Bayer Contour Next EZ
The technology used in the Bayer Contour Next EZ, to measure blood glucose, has passed in a clinical validation study, in a young population, according to a recognised standard protocol, as published in a peer-reviewed publication. It has also been assessed, in a general population, according to a non-standard protocol.
|Medaval||Recommended for children only||Validation in children|
|MDR Criteria||Neonates||Published evidence|
|Amazon Best Sellers (US)||2019||A (4.1 / 5)|
Halldorsdottir S, Warchal-Windham ME, Wallace JF, Pardo S, Parkes JL, Simmons DA. Accuracy evaluation of five blood glucose monitoring systems: the North American comparator trial. J Diabetes Sci Technol. 2013 Sep 1;7(5):1294-304. doi: 10.1177/193229681300700520. PMID: 24124957. Available from: PMC3876374.
Ad Hoc protocol General population
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: PMC4604584.
15197:2013 - Pass Neonates
CLSI:2013 - Pass Neonates
FDA:2016P - Fail Neonates
Fournier PA. Analysis of "Accuracy evaluation of five blood glucose monitoring systems: the North American comparator trial". J Diabetes Sci Technol. 2013 Sep 1;7(5):1305-7. doi: 10.1177/193229681300700521. PMID: 24124958. Available from: PMC3876375.
The publication is a letter or correspondence in which the Bayer Contour Next EZ is referenced.