Bayer Contour Link

Device Name:Contour Link
Manufacturer:Sole: Bayer Healthcare AG, 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
Assessment:

The technology used in the Bayer Contour Link, to measure blood glucose, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication. It has also been assessed, in a specific population, according to a non-standard protocol.

Accuracy AssessmentRecommendationBasis
Medaval RecommendationRecent clinical validation; older protocol

Validation Publications

de Mol P, Krabbe HG, de Vries ST, Fokkert MJ, Dikkeschei BD, Rienks R, Bilo KM, Bilo HJ. Accuracy of handheld blood glucose meters at high altitude. PLoS One. 2010 Nov 12;5(11):e15485. doi: 10.1371/journal.pone.0015485. PMID: 21103399.

Ad Hoc protocol - Pass Simulated altitude in hypobarbic chamber

Ad Hoc protocol - Fail Various altituded on Mt. Kilimanjaro

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

Chlup R, Doubravova B, Bartek J, Zapletalova J, Krystynik O, Prochazka V. Effective assessment of diabetes control using personal glucometers (CONTOURLINK, Bayer, Germany; CALLA, Wellion, Austria; LINUS, Agamatrix, USA). Dis Markers. 2013;35(6):895-905. PMID: 24427777.

Ad Hoc protocol General population

While ISO 15197:2003 and ISO 15197:2013 are mentioned, it is unclear if either was folowed.

Relevant Publications

Demircik F, Ramljak S, Hermanns I, Pfützner A, Pfützner A. Evaluation of Hematocrit Interference With MyStar Extra and Seven Competitive Devices J Diabetes Sci Technol. 2015 Mar;9(2):262-267. Epub: 2014 Dec 30. doi: 10.1177/1932296814565790. PMID: 25549636. Available from: PMC4604595.

Good accuracy with reliable correction for potential haematocrit influence.