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Letters to the Editor: Letters & Announcements

Point of Care Devices Should Not Be Relied Upon for Perioperative Glucose Measurement

Pitkin, Andrew D., MD; Coursin, Douglas, MD; Rice, Mark J., MD

Author Information
doi: 10.1213/ANE.0b013e3181f98bc9
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To the Editor

On the basis of the heretofore unproven premise that intraoperative normoglycemia during major noncardiac surgery is associated with improved outcomes, Sato et al.1 compared glucose and insulin administration while maintaining normoglycemia therapy with conventional titration of insulin dose as a means of controlling blood glucose during major hepatic resection. Their primary outcome was the proportion of measurements in the normoglycemic range in each group. Among other conceptual issues, we question the choice of the Accu-Chek® glucose monitor (Roche Diagnostics, Rotkreuz, Switzerland), especially use of it for a protocol of tight glucose control when unrecognized hypoglycemia can be dangerous2; even mild or moderate hypoglycemia has been associated with increased mortality in critically ill patients.3

Although the Accu-Chek® device was designed and marketed for self-monitoring of blood glucose at home by patients with diabetes, these meters have migrated into the perioperative and critical care arena without additional regulatory framework and with limited understanding among healthcare professionals of their inaccuracy. This is particularly true for glucose concentrations in the hypoglycemic range and where other potential sources of error, such as variations in hematocrit, are present.4 The Food and Drug Administration has issued specific guidance to manufacturers to “clarify that critically ill patients (e.g., those with severe hypotension or shock, hyperglycemic–hyperosmolar state, hypoxia, severe dehydration, diabetic ketoacidosis) should not be tested with blood glucose meters because inaccurate results may occur” (Food and Drug Administration. Draft guidance for industry and FDA staff : total product life cycle for portable invasive blood glucose monitoring systems. Rockville, MD: Center for Devices and Radiological Health; Oct 24, 2006. http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm079138.htm).

Another concern is that the authors do not specify which of the various Accu-Chek® models was used: an important point, because different devices within the Accu-Chek® product line may have different accuracy profiles.5 Also, meters from the same company evolve over time with changes in testing strip and chemical technologies.

The simplicity, ease of use, and rapid response time of self-monitoring of blood glucose meters make them attractive to use in a protocol requiring blood glucose measurement every 15 minutes, but in our view they are inappropriate devices for a clinical trial with blood glucose concentration as the primary endpoint. In addition, we would urge all anesthesiologists and critical care physicians who use these for perioperative blood glucose measurement to be sure they understand the limitations of each individual device, especially for the diagnosis of severe hypoglycemia.6

Andrew D. Pitkin, MD

Douglas Coursin, MD

Mark J. Rice, MD

Department of Anesthesiology

University of Florida College of Medicine

Gainesville, Florida

University of Wisconsin School of Medicine and

Public Health

mrice@anest.ufl.edu

REFERENCES

1. Sato H, Lattermann R, Carvalho G, Sato T, Metrakos P, Hassanain M, Matsukawa T, Schricker T. Perioperative glucose and insulin administration while maintaining normoglycemia (GIN therapy) in patients undergoing major liver resection. Anesth Analg 2010;110:1711–8
2. Akhtar S, Barash PG, Inzucchi SE. Scientific principles and clinical implications of perioperative glucose regulation and control. Anesth Analg 2010;110:478–97
3. Egi M, Bellomo R, Stachowski E, French CJ, Hart GK, Taori G, Hegarty C, Bailey M. Hypoglycemia and outcome in critically ill patients. Mayo Clin Proc 2010;85:217–24
4. Duncan K, Chapman J, Braithwaite SS, Buse J. Glucose measurement: Confounding issues in setting targets for inpatient management. Diabetes Care 2007;30:403–9
5. 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;130:1527–32
6. Rice MJ, Pitkin AD, Coursin DB. Review article: glucose measurement in the operating room: more complicated than it seems. Anesth Analg 2010;110:1056–65
© 2011 International Anesthesia Research Society