Laboratory and bedside evaluation of portable glucose meters.
A two-phase, laboratory and bedside, evaluation of blood glucose meters was conducted in this study. Four meters, the AccuData Easy (Boehringer-Mannheim, Indianapolis, IN), HemoCue Glucose (HemoCue, Mission Viejo, CA), LifeScan One Touch II (LifeScan, Milpitas, CA), and Miles Encore QA (Miles, Elkhart, IN) systems, were compared to the Nova Stat Profile 5 (Nova, Waltham, MA) as the laboratory reference. Precision, linearity, correlation to the laboratory method, interference from hematocrit, data management, and operator preference were examined. None of the meters were found to satisfy all of the study's evaluation criteria. Therefore, institutions must weigh which criteria are most important to their individual settings. Although the HemoCue Glucose was found to be technically superior, this meter had no data management capabilities. The Encore QA had greater variance and low bias, whereas the AccuData Easy had bias affected by hematocrit and glucose concentration, and the One Touch II had a negative hematocrit bias and limited linear range when compared to the Nova. Only meters meeting both minimal analytical performance and computerization requirements, the One Touch II and AccuData Easy, were selected for further evaluation. At the bedside, the One Touch II demonstrated performance consistent with the lab evaluation, whereas the AccuData Easy showed greater imprecision in the low glucose range and a correlation that varied with sample type: capillary, venous, or arterial blood. This evaluation indicates that the clinician must interpret near-patient glucose results with respect to meter limitations. FDA approval and marketing statistics, alone, are insufficient to judge the performance of the meters in routine institutional use. Independent method validation, under actual operating conditions, is a better means of predicting future performance of the meters.
Nichols
J H
JH
Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, Maryland.
Howard
C
C
Loman
K
K
Miller
C
C
Nyberg
D
D
Chan
D W
DW
D001786:Blood Glucose / Q000032:analysis*; D002624:Chemistry, Clinical / Q000295:instrumentation* / Q000379:methods*; D005069:Evaluation Studies as Topic; D006801:Humans; D007753:Laboratories; D008991:Monitoring, Physiologic; D011785:Quality Assurance, Health Care
D001786:Blood Glucose