The need for clinical accuracy guidelines for blood glucose monitors

Journal of Diabetes Science and Technology

Volumn 6, Issue 1, 2012, Pages 1-4

  Klonoff, David C ^a  

^a Mills Peninsula Health Services   (United States)

Author keywords

Accuracy; Blood glucose monitor; Error grid; FDA; ISO; Statistic

Indexed keywords

GLUCOSE; INSULIN;

BLOOD GLUCOSE MONITORING; CLINICAL LABORATORY; EDITORIAL; MEASUREMENT ACCURACY; MEASUREMENT ERROR; PRACTICE GUIDELINE; REFERENCE VALUE; STANDARD; BIOLOGICAL MODEL; DEVICES; ENDOCRINOLOGY; FOOD AND DRUG ADMINISTRATION; GLUCOSE BLOOD LEVEL; HEALTH SERVICE; HUMAN; INSTRUMENTATION; LEGAL ASPECT; PRODUCTIVITY; SENSITIVITY AND SPECIFICITY; UNITED STATES;

BLOOD GLUCOSE; BLOOD GLUCOSE SELF-MONITORING; EFFICIENCY; ENDOCRINOLOGY; EQUIPMENT AND SUPPLIES; GUIDELINES AS TOPIC; HEALTH SERVICES NEEDS AND DEMAND; HUMANS; MODELS, BIOLOGICAL; SENSITIVITY AND SPECIFICITY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84863571079     PISSN: None     EISSN: 19322968     Source Type: Journal    
DOI: 10.1177/193229681200600101     Document Type: Editorial

References (19)

1. Krouwer JS, Cembrowski GS. A review of standards and statistics used to describe blood glucose monitor performance. J Diabetes Sci Technol. 2010;4(1):75-83.
2. Boren SA, Clarke WL. Analytical and clinical performance of blood glucose monitors. J Diabetes Sci Technol. 2010;4(1):84-97.
3. Clinical Laboratory Standards Institute. EP27-P. Vol. 29, No. 16. How to construct and interpret an error grid for diagnostic assays; proposed guideline. http://www.clsi.org/source/orders/free/ep27-p.pdf. Accessed December 6, 2011.
4. http://www.clsi.org/Content/NavigationMenu/Committees/ EvaluationProtocols/ProjectsinDevelopment/Projects-in-Developm.htm. Accessed December 6, 2011.
5. 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(5):622-8. (Pubitemid 17158937)
6. 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(8):1143-8. (Pubitemid 30616803)
7. Garg SK, Potts RO, Ackerman NR, Fermi SJ, Tamada JA, Chase HP. Correlation of fingerstick blood glucose measurements with GlucoWatch biographer glucose results in young subjects with type 1 diabetes. Diabetes Care. 1999;22(10):1708-14. (Pubitemid 29458398)
8. Kollman C, Wilson DM, Wysocki T, Tamborlane WV, Beck RW. Diabetes Research in Children Network Study Group. Limitations of statistical measures of error in assessing the accuracy of continuous glucose sensors. Diabetes Technol Ther. 2005;7(5):665-72. (Pubitemid 41572065)
9. Kovatchev BP, Gonder-Frederick LA, Cox DJ, Clarke WL. Evaluating the accuracy of continuous glucose-monitoring sensors: continuous glucose-error grid analysis illustrated by TheraSense Freestyle Navigator data. Diabetes Care. 2004;27:1922-8. (Pubitemid 38989233)
10. Ellmerer M, Haluzik M, Blaha J, Kremen J, Svacina S, Toller W, Mader J, Schaupp L, Plank J, Pieber T. Clinical evaluation of alternative-site glucose measurements in patients after major cardiac surgery. Diabetes Care. 2006;29(6):1275-81. (Pubitemid 44125922)
11. Dobromylskyj MJ, Sparkes AH. Assessing portable blood glucose meters for clinical use in cats in the United Kingdom. Vet Rec. 2010;167(12):438-42.
12. Hemkens LG, Hilden KM, Hartschen S, Kaiser T, Didjurgeit U, Hansen R, Bender R, Sawicki PT. A randomized trial comparing INR monitoring devices in patients with anticoagulation selfmanagement: evaluation of a novel error-grid approach. J Thromb Thrombolysis. 2008;26(1):22-30.
13. Torreiro EG, Fernández EG, Rodríguez RM, López CV, Núñez JB. Comparative study of accuracy and clinical agreement of the CoaguChek XS portable device versus standard laboratory practice in unexperienced patients. Thromb Haemost. 2009;101(5):969-74.
14. Petersen JR, Vonmarensdorf HM, Weiss HL, Elghetany MT. Use of error grid analysis to evaluate acceptability of a point of care prothrombin time meter. Clin Chim Acta. 2010;411(3-4):131-4.
15. Klonof DC. The Food and Drug Administration is now preparing to establish tighter performance requirements for blood glucose monitors. J Diabetes Sci Technol. 2010;4(3):499-504.
16. Klonof DC. Improving the safety of blood glucose monitoring. J Diabetes Sci Technol. 2011;5(6):1307-11.
17. The Diabetes Control and Complications Research Group. The efect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993;329:977-86.
18. [No authors listed]. Rapid-acting insulin approved for marketing. Am J Health Syst Pharm. 1996;53(19):2250.
19. American Association for Clinical Chemistry. Blood glucose meters: is FDA ready to tighten up accuracy standards? Clinical Laboratory News. 2010;36(5). http://www.aacc.org/publications/cln/2010/may/Pages/CoverStory1May2010. asp. Accessed December 8, 2011.