Accuracy Assessment | Recommendation | Basis | |
BG | Medaval | ★★★ Recommendation | Recent clinical validation; recent protocol; multiple clinical validations |
BG | MDR Criteria | Self-measurement | Published evidence |
Consumer Body | Year(s) | Level | Comment | |
BG | Amazon Best Sellers (US) | Latest: 2019 | A (4.0 / 5) |
Christiansen M, Greene C, Pardo S, Warchal-Windham ME, Harrison B, Morin R, Bailey TS. A New, Wireless-enabled Blood Glucose Monitoring System That Links to a Smart Mobile Device: Accuracy and User Performance Evaluation. J Diabetes Sci Technol. 2017 May;11(3):567-73. Epub: 2017 Feb 1. doi: 10.1177/1932296817691301. PMID: 28745099. Available from: PMC5505433.
15197:2013 - Pass General population
Jendrike N, Baumstark A, Pleus S, Liebing C, Kamecke U, Haug C, Freckmann G. Accuracy of five systems for self-monitoring of blood glucose in the hands of adult lay-users and professionals applying ISO 15197:2013 accuracy criteria and potential insulin dosing errors. Curr Med Res Opin. 2019 Feb;35(2):301-311. Epub: 2018 Jul 19. doi: 10.1080/03007995.2018.1491832. PMID: 29927663.
15197:2013 - Pass General population
Pleus S, Baumstark A, Jendrike N, Mende J, Link M, Zschornack E, Haug C, Freckmann G. System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015. BMJ Open Diabetes Res Care. 2020 Jan;8(1):e001067. doi: 10.1136/bmjdrc-2019-001067. PMID: 31958308. Available from: drc.bmj.com.
15197:2013 - Pass General population (Note: Modified protocol: One reagent system lot. Also passes the more stringent criterion of at least 95% of values within ±10 mg/dL (0.56 mmol/L) or ±10% of the reference measurement procedure’s results.)
Harrison B, Brown D. Accuracy of a blood glucose monitoring system that recognizes insufficient sample blood volume and allows application of more blood to the same test strip. Expert Rev Med Devices. 2020 Jan;17(1):75-82. Epub: 2020 Jan 10. doi: 10.1080/1743444020201704253. PMID: 31825686.
Ad Hoc protocol Laboratory study (Note: Aligned with ISO 15197:2013 section 6.3.3)
Ad Hoc protocol Clinical study (n=52) (Note: Aligned with ISO 15197:2013 section 8.2)
The accuracy of the CONTOUR®NEXT ONE blood glucose monitoring system was maintained with sample re-application.
Al-Zahrani A, Alshareef R, Farahat F, Borai A. Assessing the Accuracy of Different Glucometers Based on the Laboratory Reference Method. Clin Lab. 2020 Oct 1;66(10):200132. doi: 10.7754/Clin.Lab.2020.200132. PMID: 33073954.
Unknown protocol General population
Protocol not stated in abstract.
Freckmann G, Baumstark A, Jendrike N, Mende J, Schauer S, Link M, Pleus S, Haug C. Impact of Two Different Reference Measurement Procedures on Apparent System Accuracy of 18 CE-Marked Current-Generation Blood Glucose Monitoring Systems. J Diabetes Sci Technol. 2022 Sep;16(5):1076-1088. Epub: 2020 Aug 19. doi: 10.1177/1932296820948873. PMID: 32814455. Available from: PMC9445332.
15197:2013 - Pass General population
15197:2013 - Pass General population
Parkin CG. If SMBG Accuracy Is Critical to Patient Safety, Why Are Inaccurate Meters Still on the Market? J Diabetes Sci Technol. 2017 May;11(3):574-6. Epub: 2017 Feb 1. doi: 10.1177/1932296817693256. PMID: 28745090. Available from: PMC5505436.
The publication is a letter or correspondence in which the Ascensia (Bayer) Contour Next One is referenced.
See: J Diabetes Sci Technol. 2017 May;11(3):567-573.