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RECRUITING
NCT04749693

Observational Study of the Use of DBLG1 System in Real Life

Sponsor: Diabeloop

View on ClinicalTrials.gov

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

DEVICE

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