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

Abstract

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 ±8 mg/dL from the true reference standard; at blood glucose levels >75 mg/dL 100% of the measurements are within ±15% of the true reference standard. 100% of the results are within category A of the consensus grid. Within-run precision show CV < 3.72% between 24-50 mg/dL and CV<2.22% between 500 and 600 mg/dL. The results show that the In Touch® meter exceeds the minimum criteria of both the ISO 15197:2003 and ISO 15197:2013 standards. The results from a user panel show that 100% of the respondents reported that the color touch screen, with its graphic user interface (GUI), is well labeled and easy to navigate. Conclusions: To our knowledge this is the first touch screen glucose meter and the first study where accuracy of a new BGMS has been measured against a true primary reference standard, namely IDLC-MS.