Ascensia Contour USB (Bayer)
Device Name:
Contour USB
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
Device Manual:
Click here to download the Device Manual
Description:
The Ascensia Contour USB (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 USB (Bayer), to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in four 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 Institute of Health Economics (CA) General use No evidence provided
BG MDR Criteria Self-measurement Published evidence
Validation Publications:

Harrison B, Leazenby C, Halldorsdottir S. Accuracy of the CONTOUR® blood glucose monitoring system. J Diabetes Sci Technol. 2011 Jul 1;5(4):1009-13. doi: 10.1177/193229681100500425. PMID: 21880245. Available from: PMC3192609.

15197:2003 - Pass General population

List SM, Starks N, Baum J, Greene C, Pardo S, Parkes JL, Schachner HC, Cuddihy R. Performance evaluation and labeling comprehension of a new blood glucose monitoring system with integrated information management. J Diabetes Sci Technol. 2011 Sep 1;5(5):1144-53. doi: 10.1177/193229681100500516. PMID: 22027308. Available from: PMC3208871.

15197:2003 - Pass General population

Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1060-75. PMID: 23063032. Available from: PMC3570840.

15197:2003 - Pass General population

15197:2013 - Fail General population

Pfützner A, Schipper C, Ramljak S, Flacke F, Sieber J, Forst T, Musholt PB. Evaluation of the effects of insufficient blood volume samples on the performance of blood glucose self-test meters. J Diabetes Sci Technol. 2013 Nov 1;7(6):1522-9. doi: 10.1177/193229681300700612. PMID: 24351178. Available from: PMC3876330.

15197:2003 - Fail Using insufficient blood samples (n=31)

Hasslacher C, Kulozik F, Platten I. Analytical performance of glucose monitoring systems at different blood glucose ranges and analysis of outliers in a clinical setting. J Diabetes Sci Technol. 2014 May;8(3):466-72. Epub: 2014 Feb 18. doi: 10.1177/1932296814522804. PMID: 24876607. Available from: PMC4455429.

15197:2013 - Pass General population

Relevant Publications:

Crowe DJ. Analysis of the evaluation of a new glucose meter with integrated self-management software and USB connectivity. J Diabetes Sci Technol. 2011 Sep 1;5(5):1154-6. PMID: 22027309. Available from: PMC3208872.

The publication is a letter or correspondence in which the Bayer Contour USB is referenced.

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