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Ascensia Contour Next One (Bayer)

Device Name:Contour Next One
Manufacturer:Sole: Bayer Healthcare AG, Kaiser-Willhelm-Allee, Building W11, 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
Description: The Ascensia Contour Next One (Bayer) is a clinically validated and 3-star blood glucose meter. Measurements are taken from the finger and it is intended for self-measurement and home use.
Assessment:

The technology used in the Ascensia Contour Next One (Bayer), to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.

Accuracy AssessmentRecommendationBasis
Medaval★★★ RecommendationRecent clinical validation; recent protocol; multiple clinical validations
MDR CriteriaSelf-measurementPublished evidence
 
Consumer BodyVersionQuartileComment
Amazon Best Sellers (US)2019A (4.0 / 5) 

Validation Publications

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: 101080/1743444020201704253. PMID: 31825686.

Ad Hoc protocol Laboratory study (Note: Aligned with ISO 15197:2013 section 6.3.3)

Ad Hoc protocol Clinincal 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.

Relevant Publications

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.