Bayer Contour Next

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

DeSalvo DJ, Shanmugham S, Ly TT, Wilson DM, Buckingham BA. Accuracy evaluation of blood glucose monitoring systems in children on overnight closed-loop control. J Diabetes Sci Technol. 2014 Sep;8(5):969-73. Epub: 2014 May 21. doi: 10.1177/1932296814532238. PMID: 24876427. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4455362/pdf/10.1177_1932296814532238.pdf.

15197:2003 - Pass Children (Note: Modified protocol)

15197:2013 - Pass General population (Note: Modified protocol)

Dietzen DJ, Nenninger DA, Simmons DA, Pardo S, Pandya M, Fullam J. Analytic characteristics of three Bayer contour blood glucose monitoring systems in neonates. J Diabetes Sci Technol. 2015 Mar;9(2):257-61. Epub: 2014 Nov 4. doi: 10.1177/1932296814557669. PMID: 25377056. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4604584/pdf/10.1177_1932296814557669.pdf.

15197:2013 - Pass Neonates

CLSI:2013 - Pass General population

FDA:2016P - Fail General population

Klonoff DC, Parkes JL, Kovatchev BP, Kerr D, Bevier WC, Brazg RL, Christiansen MP, Bailey TS, Nichols JH, Kohn MA. Blood Glucose Monitoring System Surveillance Program. https://www.diabetestechnology.org/surveillance.shtml [Internet] Burlingame, CA: Diabetes Technology Society; 2017 Jun 23.

DTS:2016 - Pass General population

Relevant Publications

Klaff LJ, Brazg R, Hughes K, Tideman AM, Schachner HC, Stenger P, Pardo S, Dunne N, Parkes JL. Accuracy evaluation of contour next compared with five blood glucose monitoring systems across a wide range of blood glucose concentrations occurring in a clinical research setting. Diabetes Technol Ther. 2015 Jan;17(1):8-15. doi: 10.1089/dia.2014.0069. PMID: 25260047.

Measurements from the Bayer Contour Next are compared to those from the Roche Accu-Chek Aviva Nano, the Abbott FreeStyle Lite, the J&J LifeScan OneTouch Ultra 2, the J&J LifeScan OneTouch Verio Pro and the Nipro Truetrack, though not in a formal validation.