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Accuracy of Freestyle Libre

NCT02734745 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-10-04

No results posted yet for this study

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.

Conditions

  • Diabetes Type 1

Interventions

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.

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-01
Primary Completion
2017-12-01
Completion
2017-12-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02734745 on ClinicalTrials.gov