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

Abstract

Objective:

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.

Research Design and Methods:

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.

Results:

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.

Conclusions:

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.