Accuracy of a Novel Noninvasive Multisensor Technology to Estimate Glucose in Diabetic Subjects During Dynamic Conditions.

Abstract

The purpose of this study was to determine whether an approach of multisensor technology with integrated data analysis in an armband system (SenseWear® Pro Armband, SWA) can provide estimates of plasma glucose concentration in diabetes. In all, 41 subjects with diabetes participated. On day 1 subjects underwent an oral glucose tolerance test (OGTT) and on day 2 a 60-minute treadmill test (TT). SWA plasma glucose estimates were compared against reference peripheral venous glucose concentrations. A continuous glucose monitoring device (CGM) was also placed on each subject to serve as a reference for clinical comparison. Pearson coefficient, Clarke error grid (CEG), and mean absolute relative difference (MARD) analyses were used to compare the performance of plasma glucose estimation. There were significant correlations between plasma glucose concentrations estimated by the SWA and the reference plasma glucose concentration during the OGTT (r = .65, P < .05) and the TT (r = .91, P < .05). CEG analysis revealed that during the OGTT, 93% of plasma glucose concentration readings were in the clinically acceptable zone A+B for the SWA and 95% for the CGM. During the TT, the SWA had 96% of readings in zone A+B, compared to 97% for the CGM. During OGTTs, MARDs for the SWA and CGM were 26% and 18%, respectively. During TTs, MARDs were 16% and 12%, respectively. Plasma glucose concentration estimation by the SWA's noninvasive multisensor approach appears to be feasible and its performance in estimating glucose approaches that of a CGM. The success of this pilot study suggests that multisensor technology holds promising potential for the development of a wearable, noninvasive, painless glucose monitor.