Performance and Limitations of Point-of-Care Glucose Meters for Measuring Blood Glucose Concentration in Patients with Critical Medical Conditions

Abstract

The practice of using point-of-care (POC) glucose meters on nondiabetic or critically ill patients is an off-label use that has raised concerns among the US Food and Drug Administration (FDA), Centers for Medicare and Medicaid Services (CMS), and some state health departments. Clinical laboratories have been directed to demonstrate that meters are accurate and safe in this context. To comply with these guidelines, we have conducted a risk-based validation study to establish clinical performance and limitations for POC glucose meters in patients with critical medical conditions. Blood samples from 176 patients were randomly collected from all critical care units, emergency departments, and other departments within the multiple hospitals of Kaleida Health, and assayed in duplicate on Abbott PxP glucose meters (Abbott Diabetes Care, Alameda, CA ) and Abbott Architect Analyzers (Abbott Laboratories, Abbott Park, IL). Test accuracy was evaluated by Clinical Laboratory Standards Institute (CLSI) POCT12-A3 criteria using laboratory values as references. We observed good correlation between glucose meters and laboratory analyzers. In patients with critical conditions, when blood glucose levels are below 100 mg/dL, 95.3 % of the glucose meter results agreed within 12 mg/dL of the laboratory values; when levels are above 100 mg/dL, 97.1% of the meter results agreed within 12.5% of the laboratory values. In addition, 100% of all results obtained exhibited a difference (lab analyzer - meter) of less than 15 mg/dL at glucose levels below 75 mg/dL, and 98.8% of all results exhibited a difference of less than 20% at glucose levels above 75 mg/dL. Our study results successfully meet CLSI criteria, and enable Kaleida Health to continue using these POC devices across all levels of acuity, with certain exclusions. Such exclusions are consistent with the test limitations listed in the Abbott PxP blood glucose test strip package insert: Patient may not be severely hypotensive, dehydrated, in shock or in hyperglycemic hyperosmolar state.