Diabeloop WP6.2 : Crossover Evaluation of Glycemic Control

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.

Inclusion Criteria:

• Type 1 diabetic patient for at least one year, treated by external insulin pump for at least 6 months
• Patient with 7.5 % < HbA1c < 9.5 %
• Patient practicing functional insulin therapy
• In the situation of physical activity , the patient must be able to perform one or more daily physical activities for 3 days in each treatment session
• Patient aged over 18 years
• Patient affiliated to Social Security
• Patient who agreed to participate in the study and who signed an informed consent

Exclusion Criteria:

• Type 2 diabetic patients
• Any serious illness that may impair study participation*
• Patient with insulin resistance defined in insulin requirements > 1.5 U / kg / day
• Patient no longer sensing his hypoglycemia
• Patient enjoying a measure of legal protection
• Pregnant woman or likely to be