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Ascensia Contour Next One (Bayer)
Device Name:
Contour Next One
Manufacturer:
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
Availability according to Countries or Regions:
Ireland and United States
Description:
The Ascensia Contour Next One (Bayer) is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 3-star Medaval rating. Blood glucose measurements are taken from the finger. 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 five clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval ★★★ Recommendation Recent clinical validation; recent protocol; multiple clinical validations
BG MDR Criteria Self-measurement Published evidence
Consumer BodyYear(s)LevelComment
BG Amazon Best Sellers (US) Latest: 2019 A (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: 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

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.

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