FreeStyle Libre Flash Accuracy Study

  • STATUS
    Recruiting
  • participants needed
    150
  • sponsor
    Abbott Diabetes Care
Updated on 8 November 2020
Diablo Clinical Research (2.2 mi away) Contact
insulin
type 2 diabetes mellitus
finger stick
flash

Summary

This is a non-randomized, single arm, multi-center, prospective, non-significant risk study to evaluate the FreeStyle Libre Flash Glucose Monitoring System.

Description

Up to 150 subjects will be enrolled at four (4) clinical research sites in the United States. Subjects will wear two Sensors of three unique sensor lots. Each Sensor will have a paired Reader that will be given to the subject. All Readers will be masked during the study (i.e. subjects will not be able to view glucose results obtained from the Sensor on the Reader screen). Subjects will be asked to perform at least 8 capillary Blood Glucose (BG) tests per day using the primary Reader. Interstitial glucose readings from each Sensor will be obtained with the corresponding Readers immediately following each BG test. Subjects will be instructed to report any problems with the device. Subjects will make eight (8) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Subjects will have five (5) in-clinic visits during which intravenous blood draws and YSI reference testing will occur.

Details
Treatment FreeStyle Libre Flash Glucose Monitoring System
Clinical Study IdentifierNCT03257501
SponsorAbbott Diabetes Care
Last Modified on8 November 2020

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