Type I Diabetes
Conditions
Brief summary
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.
Detailed description
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)
Interventions
DEVICEMiniMed™ 640G
The MiniMed™ 640G corresponds to the medical device = pump using for the delivery of insulin
DEVICECaptor CGM Enlite®
The Captor CGM Enlite® corresponds to the device added for the measurement of the glycemic level
DEVICESmartGuard®
This SmartGuard® function is used to improve the glycemia stability in real condition
Sponsors
ARAIR Assistance
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* type I diabetic patients undr basal/prandial diet * treated by insuline * with no insuline pump during at least 3 months * with HbA1C dosed during the 3 months before inclusion
Exclusion criteria
* minor patients * pregnant woman * already participating to another studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of hypoglycemia between a phase with no SmartGuard® function and a phase with SmartGuard® function | 6 days | 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 |
Countries
France
Outcome results
None listed