The purpose of this study is to validate current algorithms and evaluate safety and efficacy of overnight closed loop insulin delivery (FlorenceD2 system) in children with type 1 diabetes between 6 - 12 years of age in Luxembourg .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
FLORENCED2 device ensures the closed loop between Freestyle Navigator II and the DANA DIABECARE R
DECCP Clinique Pédiatrique de Luxembourg/CHL
Luxembourg, Luxembourg
DECCP Pediatric Clinic , CHLuxembourg
Luxembourg, Luxembourg
Time spent in normal glucose range ( mg/dl)
Glucose will be measured with a Continuous glucose monitoring device
Time frame: At least 5 hours between 7 pm and 7 am
glucose variability ( excursions in mg/dl)
Continuous Glucose Monitoring device
Time frame: 7 pm - 7 am
Time spent in low glucose range (< 60 mg/dl)
Continuous Glucose Monitoring
Time frame: 7 pm till 7 am
time spent in low glucose range (<70 mg/dl)
continuous glucose monitoring
Time frame: 7 pm till 7 am
time spent in high glucose range (>180mg/dl)
continuous glucose monitoring
Time frame: 7 pm - 7 am
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