Status:
RECRUITING
Observational Study of the Use of DBLG1 System in Real Life
Lead Sponsor:
Diabeloop
Conditions:
Type1diabetes
Eligibility:
All Genders
18+ years
Brief 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. ...
Detailed Description
The study is designed to address the specific requirements from National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) and to complete data obtained up to now, wi...
Eligibility Criteria
Inclusion
- patients with type 1 diabetes;
- patients who are at least 18 years old;
- patients total daily dose required must be less than 90 units (U);
- patients accepting to be treated with 100 U/mL rapid-acting insulin analog
- patients having a HbA1c ≥ 8% despite of the use of a pump for at least 6 months
- patients performing glucose self-monitoring several times ( ≥ 4) a day
- patient accepting the technology
- patients agreeing to use the system with activated loop mode during at least 75% of the
- total time of use, this will be analyzed after 1 year of use.
- patients must be affiliated to any kind of social security
Exclusion
- patients receiving a total daily dose of insulin lower than 8 U;
- patients suffering from a serious illness or having a treatment that might significantly impair diabetes physiology (iSGLT2, steroids, metformin), i.e. glucose-insulin interactions, that might interfere with the medical device (for example treatment by steroids with variable dosage during the study period);
- patients having severe uncorrected problems of hearing and/or visual acuity preventing proper use of DBLG1 System;
- patients unable to understand and perform all of the instructions regarding the devices and the clinical investigation provided by Diabeloop.
- patients planning to perform during the year of study repeated magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The G6 has not been tested in those situations. The magnetic fields and heat could damage the components of the Dexcom G6, which may cause it to display inaccurate sensor glucose readings (readings) or may prevent alerts. Without G6 readings or alarm/alert notifications, patients might be exposed to severe low or high glucose events;
- patients who are unwilling or unable to maintain contact with the healthcare professional;
- patients willing to use any insulin that is not 100 U/mL rapid-acting insulin analog with the system (for example regular insulin; long-acting insulin analog; 200 U/mL rapid-acting insulin analog)
Key Trial Info
Start Date :
May 17 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT04749693
Start Date
May 17 2021
End Date
January 1 2026
Last Update
May 7 2024
Active Locations (20)
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1
Hôpital Avicenne APHP
Bobigny, France, 93000
2
Hôpital de la cavale blanche
Brest, France, 29200
3
CHU Caen
Caen, France, 14000
4
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91100