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Clinical Trial Summary

Feasibility study, comparing experimental treatment (DBLHU closed-loop system) with reference treatment (Low Glucose Predictive Suspend system) in 7 patients going through a series of N-of-1 trials. Each N-of-1 trial consists in a prospectively planned, multiple crossover study in a single individual. Two blocks of two periods of four weeks each (closed loop or open loop) will be conducted. Within each block, the sequence closed loop-open loop or open loop-close loop is randomized. Outcomes will be analyzed on the third and fourth weeks of period. A remote monitoring system managed by specialized nurse on behalf of diabetologist, is provided in closed-loop session. An extension period of 48 weeks with the DBLHU System (closed-loop condition) will be performed at the end of the crossover study phase in real life conditions (without remote monitoring).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04042207
Study type Interventional
Source Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Contact
Status Completed
Phase N/A
Start date September 3, 2019
Completion date March 22, 2021

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