MedTrace Logo

Observational Study of the Use of DBLG1 System in Real Life

NCT04749693 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 348

Last updated 2024-05-07

No results posted yet for this study

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).

Conditions

  • Type1diabetes

Interventions

DEVICE

DBLG1 System

Use of DBLG1 System in real life condition

Sponsors & Collaborators

  • Diabeloop

    lead INDUSTRY

Principal Investigators

  • Pauline Schaepelynck · APHM Hôpital Sud Sainte Marguerite

  • Lucy Chaillous · Nantes University Hospital

  • Hélène Hanaire · University Hospital, Toulouse

  • Sandrine Lablanche · University Hospital, Grenoble

  • Alfred Penfornis · CH Sud Francilien

  • Yves Reznik · CHU CAEN

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-17
Primary Completion
2025-07-31
Completion
2026-01-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04749693 on ClinicalTrials.gov