Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump
- Conditions
- Type I Diabetes
- Registration Number
- NCT03653533
- Lead Sponsor
- ARAIR Assistance
- 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)
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
- 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
- minor patients
- pregnant woman
- already participating to another studies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pole Sante Sud Le Mans
🇫🇷Le Mans, France
Pole Sante Sud Le Mans🇫🇷Le Mans, France