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Challenges of Inpatient Blood Glucose Monitoring: Standards, Methods, and Devices to Measure Blood Glucose

  • Hospital Management of Diabetes (GE Umpierrez, Section Editor)
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Abstract

Glucose control in the hospital setting is very important. There is a high incidence of hyperglycemia, hypoglycemia, and glycemic variability in hospitalized patients. Safe insulin delivery and glucose control is dependent on reliable glucose meters and monitoring systems in the hospital. Different glucose monitoring systems use arterial, venous, central venous, and capillary blood samples. It is important for clinicians to be aware that there are limitations of specific point-of-care (POC) glucose meters and that situations exist whereby POC glucose meters as the sole measurement device should be avoided. POC meter devices are not approved by the Food and Drug Administration for use in critical care, although POC meter devices are commonly used in critical care settings and elsewhere. This review focuses on glucose assay principles, instrument technology, influences on glucose measurement, standards for glucose measurement, and an evaluation of different methods to measure blood glucose in the hospital setting.

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References

Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

  1. Joseph JI. Analysis: new point-of care blood glucose monitoring system for the hospital demonstrates satisfactory analytical accuracy using blood from critically ill patients—an important step toward improved blood glucose control in the hospital. J Diabetes Sci Technol. 2013;7(5):1288–93. This article outlines the multiple sources of blood glucose variability in hospitalized patients, specifically looking at critically ill patients. It studied the Accu-Chek Inform II BL® monitoring system and determined if it produced accurate and precise measurements of blood glucose. This will assist with removing the restrictions on point-of-care blood glucose measurement in the critically ill population.

    Article  PubMed Central  PubMed  Google Scholar 

  2. Clement S, Braithwaite SS, Magee MF, Ahmann A, Smith EP, Schafer RG, et al. Management of diabetes and hyperglycemia in hospitals. Diabetes Care. 2004;27(2):553–91.

    Article  PubMed  Google Scholar 

  3. Umpierrez GE, Smiley D, Zisman A, Prieto LM, Palacio A, Ceron M, et al. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes (RABBIT 2 Trial). Diabetes Care. 2007;30(9):2181–6.

    Article  CAS  PubMed  Google Scholar 

  4. Van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, et al. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001;345(19):1359–67.

    Article  PubMed  Google Scholar 

  5. Van den Berghe G, Wilmer A, Hermans G, Meersseman W, Wouters PJ, Milants I, et al. Intensive insulin therapy in the medical ICU. N Engl J Med. 2006;345(5):449–61.

    Article  Google Scholar 

  6. Inzucchi SE. Clinical practice. Management of hyperglycemia in the hospital setting. N Engl J Med. 2006;355(18):1903–11.

    Article  CAS  PubMed  Google Scholar 

  7. Wahl HG. How accurately do we measure blood glucose levels in intensive care unit (ICU) patients? Best Pract Res Clin Anaesthesiol. 2009;23:387–400.

    Article  CAS  PubMed  Google Scholar 

  8. Mraovic B, Schwenk ES, Epstein RH. Intraoperative accuracy of a point-of-care glucose meter compared with simultaneous central laboratory measurements. J Diabetes Sci Technol. 2012;6(3):541–6. This article retrospectively compares the accuracy of a POC glucose meter, Accu-Chek Inform®, Roche Pharmaceuticals, and compares it with central lab blood glucose measurements in an intraoperative setting. It concluded that the POC glucose meter performed poorly compared to the central lab analyzer in the intraoperative setting, thus lending to the conclusion that POC glucose meters have limitations and should not be considered as the sole measurement device intraoperatively.

    Article  PubMed Central  PubMed  Google Scholar 

  9. U.S. Food and Drug Administration. Clinical accuracy requirements for point of care blood glucose meters. Available from: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm187406.htm#transcripts. Accessed 15 Jul 2014. The FDA held a meeting during which clinical experts discussed the requirements for blood glucose meter accuracy and precision. This was in response to questions/concerns regarding the accuracy of glucose meters in health-care settings, and many providers felt that tighter performance standards were needed. These concerns arose in response to increased utilization of glucose meters in a variety of setting such as hospitals, emergency response units, nursing homes, and physicians’ offices. The appropriate analytical and clinical accuracy requirements for glucose meters were discussed, in addition to the potential benefits and challenges of meeting those requirements.

  10. Klonoff 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.

    Article  PubMed Central  PubMed  Google Scholar 

  11. Nichols JH. Blood glucose testing in the hospital: error sources and risk management. J Diabetes Sci Technol. 2011;5(1):173–7.

    Article  PubMed Central  PubMed  Google Scholar 

  12. Tonyushkima K, Nichols J. Glucose meters: a review of technical challenges to obtaining accurate results. J Diabetes Sci Technol. 2009;3(4):971–80.

    Article  Google Scholar 

  13. Blake DR, Nathan DM. Point-of-care testing for diabetes. Crit Care Nurs Q. 2004;27(2):150–61.

    Article  PubMed  Google Scholar 

  14. Farrer M, Albers CJ, Neil HA, Adams PC, Laker MF, Alberti KG. Assessing the impact of blood sample type on the estimated prevalence of impaired glucose tolerance and diabetes mellitus in epidemiological surveys. Diabet Med. 1995;12(4):325–9.

    Article  CAS  PubMed  Google Scholar 

  15. Price CP, St. John A. Chapter 20: point-of-care testing. In: CA Burtis, ER Ashwood, DE Bruns, editors. Tietz textbook of clinical chemistry and molecular diagnostics, 5th edn. Elsevier; 2011. p. 490–1.

  16. Baum JM, Monhaut NM, Parker DR, Price CP. Improving the quality of self-monitoring blood glucose measurement: a study in reducing calibration errors. Diabetes Technol Ther. 2006;8(3):347–57.

    Article  CAS  PubMed  Google Scholar 

  17. Wilding P, Ciaverelli C. Hand-held sensor systems. In: CP Price, JM Hicks, editors. Point-of-care testing. AACC; 1999. p. 58–9.

  18. College of American Pathology: point of care FAQs—quantitative testing. http://www.cap.org/apps//cap.portal?_nfpb=true&cntvwrPtlt_actionOverride=%2Fportlets%2FcontentViewer%2Fshow&_windowLabel=cntvwrPtlt&cntvwrPtlt{actionForm.contentReference}=committees%2Fpointofcare%2Fpoc_quantitativetesting.html&_state=maximized&_pageLabel=cntvwr. Accessed 25 Jul 2014.

  19. POCT 12-A3 Point of care blood glucose testing in acute and chronic facilities; approved guideline—third edition. Clinical and Laboratory Standards Institute. 2013. This is a guideline that provides instructions and recommendations concerning the administration of point-of-care (POC) blood glucose monitoring programs at acute and chronic care facilities. This document refers to quantitative in vitro POC blood glucose meter systems intended for use by health-care professionals. The criteria for accepting POC glucose meters to be used in hospital settings are in this document. Manufacturers may use this document as an indication of the clinical requirement in the marketplace.

  20. Brazg R, Hyghes K, Martin P, et al. Clinical evaluation of the FreeStyle Precision Pro system. Clin Chim Acta. 2013;421:243–50. This study evaluated the glucose test performance of the FreeStyle Precision Pro® system, a new blood glucose monitoring system with the purpose to enhance the accuracy of point-of-care testing. The intent was to find a system that helps meet the more stringent accuracy criteria of the international standard and CLSI guidelines for point-of-care glucose monitoring. This article demonstrates the possibility of more accurate point-of-care glucose testing in the setting of more precise accuracy guidelines.

    Article  CAS  PubMed  Google Scholar 

  21. Kos S, van Meerkerk A, van der Linden J, Stiphout T, Wulkan R. Validation of a new generation of POCT glucose device with emphasis on aspects important for glycemic control in hospital care. Clin Chem Lab Med. 2012;50(9):1573–80. This article studied a new point-of-care glucose device, the HemoCue® Glucose 201DMRT for its ability to assist with tight glucose control. This study contributed to finding ways to use point-of-care devices in insulin-dosage decision-making, thus lending to removal or changes in FDA labeling on point-of-care testing in critically ill populations.

    Article  CAS  PubMed  Google Scholar 

  22. Warner J, Wu J, Buckingham N, McLeod D, Mottram B, Carter A. Can one point-of-care glucose meter be used for all pediatric and adult hospital patients? Evaluation of three meters, including recently modified test strips. 2011;13(1):55–62.

  23. Hemocue brochure: glucose 201 System, http://www.cliawaived.com/web/items/pdf/HemoCue-Glucose-Reimbursement%20Brochure~3663file2.pdf. Accessed 18 Aug 2014.

  24. CAP today: product guidelines. http://www.captodayonline.com/productguides/instruments/bedside-glucose-testing-systems-february-2014/hemocue-glucose-201-dm-analyzer-bedside-glucose-2014.html. Accessed 1 Aug 2014.

  25. Accu-Chek Brochure Inform II system, http://www.accu-chekinformii.com/. Accessed 18 Aug 2014.

  26. Rebel et al. The accuracy of point-of care glucose measurements. J Diabetes Sci Technol. 2012;6(2):396–411. This article outlines the multiple variables that affect the accuracy of point-of-care glucose monitoring and measurement. All of these clinical factors contribute to the restrictions on point-of-care glucose meters in critically ill patients and help target areas to improve the accuracy in this population for the future.

    Article  PubMed Central  PubMed  Google Scholar 

  27. Abbott, Point of Care. Cartridge and test information sheets. Glucose (Art# 714177-00R) http://www.abbottpointofcare.com/Customer-Info-Center/Cartridge-and-Test-Info-Sheets.aspx. Accessed 18 Aug 2014.

  28. Karon BS, Gandhi GY, Nuttall GA, 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. Am J Clin Pathol. 2007;127(6):919–26.

    Article  CAS  PubMed  Google Scholar 

  29. Kulkarni A, Saxena M, Price G, et al. Analysis of blood glucose measurements using capillary and arterial blood samples in intensive care patients. Intensive Care Med. 2005;31:142–5.

    Article  PubMed  Google Scholar 

  30. Fogh-Andersen N, D’Orazio P. Proposal for standardizing direct-reading biosensors for blood glucose. Clin Chem. 1998;44:655–9.

    CAS  PubMed  Google Scholar 

  31. Rao LV, Jakubiak F, et al. Accuracy evaluation of a new glucometer with automated hematocrit measurement and correction. Clin Chim Acta. 2005;356(1–2):178–83.

    Article  CAS  PubMed  Google Scholar 

  32. Karon BS, Griesmann L, Scott R, et al. 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.

    Article  PubMed  Google Scholar 

  33. Robinson CS, Sharp P. Tighter accuracy standards within point-of-care blood glucose monitoring: how six commonly used systems compare. J Diabetes Sci Technol. 2012;6(3):547–54.

    Article  PubMed Central  PubMed  Google Scholar 

  34. Bϋrgi W. The volume displacement effect in quantitative analyses in red cell constituents. Z Klin Chem Klinische Biochem. 1969;7:458–60.

    Google Scholar 

  35. 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;124:1135–40.

    CAS  PubMed  Google Scholar 

  36. Wiener K. An assessment of the effect of haematocrit on the HemoCue B-Glucose Analyzer. Ann Clin Biochem. 1993;30:90–3.

    Article  CAS  PubMed  Google Scholar 

  37. Klonoff DC, Perz JF. Assisted monitoring of blood glucose: special safety needs for a new paradigm in testing glucose. J Diabetes Sci Technol. 2010;4(5):1027–31.

    Article  PubMed Central  PubMed  Google Scholar 

  38. Ginsberg BH. We need tighter regulatory standards for blood glucose monitoring, but they should be for accuracy disclosure. J Diabetes Sci Technol. 2010;4(5):1265–8.

    Article  PubMed Central  PubMed  Google Scholar 

  39. NICE SUGAR Study Investigators, Finfer S, Chittock DR, Su SY, Blair D, Foster D, et al. Intensive versus conventional glucose control in critically ill patients. N Engl J Med. 2009;360:1283–97.

    Article  Google Scholar 

  40. Pitkin A, Rice MJ. Challenges to glycemic measurement in the perioperative and critically ill patient: a review. J Diabetes Sci Technol. 2009;3(6):1270–81.

    Article  PubMed Central  PubMed  Google Scholar 

  41. Harrison JG. Accuracy of fingerstick glucose values in shock patients. Am J Crit Care. 1995;4:44–8.

    PubMed  Google Scholar 

  42. VHA Pathology & Laboratory Medicine Service. FDA labeling change on point of care (POC) glucose devices. http://www.pharmamedtechbi.com/~/media/Supporting%20Documents/The%20Gray%20Sheet/40/19/VA%20Directive%20on%20FDA%20Guidances.pdf. Accessed 7 Aug 2014.

  43. Clinical Laboratory Improvement Amendments (CLIA). How to obtain a certificate of waiver. http://www.cms.gov/Regulations-and Guidance/Legislation/CLIA/downloads/howobtaincertificateofwaiver.pdf. Accessed 21 Aug 2014.

  44. CAP personnel requirements by testing complexity. http://www.cap.org/apps/docs/laboratory_accreditation/build/pdf/personnel_requirements_by_testing_complexity.pdf. Accessed 21 Aug 2014.

  45. https://www.abbottdiabetescare.com/press-room/2013/2013-e.html. Accessed 27 Aug 2014.

  46. http://www.clpmag.com/2013/09/poc-glucose-monitoring-are-we-doing-it-better-2/. Accessed 25 Jul 2014.

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Acknowledgments

The authors gratefully thank the staff at the Medical University of South Carolina and the Ralph H. Johnson Veterans Affairs Medical Center in Charleston, South Carolina, for their invaluable contributions. The contents of this article do not represent the views of the Department of Veterans Affairs or the United States Government.

Compliance with Ethics Guidelines

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Conflict of Interest

Kathie L. Hermayer, Aundrea S. Loftley, Sumana Reddy, Satya Nandana Narla, Nina A. Epps, and Yusheng Zhu declare that they have no conflict of interest.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.

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Authors and Affiliations

  1. Division of Endocrinology, Diabetes, and Medical Genetics, Medical University of South Carolina, 96 Jonathan Lucas Street, MSC 624, Charleston, SC, 29425, USA

    Kathie L. Hermayer

  2. Ralph H. Johnson Veteran’s Affairs Medical Center, 109 Bee Street, Charleston, SC, 29401, USA

    Kathie L. Hermayer

  3. Division of Endocrinology, Diabetes, and Medical Genetics, Medical University of South Carolina, 96 Jonathan Lucas Street, MSC 624, Charleston, SC, 29425, USA

    Aundrea S. Loftley & Sumana Reddy

  4. Department of Pathology & Laboratory Medicine, Medical University of South Carolina, 171 Ashley Avenue, MSC 908, Suite 309, Charleston, SC, 29425, USA

    Satya Nandana Narla & Yusheng Zhu

  5. Laboratory Services, Point of Care Testing, Quality & Safety, Medical University of South Carolina, 165 Ashley Avenue, Room 335, Charleston, SC, 29425, USA

    Nina A. Epps

Authors
  1. Kathie L. Hermayer
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  2. Aundrea S. Loftley
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Correspondence to Kathie L. Hermayer.

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This article is part of the Topical Collection on Hospital Management of Diabetes

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Hermayer, K.L., Loftley, A.S., Reddy, S. et al. Challenges of Inpatient Blood Glucose Monitoring: Standards, Methods, and Devices to Measure Blood Glucose. Curr Diab Rep 15, 10 (2015). https://doi.org/10.1007/s11892-015-0582-9

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