Lab Med Online.  2014 Jan;4(1):15-21.

Evaluation of the Wisecheck Glucose Monitoring System

• Kwon S
• Kim HN
• Ko SY
• Cho CH
• Kim JS
• Lim CS

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.

Keyword

Glucometer; Blood glucose; Diabetes mellitus

MeSH Terms

Blood Glucose
Diabetes Mellitus
Glucose*
Methods
Blood Glucose
Glucose

Figure

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  Fig. 1 Linearity of the glucose concentrations measured using Wise-check.

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  Fig. 2 Correlation of glucose concentrations measured using 3 glucometers (Wisecheck, ACCU-CHEK Performa, and SD GlucoLink) with those measured using Toshiba 200FR.

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  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.

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