Q&A: IBD wearable alerts patients ‘in real time’ about impending disease flares
SAN FRANCISCO — IBD Aware, a wearable medical device in development for patients with inflammatory bowel disease, aims to improve disease monitoring by continuously measuring biomarkers in sweat, according to the creators of the device.
“Wearables are devices that are essentially completely noninvasive,” Shalini Prasad, PhD, professor in the department of bioengineering at the University of Texas at Dallas and co-founder of EnLiSense, told Healio. “They look at the biochemistry of the individual, which currently is done through blood or stool testing, and even imaging. Wearables simplify that by allowing you to noninvasively gather that information at both the current testing time and across periods of time when the wearable is worn by the individual.”
According to Prasad, a presenter at Crohn’s & Colitis Congress, what sets the IBD Aware (EnLiSense) platform apart from other wearable technologies is its continual monitoring of inflammation levels through passive, everyday perspiration, which is “truly representative” of what is happening within the body.
Sriram Muthukumar, PhD, CEO and co-founder of EnLiSense, added that the advantage of this technology is the ability to alert patients with IBD “in real time” when their biochemical expression indicates an upcoming disease flare or elevated disease activity — before symptomology has even set in.
In a Healio interview exclusive, Muthukumar and Prasad dive deeper into the intricacies of the technology, its benefits and how the long-term logging of “actionable data” empowers patients to take control of their chronic disease.
Healio: What key biomarkers does IBD Aware test for and how do they inform providers on a patient’s current disease state?
Prasad: IBD is a disease of inflammation and, right now, any clinical care is predicated on two aspects: measurements of serum C-reactive protein, which is done through blood sampling, and fecal calprotectin. There are well-established thresholds for both, and clinical decisions are made based on these measurements.
The second aspect is that most biologics for reducing inflammation given to IBD patients typically act on reducing tumor necrosis factor-alpha levels, which is another inflammatory protein the body produces.
IBD Aware has a sensor that looks at four biomarkers: CRP, calprotectin, TNF-a — because those expression levels are connected and indicative of the therapy regimen — and interleukin-6. These four markers come out in passively perspired sweat that is representative of what is happening in the body, which provides a temporal profile of the disease expression for the individual.
Healio: Does IBD Aware require continuous wear or only periodic use?
Muthukumar: This really depends on the disease state. With IBD, once patients are in remission they want to stay in remission, and that is where most of the efforts are being applied. We anticipate that IBD Aware will go through an FDA 510(k) regulatory classification as a Class II medical device that will be prescribed by the clinician to the patient, based on their disease activity level.
If the patient is experiencing inactive disease or they are not showing any signs that they are likely to flare, then this does not need to be a continuous-wear device. Conversely, there are going to be people who are showing they are likely to flare or have indeterminate or unpredictable flare, so they are most likely candidates where the clinician may recommend more continuous wear.
Using those [biomarker] levels, the clinician can remotely monitor the patient and then decide to do follow-up imaging or lab tests as required. Currently these tests can be very expensive and inconvenient for the patient. Using IBD Aware to remotely monitor the inflammation can help the clinician decide when the patient needs follow-up imaging and/or lab testing done and thus help lower the disease burden on the patient. Whether the device is going to used continuously or periodically is really between the clinician and the patient.
Healio: How does this technology benefit the patient?
Muthukumar: The advantage of this wearable is that it is going to provide alerts in real time, which means that patients and providers could see the biochemical expression even before IBD symptoms start to show. Of course, the $64,000 question every clinician wants to know is how soon before an upcoming flare would they know. That is going to be subjective to the patient because not every individual is the same: Each person’s colon and disease are going to be slightly different.
But this is where the clinician looks at past performance, like over the last week, last month or the last 3 months, to see how the inflammation levels have been trending using IBD Aware. And when they see that inflammation levels are getting elevated above the clinically established threshold, they will be able to determine the likelihood of whether the patient is going to have a flare within 6 to 24 hours and make informed actions on preventative care.
This early monitoring system is what we plan to provide with the platform, because resolution of inflammation is the key to minimizing disease progression in IBD patients.
Prasad: I would like to add that this is very individualized. The longer the patient wears it, the more the sensor technology will learn about the patient’s performance and profile to determine whether they are within an acceptable range. It uses a learning model to assess the prediction of disease activity based on the past levels of inflammation seen in the patient.
This is very future-looking, too, because right now what the wearable can do is disease-activity monitoring and thresholding, but it has the potential to look at actionable time- based data that truly empower patients and clinicians in disease management and treatment.
Healio: What advice would you give to physicians who are hesitant to use this type of technology?
Prasad: When a patient is coming out of an active disease state and they have achieved clinical remission, the disease still could be very unstable. A technology like this can give insight into how the patient is performing day by day.
With IBD Aware, physicians have the ability to see between those time points — stable to unstable disease and vice versa — and that would perhaps give reassurance. This is essentially augmenting the current state of standard of care, not replacing it, to facilitate better closing of the loop for every individual.
Healio: What else should our readers know about this device?
Muthukumar: Providers and patients can learn more and enroll in our studies by visiting www.ibdwearable.com.
We would like to get as many patients enrolled as we can, because IBD is also a disease that is diverse; it is not one-size-fits-all. We would like to get people from different walks of life, different communities and socioeconomic backgrounds and see how this disease manifests and is impacted by the patients’ quality of life.
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Prasad S, et al. Predicting the future: Predictive AI, wearable monitoring and novel treatments in IBD. Presented at: Crohn’s and Colitis Congress; Feb. 6-8, 2025; San Francisco.