Clinical trial NCT02627911: Diabeloop WP6.2 : Crossover Evaluation of Glycemic Control
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 .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Closed Loop
Diabetes Mellitus, Type 1
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of time spent in the tight glycemic control area 80-140 mg / dl during the night, continuously measured for 3 days with CGM
timeFrame: during the night for 3 days for each period
Secondary outcomes:
measure: Percentage of time spent in the area glycemic reference 70-180 mg / dl during the night measured continuously for 3 days with CGM
timeFrame: during the night for 3 days for each period
measure: 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
timeFrame: during 3 days for each period
measure: Measurement of time spent in blood glucose <70 mg / dl and blood glucose > 180 mg / dl
timeFrame: during 3 days for each period
measure: Average blood glucose levels throughout the period and sub- periods: sedentarity, prandial and physical activity.
timeFrame: during 3 days for each period
measure: Calculated risks of hypo- and hyperglycemia ( LBGI , HBGI ) throughout the period and sub- periods: physical inactivity, prandial and physical activity
timeFrame: during 3 days for each period
measure: Measuring the oral carbohydrates intake
timeFrame: during 3 days for each period
measure: 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
timeFrame: during 3 days for each period
measure: Total supplies of insulin during tests (total unit of insulin)
timeFrame: during 3 days for each period
measure: Average peak postprandial glycemic according meals and delays occurred
timeFrame: during 3 days for each period
measure: Number of technical problems causing interruptions of the closed loop
timeFrame: during 3 days for the closed loop period
measure: 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 )
timeFrame: during 3 days for each period
measure: Nadir glycemic means after physical activity and time of occurrence.
timeFrame: during 3 days for each period
measure: Measurement of AUC during physical activity , the two hours, then to lunch time , during dinner and throughout the night
timeFrame: during 3 days for each period
Other outcomes:
Locations:
city: Besançon
country: France
facility: Hôpital Jean Minjoz
city: Caen
country: France
facility: Centre Hospitalier Universitaire
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud-Francilien
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire
city: Marseille
country: France
facility: Centre Hospitalier Universitaire
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire
city: Nancy
country: France
facility: Centre Hospitalier Universitaire
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire
Study officials:
References: