Validation of a new OptiScanner™ 5000 system for an intermittent glucose monitoring

Alessandra Barassi1,1,*, Michele Umbrello2, Clara Anna Linda Damele1, Francesca Ghilardi1, Rossana Stefanelli3, Gaetano Iapichino4, GianVico Melzi d'Eril1

1Laboratorio di Analisi, Ospedale San Paolo, Dipartimento di Scienze della Salute, Università degli Studi di Milano, 2UO Anestesia e Rianimazione, Polo Universitario San Paolo, 3Laboratorio di Analisi, Ospedale San Paolo, 4Dipartimento di Scienze Biomediche, Chirurgiche e Odontoiatriche, UO Anestesia e Rianimazione, Polo Universitario San Paolo, Università di Milano, Milan, Italy

Introduction: 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.

Objectives: The objective of this study was to evaluate the accuracy and performance of the OptiScanner™ 5000 system on different pools of blood.

Methods: The OptiScanner™ 5000 system consists of a cuvette and onboard spectrometer that uses 25 wavelengths to estimate glucose. Specifically, 11 of the filters are between 7 and 8 mm, 6 of the filters are between 8 and 9 mm and 8 of the filters are between 9 and 10 mm. The device is intended to connect to an existing blood access port of the patient, requiring no additional cannula insertion. A small sample of venous blood is withdrawn, the plasma is separated using a centrifuge within the system, and a glucose reading is produced every 15 min. 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) across a broad range of glucose values over a three day period to obtain 80-90 paired measurements. The comparison between Central Laboratory glucose determinations was performed with simple linear regression and Bland Altman analysis. A Clarke Error Grid (CEG) was built to quantify the clinical accuracy of blood glucose determinations generated by the OptiscannerTM 5000 as compared to Central Laboratory measurements.

Results: A total of 81 paired measurements, distributed between 33 and 320 mg/100 mL of glucose, were performed. The aggregate data points were within International Organization for Standardization standards, with 100% of the glucose values within ±20%.

Conclusion: The current study suggests that a mid-IR fixed-wavelength (OptiScanner) can measure glucose accurately across a wide range of glucose values, particularly, in plasma of Intensive Care Unit patients.

Keywords: Method