• Jeffrey Anton DuBois, Robbert Jan Slingerland, Marion Fokkert, Alain Roman, Nam Khoa Tran, William Clarke, David Alan Sartori, Tina Louise Palmieri, Andrei Malic, Martha Elizabeth Lyon, and Andrew William Lyon.
• 1Department of Medical and Scientific Affairs, Nova Biomedical, Waltham, MA.2Department of Clinical Chemistry, Isala, Zwolle, Netherlands.3Department of Surgical Intensive Care, Université Libre de Bruxelles, Saint-Pierre University Hospital, Brussels, Belgium.4Department of Pathology and Laboratory Medicine, University of California Davis School of Medicine, Sacramento, CA.5Department of Pathology and Laboratory Medicine, Johns Hopkins Medical Center, Baltimore, MD.6Division of Burn and Reconstructive Surgery, Department of Surgery, University of California Davis School of Medicine, Sacramento, CA.7Department of Pathology and Laboratory Medicine, Saskatoon Health Region, Saskatoon, SK.
• Crit. Care Med. 2017 Apr 1; 45 (4): 567-574.

ObjectivesNew data have emerged from ambulatory and acute care settings about adverse patient events, including death, attributable to erroneous blood glucose meter measurements and leading to questions over their use in critically ill patients. The U.S. Food and Drug Administration published new, more stringent guidelines for glucose meter manufacturers to evaluate the performance of blood glucose meters in critically ill patient settings. The primary objective of this international, multicenter, multidisciplinary clinical study was to develop and apply a rigorous clinical accuracy assessment algorithm, using four distinct statistical tools, to evaluate the clinical accuracy of a blood glucose monitoring system in critically ill patients.DesignObservational study.SettingFive international medical and surgical ICUs.PatientsAll patients admitted to critical care settings in the centers.InterventionsNone.Measurements And Main ResultsGlucose measurements were performed on 1,698 critically ill patients with 257 different clinical conditions and complex treatment regimens. The clinical accuracy assessment algorithm comprised four statistical tools to assess the performance of the study blood glucose monitoring system compared with laboratory reference methods traceable to a definitive standard. Based on POCT12-A3, the Clinical Laboratory Standards Institute standard for hospitals about hospital glucose meter procedures and performance, and Parkes error grid clinical accuracy performance criteria, no clinically significant differences were observed due to patient condition or therapy, with 96.1% and 99.3% glucose results meeting the respective criteria. Stratified sensitivity and specificity analysis (10 mg/dL glucose intervals, 50-150 mg/dL) demonstrated high sensitivity (mean = 95.2%, SD = ± 0.02) and specificity (mean = 95. 8%, SD = ± 0.03). Monte Carlo simulation modeling of the study blood glucose monitoring system showed low probability of category 2 and category 3 insulin dosing error, category 2 = 2.3% (41/1,815) and category 3 = 1.8% (32/1,815), respectively. Patient trend analysis demonstrated 99.1% (223/225) concordance in characterizing hypoglycemic patients.ConclusionsThe multicomponent, clinical accuracy assessment algorithm demonstrated that the blood glucose monitoring system was acceptable for use in critically ill patient settings when compared to the central laboratory reference method. This clinical accuracy assessment algorithm is an effective tool for comprehensively assessing the validity of whole blood glucose measurement in critically ill patient care settings.

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