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Observational Study of the Use of DBLG1 System in Real Life
Sponsor: Diabeloop
Summary
This study will be conducted on human subjects and is observational, prospective and uncontrolled, defined as a category 3 according to the Jardé Law (RIPH3). It is a national and multicentric study. Enrolled patients are Type 1 Diabetes (T1D) patients who receive the DBLG1 System (CE marked medical device) to be treated. Patients have their regular visits with their own clinician. No change from their usual care must and will be done, including trainings and treatment. At the end of the study, patients will keep their system for their usual care and will continue having usual follow-up visits with their clinician. Data related to their glycemia, complications and quality of life will be collected for 1 year from the beginning of their treatment. A comparison with data collected during the 2 weeks of run-in period, prior to the activation of loop mode, is planned. In case the run-in phase lasts longer than 2 weeks, data collected from the two last weeks only will be kept for analysis and comparison. The study is completed when all patients have their "end of study" file completed in the electronic Case Report Form (eCRF).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
348
Start Date
2021-05-17
Completion Date
2026-01
Last Updated
2024-05-07
Healthy Volunteers
No
Conditions
Interventions
DBLG1 System
Use of DBLG1 System in real life condition
Locations (20)
Hôpital Avicenne APHP
Bobigny, France
Hôpital de la cavale blanche
Brest, France
CHU Caen
Caen, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France
CHU Bocage Central
Dijon, France
Hôpital Simone Veil
Eaubonne, France
CHU Grenoble
Grenoble, France
Groupe Hospitalier La Rochelle - Ré - Aunis
La Rochelle, France
CHU Lille
Lille, France
Diab-e-Care
Lyon, France
Hôpital Européen
Marseille, France
Hôpital la conception, pole ENDO
Marseille, France
hôpital Nord Laennec
Nantes, France
Lariboisière - Fernand Widal APHP
Paris, France
Hôpital Bichet Claude Bernard - APHP
Paris, France
Clinique Princess
Pau, France
CHU Reims
Reims, France
Hôpital Pontchaillou
Rennes, France
Hôpital civil de Strasbourg
Strasbourg, France
Hôpital de Rangueil
Toulouse, France