Performance Evaluation of Blood Glucose Monitoring Devices

Diabetes Technology and Therapeutics

Volumn 5, Issue 5, 2003, Pages 749-768

  Chen, Ellen T ^a   Nichols, James H ^b,e   Duh, Show Hong ^c   Hortin, Glen ^d  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b DEPARTMENT OF PATHOLOGY   (United States)

^c UNIVERSITY OF MARYLAND MEDICAL SYSTEM   (United States)

^d NATIONAL INSTITUTES OF HEALTH   (United States)

^e BAYSTATE HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HEXOKINASE;

ACCURACY; ARTICLE; BLOOD GLUCOSE MONITORING; CONFIDENCE INTERVAL; CORRELATION COEFFICIENT; GLUCOSE BLOOD LEVEL; HUMAN; HUMAN TISSUE; LINEAR REGRESSION ANALYSIS; MEASUREMENT; PRIORITY JOURNAL; STANDARDIZATION;

BLOOD CHEMICAL ANALYSIS; BLOOD GLUCOSE; CHROMATOGRAPHY, GAS; EVALUATION STUDIES; HUMANS; LINEAR MODELS; QUALITY CONTROL; REFERENCE VALUES; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0242300691     PISSN: 15209156     EISSN: None     Source Type: Journal    
DOI: 10.1089/152091503322526969     Document Type: Article

References (68)

1. Mokdad AH, Ford ES, Bowman BA, Nelson DE, Engelgau MM, Vinicor F, Marks JS: Diabetes trends in the U.S.: 1990-1998. Diabetes Care 2000;23:1278-1283.
2. McCarty D, Amos A, Zimmet P: The rising global burden of diabetes and its complications: estimates and projections to the year 2010. Diabet Med 1997;14(Suppl 5):S1-S85
3. Panzaram G: Mortality and survival in type 2 diabetes mellitus. Diabetologia 1990;39:540-545.
4. Laakso M: Hyperglycemia and cardiovascular disease in type 2 diabetes mellitus. Diabetes 1999;48:937-942.
5. 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 mellitus. N Engl J Med 1993;329:977-986.
6. UK Prospective Diabetes Study Group: Intensive blood glucose control with sulphonylureas or insulin compared witfh conventional treatment and risk of complication in patients with type 2 diabetes (UKPDS 33). Lancet 1998;352:837-853.
7. Sonksen PH, Judd SL, Lowy C: Home monitoring of blood glucose. Method for improving diabetic control. Lancet 1978;1:729-732.
8. Walford S, Gale EA, Allison SP, Tattersall RB: Self monitoring of blood glucose improvement of diabetic control. Lancet 1978;1:732-735.
9. Skyler JS, Lasky IA, Skyler DI, Robertson EG, Mintz DH: Home blood glucose monitoring as an aid in diabetes management. Diabetes Care 1978;1:150-157.
10. American Diabetes Association: Clinical practice recommendations 2000: implications of the Diabetes Control and Complications Trial. Diabetes Care 2000;23(Suppl 1):S24-S26.
11. American Diabetes Association: Tests of glycemia in diabetes. Diabetes Care 2000;23(Suppl 1):S80-S82.
12. Geffken G, Winter WE: Hardware and software in diabetes mellitus: performance characteristics of handheld glucose testing devices and the application of glycemic testing to patients' daily diabetes management. Clin Chem 2001;47:11-12.
13. Sacks DB, Bruns DE, Goldstein DE, Maclaren NK, McDonald JM, Parrott M: Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes. Clin Chem 2002;48:436-472.
14. Weitgasser R, Gappmayer B, Pichler M: Newer portable glucose meters #8212; analytical improvement compared with previous generation devices. Clin Chem 1999;45:1821-1825.
15. Chance JJ, Li DJ, Jones KA, Dyer KL, Nichols JH: Technical evaluation of five glucose meters with data management capabilities. Am J Clin Pathol 1999;111:547-556.
16. Greyson J: Quality control in patient self-monitoring of blood glucose. Diabetes Care 1993;16:1306-1308.
17. Improving glucose monitoring for diabetics. FDA Consumer 1990;May:32-35.
18. Consensus Development Panel: Consensus statement on self-monitoring of blood glucose. Diabetes Care 1987;10:95-99.
19. Price CP, Burrin JM, Nattrass M: Extra-laboratory blood glucose measurement: a policy statement. Diabet Med 1988;5:705-709.
20. American Diabetes Association. Self-monitoring of blood glucose. Diabetes Care 1994;17:81-86.
21. Center for Devices and Radiological Health, U.S. Food and Drug Administration. Draft guidance document: Review criteria for assessment of portable blood glucose monitoring in vitro diagnostic devices using glucose oxidase, dehydrogenase or hexokinase methodology, February 28, 1997. Available online at: www.fda.gov
22. ISO/DIS 15197 document: Requirements for in vitro blood glucose monitoring systems for self-testing in managing diabetes mellitus, 2002. Available online at: www.iso.org
23. 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.
24. Weiss SL, Cembrowski GS, Mazze RS: Patient and physician analytic goals for self-monitoring blood glucose instruments. Am J Clin Pathol 1994;102:611-615.
25. Skeie S, Thue G, Sandberg S: Patient-derived quality specifications for instruments used in self-monitoring of blood glucose. Clin Chem 2001;47:67-73.
26. Chmielewski SA: Advances and strategies for glucose monitoring. Am J Clin Pathol 1995;104(Suppl 1):S59-S71.
27. Hortin GL: Handbook of Bedside Glucose Testing. Washington, DC: American Association of Clinical Chemistry Press, 1998.
28. Tamada JA, GargS, Jovanovic L, Pitzer KR, Fermi S, Potts RO, Cygnus Research Team: Noninvasive glucose monitoring: comprehensive clinical results. JAMA 1999;282:1839-1844.
29. Mastrototaro J: The MiniMed continuous glucose monitoring system. J Pediatr Endocrinol Metab 1999;12:751-758.
30. Naito HK, Kwak YS, Cottingham C: Accuracy of the One Touch II whole blood glucose analyzer when used by analysis with diverse technical backgounds. J Fam Pract 1993;37:153-157.
31. Fangbanel GSL, Morales M, Torres E, Chavira J, Sotres D, Valles V: Comparative accuracy of glucose monitors. Arch Med Res 1998;29:325-329.
32. Glasmacher AG, Brennemann W, Hahn C, Wehnert S, Lohr U, Kutschkow R: Evaluation of five devices for self-monitoring of blood glucose in the normoglycaemic range. Exp Clin Endocrinol Diabetes 1998;106:360-364.
33. Perkins SL, Doelle H, Escares E, Forsythe J, Pronovost C, Taylor-Clapp S: Laboratory and clinical evaluation of two glucose meters for the neonatal intensive care unit. Clin Biochem 1998;31:67-71.
34. Moses R, Schier G, Mathews J, Davis W: The accuracy of home glucose meters for the glucose range anticipated in pregnancy. Aust NZ J Obstet Gynaecol 1997;37:282-286.
35. Jones BA, Bachner P, Howanitz PJ: Bedside glucose monitoring: A College of American Pathologists Q-Probes study of the program characteristics and performance in 605 institutions. Arch Pathol Lab Med 1993;117:1080-1087.
36. Novis DA, Jones BA: Interinstitutional comparison of bedside blood glucose monitoring program characteristics, accuracy performance, and quality control documentation: a College of American Pathologists Q-Probes study of bedside blood glucose monitoring performed in 226 small hospitals. Arch Pathol Lab Med 1998;122:495-502.
37. Stahl M, Jorgensen LGM, Petersen PH, Brandslund I, Olivarius NDF, Borch-Johnsen K: Optimization of preanalytical conditions and analysis of plasma glucose. 1. Impact of the new WHO and ADA recommendations on diagnosis of diabetes mellitus. Scand J Clin Lab Invest 2001;61:169-180.
38. College of American Pathologists: Participant Summary for Survey C-B, General Chemistry, Survey 2001 C-B. Northfield, IL: College of American Pathologists, 2001:27-29.
39. Ross JW, Miller G, Myers GL, Praestgaard J: The accuracy of laboratory measurements in clinical chemistry. A study of 11 routine chemistry analytes in the College of American Pathologists chemistry survey with fresh frozen serum, definitive methods, and reference methods. Arch Pathol Lab Med 1998;122:587-608.
40. Tang Z, Lee JH, Louie RF, Kost GJ: Effects of different hematocrit levels on glucose measurements with handheld meters for point-of-care testing. Arch Pathol Lab Med 2000;124:1135-1140.
41. Fogh-Andersen N, D'Orazio P: Proposal for standardizing direct-reading biosensors for blood glucose. Clin Chem 1998;44:655-659.
42. IFCC Scientific Division, Working Group on Elecrrodes: IFCC recommendations on reporting results for blood glucose. Clin Chim Acta 2001;307:205-209.
43. Larsson-Conn U: Differences between capillary and venous blood glucose during oral glucose tolerance tests. Scand J Clin Lab Invest 1976;36:85-88.
44. Poirier JY, Le Prieur N, Campion L, Guilhem I, Allannic H, Maugendre D: Clinical and statistical evaluation of self-monitoring blood glucose meters. Diabetes Care 1998;21:1919-1924.
45. White E, Welch MJ, Sun T, Sniegoski LT, Schaffer R, Hertz HS, Cohen A: The accurate determination of serum glucose by isotope dilution mass spectrometry - two methods. Biomed Mass Spectrom 1982;9:395-405.
46. Kost GJ, Nguyen TH, Tang Z: Whole-blood glucose and lactate: trilayer biosensors, drug interference, metabolism, and practice guide. Arch Pathol Lab Med 2000;124:1128-1134.
47. Chen ET, Luu H-MD, Schroeder LW: Error analysis of three commonly used blood glucose methods in two accredited clinical laboratories [abstract]. Clin Chem 1998;44:Al39.
48. National Committee for Clinical Laboratory Standards (NCCLS) EP9-P: User Comparison of Quantitative Clinical Laboratory Methods Using Patient Samples. Approved Guideline. Villanova, PA: NCCLS, 1993.
49. National Committee for Clinical Laboratory Standards (NCCLS) EP5-T2: Precision Performance of Clinical Chemistry Devices, 2nd ed.: Tentative Guideline. Villanova, PA: NCCLS, 1992.
50. National Committee for Clinical Laboratory Standards (NCCLS) EP6-T: Evaluation of the Linearity of Quantitative Analytical Methods. Villanova, PA: NCCLS, 1992.
51. Kaplan LA, Pesce A: Clinical Chemistry Theory, Analysis, Correlation, 3rd ed. St. Louis: Mosby, 1996:353.
52. 2001 US Hospitals Point-of-Care Survey Report. June 2001. Stamford, CT: Enterprise Analysis Corporation.
53. National Committee for Clinical Laboratory Standards (NCCLS) C30-A. Villanova, PA: NCCLS, 1992.
54. American Diabetes Association: Consensus statement on self-monitoring of blood glucose. Diabetes Care 1996;9(Suppl):S62-S66.
55. American Diabetes Association: Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes Care 2002;25(Suppl):S5-S20.
56. U.S. Food and Drug Administration: Draft guidance to manufacturers of in vitro analytical test systems for preparation of premarket submissions implementing the clinical laboratory improvement amendments of 1988). Federal Register January 12, 1993;50(7).
57. Cox DJ, Kovatchev BP, Clarke WL, Gonder-Frederick LA, Trajanoski Z: Accuracy of home blood glucose meters for prediction of severe hypoglycemia (SH) [abstract]. Diabetes 1999;48(Suppl 1):A101
58. Kovatchev BP, Cox DJ, Gonder-Frederick LA, Clarke WL: Symmetrization of the blood glucose measurement scale and its applications. Diabetes Care 1997;20:1655-1658.
59. Nichols JH, Howard C, Loman K, Miller C, Nyberg D, Chan DW: Laboratory and bedside evaluation of portable glucose meters. Am J Clin Pathol 1995;103:244-251.
60. Kost GJ, Vu HT, Lee JH, Bourgeois P, Kiechle FL, Martin C, Miller SS, Okorodudu AO, Podczasy JJ, Webster R, Whitlow KJ: Multicenter study of oxygen-in-sensitive handheld glucose point-of-care testing in critical care/hospital/ambulatory patients in the United States and Canada. Crit Care Med 1998;26:581-590.
61. Louie RF, Tang Z, Sutton DV, Lee JH, Kost GJ: Point-of-care testing: effects of critical care variables, influence of reference instruments, and a modular glucose meter design. Arch Pathol Lab Med 2000;124:257-266.
62. Meehan CD, Bove LA, Jennings AS: Comparison of first-generation and second-generation blood glucose meters for use in a hospital setting. Diabetes Educ 1992;18:228-231.
63. Johnson RN, Baker JR: Accuracy of devices used for self-monitoring of blood glucose. Ann Clin Biochem 1998;35:68-74.
64. Glasmacher AG, Brennemann W, Hahn C, Marko C, Wehnert S, Löhr U, Kutschkow R: Evaluation of five devices for self-monitoring of blood glucose in the normoglycaemic range. Exp Clin Endocrinol Diabetes 1998;106:360-364.
65. Workshop on Measurement Traceability for Clinical Laboratory Testing and In Vitro Diagnostic Test Systems, November 2-3, 2000. Sponsored by NIST, Gaithersburg, MD.
66. Ladenson JH, Tsai LM, Michael JM, Kessler G, Joist H: Serum versus heparinized plasma for eighteen common chemistry tests: is serum the appropriate specimen? Am J Clin Pathol 1974;62:545-552.
67. Nichols JH: Limitations of point-of-care testing. Diabetes Technol Ther 2000;2:363-365.
68. Skeie S, Thue G, Nerhus K, Sandberg S: Instruments for self-monitoring of blood glucose: comparisons of testing quality achieved by patients and a technician. Clin Chem 2002;48:994-1003.