Comparative Accuracy of 17 Point-of-Care Glucose Meters

Laya Ekhlaspour, Debbie Mondesir, Norman Lautsch, Courtney Balliro, Mallory Hillard, Kendra Magyar, Laura Goergen Radocchia, Aryan Esmaeili, Manasi Sinha, Steven J Russell, Laya Ekhlaspour, Debbie Mondesir, Norman Lautsch, Courtney Balliro, Mallory Hillard, Kendra Magyar, Laura Goergen Radocchia, Aryan Esmaeili, Manasi Sinha, Steven J Russell

Abstract

Background: The accuracy of point-of-care blood glucose (BG) meters is important for the detection of dysglycemia, calculation of insulin doses, and the calibration of continuous glucose monitors. The objective of this study was to compare the accuracy of commercially available glucose meters in a challenging laboratory study using samples with a wide range of reference BG and hemoglobin values.

Methods: Fresh, discarded blood samples from a hospital STAT laboratory were either used without modification, spiked with a glucose solution, or incubated at 37°C to produce 347 samples with an even distribution across reference BG levels from 20 to 440 mg/dl and hemoglobin values from 9 to 16 g/dl. We measured the BG of each sample with 17 different commercially available glucose meters and the reference method (YSI 2300) at the same time. We determined the mean absolute relative difference (MARD) for each glucose meter, overall and stratified by reference BG and by hemoglobin level.

Results: The accuracy of different meters widely, exhibiting a range of MARDs from 5.6% to 20.8%. Accuracy was lower in the hypoglycemic range, but was not consistently lower in samples with anemic blood hemoglobin levels.

Conclusions: The accuracy of commercially available glucose meters varies widely. Although the sample mix in this study was much more challenging than those that would be collected under most use conditions, some meters were robust to these challenges and exhibited high accuracy in this setting. These data on relative accuracy and robustness to challenging samples may be useful in informing the choice of a glucose meter.

Keywords: MARD; accuracy; blood glucose; diabetes; glucose meter; hemoglobin; plasma glucose.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: After the results of the study were obtained, SJR requested and received a donation of glucose meters and strips from Nova Biomedical for several studies of automated glucose control. The Nova Biomedical meters and strips used for this study were not donated, but were purchased at retail from a distributor. SJR has received support-in-kind (loaned equipment) for another study from Abbott Diabetes Care. None of the other authors have conflicts to report.

Figures

Figure 1.
Figure 1.
MARD of evaluated glucose meters, shown as the point estimate of the MARD and the 95% confidence interval. Meters are listed in order of increasing overall MARD.
Figure 2.
Figure 2.
Relative differences (RD) plots (relative difference of meter plasma glucose minus reference plasma glucose versus reference plasma glucose). Meters are ordered by increasing overall MARD.
Figure 3A.
Figure 3A.
Relationship between FDA decision date and overall MARD.
Figure 3B.
Figure 3B.
Relationship between MARD and retail strip price. Meters with MARDs

Source: PubMed

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