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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual System (open-loop) | Other | In open loop, the patient will be provided with its usual pump and a CGM. To estimate rest and physical activity in patients being sedentary situation ( Centers : Caen, Nancy & Strasbourg) or in situations of physical activity ( Centers : CHSF Marseille and Besancon ) , the usual system will be complemented by an accelerometer " ActiGraph " and a " ActiHeart " heart rate monitor. |
|
| DIABELOOP System (closed-loop) | Experimental | In the closed loop, the patient's pump will be replaced by the Diabeloop system consisting of insulin pump Cellnovo driven by remote control augmented by Diabeloop software and connected to the CGM. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabeloop System | Device | Insulin delivery |
| |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Jean Minjoz | Besançon | 25030 | France | |||
| Centre Hospitalier Universitaire |
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| Continuous Glucose Monitoring |
| Device |
|
| Accelerometer and heart rate monitor | Device | Monitoring and measurement of physical activity |
|
| Meals | Dietary Supplement | Calibrated meals for all patients and outstanding dinners for patients being in outstanding meals situation (Centers : Grenoble, Toulouse, Montpellier) |
|
| 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 |
| Total supplies of insulin during tests (total unit of insulin) | during 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 |
| Caen |
| 14033 |
| France |
| Centre Hospitalier Sud-Francilien | Corbeil-Essonnes | 91100 | France |
| Centre Hospitalier Universitaire | Grenoble | 38700 | France |
| Centre Hospitalier Universitaire | Marseille | 13000 | France |
| Centre Hospitalier Universitaire | Montpellier | 34295 | France |
| Centre Hospitalier Universitaire | Nancy | 54000 | France |
| Centre Hospitalier Universitaire | Strasbourg | 67000 | France |
| Centre Hospitalier Universitaire | Toulouse | 31400 | France |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| D000070276 | Heart Rate Determination |
| D062407 | Meals |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D010808 | Physical Examination |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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