Closed Loop, Diabetes Mellitus, Type 1
Conditions
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.
Interventions
DEVICEDiabeloop System
Insulin delivery
DEVICEContinuous Glucose Monitoring
DEVICEAccelerometer and heart rate monitor
Monitoring and measurement of physical activity
DIETARY_SUPPLEMENTMeals
Calibrated meals for all patients and outstanding dinners for patients being in outstanding meals situation (Centers : Grenoble, Toulouse, Montpellier)
Sponsors
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of time spent in the tight glycemic control area 80-140 mg / dl during the night, continuously measured for 3 days with CGM | during the night for 3 days for each period |
Secondary
| Measure | Time frame |
|---|---|
| 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 | during 3 days for each period |
| Measurement of time spent in blood glucose <70 mg / dl and blood glucose > 180 mg / dl | during 3 days for each period |
| Average blood glucose levels throughout the period and sub- periods: sedentarity, prandial and physical activity. | 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 | during 3 days for each period |
| Measuring the oral carbohydrates intake | 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 | during 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 | during the night for 3 days for each period |
| Average peak postprandial glycemic according meals and delays occurred | during 3 days for each period |
| Number of technical problems causing interruptions of the closed loop | 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 ) | during 3 days for each period |
| Nadir glycemic means after physical activity and time of occurrence. | 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 | during 3 days for each period |
| Total supplies of insulin during tests (total unit of insulin) | during 3 days for each period |
Countries
France
Outcome results
None listed