Bayer Contour USB

Device Name:Contour USB
Manufacturer:Bayer Healthcare AG, 51368 Leverkusen, GERMANY.
Measuring functions:Blood glucose
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Finger
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment: The technology used in the Bayer Contour USB, to measure blood glucose, has passed in three validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.
Validation Publications

Harrison B, Leazenby C, Halldorsdottir S. Accuracy of the CONTOUR® blood glucose monitoring system. J Diabetes Sci Technol. 2011 Jul 1;5(4):1009-13. PMID: 21880245. Available from: www.ncbi.nlm.nih.gov/pmc/articles/PMC3192609/pdf/dst-05-1009.pdf.

15197:2003 - Pass General population

List SM, Starks N, Baum J, Greene C, Pardo S, Parkes JL, Schachner HC, Cuddihy R. Performance evaluation and labeling comprehension of a new blood glucose monitoring system with integrated information management. J Diabetes Sci Technol. 2011 Sep 1;5(5):1144-53. PMID: 22027308. Available from: www.ncbi.nlm.nih.gov/pmc/articles/PMC3208871/pdf/dst-05-1144.pdf.

15197:2003 - Pass General population

Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1060-75. PMID: 23063032. Available from: www.ncbi.nlm.nih.gov/pmc/articles/PMC3570840/pdf/dst-06-1060.pdf.

15197:2003 - Pass General population

15197:2013 - Fail General population

Pfützner A, Schipper C, Ramljak S, Flacke F, Sieber J, Forst T, Musholt PB. Evaluation of the effects of insufficient blood volume samples on the performance of blood glucose self-test meters. J Diabetes Sci Technol. 2013 Nov 1;7(6):1522-9. doi: 10.1177/193229681300700612. PMID: 24351178. Available from: www.ncbi.nlm.nih.gov/pmc/articles/PMC3876330/pdf/dst-07-1522.pdf.

15197:2003 - Fail Using insufficient blood samples (n=31)

Relevant Publications

Crowe DJ. Analysis of the evaluation of a new glucose meter with integrated self-management software and USB connectivity. J Diabetes Sci Technol. 2011 Sep 1;5(5):1154-6. PMID: 22027309. Available from: www.ncbi.nlm.nih.gov/pmc/articles/PMC3208872/pdf/dst-05-1154.pdf.

The publication is a letter or correspondence in which the Bayer Contour USB is referenced.