Evaluation of the Wisecheck Glucose Monitoring System

Seonhee Kwon; Ha Nui Kim; Sun-Young Ko; Chi Hyun Cho; Jang Su Kim; Chae Seung Lim

doi:10.3343/lmo.2014.4.1.15

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Kwon, Kim, Ko, Cho, Kim, and Lim: Evaluation of the Wisecheck Glucose Monitoring System

Original Article

Clinical Chemistry

Laboratory Medicine Online 2014; 4(1): 15-21.

Published online: 1 January 2014

DOI: https://doi.org/10.3343/lmo.2014.4.1.15

Evaluation of the Wisecheck Glucose Monitoring System

Seonhee Kwon, M.D., Ha Nui Kim, M.D., Sun-Young Ko, M.D., Chi Hyun Cho, M.D., Jang Su Kim, M.D., Chae Seung Lim, M.D.

Department of Laboratory Medicine, Brain Korea 21 Graduate School of Medicine, College of Medicine, Korea University, Seoul, Korea.

Corresponding author: Chae-Seung Lim. Department of Laboratory Medicine, Korea University Guro Hospital, 97 Gurodong-gil, Guro-gu, Seoul 152-703, Korea. Tel: +82-2-2626-3245, Fax: +82-2-2626-1465, malarim@korea.ac.kr

Received 5 October 2012 Revised 11 June 2013 Accepted 11 June 2013

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

Glucometers are widely used for self-monitoring and point-of-care testing in diabetes management. We evaluated the performance of the recently developed Wisecheck Glucose Monitoring System (Wisemeditech, Korea) compared to that of 2 other well-known glucometer systems.

Methods

The Wisecheck glucometer was evaluated for precision, linearity, and carryover rate. One-hundred fifty samples samples were tested, and the results obtained from the Wisecheck glucometer, ACCU-CHEK Performa (Roche Diagnostics, Germany) and SD GlucoLink (SD Diagnostics, Korea) were compared to those obtained using the laboratory reference method from the Toshiba 200FR (Toshiba, Japan), according to the Clinical and Laboratory Standards Institute (CLSI) guidelines.

Results

The coefficient of variation (CV) values for within-run imprecision at low, middle, and high levels were 2.06%, 1.02%, and 2.02%, respectively, and the CV values for total-run imprecision at low, middle, and high levels were 2.98%, 2.41%, and 1.88%, respectively. In the linearity test, the coefficient of determination (R²) was 0.9985 in glucose concentration ranging from 48.6 mg/dL to 428 mg/dL (P<0.0001). The results obtained using the Wisecheck glucometer were well correlated with those obtained using the Toshiba 200FR (R²=0.980, P<0.0001). The carryover rate was 0.12%.

Conclusions

The Wisecheck glucometer showed good precision, linearity, and correlation with the reference method. It provided rapid and reliable measurements of blood glucose levels and seemed appropriate for use in diabetes management.

Keywords: Glucometer, Blood glucose, Diabetes mellitus

Figures and Tables

Fig. 1

Linearity of the glucose concentrations measured using Wise-check.

Fig. 2

Correlation of glucose concentrations measured using 3 glucometers (Wisecheck, ACCU-CHEK Performa, and SD GlucoLink) with those measured using Toshiba 200FR.

Fig. 3

Bland-Altman difference plots and Bland-Altman % difference plots of the mean values obtained using the glucometers, Wisecheck, ACCU-CHEK Performa, and SD GlucoLink versus those obtained using Toshiba200FR. The mean difference (solid line) and limits of agreement (mean±2SD, dotted line) are shown.

Table 1

Precision of the 3 glucometers used for the measurement of 3 different glucose levels

^*Wisecheck (Wisemeditech, Korea); ^†ACCU-CHEK® Performa (Roche Diagnostics, Germany); ^‡SD GlucoLink (SD Diagnostics, Korea).

Notes

This article is available from http://www.labmedonline.org

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