The purpose of this study is to characterize the Freestyle Libre Flash Glucose Monitoring System performance with respect to YSI reference venous plasma sample measurements.
Up to 200 subjects will be enrolled in this study at a total of 6 clinical research sites in the United States. Subjects will wear a total of two (2) sensors, one on the back of each upper arm. 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 six (6) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Subjects will have three (3) in-clinic visits during which intravenous blood draws and YSI reference testing will occur.
Study Type
OBSERVATIONAL
Enrollment
153
Subjects will wear the Abbott Sensor based FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes
AMCR
Escondido, California, United States
Sansum Diabetes Research Institute
Santa Barbara, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States
System Performance
System Performance will be characterized with respect to YSI reference venous plasma measurements
Time frame: approximately 45 days
System Related Adverse Device Effects
System will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants
Time frame: Up to 45 days
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Rainier Clinical Research Center
Renton, Washington, United States