Accuracy Assessment | Recommendation | Basis | |
BG | Medaval | Legacy approval | Older clinical validation; older protocol |
BG | Institute of Health Economics (CA) | General use | No evidence provided |
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 High Altitude (Note: Simulated altitude in hypobarbic chamber)
Ad Hoc protocol - Fail High Altitude (Note: Various altitudes 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.
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.