Performance and System Validation of a New Cellular-Enabled Blood Glucose Monitoring System Using a New Standard Reference Measurement Procedure of Isotope Dilution UPLC-MRM Mass Spectrometry.

Background:We evaluated the accuracy, precision, and linearity of the In Touch® blood glucose monitoring system (BGMS), a new color touch screen and cellular-enabled blood glucose meter, using a new rapid, highly precise and accurate 13C6 isotope-dilution liquid chromatography-mass spectrometry method (IDLC-MS).Methods:Blood glucose measurements from the In Touch® BGMS were referenced to a validated UPLC-MRM standard reference measurement procedure previously shown to be highly accurate and precise. Readings from the In Touch® BGMS were taken over the blood glucose range of 24-640 mg/dL using 12 concentrations of blood glucose. Ten In Touch® BGMS and 3 lots of test strips were used with 10 replicates at each concentration. A lay user study was also performed to assess the ease of use.Results:At blood glucose concentrations 75 mg/dL 100% of the measurements are within ±15% of the true reference...