Wavesense technology glucometer Linus for routine self-monitoring and clinical practice

Abstract

Conventional glucometer systems for plasma/blood glucose monitoring are based on colorimetry or static electrochemistry using a fixed input signal. The recent glucometer Linus, Wellion, Agamatrix, USA, based on wavesense dynamic electrochemistry, uses a time-varying input signal to give a more accurate glucose reading. The purpose of this study was to compare the plasma glucose (PG) readings obtained by nursing staff from glucometer Linus and PG values estimated on an approved analyzer Daytona™, Randox, Global Medical Instrumentation, Inc., MN, USA. In the course of 5weeks, 221 fingerprick capillary blood samples were taken from persons with diabetes at different times and investigated using glucometer Linus. Within two following minutes, blood from the same fingerprick was also collected in a tube and centrifuged; the plasma was analyzed on the Daytona™ analyzer. Statistical analysis was performed using the software SPSS v. 15.0, SPSS Inc., Chicago, IL, USA. A total of 221 paired PG values were plotted on the error grid diagram indicating that 218 values (98.6%) of the glucose readings (Linus vs. Daytona) were within the clinically accurate zone A (maximum difference ±20%) and 3 values (1.4%) within the acceptable zone B. Daytona showed 4 PG values <4.2mmol/l (75mg/dl) and their difference of respective Linus readings was always <0.83mmol/l (15mg/dl). Correlation of results was strong (r=0.992). Glucometer Linus readings correspond to the ISO and FDA standards. So, Linus appears to be an accurate device for PG-self-monitoring and clinical practice.