Accuracy evaluation of five blood glucose monitoring systems obtained from the pharmacy: A European multicenter study with 453 subjects

Diabetes Technology and Therapeutics

Volumn 14, Issue 4, 2012, Pages 330-337

  Tack, Cornelius ^a   Pohlmeier, Harald ^b   Behnke, Thomas ^c   Schmid, Volkmar ^d   Grenningloh, Marco ^d   Forst, Thomas ^e   Pfützner, Andreas ^e  

^a RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^b Zentrum für Diabetes und Gefäßerkrankungen Münster   (Germany)

^c Diabetes Zentrum Neuwied   (Germany)

^d IKFE CRO GmbH   (Germany)

^e IKFE   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE;

ADULT; ADVERSE OUTCOME; AGED; ANALYZER; ARTICLE; BLOOD GLUCOSE MONITORING; CONTROLLED STUDY; GLUCOSE ASSAY; GLUCOSE BLOOD LEVEL; HUMAN; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MEASUREMENT ERROR; MULTICENTER STUDY; PRICK TEST; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; REFERENCE VALUE;

BLOOD GLUCOSE; BLOOD GLUCOSE SELF-MONITORING; DIABETES MELLITUS; EUROPEAN CONTINENTAL ANCESTRY GROUP; FEMALE; GERMANY; HUMANS; MALE; NETHERLANDS; PHARMACIES; POSTPRANDIAL PERIOD; PROSPECTIVE STUDIES; REPRODUCIBILITY OF RESULTS;

EID: 84859313151     PISSN: 15209156     EISSN: 15578593     Source Type: Journal    
DOI: 10.1089/dia.2011.0170     Document Type: Article

References (13)

1. International Diabetes Federation: Diabetes Atlas, 4th ed. Brussels: International Diabetes Federation, 2009.
2. Kristensen GB, Monsen G, Skeie S, Sandberg S: Standardized evaluation of nine instruments for self-monitoring of blood glucose. Diabetes Technol Ther 2008;10:467-477.
3. Freckmann G, Baumstark A, Jendrike N, Zschornack E, Kocher S, Tshiananga J, Heister F, Haug C: System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197. Diabetes Technol Ther 2010; 12:221-231.
4. Kuo CY, Hsu CT, Ho CS, Su TE, Wu MH, Wang CJ: Accuracy and precision evaluation of seven self-monitoring blood glucose systems. Diabetes Technol Ther 2011;13:596-600.
5. ISO 15197:2003: In Vitro Diagnostic Test Systems Requirements for Blood-Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus. Geneva: World Health Organization, 2003.
6. ISO 15197:2010: In Vitro Diagnostic Test Systems Requirements for Blood-Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus (ISO/DIS 15197: 2010); German version prEN ISO 15197:2010. www .slideshare.net/saccharun/iso-15197-ge (accessed November 2011).
7. Passing H, Bablok W: A new biometrical procedure for testing the equality of measurements from two different analytical methods. Applications of linear regression procedures for method comparison studies in clinical chemistry, Part I. J Clin Chem Clin Biochem 1983;21:709-720. (Pubitemid 14208512)
8. Clarke WL, Cox D, Gonder-Frederick LA, Carter W, Pohl SL: Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care 1987;10:622-628. (Pubitemid 17158937)
9. Parkes JL, Slatin SL, Pardo S, Ginsberg BH: A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care 2000;23:1143-1148. (Pubitemid 30616803)
10. Ng R, Lock J: Can glucose meters meet tighter accuracy requirements? [abstract]. Diabetologia 2010;53(Suppl 1):S418.
11. Lock JP, Brazg R, Bernstein RM, Taylor E, Patel M, Ward J, Alva S, Chen T, Welsh Z, Amor W, Bhogal C, Ng R: Performance of a new test strip for FreeStyle blood glucose monitoring systems. Diabetes Technol Ther 2011;13:1-10.
12. Twomey PM: Plasma glucose measurement with the Yellow Springs Glucose 2300 STAT and the Olympus AU640. J Clin Pathol 2004;57:752-754.
13. Genter P, Ipp E: Accuracy of plasma glucose measurements in the hypoglycemic range. Diabetes Care 1994;17:595-598. (Pubitemid 24161984)