FreeStyle Libre Flash Glucose Monitoring System Accuracy

Completed

• Conditions: Diabete Mellitus

• Registration Number: NCT03159546
• Lead Sponsor: Abbott Diabetes Care

Brief Summary

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

Detailed Description

Up to 60 subjects will be enrolled at up to six 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 follow the same BG testing schedule during in-clinic visits. Subjects will be instructed to report any problems with the device. Subjects will make seven (7) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Subjects will have four (4) in-clinic visits during which intravenous blood draws and YSI reference testing will occur.

Study Timeline

• Study Start: 2017-05-13
• Study First Submitted: 2017-05-17
• Study First Submitted QC: 2017-05-17
• Study First Posted: 2017-05-18
• Primary Completion: 2017-07-18
• Study Completion: 2017-08-24
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-01
• Last Update Posted: 2017-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
System Performance	Approximately 32 hours	System performance will be characterized with respect to YSI reference venous plasma sample measurements.
System Related adverse device effects	Up to 42 days	System will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.

Trial Locations

Locations (4)

Diablo Clinical Research; 🇺🇸 Walnut Creek, California, United States

William Sansum Diabetes Center; 🇺🇸 Santa Barbara, California, United States

Rainier Clinical Research Center; 🇺🇸 Renton, Washington, United States

Rocky Mountain Diabetes & Osteoporosis Center; 🇺🇸 Idaho Falls, Idaho, United States