Accuracy Assessment | Recommendation | Basis | |
BG | Medaval | Recommended for children only | Validation in children |
BG | Institute of Health Economics (CA) | General use | No evidence provided |
BG | MDR Criteria | Neonates | Published evidence |
Consumer Body | Year(s) | Level | Comment | |
BG | Amazon Best Sellers (US) | Latest: 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 Ascensia (Bayer) Contour Next EZ is referenced.