Barron Associates Completes Pilot Study of Diabetic Foot Health Monitoring System

The prevalence of diabetes mellitus in the U.S. is high and increasing in both adults and children—over 1.5 million Americans are diagnosed with diabetes annually. Among the consequences of diabetes, diabetic foot ulcers (DFUs) are a common and major complication, resulting in lower quality-of-life, hospitalization, disability, amputation, and even death. Research suggests that active management of foot health can prevent the occurrence and reoccurrence of a DFU; however, approaches must be multifaceted and require continual monitoring from both patients and caregivers. The Barron Associates SoleSaver system is a sensor-enabled, unobtrusive, and non-binding foot-worn garment that can be used to continually monitor multiple facets of foot health in order to maximize DFU prevention and minimize DFU recurrence.

In this study, prototype units were designed, built, and passed engineering evaluations; participants successfully used the prototypes and a laboratory criterion system simultaneously; statistical equivalence between SoleSaver and the criterion system was achieved at the p <= 0.01 level for all quantities; ICC, concordance, and correlation were all high; and the median System Usability Scale (SUS) score was 85, which represents an “A” grade and is a remarkable accomplishment for an early prototype.