Bedside Glucose Monitoring-Is it Safe? A New, Regulatory-Compliant Risk Assessment Evaluation Protocol in Critically Ill Patient Care Settings.
OBJECTIVE
New 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.


METHODS
Observational study.


METHODS
Five international medical and surgical ICUs.


METHODS
All patients admitted to critical care settings in the centers.


METHODS
None.


RESULTS
Glucose 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.


CONCLUSIONS
The 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.
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.
Jeffrey Anton
JA
DuBois
Robbert Jan
RJ
Slingerland
Marion
M
Fokkert
Alain
A
Roman
Nam Khoa
NK
Tran
William
W
Clarke
David Alan
DA
Sartori
Tina Louise
TL
Palmieri
Andrei
A
Malic
Martha Elizabeth
ME
Lyon
Andrew William
AW
Lyon
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D001786:Blood Glucose / Q000032:analysis*; D002648:Child; D002675:Child, Preschool; D019411:Clinical Laboratory Techniques; D003422:Critical Care; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000175:diagnosis; D007004:Hypoglycemic Agents / Q000008:administration & dosage; D007223:Infant; D007328:Insulin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000009:adverse effects / Q000295:instrumentation / Q000592:standards*; D009010:Monte Carlo Method; D019095:Point-of-Care Systems / Q000331:legislation & jurisprudence / Q000592:standards*; D012189:Retrospective Studies; D018570:Risk Assessment / Q000331:legislation & jurisprudence / Q000379:methods; D012680:Sensitivity and Specificity; D055815:Young Adult
D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin