User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)

This clinical trial will assess the performance (accuracy) of the CONTOUR NEXT and the CONTOUR TV3 monitoring systems ("BGMS") by lay users enrolled as subjects in the study, and by health care professionals. According to a randomization schedule, subjects will be assigned to use either the CONTOUR NEXT or CONTOUR TV3 meters first and then switch and use the second meter, performing the same testing with both meters. They will learn to use the assigned meter by reading the corresponding User Guide (UG) and Quick Reference Guide (QRG). Each subject will perform one fingerstick self-test a palm (AST) test and the study staff will perform a fingerstick test on the subject. All subject self-test results and study staff results will be compared to results from the reference analyzer from a deeper fingerstick. Hematocrit will be measured for all subjects. After testing, all subjects will then complete a questionnaire (Questionnaire 1) to provide feedback on the meter system and instructions for use (UG and QRG). Subjects with diabetes will also have their glucose tested via venipuncture. After all testing is completed on these subjects, the study staff will demonstrate several features of the meter system that would not necessarily be experienced during the brief accuracy testing. These subjects with diabetes will be given a second questionnaire (Questionnaire 2) to provide feedback about the new features of the system. After completing the study procedures for one BGMS, all subjects will then repeat all of these procedures using the second BGMS, except the hematocrit and venipuncture procedures.

Inclusion criteria

• Males and females, 18 years of age and older
• Ability to speak, read and understand English. Subjects must demonstrate ability to read a paragraph from the first page of the User Guide to qualify for the study.
• Willing to complete all study procedures.

Exclusion criteria

• Hemophilia or any other bleeding disorder.
• Pregnancy (self-reported).
• Physical, visual or neurological impairments that would make the person unable to perform testing with the BGMS.
• Previous participation in a blood glucose monitoring study using the Ascensia CONTOUR NEXT or CONTOUR TV3 BGMS.
• Working for a medical laboratory, hospital or other clinical setting that involves training on or clinical use of blood glucose monitors.
• Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company.
• A condition, which in the opinion of the investigator or designee, would put the person or study conduct at risk.