to Skin Temperature Monitoring in Journal of Medical Internet Research (JMIR)
— Paper details results of first at-home, continuous, wireless temperature monitoring system to detect onset of diabetic foot ulcers caused by neuropathy
— Temperatures measured by standalone sensors were within 0.2℃ of the reference standard
–Data demonstrates potential as promising approach for early warning of foot ulcers, Charcot foot, and re-ulceration
SAN FRANCISCO–(BUSINESS WIRE)–Siren, the health technology company that developed Neurofabric™, a machine-washable, machine-dryable smart textile with built-in sensors, today announced publication of a foundational paper supporting its approach in Journal of Medical Internet Research (JMIR), the leading peer-reviewed journal for digital medicine, and health & healthcare in the Internet age. In the paper, a team of international researchers led by Ran Ma, co-founder and CEO, and Alexander M Reyzelman, DPM; Samuel Merritt University, detail the role of Siren’s Diabetic Sock and Foot Monitoring System in maintaining continuous, wireless skin temperature monitoring for users at-home, demonstrating the potential for the reduction of foot ulceration for diabetic patients.
“Diabetic foot ulcers (DFU) result in considerable cost to the healthcare system when immediate ulcers, social services, home care, and subsequent ulcers are taken into consideration,” said Alexander M Reyzelman, DPM; Samuel Merritt University and lead author on the paper. “The cost per ulcer is over $33,000 per year and the cost per leg amputation is more than $100,000 per year. Over 100,000 legs are lost to diabetes each year. In diabetic foot complications such as foot ulcers, elevated temperatures in regions of the foot have been shown to be a precursor for ulceration.”
The JMIR publication details Siren’s pilot study of its Diabetic Sock and Foot Monitoring System to assess how comfortable their sensor-embedded socks were for daily use, and whether observed temperatures correlated with clinical observations.
In the study, patients wore the socks at home for a median of 7 hours, reporting that they felt just like their normal, everyday socks. Their stated willingness to wear the socks every day underscores the socks’ suitability for home use, suggesting that Neurofabric can seamlessly integrate into the life of the wearer.
“Several tools have been developed to measure plantar temperatures and the progression of foot ulcers, but they only measure temperature once a day which can lead to false-positives, or are only available for in-clinic use and not at home,” said Ran Ma, co-founder and CEO of Siren. “Now, for the first time, we highlight the striking connection between our Neurofabric’s powerful ability to capture data at home, every single second. The data is incredibly meaningful—it’s the largest amount of patient data that physicians have had wireless access to in real-time. This solidifies the potential for Neurofabric to change the trajectory of diabetic foot ulcerations and the many complications that can occur from it—including sepsis, and lower limb amputations.”
Patients also reported that Siren’s mobile app was easy to use and navigate. Through the mobile app, wearers can view the current temperature as measured at six points on the user’s foot. While the app was not set up to generate alerts in this study, users can receive a notification on their phone when a temperature increase is detected between contralateral positions.
“Digital health is a vast and burgeoning field and spans several aspects of health management—Neurofabric can facilitate the management of chronic conditions at home, including the effective and timely management of DFUs,” said Henk Jan Scholten, co-founder and COO of Siren. “The JMIR publication sheds light on both the ability of these Neurofabrics to improve quality of life for diabetes patients, and Siren’s first use-case to empowering people to take their health into their own hands.”
Siren is initiating a large-scale patient study in 2019.
Read the JMIR paper in full here: Continuous Temperature-Monitoring Socks for Home Use in Patients With Diabetes: Observational Study
Founded in August 2016, Siren is a health technology company and the maker of Neurofabric™, machine-washable, machine-dryable smart textiles. Siren’s first product, Siren Diabetic Socks, are designed to help people with diabetes avoid amputations. Siren was previously named AARP Consumer’s Choice Award winner, 2017 CES TechCrunch Hardware Battlefield, 2018 CES Best of Innovation, Fast Co.’s 2018 Innovation by Design Award Honorable Mention, and 2018 ADA Healthtech Showcase winner. Siren’s investors include DCM, Khosla Ventures and Founders Fund.