An observational study in Diabetes Mellitus, sponsored by Abbott Diabetes Care. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-09.
Sponsored by Abbott Diabetes Care · Observational
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 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.
Subjects with type 1 or type 2 diabetes requiring multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII).
Exclusion Criteria:
Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes.
System Performance with respect to YSI reference venous plasma sample measurements.
System performance will be characterized with respect to YSI reference venous plasma sample measurements.
Time frame: Approximately 35 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 51 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Abbott Diabetes Care