueux, France
CHU Poitiers
Poitiers, France
Hôpital NOVO, Site Pontoise
Pontoise, France
CHU Toulouse
Toulouse, France
CHRU Nancy-Hôpitaux de Brabois Adultes
Vandœuvre-lès-Nancy, France
CH Bretagne Atlantique
Vannes, France
Hôpital Robert Schuman-UNEOS
Vantoux, France