REAL-TIME CONTINUOUS REPORTING OF IBD BIOMARKERS IN SWEAT

Abstract

Abstract INTRODUCTION Calprotectin and C-reactive protein (CRP) are key biomarkers to assess a flare-up and inflammation in IBD patients. Flare-ups in IBD patients can create excruciating pain, discomfort, and occur in a random way. Therefore, continuous monitoring of these biomarkers in real-time can aid in providing active feedback and decision support on the health state for better IBD patient management. This work demonstrates a novel way of empowering IBD patients with actionable data through capturing temporal profiles of IBD markers (Calprotectin and CRP) from sweat for patient-driven outcomes. MATERIALS AND METHODS 10 healthy and one IBD subject were recruited in compliance with an approved IRB at UT Dallas. The levels of Calprotectin were quantified using the SWEATSENSER and ELISA. The basal levels of Calprotectin were compared between healthy and IBD cohort. Further, the wearable SWEATSENSER was used to measure CRP and Calprotectin continuously for a minimum of 6 hours. The levels of the study biomarkers were compared between healthy and IBD subjects to determine the statistical significance in differentiating between both the cohorts. RESULTS CRP levels between healthy and IBD subjects were measured through continuous monitoring using the SWEATSENSER for up to 24 hours over multiple days. Figure 1A shows a comparison between healthy (n=108 data points) and IBD (n=43 data points) CRP levels in sweat and a statistically significant difference between(p<0.05) was achieved. The levels were computed as a time-average of every 2 hours. Further, healthy calprotectin levels ranged 379 ng/mL while, the basal levels in IBD subject were reported to be 620 ng/mL as demonstrated in Figure 1B. The basal levels of calprotectin were significantly different between healthy and IBD subjects confirming the first proof-of-feasibility of real-time monitoring of IBD markers from sweat in detecting elevated IBD levels and an impending flare-up. CONCLUSION The SWEATSENSER device can differentiate the marker levels between healthy and IBD subjects. The developed device can be useful in better management of IBD patients by monitoring biomarker levels in real-time to report an impending flare-up. Further, the feasibility of real-time monitoring of CRP and Calprotectin using SWEATSENSER enables actionable data to patients during transition from remission to relapse of the disease. This is the first in-human demonstration of a wearable technology for tracking and stratification between healthy and IBD subjects.