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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Insulin delivery
Monitoring and measurement of physical activity
Calibrated meals for all patients and outstanding dinners for patients being in outstanding meals situation (Centers : Grenoble, Toulouse, Montpellier)
Hôpital Jean Minjoz
Besançon, France
Centre Hospitalier Universitaire
Caen, France
Centre Hospitalier Sud-Francilien
Corbeil-Essonnes, France
Centre Hospitalier Universitaire
Grenoble, France
Centre Hospitalier Universitaire
Marseille, France
Centre Hospitalier Universitaire
Montpellier, France
Centre Hospitalier Universitaire
Nancy, France
Centre Hospitalier Universitaire
Strasbourg, France
Centre Hospitalier Universitaire
Toulouse, France
Percentage of time spent in the tight glycemic control area 80-140 mg / dl during the night, continuously measured for 3 days with CGM
Time frame: during the night for 3 days for each period
Percentage of time spent in the area glycemic reference 70-180 mg / dl during the night measured continuously for 3 days with CGM
Time frame: during the night for 3 days for each period
Percentage of time spent in the glycemic range 70-180 mg / dl at d3 versus d1 during closed-loop period comparing with d3 versus d1 during open-loop period
Time frame: during 3 days for each period
Measurement of time spent in blood glucose <70 mg / dl and blood glucose > 180 mg / dl
Time frame: during 3 days for each period
Average blood glucose levels throughout the period and sub- periods: sedentarity, prandial and physical activity.
Time frame: during 3 days for each period
Calculated risks of hypo- and hyperglycemia ( LBGI , HBGI ) throughout the period and sub- periods: physical inactivity, prandial and physical activity
Time frame: during 3 days for each period
Measuring the oral carbohydrates intake
Time frame: during 3 days for each period
Number of hypoglycemic events , defined by any threshold crossing 70 mg / dL ( 3.9 mml / L) , and < 54 mg / dL ( 3 mmol / l ) measured by the CGM
Time frame: during 3 days for each period
Total supplies of insulin during tests (total unit of insulin)
Time frame: during 3 days for each period
Average peak postprandial glycemic according meals and delays occurred
Time frame: during 3 days for each period
Number of technical problems causing interruptions of the closed loop
Time frame: during 3 days for the closed loop period
Comparison of postprandial blood glucose sensor 2h , 3h and 4h and AUC in identical conditions of meals, to evaluate the efficacy and safety ( time spent in hypoglycemia, hyperglycemia and euglycemia )
Time frame: during 3 days for each period
Nadir glycemic means after physical activity and time of occurrence.
Time frame: during 3 days for each period
Measurement of AUC during physical activity , the two hours, then to lunch time , during dinner and throughout the night
Time frame: during 3 days for each period
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