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: * phase 1: insulin pump without captor (12 weeks) * phase 2: insulin pump with captor and without SmartGuard® function (4X6 days; 4 weeks) * phase 3: insulin pump with captor and with SmartGuard® function (6X6 days; 6 weeks) * phase 4: insulin pump without captor (4 weeks)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
The MiniMed™ 640G corresponds to the medical device = pump using for the delivery of insulin
The Captor CGM Enlite® corresponds to the device added for the measurement of the glycemic level
This SmartGuard® function is used to improve the glycemia stability in real condition
Pole Sante Sud Le Mans
Le Mans, France
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
Time frame: 6 days
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