User Performance Evaluation of Contour® Next One, Accu-Chek® Aviva Connect, FreeStyle Freedom Lite, OneTouch® Verio and GlucoMen® Areo Blood Glucose Monitoring Systems Following ISO 15197:2013

"This is a user performance study, that is intended to show whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system (BGMS).~The subjects' measurement technique (e.g. applying blood onto the system reagent, reading the result) will be observed and documented by study personnel.~Immediately after the measurement by the subject, the study personnel will perform a measurement with the same test meter.~Measurement results obtained by the subjects with the BGMS will be compared to measurement results obtained with the comparison method.~Sample collection for the comparison measurement will be performed by study personnel within 5 min after the subject's measurement with the test meter.~The samples will be collected from the subjects' skin puncture (if possible), an additional skin puncture (if required) will be documented.~An additional skin puncture will be performed by study personnel with single-use lancing devices."