This is a non-randomized, single arm, multi-center, prospective, non-significant risk study to evaluate the FreeStyle Libre Flash Glucose Monitoring System.
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 Type
OBSERVATIONAL
Enrollment
50
Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes.
William Sansum Diabetes Center
Santa Barbara, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Rocky Mountain Diabetes & Osteoporosis Center
Idaho Falls, Idaho, United States
Rainier Clinical Research Center
Renton, Washington, United States
System Performance
System performance will be characterized with respect to YSI reference venous plasma sample measurements.
Time frame: Approximately 32 hours
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 42 days
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