Bedside glucose monitoring-is it safe? A new, regulatory-compliant risk assessment evaluation protocol in critically ill patient care settings
Open accessAbstract
Objectives: 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. Design: Observational study. Setting: Five international medical and surgical ICUs. Patients: All patients admitted to critical care settings in the centers. Interventions: None. Measurements and Main 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.
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POC blood glucose monitors provide the advantage of immediate bedside results, and studies suggest that while POC measurements are less accurate and less precise than those from laboratory glucose analyzers, they provide adequate information for usual practice except in rare instances where care has been compromised.
“POC blood glucose monitors provide the advantage of immediate bedside results, and studies suggest that while POC measurements are less accurate and less precise than those from laboratory glucose analyzers, they provide adequate information for usual practice except in rare instances where care has been compromised (40,41).”
From 16. Diabetes Care in the Hospital: Standards of Care in Diabetes—2026 (2026) · cites this paper as [40]
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Experimental — accuracy not yet measuredThe balance between analytic requirements (e.g., accuracy, precision, and interference) and clinical requirements (e.g., rapidity, simplicity, and POC) has not been uniformly resolved, and most hospitals have arrived at their own policies to balance these parameters.
“The balance between analytic requirements (e.g., accuracy, precision, and interference) and clinical requirements (e.g., rapidity, simplicity, and POC) has not been uniformly resolved (39)(40)(41)(42), and most hospitals have arrived at their own policies to balance these parameters.”
From 16. Diabetes Care in the Hospital: Standards of Care in Diabetes—2026 (2026) · cites this paper as [40]
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Experimental — accuracy not yet measured
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Technical Aspects of the Parkes Error Grid
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16. Diabetes Care in the Hospital: Standards of Care in Diabetes—2026
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A multicenter evaluation of a point-of-care blood glucose meter system in critically ill patients
Nichols, J. H., Brandler, E. S., Fantz, C. R., Fisher, K., Goodman, M. D., Headden, G., Hoppensteadt, D., Matika, R., Peacock, W. F., Rodrigo, J., et al. (2021) · The Journal of Applied Laboratory Medicine · doi:10.1093/jalm/jfab005 · Cited by 19 · see citing works
Self-citation
- Authors
- DuBois, J. A., Slingerland, R. J., Fokkert, M., Roman, A., Tran, N. K., Clarke, W., Sartori, D. A., Palmieri, T. L., Malic, A., Lyon, M. E., & Lyon, A. W.
- Affiliations
- Nova Medical (United States) (US)
- Isala (NL)
- Université Libre de Bruxelles (BE)
- University of California Davis Medical Center (US)
- Johns Hopkins University (US)
- Saskatchewan Health Authority (CA)
- Corresponding author
- DuBois, Jeffrey Anton
- ORCID
- Venue
- Critical Care Medicine
- Published
- 2017-04
- Volume
- 45
- Issue
- 4
- Pages
- 567-574
- ISSN
- 0090-3493 (ISSN-L)
- PMC
- PMC5345889
- OpenAlex
- W2589109051
- Cited by
- 59
- References
- 2
- Citations by year
- 2026: 5 · 2025: 1 · 2024: 9 · 2023: 5 · 2022: 5 · 2021: 6 · 2020: 7 · 2019: 11 · 2018: 4 · 2017: 6
- FWCI
- 6.06
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Critical Care Medicine (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Dépôt institutionnel de l'Université libre de Bruxelles (Université Libre de Bruxelles) (submittedVersion)
- Funders
- National Institutes of Health (UL1TR000002, UL1TR001860)
- National Heart, Lung, and Blood Institute (K12HL108964)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hyperglycemia and glycemic control in critically ill and hospitalized patients
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Health Professions › Emergency Medical Services › Patient Safety and Medication Errors
- Keywords
- blood glucose monitoring, point-of-care testing, critically ill patients, glucose meter accuracy, insulin dosing errors, hypoglycemia detection, Monte Carlo simulation, regulatory compliance, FDA guidance, intensive care unit, sensitivity and specificity
- MeSH terms
- Adolescent, Adult, Aged, Aged, 80 and over, Algorithms, Blood Glucose, Child, Child, Preschool, Critical Care, Female, Humans, Hypoglycemia, Hypoglycemic Agents, Infant, Insulin, Male, Middle Aged, Monitoring, Physiologic, Monte Carlo Method, Retrospective Studies, Sensitivity and Specificity, Risk Assessment, Point-of-Care Systems, Clinical Laboratory Techniques, Young Adult
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