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New Project Looks to Turn a Bandage into an mHealth Sensor

North Carolina State University's ASSIST Center is working on a digital health patch to help clinicians monitor tissue oxygen in patients undergoing peripheral artery disease treatment.

Source: ThinkStock

By Eric Wicklund

- North Carolina State University is launching a federally funded project to create a wearable mHealth sensor capable of continuously monitoring the amount of oxygen in surrounding tissue.

Wearables have long held promise in healthcare for the potential to monitor a patient’s vital signs in real time, but few have been able to vault the barrier of continuously tracking and sending medical grade data. NCSU researchers are hoping to push the technology forward with a wearable patch that can keep track of tissue oxygen.

With a $1.5 million Phase II Small Business Innovation Research (SBIR) grant from the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH), NCSU’s ASSIST Center will work with mHealth company Profusa to develop an ultrathin, flexible patch for patients undergoing treatment for peripheral artery disease (PAD).

The ‘bandage reader’ would integrate with Profusa’s Lumee Oxygen Platform, an mHealth sensor designed to measure oxygen. In treatment of patients with PAD, it allows clinicians to continuously monitor tissue oxygen levels and adjust therapy when needed.

"The goal of our collaboration is to develop a bandage-like version of Profusa's first-generation optical reader that is flexible, disposable, and conforms to the foot for continuous monitoring of tissue oxygen levels during revascularization and restenosis in patients with PAD," Natalie Wisniewski, PhD, San Francisco-based Profusa's chief technology officer and principle investigator of the program, said in a press release. "The impact of our alliance has the potential to be transformative, not just for PAD, but for the broad field of mobile health monitoring.”

PAD affects some 202 million people globally and about 12 million in the U.S., where it accounts for about $74 million annual in annual healthcare spending. Studies have found that 60 percent of patients with PAD experience potentially serious side-effects within two years of a medical intervention, such as a stent or balloon treatment.

Researchers across the country are bringing mHealth to bear on this challenge, in hope of reducing the side-effects and improving treatment outcomes.

Last September, the Stanford University School of Medicine launched a clinical study on Apple’s ResearchKit platform to track daily activity and gather data from as many as 5,000 patients diagnosed with PAD.

“We hope to gain insights into patterns of disease progression over time by collecting participants’ activity data from their iPhones,” Oliver Aalami, MD, clinical associate professor of vascular surgery and lead investigator of the study, said in a release issued by Stanford. “We will be looking for any changes in activity patterns that may indicate disease advancement.”

The National Science Foundation-sponsored Nanosystems Engineering Research Center (NERC) for Advanced Self-Powered Systems of Integrated Sensors and Technologies (ASSIST) has been working for some time on developing wearable patches for the “simultaneous, continuous, non-invasive monitoring of multiple biomarkers.” Much of the work has been done with support from the Defense Advanced Research Projects Agency (DARPA).

"Our joint programs with Profusa exemplify ASSIST's mission to empower physicians and their patients with innovative technology that enables real-time monitoring of health and disease,” Michael Daniele, PhD, the ASSIST Center’s site lead for the project, said in the press release.

With the ability to offer continuous, non-invasive monitoring, wearable patches are one of mHealth’s hottest topics these days. Boston’s Brigham and Women’s Hospital is due to scale up a remote patient monitoring project started last fall that measures how biosensor patches can be used to monitor patients at home with heart failure, COPD, cellulitis or complicated urinary tract infection.

“The evolution of digital medicine makes us even more confident in the home hospital model for our patients,” David Levine, MD, a General and Internal Medicine Fellow at Brigham and Women’s and the study’s principal investigator, said in a recent press release. “The purpose of this study is to show how we can deliver superior outcomes at a lower cost for patients who otherwise would be hospitalized.”

“We are in a very exciting era of medicine where clinical-grade biosensors and analytics are capable of delivering continuous physiological insight that was traditionally only available in the hospital environment,” he added.

Patches and sensor-embedded bandages are also being tested for use in athletics, skin cancer detection, addiction treatment and medication adherence.

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