Handheld and Wearable Tools for Diabetes Pain (Interview)

It’s a big challenge to measure and manage diabetes pain.

But two tools developed by NeuroMetrix, Inc. – the NC-stat®® DPNCheck® and the SENSUS™ Pain Management System – offer paths forward in both areas. DPNCheck can be held in doctors’ hands, while people with diabetes can wear the SENSUS device, offering a level of convenience previously unavailable.

We spoke with Shai N. Gozani, M.D., Ph.D., President and Chief Executive Officer of NeuroMetrix, to get the details.

Can you give us an overview of the problem your technologies are designed to address?

Progressive nerve damage affects about 50 percent of people with diabetes, a condition called diabetic peripheral neuropathy or DPN. This complication of diabetes leads to loss of feeling in feet and, if untreated and unmanaged, dramatically increases the risk of foot ulcers and amputation. Furthermore, about half of those with DPN suffer from an incredibly disruptive condition called painful diabetic neuropathy (PDN), which causes moderate to severe pain in the toes, feet, legs and sometimes hands and arms. Sufferers report sensations such as stabbing, burning and lancinating pain. This chronic pain decreases quality of life and makes getting a good night’s sleep a real challenge.

What is DPNCheck and how does it help doctors evaluate neuropathies?

DPNCheck provides a fast, accurate test to evaluate peripheral neuropathies like DPN. The handheld device measures sural nerve conduction – a more sensitive way to detect DPN than traditional detection tools can provide. DPNCheck can detect DPN early on, even in the absence of symptoms and signs, and measure severity while monitoring changes over time and in response to treatment.

The DPNCheck testing process is typically performed by medical staff and takes about a minute. First, the patient is positioned on a table and the testing area prepared. A biosensor is then placed on the device and gel applied; the DPNCheck is subsequently positioned on the patient’s leg and the test initiated. The results can then be read on a digital display on the device.

What is SENSUS, how does it work and how does it help diabetes patients?

The SENSUS™ Pain Management System is designed for people living with PDN and other chronic pain. Worn on the leg, just below the knee, it’s activated by pressing a button. Whenever pain relief is needed, the device stimulates the sensory nerves in the legs. Each session lasts 60 minutes with pain relief starting in about 10 minutes, and often lasting 30-60 minutes following the end of the session.

This approach to pain management offers several potential benefits. It might offer fast-acting relief from chronic pain. Second, it is non-narcotic and non-addictive and thus avoids the potential for significant side effects. Third, the one-button control means patients don’t have to fumble with advanced instrumentation. Furthermore, the device is lightweight and low-profile, and can be worn under clothing. SENSUS is the only FDA-approved device of its kind that can also be worn during sleep.

Whether prescribed by itself or in conjunction with common pain medications, SENSUS is wearable technology providing on-demand pain relief for people living with PDN. A new over-the-counter product based on the technology in SENSUS is now being developed.

We believe that new technological options like DPNCheck and SENSUS can help to advance the standard of care for people with diabetes and their healthcare providers.

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