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

Current Medical Research and Opinion

Volumn 30, Issue 2, 2014, Pages 185-190

  Pfutzner A ^a   Hengesbach, C ^a   Demircik, F ^a   Schipper, C ^a   Forst, T ^a   Musholt, P B ^a,b  

^a IKFE Institute for Clinical Research and Development   (Germany)

^b Profil Mainz   (Germany)

Author keywords

Blood glucose meters; Glucose monitoring; New ISO criteria; System accuracy

Indexed keywords

GLUCOSE; GLUCOSE BLOOD LEVEL;

ACCURACY; ADULT; AGED; ARTICLE; BLOOD GLUCOSE METER; BLOOD GLUCOSE MONITORING; BLOOD SAMPLING; FEMALE; GLUCOSE BLOOD LEVEL; HUMAN; MAJOR CLINICAL STUDY; MALE; MEASUREMENT; MIDDLE AGED; PERFORMANCE; POST HOC ANALYSIS; PRACTICE GUIDELINE; SELF EVALUATION; YOUNG ADULT; ADOLESCENT; ANALYSIS; BLOOD; DEVICES; DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; EUROPE; EVALUATION STUDY; STANDARDS;

ADOLESCENT; ADULT; AGED; BLOOD GLUCOSE; BLOOD GLUCOSE SELF-MONITORING; DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; EUROPE; FEMALE; GUIDELINE ADHERENCE; HUMANS; MALE; MIDDLE AGED; YOUNG ADULT;

EID: 84893247079     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007995.2013.858617     Document Type: Article

References (13)

1. American Diabetes Association. Standards of Medical Care in Diabetes. Diabetes Care 2012;36(Suppl 1):S11-63
2. International Diabetes Federation. Self-monitoring of blood glucose in noninsulin treated patients with type 2 diabetes. Available at: Www.IDF.org. Accessed 31 Aug 2013
3. 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)
4. 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
5. 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
6. Twomey PM. Plasma glucose measurement with the Yellow Springs Glucose 2300 STAT and the Olympus AU640. J Clin Pathol 2004;57:752-4
7. Genter P, Ipp E. Accuracy of plasma glucose measurements in the hypoglycemic range. Diabetes Care 1994;17:595-8
8. Musholt PB, Schipper C, ThoméN, et al. Dynamic electrochemistry corrects for hematocrit interference on blood glucose determinations with patient selfmeasurement devices. J Diabetes Sci Technol 2004;5:1167-75
9. 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
10. Schipper C, Musholt PB, Ramljak S, et al. Genauigkeit und Prä zision von Blutzuckermessgerä ten 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
11. Iyengar S, Hall EA. Phasor transform to extract glucose and ascorbic acid data in an amperometric sensor. Analyst 2000;125:1987-92
12. Iyengar S, Wiley M, Nadeau D. Performance of the WaveSenseTM-Enabled Glucose Monitoring System Across Multiple Lots. Diabetes Stoffw Herz 2007;16:15-20
13. Kempf K, Heinemann L. Dynamische Elektrochemie: Eine eine innovative Methode zur hochqualitativen Blutglukosemessung. Diabetologie 2012;7: 121-6