NCT02734745

Accuracy of Freestyle Libre

Accuracy of Flash Glucose Monitoring Freestyle Libre (Abbott) in Home Setting and In-patient Setting During Hypo - Hyperglycemia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: University of Padova · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes Type 1

Interventions

Type	Name	Description
DEVICE	flash glucose monitoring	Patients will use Freestyle Libre for 14 days at home, during this period they will have to perform at least 7 measurements of capillary blood glucose per day . Patients also will go to our clinical center on two separate occasions , to run a test breakfast. In one of the two occasions it will be specifically induced a moderate initial hyperglycemia and subsequent hypoglycemia . During the test meal and in the subsequent hours for a total of 6 hours , will be carried out frequent blood sampling for measurement of blood glucose using the Yellow Springs glucose analyzer ( YSI system ) , simultaneous measurements with Freestyle Libre and with glucometer.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-04-12
• Last updated: 2017-10-04

Locations

1 site across 1 country: Italy