Analytical and clinical performance of blood glucose monitors

Journal of Diabetes Science and Technology

Volumn 4, Issue 1, 2010, Pages 84-97

  Boren, Suzanne Austin ^a,b,c   Clarke, William L ^d  

^a VETERANS AFFAIRS MEDICAL CENTER   (United States)

^b UNIVERSITY OF MISSOURI   (United States)

^c University of Missouri   (United States)

^d UNIVERSITY OF VIRGINIA HEALTH SYSTEM   (United States)

Author keywords

Diabetes mellitus; Glucose; Glycemic control; Laboratory techniques and procedures; Point of care

Indexed keywords

AMBULATORY MONITORING; BLOOD; BLOOD GLUCOSE MONITORING; DIABETES MELLITUS; EQUIPMENT; EVALUATION; GLUCOSE BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; INSTRUMENTATION; METHODOLOGY; PRODUCTIVITY; REVIEW; STANDARD;

BLOOD GLUCOSE; BLOOD GLUCOSE SELF-MONITORING; DIABETES COMPLICATIONS; DIAGNOSTIC EQUIPMENT; EFFICIENCY; HUMANS; HYPOGLYCEMIA; MONITORING, AMBULATORY;

EID: 77954685027     PISSN: None     EISSN: 19322968     Source Type: Journal    
DOI: 10.1177/193229681000400111     Document Type: Conference Paper

References (40)

1. Bergenstal RM. Evaluating the accuracy of modern glucose meters. Insulin. 2008;3:5-14.
2. Arabadjief D, Nichols JH. Assessing glucose meter accuracy. Curr Med Res Opin. 2006;2(11):2167-74.
3. Bode BW. The accuracy and interferences in self-monitoring of blood glucose. US Endocr Dis Touch Brief. 2007;4-6.
4. Dungan K, Braithwaite SS, Chapman J, Buse J. Glucose measurement: confounding issues in setting targets for inpatient management. Diabetes Care. 2007;30(2):403-9.
5. Hirsch IB, Bode BW, Childs BP, Close KL, Fisher WA, Gavin JR, Ginsberg BH, Raine CH, Verderese CA. Self-monitoring of blood glucose (SMBG) in insulin- and non-insulin-using adults with diabetes: consensus recommendations for improving SMBG accuracy, utilization, and research. Diabetes Technol Ther. 2008;10(6):419-39.
6. Mahoney JJ, Ellison JM. Assessing glucose monitor performance--a standardized approach. Diabetes Technol Ther. 2007;9(6):545-52.
7. Bewley B, O'Rahilly S, Tassell R, DuBois J, Donald E. Evaluation of the analytical specificity and clincal application of a new generation hospital-based glucose meter in a dialysis setting. Point Care. 2009;8(2):61-7.
8. Chan PC, Rozmanc M, Seiden-Long I, Kwan J. Evaluation of a point-of-care glucose meter for general use in complex tertiary care facilities. Clin Biochem. 2009;42(10-11):1104-12.
9. Chen ET, Nichols JH, Duh SH, Hortin G. Performance evaluation of blood glucose monitoring devices. Diabetes Technol Ther. 2003;5(5):749-68.
10. Cohen M, Boyle E, Delaney C, Shaw J. A comparison of blood glucose meters in Australia. Diabetes Res Clin Pract. 2006;71(2):113-8.
11. Flore KM, Fiers T, Delanghe JR. Critical evaluation of connectivitybased point of care testing systems of glucose in a hospital environment. Clin Chem Lab Med. 2008;46(12):1763-8.
12. Karon BS, Griesmann L, Scott R, Bryant SC, Dubois JA, Shirey TL, Presti S, Santrach PJ. Evaluation of the impact of hematocrit and other interference on the accuracy of hospital-based glucose meters. Diabetes Technol Ther. 2008;10(2):111-20.
13. Kimberly MM, Vesper HW, Caudill SP, Ethridge SF, Archibold E, Porter KH, Myers GL. Variability among five over-the-counter blood glucose monitors. Clin Chim Acta. 2006;364(1-2):292-7.
14. Kost GJ, Tran NK, Abad VJ, Louie RF. Evaluation of point-of-care glucose testing accuracy using locally-smoothed median absolute difference curves. Clin Chim Acta. 2008;389(1-2):31-9.
15. Kost GJ, Tran NK, Louie RF, Gentile NL, Abad VJ. Assessing the performance of handheld glucose testing for critical care. Diabetes Technol Ther. 2008;10(6):445-51.
16. Lippi G, Salvagno GL, Guidi GC, Negri M, Rizzotti P. Evaluation of four portable self-monitoring blood glucose meters. Ann Clin Biochem. 2006;43(Pt 5):408-13.
17. Rao LV, Jakubiak F, Sidwell JS, Winkelman JW, Snyder ML. Accuracy evaluation of a new glucometer with automated hematocrit measurement and correction. Clin Chim Acta. 2005;356(1-2):178-83.
18. Savoca R, Jaworek B, Huber AR. New "plasma referenced" POCT glucose monitoring systems--are they suitable for glucose monitoring and diagnosis of diabetes? Clin Chim Acta. 2006;372(1-2):199-201.
19. Slingerland RJ, Muller W, Meeues JT, Van Blerk I, Gouka-Tseng C, Dollahmoersid R, Witteveen C, Vroonhof K. The quality of blood glucose meters in the Netherlands 5 years after introduction of the CE/IVD directive. Ned Tijdschr Klin Chem Labgeneesk. 2007;32:202-4.
20. Thomas A, Sall S, Roberts C, Drayton M, DuBois J, Clampitt R. An evaluation of the analytical performance of a new-generation hospital-based glucose meter and an assessment of its clinical reliability in a neonatal care unit. Point Care. 2009;8:68-73.
21. Alto WA, Meyer D, Schneid J, Bryson P, Kindig J. Assuring the accuracy of home glucose monitoring. J Am Board Fam Pract. 2002;15(1):1-6.
22. Weinzimer SA, Beck RW, Chase HP, Fox LA, Buckingham BA, Tamborlane WV, Kollman C, Coffey J, Xing D, Ruedy KJ; Diabetes Research in Children Network Study Group. Accuracy of newer generation home blood glucose meters in a diabetes research in children network (DirecNet) inpatient exercise study. Diabetes Technol Ther. 2005;7(5):675-83.
23. Garg SK, Carter JA, Mullen L, Folker AC, Parkes JL, Tideman AM. The clinical performance and ease of use of a blood glucose meter that uses a 10-test disk. Diabetes Technol Ther. 2004;6(4):495-502.
24. Henry MJ, Major CA, Reinsch S. Accuracy of self-monitoring of blood glucose: impact on diabetes management decisions during pregnancy. Diabetes Educ. 2001;27(4):521-9.
25. Kilo C, Pinson M, Joynes JO, Joseph H, Monhaut N, Parkes JL, Baum J. Evaluation of a new blood glucose monitoring system with auto-calibration. Diabetes Technol Ther. 2005;7(2):283-94.
26. Kilo C Sr, Dickey WT Jr, Joynes JO, Pinson MB, Baum JM, Parkes JL, Parker DR. Evaluation of a new blood glucose monitoring system with auto-calibration for home and hospital bedside use. Diabetes Res Clin Pract. 2006;74(1):66-74.
27. Kristensen GB, Nerhus K, Thue G, Sandberg S. Results and feasibility of an external quality assessment scheme for selfmonitoring of blood glucose. Clin Chem. 2006;52(7):1311-7.
28. Kristensen GB, Monsen G, Skeie S, Sandberg S. Standardized evaluation of nine instruments for self-monitoring of blood glucose. Diabetes Technol Ther. 2008;10(6):467-77.
29. Meynaar IA, van Spreuwel M, Tangkau PL, Dawson L, Visser SS, Rijks L, Vlieland TV. Accuracy of AccuChek glucose measurement in intensive care patients. Crit Care Med. 2009;37(10):2691-6.
30. Boyd JC, Bruns DE. Quality specifications for glucose meters: assessment by simulation modeling of errors in insulin dose. Clin Chem. 2001;47(2):209-14.
31. Karon BS, Deobald G, Klee GG. Effect of different glucose meter error tolerances on dosing errors during intravenous insulin administration. Point Care. 2008;7(3):124.
32. Clarke W, Cox D, Gonder-Frederick L, Carter W, Pohl S. Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care. 1987;10(5):622-8.
33. Pohl S, Gonder-Frederick L, Cox D, Evans W. Self-measurement of blood glucose concentration: clinical significance of patientgenerated measurements. Diabetes Care. 1985;8(6):617-9.
34. International Organization for Standardization. In vitro diagnostic test systems: requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197). Geneva: International Organization for Standardization; 2003.
35. Parkes JL, Pardo S, Slatin SL, Ginsberg BH. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care. 2000;23(8):1143-8.
36. Klonoff D. The need for separate performance goals for glucose sensors in the hypoglycemic, normoglycemia, and hyperglycemic ranges. Diabetes Care. 2004;27:834-6.
37. US Food and Drug Administration. Review criteria assessment of portable blood glucose monitoring in vitro diagnostic devices using glucose oxidase, dehydrogenase, or hexokinase methodology (version 02/14/96). Available from: www.fds.cdrh/ode/glu.html.
38. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes. N Engl J Med. 1993;329(14):977-86.
39. Scott MG, Bruns DE, Boyd JC, Sacks DB. Tight glucose control in the intensive care unit: are glucose meters up to the task? Clin Chem. 2009;55(1):18-20.
40. American Diabetes Association. Self-monitoring of blood glucose. Diabetes Care. 1994;17(1):81-6.