Evaluation of the performance of a new OptiScanner™ 5000 system for an intermittent glucose monitoring.

BACKGROUND

Mid-infrared spectral technology has shown a high degree of promise in detecting glucose in plasma. OptiScan Biomedical has developed a glucose monitor based on mid-infrared spectroscopy that withdraws blood samples and measures plasma glucose. The objective of this study was to evaluate the accuracy and performance of the OptiScanner™ 5000 system on different pools of blood.

METHODS

This study was performed to validate the blood glucose measurements obtained with the OptiScanner™ 5000 by comparing them to Central Laboratory glucose measurements (VITROS® 5600 Integrated System) as a comparative method across a broad range of glucose values over a three day period to obtain 80-90 paired measurements.

RESULTS

A total of 81 paired measurements, distributed between 33 and 320mg/100mL of glucose, were performed. The aggregate data points were within International Organization for Standardization standards, with 100% of the glucose values within ±15%.

CONCLUSIONS

The current study suggests that a mid-IR fixed-wavelength system (OptiScanner) can measure glucose accurately across a wide range of glucose values in plasma of ICU patients.