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

Completed · Not applicable

Conditions studied: Diabetes Mellitus

In brief

This study will collect lay user ("subjects") and healthcare professional information on the performance of two different blood glucose monitors, the CONTOUR NEXT and the CONTOUR TV3, in people with and without diabetes. Each subject will use both meters, at different times and in different order, using a fingerstick(s) to collect meter samples. Meter results will be compared to standardized test system to assess the accuracy of the meters' results. Additionally, a blood sample will be drawn from the subject's arm by a trained healthcare professional for testing on both BGMS. Subjects will also be asked to complete a questionnaire to rate their experience using the meters and to evaluate the meter's Instructions for Use. After all testing and the first questionnaire have been completed, the study staff will demonstrate only to subjects with diabetes several features of the meters that would not necessarily be experienced during the meter testing. These subjects will then answer questions about the features in a second questionnaire.

Key facts

Study ID

NCT03730480

Run by

Ascensia Diabetes Care

People needed

372

Starts

2018-09-06

Expected to finish

2018-10-31

Last updated by the study team

2022-01-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• AMCR Institute — Escondido, California, United States
• Ranier Clinical Research Center, Inc. — Renton, Washington, United States

Full record on ClinicalTrials.gov

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