Diabetes Type 1 Clinical Trial
Official title:
Accuracy of Flash Glucose Monitoring Freestyle Libre (Abbott) in Home Setting and In-patient Setting During Hypo - Hyperglycemia
This is an open-label, mono-centre, interventional study.The aim of this trial is to assess accuracy and reliability of a flash glucose monitoring system, the freestyle Libre (Abbott, CA, USA), in patients with type 1 diabetes.
Objective: To assess accuracy and reliability of a new-to-market flash glucose monitoring
system, the freestyle Libre (Abbott, CA, USA), in patients with type 1 diabetes.
Study design: open-label, mono-centre interventional study. Patients will wear freestyle
Libre for 14 days in the home setting. There will be no limitations in food intake or in
physical activity, but patients will have at least 7 finger-stick/days. Patients will have 2
visits in our clinical center and in these visits we'll compare freestyle Libre values with
blood sampling to determine glucose values with YSI, during euglycemia and during glucose
excursion and induced hypo-hyperglycemia.
Study population: 48 patients will be included in this trial. Every patient will wear device
for 14 days at home and during 2 visits at CRC Study endpoints: main endpoint will be the
evaluation of freestyle Libre accuracy during real life compared to glucometer values and to
YSI glucose values (during 2 visits). A separate analysis will be performed on the accuracy
of the freestyle Libre in the hypoglycaemic (defined as a blood glucose value ≤3.9 mmol/L)
and hyperglycaemic area (defined as a blood glucose value ≥10.0 mmol/L). Additionally, a
separate analysis will be performed to assess device performance and accuracy per day of
device life.
If patients enrolled in the study use Dexcom G4 or G5 (CGM) and wanted to continue to use it,
he/she can do so. In this case we can compare the accuracy of Libre even towards Dexcom G4/G5
device.
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