Diabetes Mellitus, Type 1 Clinical Trial
Official title:
DIABELOOP WP6.2 : Crossover Evaluation of Glycemic Control Provided for Three Days by the Artificial Pancreas Diabeloop Compared to Conventional Treatment by External Insulin Pump in Patients With Type 1 Diabetes in Sedentary Position, Outstanding Meals and Physical Activity .
The study will be conducted in crossover trial, with two 72-hour hospitalization separated
by a period Wash-out of at least one week. Each hospitalization is a period of treatment.
According to randomization, patients will be provided with either Diabeloop system or the
usual system.
In both treatment periods:
- patients in a situation of sedentarity or physical activity, will be equipped with
ActiGraph (measuring motricity) and a ActiHeart ( measuring heart rate)
- meals and physical activities will be similar in both periods
- the same blood glucose meter will be used throughout the duration of the study.
- the capillary blood glucose will be performed : before bolus and 2 hours after a meal,
before exercise, in case of hypo or hyper-glycemic episodes and when the patient and /
or investigator deem it necessary.
n/a
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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