Diabetes Mellitus, Type 1 Clinical Trial
Official title:
Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop for Three Months at Home in Comparison With Conventional Treatment by External Insulin Pump in Patients With Type 1 Diabetes.
The study will be conducted in crossover trial, with two 12-weeks periods separated by a
Wash-out period of at least one month. According to randomization ,patients will be provided
with either Diabeloop system or the usual system.
Patients will be trained for the use of blood glucose meter, of external Insulin Pump and
Diabeloop system.
In both treatment periods, the same blood glucose meter will be used throughout the duration
of the study.
In two centers (Centre Hospitalier Sud-Francilien and Grenoble), a pre-study will be
performed during four weeks to improve the efficacy of Diabeloop system with data collection,
to test the manual settings by health care providers and patients and to check the
good-working of the follow-up platform.
n/a
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