The Accuracy of Point-of-Care Glucose Measurements

Control of blood glucose (BG) in an acceptable range is a major therapy target for diabetes patients in both the hospital and outpatient environments. This review focuses on the state of point-of-care (POC) glucose monitoring and the accuracy of the measurement devices. The accuracy of the POC glucose monitor depends on device methodology and other factors, including sample source and collection and patient characteristics. Patient parameters capable of influencing measurements include variations in pH, blood oxygen, hematocrit, changes in microcirculation, and vasopressor therapy. These elements alone or when combined can significantly impact BG measurement accuracy with POC glucose monitoring devices (POCGMDs). In general, currently available POCGMDs exhibit the greatest accuracy within the range of physiological glucose levels but become less reliable at the lower and higher ranges of BG levels. This issue raises serious safety concerns and the importance of understanding the limitations of POCGMDs. This review will discuss potential interferences and shortcomings of the current POCGMDs and stress when these may impact the reliability of POCGMDs for clinical decision-making.

[1]  D. Cox,et al.  Evaluating Clinical Accuracy of Systems for Self-Monitoring of Blood Glucose , 1987, Diabetes Care.

[2]  M. Comtat,et al.  Enzymatic amplification for spectrophotometric and electrochemical assays of NAD+ and NADH. , 1989, Analytical biochemistry.

[3]  W. Thrash,et al.  Performance of Seven Blood Glucose Testing Systems at High Altitude , 1989, The Diabetes educator.

[4]  M. Mahoney.  Fingerstick glucose determination in shock , 1991 .

[5]  I Gibb,et al.  HemoCue: evaluation of a portable photometric system for determining glucose in whole blood. , 1992, Clinical chemistry.

[6]  K. Wiener.  An Assessment of the Effect of Haematocrit on the Hemocue Blood Glucose Analyser , 1993, Annals of clinical biochemistry.

[7]  R. Maser,et al.  Use of arterial blood with bedside glucose reflectance meters in an intensive care unit: Are they accurate? , 1994, Critical care medicine.

[8]  E. Kilpatrick,et al.  Variations in Sample pH and pO2 Affect ExacTech Meter Glucose Measurements , 1994, Diabetic medicine : a journal of the British Diabetic Association.

[9]  T. Whitley,et al.  Accuracy of fingerstick glucose values in shock patients. , 1995, American journal of critical care : an official publication, American Association of Critical-Care Nurses.

[10]  D. Cox,et al.  Understanding Error Grid Analysis , 1997, Diabetes Care.

[11]  R. Weitgasser,et al.  Newer portable glucose meters--analytical improvement compared with previous generation devices? , 1999, Clinical chemistry.

[12]  G J Kost,et al.  Point-of-care glucose testing: effects of critical care variables, influence of reference instruments, and a modular glucose meter design. , 2000, Archives of pathology & laboratory medicine.

[13]  G J Kost,et al.  Effects of drugs on glucose measurements with handheld glucose meters and a portable glucose analyzer. , 2000, American journal of clinical pathology.

[14]  G J Kost,et al.  Effects of pH on glucose measurements with handheld glucose meters and a portable glucose analyzer for point-of-care testing. , 2000, Archives of pathology & laboratory medicine.

[15]  B H Ginsberg,et al.  A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. , 2000, Diabetes care.

[16]  G J Kost,et al.  Oxygen effects on glucose measurements with a reference analyzer and three handheld meters. , 2000, Diabetes technology & therapeutics.

[17]  J G Ray,et al.  Pilot study of the accuracy of bedside glucometry in the intensive care unit , 2001, Critical care medicine.

[18]  P J Stout,et al.  Comparison of glucose levels in dermal interstitial fluid and finger capillary blood. , 2001, Diabetes technology & therapeutics.

[19]  G J Kost,et al.  Oxygen effects on glucose meter measurements with glucose dehydrogenase- and oxidase-based test strips for point-of-care testing , 2001, Critical care medicine.

[20]  B. Bistrian,et al.  Intensive insulin therapy in critically ill patients. , 2002, The New England journal of medicine.

[21]  James H Nichols,et al.  Performance evaluation of blood glucose monitoring devices. , 2003, Diabetes technology & therapeutics.

[22]  T. Forst,et al.  Investigation on the accuracy of the blood glucose monitoring device Prestige IQ. , 2003, Diabetes, nutrition & metabolism.

[23]  A multicenter study of the accuracy of the One Touch Ultra home glucose meter in children with type 1 diabetes. , 2003, Diabetes technology & therapeutics.

[24]  Chien-Chih Chen,et al.  Accuracy of the EasyTouch blood glucose self-monitoring system: a study of 516 cases. , 2004, Clinica chimica acta; international journal of clinical chemistry.

[25]  M. Agarwal,et al.  Evaluation of a glucose meter against analytical quality specifications for hospital use. , 2004, Clinica chimica acta; international journal of clinical chemistry.

[26]  Brian Hutton,et al.  Reliability of point-of-care testing for glucose measurement in critically ill adults* , 2005, Critical care medicine.

[27]  B. Afessa,et al.  Agreement between bedside blood and plasma glucose measurement in the ICU setting. , 2005, Chest.

[28]  G. Lipowsky,et al.  The Accutrend sensor glucose analyzer may not be adequate in bedside testing for neonatal hypoglycemia , 2006, European Journal of Pediatrics.

[29]  R. Hawkins,et al.  Evaluation of Roche Accu-Chek Go and Medisense Optium blood glucose meters. , 2005, Clinica chimica acta; international journal of clinical chemistry.

[30]  T. Veneman,et al.  Comparison of the accuracy of the HemoCue glucose analyzer with the Yellow Springs Instrument glucose oxidase analyzer, particularly in hypoglycemia. , 2005, European journal of endocrinology.

[31]  Roy A Kaplan,et al.  Accuracy and utility of a 10-test disk blood glucose meter. , 2005, Diabetes research and clinical practice.

[32]  J. Winkelman,et al.  Accuracy evaluation of a new glucometer with automated hematocrit measurement and correction. , 2005, Clinica chimica acta; international journal of clinical chemistry.

[33]  Jerzy W. Naskalski,et al.  Quality Control of SMBG in Clinical Practice , 2005, Scandinavian journal of clinical and laboratory investigation. Supplementum.

[34]  Matthew Cohen,et al.  A comparison of blood glucose meters in Australia. , 2006, Diabetes research and clinical practice.

[35]  P. Marik,et al.  ACCURACY OF BEDSIDE CAPILLARY BLOOD GLUCOSE MEASUREMENTS IN CRITICALLY ILL PATIENTS.: 259 , 2006 .

[36]  G. Van den Berghe,et al.  Intensive insulin therapy in the medical ICU. , 2006, The New England journal of medicine.

[37]  R. Busch,et al.  Precision and accuracy of two blood glucose meters: FreeStyle Flash versus One Touch Ultra. , 2006, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[38]  Martin H Kroll,et al.  The variability of results between point-of-care testing glucose meters and the central laboratory analyzer. , 2006, Archives of pathology & laboratory medicine.

[39]  G. Lippi,et al.  Evaluation of four portable self-monitoring blood glucose meters , 2006, Annals of clinical biochemistry.

[40]  J. Nichols,et al.  Assessing glucose meter accuracy , 2006, Current medical research and opinion.

[41]  Interference of Accel wipes with LifeScan SureStep Flexx glucose meters. , 2006, Clinical biochemistry.

[42]  Katsuhiko Kuwa,et al.  Approved IFCC recommendation on reporting results for blood glucose: International Federation of Clinical Chemistry and Laboratory Medicine Scientific Division, Working Group on Selective Electrodes and Point-of-Care Testing (IFCC-SD-WG-SEPOCT) , 2006, Clinical chemistry and laboratory medicine.

[43]  C. Bellini,et al.  Reliability assessment of glucose measurement by HemoCue analyser in a neonatal intensive care unit. , 2007, Clinical chemistry and laboratory medicine.

[44]  Hartzell V Schaff,et al.  Accuracy of roche accu-chek inform whole blood capillary, arterial, and venous glucose values in patients receiving intensive intravenous insulin therapy after cardiac surgery. , 2007, American journal of clinical pathology.

[45]  Maryclare Prasnikar,et al.  Comparison of point-of-care and laboratory glucose analysis in critically ill patients. , 2007, American journal of critical care : an official publication, American Association of Critical-Care Nurses.

[46]  Amy Callahan,et al.  Accuracy of bedside capillary blood glucose measurements in critically ill patients , 2006, Intensive Care Medicine.

[47]  J. G. van der Hoeven,et al.  Accuracy of bedside glucose measurement from three glucometers in critically ill patients* , 2008, Critical care medicine.

[48]  J. Dora,et al.  Standards of Medical Care in Diabetes—2008 , 2008, Diabetes Care.

[49]  B. Karon,et al.  Evaluation of the Impact of Hematocrit and Other Interference on the Accuracy of Hospital-Based Glucose Meters , 2008 .

[50]  B. Karon,et al.  Evaluation of the impact of hematocrit and other interference on the accuracy of hospital-based glucose meters. , 2008, Diabetes technology & therapeutics.

[51]  Lothar Siekmann,et al.  State of the art in trueness and interlaboratory harmonization for 10 analytes in general clinical chemistry. , 2008, Archives of pathology & laboratory medicine.

[52]  A. Vuagnat,et al.  Accuracy of bedside glucometry in critically ill patients: influence of clinical characteristics and perfusion index. , 2008, Mayo Clinic proceedings.

[53]  V. Cardenas,et al.  Comparison of POCT and central laboratory blood glucose results using arterial, capillary, and venous samples from MICU patients on a tight glycemic protocol. , 2008, Clinica chimica acta; international journal of clinical chemistry.

[54]  Joakim Hagvik.  Comment on: Bellini C, Serra G, Risso D, Mazzella M, Bonioli E. Reliability assessment of glucose measurement by HemoCue analyser in a neonatal intensive care unit. Clin Chem Lab Med 2007;45(11):1549–54 , 2008, Clinical chemistry and laboratory medicine.

[55]  G. Cembrowski,et al.  Accuracy of glycemic measurements in the critically ill. , 2008, Diabetes technology & therapeutics.

[56]  R. Busch,et al.  A glucose meter accuracy and precision comparison: the FreeStyle Flash Versus the Accu-Chek Advantage, Accu-Chek Compact Plus, Ascensia Contour, and the BD Logic. , 2008, Diabetes technology & therapeutics.

[57]  D. Alter,et al.  Tight glycemic control and point-of-care testing. , 2009, Clinics in laboratory medicine.

[58]  M. J. Rice,et al.  Challenges to Glycemic Measurement in the Perioperative and Critically Ill Patient: A Review , 2009, Journal of diabetes science and technology.

[59]  S. Crawford.  The U.S. Food and Drug Administration , 2009 .

[60]  Mary T Korytkowski,et al.  American Association of Clinical Endocrinologists and American Diabetes Association consensus statement on inpatient glycemic control. , 2009, Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists.

[61]  Lisa Halvorsen,et al.  Differences in glucose values obtained from point-of-care glucose meters and laboratory analysis in critically ill patients. , 2009, American journal of critical care : an official publication, American Association of Critical-Care Nurses.

[62]  Richard Hellman,et al.  American Association of Clinical Endocrinologists and American Diabetes Association consensus statement on inpatient glycemic control. , 2009, Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists.

[63]  R. Busch,et al.  Accuracy and precision of four value-added blood glucose meters: the Abbott Optium, the DDI Prodigy, the HDI True Track, and the HypoGuard Assure Pro. , 2009, Diabetes technology & therapeutics.

[64]  Stephane Heritier,et al.  Intensive versus conventional glucose control in critically ill patients. , 2009, The New England journal of medicine.

[65]  Ksenia Tonyushkina,et al.  Glucose Meters: A Review of Technical Challenges to Obtaining Accurate Results , 2009, Journal of diabetes science and technology.

[66]  Brenda G Fahy,et al.  Glucose control in the intensive care unit , 2009, Critical care medicine.

[67]  C. Florkowski,et al.  Comparison of blood glucose meters in a New Zealand diabetes centre , 2009, Annals of clinical biochemistry.

[68]  P. Tangkau,et al.  Accuracy of AccuChek glucose measurement in intensive care patients * , 2009, Critical care medicine.

[69]  Desmond E. Williams,et al.  Full Accounting of Diabetes and Pre-Diabetes in the U.S. Population in 1988–1994 and 2005–2006 , 2009, Diabetes Care.

[70]  Devery Howerton,et al.  Proficiency testing performance in US laboratories: results reported to the Centers for Medicare & Medicaid Services, 1994 through 2006. , 2010, Archives of pathology & laboratory medicine.

[71]  S. Elatrous,et al.  Bedside capillary blood glucose measurements in critically ill patients: influence of catecholamine therapy. , 2010, Diabetes research and clinical practice.

[72]  Douglas B Coursin,et al.  Glucose Measurement in the Operating Room: More Complicated than It Seems , 2010, Anesthesia and analgesia.

[73]  P. Desmeules,et al.  Disinfectant wipes containing hydrogen peroxide induce overestimation of glucose results obtained with Lifescan SureStep Flexx® glucose meter. , 2010, Clinical biochemistry.

[74]  George G Klee,et al.  Glucose meter performance criteria for tight glycemic control estimated by simulation modeling. , 2010, Clinical chemistry.

[75]  Santhisagar Vaddiraju,et al.  Technologies for Continuous Glucose Monitoring: Current Problems and Future Promises , 2010, Journal of diabetes science and technology.

[76]  Jan S Krouwer,et al.  A Review of Standards and Statistics Used to Describe Blood Glucose Monitor Performance , 2010, Journal of diabetes science and technology.

[77]  Å. Lernmark,et al.  Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus , 2002, Diabetes Care.

[78]  M. J. Rice,et al.  Assessing point-of-care hemoglobin measurement: be careful we don't bias with bias. , 2011, Anesthesia and analgesia.

[79]  T. Heise,et al.  Automated Near-Continuous Glucose Monitoring Measured in Plasma Using Mid-Infrared Spectroscopy , 2011, Journal of diabetes science and technology.

[80]  Andreas Pfützner,et al.  Dynamic Electrochemistry Corrects for Hematocrit Interference on Blood Glucose Determinations with Patient Self-Measurement Devices , 2011, Journal of diabetes science and technology.

[81]  M. J. Rice.  Dynamic Electrochemistry: A Step in the Right Direction , 2011, Journal of diabetes science and technology.

[82]  M. J. Rice,et al.  Intravenous Fluids Cause Systemic Bias in a Conductivity-Based Point-of-Care Hematocrit Meter , 2012, Anesthesia and analgesia.