Variability among five over-the-counter blood glucose monitors

Clinica Chimica Acta

Volumn 364, Issue 1-2, 2006, Pages 292-297

  Kimberly, Mary M ^a   Vesper, Hubert W ^a   Caudill, Samuel P ^a   Ethridge, Steven F ^a   Archibold, Enada ^a   Porter, Kimberly H ^b   Myers, Gary L ^a  

^a NATIONAL CENTER FOR ENVIRONMENTAL HEALTH   (United States)

^b International Medical Press   (United States)

Author keywords

Analysis of variance; Diabetes mellitus; Glucose; Self monitoring of blood glucose; Variability

Indexed keywords

ADULT; AGED; ANALYSIS OF VARIANCE; ANALYTIC METHOD; ARTICLE; BLOOD GLUCOSE MONITORING; CONTROLLED STUDY; DIABETES MELLITUS; FEMALE; GLUCOSE BLOOD LEVEL; HUMAN; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL;

ADULT; ALGORITHMS; ANALYSIS OF VARIANCE; BLOOD GLUCOSE; BLOOD GLUCOSE SELF-MONITORING; DIABETES MELLITUS; FEMALE; HUMANS; MALE; MIDDLE AGED; MONITORING, PHYSIOLOGIC; REFERENCE STANDARDS; REFERENCE VALUES; REPRODUCIBILITY OF RESULTS;

EID: 31044455219     PISSN: 00098981     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cca.2005.07.027     Document Type: Article

References (25)

1. T.P. Henning, and D.D. Cunningham Biosensors for personal diabetes management G Ramsay Commercial biosensors: applications to clinical, bioprocess, and environmental samples 1998 John Wiley New York 3 46
2. K.R. Ervin, and E.J. Kiser Issues and implications in the selection of blood glucose monitoring technologies Diabetes Technol Ther 1 1999 3 11
3. American Diabetes Association Tests of glycemia in diabetes Diabetes Care 27 S1 2004 S91 S93
4. International Standards Organization In vitro diagnostic test systems - requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. ISO 15197 2003 International Standards Organization Geneva, Switzerland
5. J.H. Nichols, C. Howard, K. Loman, C. Miller, D. Nyberg, and D.W. Chan Laboratory and bedside evaluation of portable glucose meters Am J Clin Pathol 103 1995 244 251
6. R.N. Johnson, and J.R. Baker Accuracy of devices used for self-monitoring of blood glucose Ann Clin Biochem 35 1998 68 74
7. A.G. Glasmacher, W. Brennemann, and C. Hahn Evaluation of five devices for self-monitoring of blood glucose in the normoglycemic range Exp Clin Endocrinol Diabetes 106 1998 360 364
8. R.N. Johnson, and J.R. Baker Analytical error of home glucose monitors: a comparison of 18 systems Ann Clin Biochem 36 1999 72 79
9. R. Weitgasser, B. Gappmayer, and M. Pichler Newer portable glucose meters - analytical improvement compared with previous generation devices? Clin Chem 45 1999 1821 1825
10. E.T Chen, J.H. Nichols, S.-H. Duh, and G. Hortin Performance evaluation of blood glucose monitoring devices Diabetes Technol Ther 5 2003 749 768
11. M.M. Kimberly, G.L. Myers, H.W. Vesper, S.F. Ethridge, E. Archibold, and K.H. Porter Glucose monitor variability project Diabetes Techol Ther 6 2004 220 [abstract]
12. H. Scheffe The analysis of variance 1959 John Wiley New York
13. M.M. Kimberly, S.P. Caudill, and H.W. Vesper Within-person, among-finger variability of capillary blood glucose measurements Clin Chem 50 2004 2389 2391
14. M.S. Bartlett Some applications of statistical methods of research in agriculture and applied biology J Roy Stat Soc Suppl 4 1937 137 183
15. S. Skeie, G. Thue, and S. Sandberg Patient-derived quality specifications for instruments used in self-monitoring of blood glucose Clin Chem 47 2001 67 73
16. American Diabetes Association Standards of medical care in diabetes Diabetes Care 27 S1 2004 S15 S35
17. D.B. Sacks, D.E. Bruns, D.E. Goldstein, N.K. Maclaren, J.M. McDonald, and M. Parrott Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus Clin Chem 48 2002 436 472
18. J.C. Boyd, and D.E. Bruns Quality specifications for glucose meters: assessment by simulation modeling of errors in insulin dose Clin Chem 47 2001 209 214
19. R. Kaye, and V.M. Chenault An overview of human factors engineering at CDRH in the safety and effectiveness of blood glucose meters Diabetes Technol Ther 4 2002 247 251
20. R.F. Louie, Z. Tang, K.J. Chang, and G.J. Kost Measurement variability between test strip lots on five handheld glucose meter systems Clin Chem 46 6S 2000 A14
21. M.J. Welch NIST's role in measurement accuracy for diagnosis and monitoring of diabetes Diabetes Technol Ther 4 2002 77 79
22. J. Neese, P. Duncan, D. Bayse, M. Robinson, T. Cooper, and C. Stewart Development and evaluation of a hexokinase/glucose-6-phosphate dehydrogenase procedure for use as a national glucose reference method. HEW Publication No. (CDC) 77-8330 1976 Centers for Disease Control Atlanta
23. U. Hannestad, and A. Lundblad Accurate and precise isotope dilution mass spectrometry method for determining glucose in whole blood Clin Chem 43 1997 794 800
24. H.W. Vesper, E. Archibold, K. Porter, and G.L. Myers Assessment of a reference procedure to collect and analyze glucose in capillary whole blood Clin Chem 51 2005 901 903
25. J.H. Nichols What is accuracy and how close must the agreement be? Diabetes Technol Ther 7 2005 558 562