Diabetes Mellitus, Type 1 Clinical Trial
Official title:
An Open-label, Three-center, Randomized, Two-session, Crossover Study, to Assess 4 Days Inpatient, and 6-week Follow-up Home Study Phase Under Remote Monitoring at Only French Centers, the Efficacy and the Safety of the Diabeloop Closed-loop Glucose Control Compared With Sensor-augmented Pump Therapy, in Young Children With Type 1 Diabetes.
An open-label, three-center, randomized, two-session, 4 days inpatient and 6-week follow-up
home study phase, crossover study comparing Diabeloop closed-loop (CL) system and
sensor-augmented pump (SAP) therapy.
The follow-up home study phase will be done only in French centers for a sub study. During
this session, patient wearing the closed-loop system will benefit of a 24h/24, 7 d/7, remote
monitoring follow-up by specialized nurses, under supervision of a diabetologist. A
visualization of glucose CGM curves, insulin delivery, meal and physical activity
announcements will be available online through secured website, and the system will send
automated message in case of predetermined situations as persistent too high or too low Blood
Glucose (BG). Custom settings will be possible by the nurses during the follow-up period.
n/a
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