Assessing the Performance of a Noninvasive Glucose Monitor in People with Type 2 Diabetes with Different Demographic Profiles

Abstract

Background. Noninvasive glucose-monitoring devices represent an exciting frontier in diabetes research. GlucoTrack® is a noninvasive device that indirectly measures glucose fluctuation in the earlobe tissue. However, GlucoTrack measurements may be susceptible to effects of quasi-stable factors that may be affected by demographic profiles. The current study, thus, examined device performances in people with type 2 diabetes with different demographic profiles, focusing on age, gender, body mass, and whether the earlobe is pierced. Materials and Methods. Clinical trials were conducted on 172 type 2 adult diabetic subjects. Device performance was clinically evaluated using the Clarke error grid (CEG) analysis and statistically assessed using absolute relative difference (ARD). Results. CEG analysis revealed that 97.6% of glucose readings were within the clinically acceptable CEG A + B zones. Mean and median ARD were 22.3% and 18.8%, respectively. Likelihood ratio and parametric bootstrap tests revealed that there were no significant differences in ARD values across age, gender, body mass, and whether the earlobe was pierced, indicating that the accuracy of GlucoTrack remains consistent across the tested demographic profiles. Conclusions. Our results suggest that GlucoTrack performance does not depend on demographic profiles of its users and it is thus suitable for various people with type 2 diabetes.