Assessing the performance of handheld glucose testing for critical care

Diabetes Technology and Therapeutics

Volumn 10, Issue 6, 2008, Pages 445-451

  Kost, Gerald J ^a,c   Tran, Nam K ^a   Louie, Richard F ^a   Gentile, Nicole L ^a   Abad, Victor J ^b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b Epsilon Group   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE OXIDASE;

ARTICLE; BLOOD GLUCOSE METER; CALIBRATION; CLINICAL CHEMISTRY; CLINICAL LABORATORY; COMPARATIVE STUDY; CONTROLLED STUDY; DIAGNOSTIC ERROR; ENZYME ELECTRODE; GLUCOSE BLOOD LEVEL; GLUCOSE TOLERANCE; GLUCOSE TOLERANCE TEST; GLYCEMIC CONTROL; HOSPITAL ORGANIZATION; HUMAN; INTENSIVE CARE; LINEAR REGRESSION ANALYSIS; PLOTS AND CURVES; POINT OF CARE TESTING; PRIORITY JOURNAL; STANDARDIZATION; TEST STRIP; VENOUS BLOOD;

BLOOD GLUCOSE; CALIBRATION; CRITICAL CARE; HUMANS; LEAST-SQUARES ANALYSIS; POINT-OF-CARE SYSTEMS; PREDICTIVE VALUE OF TESTS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY;

EID: 57349154521     PISSN: 15209156     EISSN: None     Source Type: Journal    
DOI: 10.1089/dia.2008.0049     Document Type: Article

References (31)

1. 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;389:31-39.
2. Bland JM, Altman DG: Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986;1(8476):307-310.
3. International Organization for Standardization: In Vitro Diagnostic Test Systems - Requirements for Blood-Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus. International Standard. Report Number ISO 15197:2003(E). Geneva: International Organization for Standardization, 2003.
4. 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
5. Draft Guidance for Industry and FDA Staff-Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems. http://www.fda.gov/cdrh/ oivd/guidance/1603.html (accessed February 2, 2008).
6. Kost GJ, Louie R, Veerasamy N, Aleman K, Tran NK, Tang Z: Meeting the challenge of the International Standard ISO 15197 for capillary glucose accuracy [abstract]. Clin Chem 2005;51:A255.
7. 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-insensitive 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.
8. Lazar HL, Chipkin SR, Fitzgerald CA, Bao Y, Cabral H, Apstein CS: Tight glycemic control in diabetic coronary artery bypass graft improves perioperative outcomes and decreases recurrent ischemic events. Circulation 2004;109:1497-1502.
9. Zimmerman CR, Mlynarek ME, Jordan JA, Rajda CA, Horst HM: An insulin infusion protocol in critically ill cardiothoracic surgery patients. Ann Pharmacother 2004;38:1123-1129.
10. Krinsley JS, Grover A: Severe hypoglycemia in critically ill patients: risk factors and outcomes. Crit Care Med 2007;35:2262-2267.
11. Goldberg PA, Siegel MD, Sherwin RS, Halickman JI, Lee M, Bailey VA, Lee SL, Dziura JD, Inzucchi SE: Implementation of a safe and effective insulin infusion protocol in a medical intensive care unit. Diabetes Care 2004;27:461-467.
12. Meynaar IA, Dawson L, Tangkau PL, Salm E, Rijks L: Introduction and evaluation of a computerized insulin protocol. Intensive Care Med 2007;33:591-596.
13. Carr JM, Sellke FW, Fey M, Doyle MJ, Krempin JA, de la Torre R, Liddicoat JR: Implementing tight glucose control after coronary artery bypass surgery. Ann Thorac Surg 2005;80:902-909.
14. Pham TN, Warren AJ, Phan HH, Molitor F, Greenhalgh DG, Palmieri TL: Impact of tight glycemic control in severely burned children. J Trauma 2005;59:1148-1154.
15. Plank J, Blaha J, Cordingley J, Wilinska ME, Chassin LJ, Morgan C, Squire S, Haluzik M, Kremen J Svacina S, Toller W, Plasnik A, Ellmerer M, Hovorka R, Pieber TR: Multicentric, randomized, controlled trial to evaluate blood glucose control by the model predictive control algorithm versus routine glucose management protocols in intensive care unit patients. Diabetes Care 2006;29:271-276.
16. Van den Berghe G, Wouters P, Weekers F, Baxter RC, Wouters P, Iranmanesh A, Bouillon R, Veldhuis JD: Intensive insulin therapy in critically ill patients. N Engl J Med 2001;345:1359-1367.
17. Van den Berghe G, Wouters PJ, Bouillon R, Weekers F, Verwaest C, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P: Outcome benefit of intensive insulin therapy in the critically ill: insulin dose versus glycemic control. Crit Care Med 2003;31:359-366.
18. Van den Berghe G, Woulters PJ, Kesteloot K, Hilleman DE: Analysis of healthcare resource utilization with intensive insulin therapy in critically ill patients. Crit Care Med 2006;34:612-616.
19. Khan AI, Vasquez Y, Gray J, Wians FH Jr, Kroll MH: The variability of results between point-of-care testing glucose meters and the central laboratory analyzer. Arch Pathol Lab Med 2006;130:1527-1532.
20. Louie RF, Tang Z, Sutton DV, Lee JH, Kost GJ: Point-of-care glucose testing: effects of critical care variables, influence of reference instruments, and a modular glucose meter design. Arch Pathol Lab Med 2000;124:257-266.
21. 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.
22. Tang Z, Louie RF, Lee JH, Miller EE, Kost GJ: Oxygen effects on glucose meter measurements with glucose dehydrogenase- and oxidase-based test strips for point-of-care testing. Crit Care Med 2001;29:1062-1070.
23. Kost GJ: Preventing medical errors in point-of-care testing: security, validation, performance, safeguards, and connectivity. Arch Pathol Lab Med 2001;125:1307-1315.
24. Sumner SL, Louie RF, Vo L, Assistin R, Tran NK, Kost GJ: Environmental limits of POCT: relevance to disaster readiness [abstract]. Clin Chem 2007;53:A219.
25. Desachy A, Vuagnat AC, Ghazali AD, Baudin OT, Longuet OH, Calvat SN, Gissot V: Accuracy of bedside glucometry in critically ill patients: Influence of clinical characteristics and perfusion index. Mayo Clin Proc 2008;83:400-405.
26. Fahy BG, Coursin DB: Critical glucose control: the devil is in the details. Mayo Clin Proc 2008;83:394-397.
27. Food and Drug Administration: Important Safety Information on Interference with Blood Glucose Measurement Following Use of Parenteral Maltose/Parenteral Galactose/Oral Xylose-Containing Products. http://www. fda.gov/cber/safety/maltose110405.htm (accessed February 2, 2008).
28. Gaines AR, Pierce R, Bernhardt PA; Food and Drug Administration: Fatal Iatrogenic Hypoglycemia: Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product. April 18, 2008. http://www.fda.gov/cber/safety/glucfalse.htm (accessed August 3, 2008).
29. 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;356:178-183.
30. 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;10:111-120.
31. Holtzinger C, Szelag E, DuBois JA, Shirey TL, Presti S: Evaluation of a new POCT bedside glucose meter and strip with hematocrit and interference corrections. Point of Care 2008;7:5-10.