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RECRUITING
NCT07048795

Impact of the Mylife CamAPS FX System With the DEXCOM G6 Sensor on T1D Patients in France

Sponsor: mylife Diabetes Care AG

View on ClinicalTrials.gov

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

OTHER

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