The accuracy of a non-invasive glucose monitoring device does not depend on clinical characteristics of people with type 2 diabetes mellitus

摘要

>Objective: GlucoTrack is a non-invasive device that indirectly measures glucose fluctuation in the earlobe tissue. Thus, its accuracy may be subjected to a time lag between glucose concentration in blood and tissue. This time lag was shown to depend on individual characteristics related to microvascular complications, such as diabetes duration, HbA1c level, and smoking history. Therefore, the current study investigated the effects of these factors on GlucoTrack performance. >Research design and methods: Clinical trials were conducted on 114 people with type 2 diabetes. Device performance was clinically evaluated using Clarke error grid (CEG) analysis and numerically evaluated using the distribution of absolute relative difference (ARD) values. >Results: CEG analysis revealed that 98.0% of glucose readings were within the clinically acceptable CEG A + B zones. Total mean ARD was 22.7%. Clinical and numerical accuracies were comparable between never smokers and former/current smokers, but slightly reduced in the HbA1c ≥ 7.5% group and in the diabetes duration ≥15 years group. Yet, likelihood ratio and parametric bootstrap tests statistically demonstrated that ARD values did not depend on diabetes duration, HbA1c level, or smoking history. >Conclusions: GlucoTrack performance does not depend on diabetes duration, HbA1c level, and smoking history, indicating the device is suitable for various people with type 2 diabetes.