RecruitingNCT04749693

Observational Study of the Use of DBLG1 System in Real Life


Sponsor

Diabeloop

Enrollment

348 participants

Start Date

May 17, 2021

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study observes how well the DBLG1 closed-loop insulin pump system (an "artificial pancreas" device that automatically adjusts insulin based on continuous glucose readings) performs in real-life use among people with type 1 diabetes whose blood sugar is not well controlled. **You may be eligible if...** - You have type 1 diabetes - You are 18 or older - Your daily insulin requirement is under 90 units - Your HbA1c is 8% or higher despite using an insulin pump for at least 6 months - You check your blood sugar at least 4 times per day - You are willing to use the DBLG1 system with the automated loop mode activated **You may NOT be eligible if...** - Your daily insulin dose exceeds 90 units - You do not use a compatible rapid-acting insulin (100 U/mL) - You are unable or unwilling to self-monitor blood glucose frequently - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDBLG1 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

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NCT04749693


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