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Difficulties for recruitment
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This study compares the apparition of hypoglycaemia in type I diabetic patients between 2 phases: the one without the use of SmartGuard® function and the one with the use of SmartGuard® function.
The aim of this study is to compare SmartGuard® function with captor and insulin pump to improve the glycemia stability in real condition.
There are several phases:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MiniMed™ 640G alone | Other | MiniMed™ 640G (insulin pump) is used without Captor CGM Enlite® (captor) at phase 1 and phase 4 of the study. ADDQoL, BIPQ and HADS questionnaire are performed. |
|
| MiniMed™ 640G + Captor CGM Enlite® | Other | insulin pump coupled with captor without SmartGuard® function tat phase 2 of the study. ADDQoL, BIPQ and HADS questionnaire are performed. |
|
| MiniMed™ 640G + Captor + SmartGuard® | Other | insulin pump + captor + SmartGuard® function are used at phase 3 of the study. ADDQoL, BIPQ and HADS questionnaire are performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiniMed™ 640G | Device | The MiniMed™ 640G corresponds to the medical device = pump using for the delivery of insulin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of hypoglycemia between a phase with no SmartGuard® function and a phase with SmartGuard® function | The primary outcome is the area between the glycemic curve and the hypoglycemic level (70 mg/dL), measured between the 6 last days of the phase without SmartGuard® function and the 6 last days with the use of SmartGuard® function | 6 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pole Sante Sud Le Mans | Le Mans | France |
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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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| Captor CGM Enlite® | Device | The Captor CGM Enlite® corresponds to the device added for the measurement of the glycemic level |
|
| SmartGuard® | Device | This SmartGuard® function is used to improve the glycemia stability in real condition |
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |