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Current Medical Research and Opinion Volume 30, 2014 - Issue 2
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Research Articles

Performance of blood glucose meters in compliance with current and future clinical ISO15197 accuracy criteria

A. PfütznerIKFE – Institute of Clinical Research and Development MainzGermanyCorrespondence[email protected]
,
C. HengesbachIKFE – Institute of Clinical Research and Development MainzGermany
,
F. DemircikIKFE – Institute of Clinical Research and Development MainzGermany
,
C. SchipperIKFE – Institute of Clinical Research and Development MainzGermany
,
T. ForstIKFE – Institute of Clinical Research and Development MainzGermany
&
P.B. MusholtIKFE – Institute of Clinical Research and Development MainzGermany
Pages 185-190 | Accepted 21 Oct 2013, Published online: 06 Nov 2013

References

  • American Diabetes Association. Standards of Medical Care in Diabetes. Diabetes Care 2012;36(Suppl 1):S11-63
  • International Diabetes Federation. Self-monitoring of blood glucose in non-insulin treated patients with type 2 diabetes. Available at: www.IDF.org. Accessed 31 Aug 2013
  • DIN EN ISO 15197: In Vitro Diagnostic Test Systems – Requirements for Blood Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus (ISO15197:2003(E))
  • Pfützner A, Mitri M, Musholt PB, et al. Clinical assessment of the accuracy of blood glucose measurement devices. Curr Med Res Opin 2012;28:525-31
  • DIN EN ISO 15197: In Vitro Diagnostic Test Systems – Requirements for Blood Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus DRAFT (ISO/DIS 15197:2010)
  • Twomey PM. Plasma glucose measurement with the Yellow Springs Glucose 2300 STAT and the Olympus AU640. J Clin Pathol 2004;57:752-4
  • Genter P, Ipp E. Accuracy of plasma glucose measurements in the hypoglycemic range. Diabetes Care 1994;17:595-8
  • Musholt PB, Schipper C, Thomé N, et al. Dynamic electrochemistry corrects for hematocrit interference on blood glucose determinations with patient self-measurement devices. J Diabetes Sci Technol 2004;5:1167-75
  • Ramljak S, Lock JP, Schipper C, et al. Hematocrit Interference of Blood Glucose Meters for Self-measurement. J. Diabetes Sci Technol 2013;7:179-89
  • Schipper C, Musholt PB, Ramljak S, et al. Genauigkeit und Präzision von Blutzuckermessgeräten der ‘Klasse A’ und ‘Klasse B’. [Accuracy and precision of ‘class A’ and ‘class B’ blood glucose meters]. Diabetes Stoffw Herz 2012;2:151-55
  • Iyengar S, Hall EA. Phasor transform to extract glucose and ascorbic acid data in an amperometric sensor. Analyst 2000;125:1987-92
  • Iyengar S, Wiley M, Nadeau D. Performance of the WaveSense™-Enabled Glucose Monitoring System Across Multiple Lots. Diabetes Stoffw Herz 2007;16:15-20
  • Kempf K, Heinemann L. Dynamische Elektrochemie: eine eine innovative Methode zur hochqualitativen Blutglukosemessung. Diabetologie 2012;7:121-6

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