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The study will be conducted, in cross-over with a time interval of at least 2 days between 2 treatment periods. Patients will be randomized into 2 groups According to the order of the randomization, patients will bear the JewelPump for 5 days, followed by a period of 5 days of treatment with their usual pumps.
The JewelPump (Debiotech) will be compared to the conventional pumps. Patients will treated with the JewelPump during 5 days, and with their usual pump during 5 other days.
The study will be conduct with 15 patients at the following investigation centers : Corbeil Hospital, CHU of Strasbourg, and CHRU of Marseille.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JewelPump | Experimental | JewelPump for the first treatment period followed by the usual pump for the second treatment period |
|
| Usual insulin pump | Active Comparator | Patients in the arm 2, will have the usual insulin pump for the first treatment period, followed with the second period which they will have the JewelPump. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JewelPump | Device |
| ||
| usual insulin pump |
| Measure | Description | Time Frame |
|---|---|---|
| Time spent in glycemic area 70-180 mg / dl, measured continuously for 5 days with a continuous glucose monitoring (CGM) DEXCOM G4 | Evaluate the non-inferiority of JewelPump compared to the usual pump patient, on glycemic control. | up to 5 days of each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Time spent in the strict glycemic area 80-140 mg / dl | Evaluate the superiority of JewelPump versus usual pump; | up to 5 days of each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Time spent below 70 mg / dl | up to 5 days in each treatment period | |
| Time spent above 180mg/dl; | up to 5 days in each treatment period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvia FRANC, MD | Centre Hospitalier Sud Francilien | Principal Investigator |
| Nathalie JEANDIDIER, Pr. | University Hospital, Strasbourg, France | Principal Investigator |
| Denis RACCAH, Pr. | Centre Hospitalier Universitaire de Marseille | Principal Investigator |
| Guillaume CHARPENTIER, MD | Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Sud Francilien | Évry | 91000 | France | |||
| CHU Marseille-Hôpital Nord |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Device |
|
| Marseille |
| 13000 |
| France |
| CHU Strasbourg | Strasbourg | 67091 | France |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |