Data Supports Efficacy of Continuous Calprotectin Monitoring Wearable for IBD Management

EnLiSense is sharing study data that validates the efficacy of its IBD Aware platform, an inflammatory bowel disease (IBD) management solution.

The study showcases IBD Aware’s ability to non-invasively monitor calprotectin levels in both active and remission phases of IBD. The validation of real-time, accurate biomarker tracking will help clarify EnLiSense’s next steps as the company works to advance data and AI analytics and support clinicians with decision-support tools.

“This clinical validation not only confirms our wearable’s role in utilizing calprotectin for managing inflammatory conditions but also signifies the beginning of a new era in disease management, enhanced by AI,” EnLiSense Co-Founder Dr. Shalini Prasad, Ph.D., professor and Department Head of Bioengineering at the University of Texas at Dallas. “Beyond illustrating our device’s capability to monitor a range of IBD biomarkers, it propels us towards a future where personalized care is the norm, not the exception. We are committed to continuous innovation and collaboration to further refine our technologies, empowering both patients and healthcare providers with deeper, actionable insights.”
 
In collaboration with the University of Chicago and funded by the Crohn’s & Colitis Foundation, the study, “Continuous Monitoring of CRP, IL-6, and Calprotectin in Inflammatory Bowel Disease Using a Perspiration-Based Wearable Device,” was published in Inflammatory Bowel Diseases Journal. The study successfully “demonstrated the clinical utility of perspiration as a noninvasive, continuous marker of gut inflammation.” This research not only reinforces the IBD Aware device’s potential role in the future of inflammation monitoring but also lays the groundwork for novel approaches to predicting and proactively managing IBD flares, leveraging extensive datasets of inflammatory biomarkers like calprotectin directly from the patient.
 
“The ability to continuously and accurately monitor calprotectin levels via perspiration and using a wearable technology is an important milestone for our field,” study co-investigator David T. Rubin, M.D., Joseph B. Kirsner Professor of Medicine and director of the IBD Center at the University of Chicago, stated. “The continuous monitoring of calprotectin provides critical insights into the nuances of disease relapse and progression and can enable the timely identification of disease activity and subsequent disease interception through adjustments in treatments.”
 
The study included 33 participants demonstrating the effectiveness of the IBD Aware device to monitor essential inflammatory biomarkers like calprotectin using sweat sensors. Notably, the device detected significantly higher calprotectin levels in individuals with active IBD compared to those in remission (P < .05), highlighting its capacity for real-time monitoring. A significant correlation was found between perspiration and serum calprotectin levels (R² = 0.7195) and C-reactive protein (R² = 0.615), demonstrating the precise measurements taken by the device. These results not only affirm the accuracy of the IBD Aware device, but demonstrate its utility in the shifting paradigm of proactive IBD management that emphasizes continuous, data-driven decision-making, according to EnLiSense. The promising results of this study have given way to broader and more comprehensive studies, including those at the University of Chicago, to delve deeper into the potential of this wearable device to improve IBD care, enabling disease monitoring strategies that are increasingly personalized and proactive.
 
“Our patient-centric vision for the Foundation’s Novel Technologies Initiative was to enable for the first time the development of wearable biosensors that can detect biomarkers like calprotectin in a minimally invasive and in real-time manner,” noted Dr. Andrés Hurtado-Lorenzo, Ph.D., senior vice president, Translational Research & IBD Ventures at the Crohn’s & Foundation. “The IBD Aware device exemplifies our dedication to empowering healthcare professionals and enhancing patient outcomes through remote and continuous monitoring.” 
 
EnLiSense develops advanced sweat sensor technology for real-time, non-invasive monitoring. Its offerings include both a first-of-its-kind device and an advanced data and AI platform, blending hardware with sophisticated analytics. Its flagship products, IBD Aware and Corti, are touted as gateways to a new era in personalized healthcare, as they facilitate proactive chronic disease management in conditions like inflammatory bowel disease (IBD) and stress-related disorders, offering clinicians and patients insights into both physiological and disease states for treatment timing and effectiveness, symptom management, and dietary and lifestyle adjustments—aspects previously inaccessible in real-time. The technology is validated to continuously monitor a comprehensive range of biomarkers including Calprotectin, CRP, TNF-Alpha, IL-6, Cortisol, Melatonin, Glucose, and many others, transforming how healthcare professionals and patients approach treatment and management. EnLiSense continues to expand research and development efforts into new biomarkers and disease applications, broadening the scope of the technology platform to encompass a wider spectrum of chronic conditions.