Dataset Information

Using Radar Plots to Demonstrate the Accuracy and Precision of 6 Blood Glucose Monitoring Systems.

ABSTRACT:

Background

Previously, fingertip capillary blood glucose measurements from the CONTOUR^®NEXT (CN) blood glucose monitoring system (BGMS) and 5 other BGMSs were evaluated in comparison with measurements from a reference YSI glucose analyzer. Here, we use Radar Plots to graphically represent the accuracy and precision results from the previous study, including whether they met ISO 15197:2013 accuracy criteria.

Method

A Radar Plot, a new method for capturing a distinct, single visualization of BGMS analytical performance, is a collection of concentric circles, each representing a particular magnitude of error. The center of the plot represents zero error (BGMS result is equivalent to reference result); as points are more distant from the center, the error increases, expressed in units of mg/dL or percentage for YSI values <100 and ≥100 mg/dL, respectively. The position of the data point above or below the horizontal line bisecting the plot indicates whether the BGMS measurement error was positive (BGMS result > YSI result) or negative (BGMS result < YSI result). Points within the "15-15 Zone," representing ±15 mg/dL or ±15% error, satisfy ISO 15197:2013 accuracy criteria.

Results

The percentage of results within the 15-15 Zone ranged from 83.6% to 99.8% for the 6 BGMSs (99.6% for CN).

Conclusions

Radar Plots provide a different method for visually comparing the analytical performance of multiple BGMSs. The tight clustering of data points at the center of the CN Radar Plot illustrates the analytical performance of CN compared with 5 other BGMSs.

SUBMITTER: Pardo S

PROVIDER: S-EPMC5950999 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionSufficiently high analytical quality of blood glucose monitoring systems (BGMS) is a prerequisite for efficient diabetes therapy. In this study we assessed system accuracy, measurement repeatability, intermediate measurement precision, user performance, and the influence of hematocrit on two CE-marked blood glucose monitoring systems. For one BGMS, measurement accuracy using venous samples was additionally investigated.MethodsStudy procedures were based on the International Organization of Standardization (ISO) 15197:2013/EN ISO 15197:2015 ("ISO 15197"). User performance included data from 100 subjects who used one test strip lot, whereas for all other analyses three different reagent system lots were used. For system accuracy assessment, 100 capillary samples were measured in duplicate with each of three reagent system lots per system, resulting in 600 results per system.ResultsCareSens S Fit and CareSens H Beat both fulfilled the ISO 15197 accuracy criteria with 97.5-100% of each test strip lot's results falling within ± 15 mg/dL or ± 15% of the results of the comparison method and 100% of results in consensus error grid (CEG) zone A for all three lots. User performance evaluation revealed sufficient accuracy in the hands of lay users although some handling errors were documented by study staff. Assessment of measurement repeatability and intermediate measurement precision is given by standard deviation (SD) (glucose levels < 100 mg/dL) and by coefficient of variation (CV) (glucose concentrations ≥ 100 mg/dL). SD was ≤ 4.1 mg/dL and CV ≤ 4.2% for measurement repeatability and SD was ≤ 2.2 mg/dL and CV ≤ 2.6% for intermediate measurement precision. In case of hematocrit influence, both BGMS complied with all three tested lots with the defined criteria.ConclusionBoth BGMS analyzed in this study fulfilled the required accuracy criteria of ISO 15197. They showed high precision, good performance in the hands of lay users, and the influence of hematocrit was acceptable in the labeled range.