Siren is thrilled to announce the publication of its first clinical trialin Journal of Medical Internet Research (JMIR), the leading peer-reviewed journal for digital medicine, and health and healthcare in the Internet age. In the paper, Ran Ma, Siren's co-founder and CEO, and Alexander Reyzelman,Doctor of Podiatric Medicine at Samuel Merritt University, share the results of the first study to use at-home, continuous temperature monitoring via Siren’s Diabetic Sock and Foot Monitoring System. The data collected in the study shows how Siren's temperature-monitoring technology, called Neurofabric(™), can help reduce foot ulcers caused by diabetes and neuropathy.

Reducing Costs of Diabetic Foot Ulcers with Continous, At-Home Temperature Monitoring

“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 Dr. Reyzelman. “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 shows how comfortable Siren Socks were to wear daily, even with temperature sensors woven into the fabric of the socks. It also showed how the temperatures collected by the socks matched up with what was seen in the clinic.

How Neurofabric Enables Continous, At-Home Temperature Monitoring

In the study, patients wore the socks at home for a median of 7 hours and said that the Siren Socks felt just like their normal, everyday socks. The patients were willing to wear the socks every day, which shows that Neurofabric, the sensor-embedded fabric created by Siren, can seamlessly integrate into the daily 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.”

The Future of Neurofabrics to Empower People with Diabetes

Patients also said that Siren’s mobile app was easy to use. Using 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 give alerts in this study, users can receive a notification on their phone when a temperature increase is detected between a spot on one foot versus the same spot on the opposite foot.

“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 will be working on a large-scale patient study in 2019.

You can read the JMIR paper in full here.

For more information about the Siren Diabetic Socks and Foot Monitoring System, please visit our website.

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