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Technology to Improve Treatment of Diabetic Complications

diabetesBy Shai N. Gozani, M.D., Ph.D.

Neuropathy, or nerve disease, is one of the most common complications of diabetes affecting about half of the diabetic population. Its implications can be severe: foot ulcers leading to amputations and disabling chronic pain. The annual cost of treating diabetic neuropathies has been estimated at $14 billion in the United States. Traditional medical practice to detect neuropathy includes an annual foot examination with a test for sensory perception such as a 5.07|10-g monofilament or a tuning fork. These subjective tests are generally conclusive when neuropathy has progressed to the loss of protective sensation but they are ineffective tools for early detection of neuropathy. As a result, opportunities for early interventions which may prevent or slow the progression of peripheral neuropathy are missed. The consequences in terms of quality of life and cost of health care can be daunting.

NeuroMetrix, Inc. has a major focus on diabetic neuropathies. The company develops wearable medical technology and point-of-care tests that help patients and physicians better manage chronic pain, nerve diseases, and sleep disorders.

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Dr. Shai N. Gozani

NeuroMetrix developed NC-stat DPNCheck, which is a rapid, accurate, and quantitative point-of-care test for peripheral neuropathies such as diabetic neuropathy. DPNCheck employs a handheld device and disposable biosensor to perform a nerve conduction test of the sural nerve. The test presents standard quantitative measures of nerve integrity: conduction velocity and response amplitude. Clinical interpretation of test results is straightforward using the interpretation guide which sets out clearly defined normal limits (>4 mV and >40 m/sec). PC software is provided for report generation and patient records. The DPNCheck test is typically performed by medical staff and takes about a minute with test results immediately presented on the device’s digital display.

DPNCheck was designed to assist in the early detection of diabetic neuropathy, including in the absence of symptoms and signs, thereby presenting opportunities to intervene and reduce costs. In addition to helping confirm or rule out diabetic neuropathy, the test helps quantify severity; monitor changes in neuropathy over time and in response to treatment; and identify those patients with neuropathy who are at highest risk for neuropathy-related complications such as foot ulcers, neuropathic pain and falls. It can improve the effectiveness of neuropathy detection programs and is ideal for health risk assessment service providers for in-home use and clinic-based health risk assessments.

About one quarter of people with diabetes suffer chronic pain which can be disabling to normal activity and can interrupt sleep. NeuroMetrix has developed and markets the SENSUS pain management system for the management of chronic pain. SENSUS is a wearable transcutaneous electrical nerve stimulator indicated for management of chronic pain, and is the only such device cleared by the FDA for use during sleep. It is lightweight and can be worn during the day while remaining active, and at night while sleeping. SENSUS is beneficial in treating various forms of chronic pain, particularly neuropathic pain such as painful diabetic neuropathy. SENSUS is designed for easy and convenient use. It is non-invasive and worn on the leg, just below the knee, and is activated by pressing a button. Whenever a patient need pain relief, the patient activates the device to stimulate the sensory nerves in the legs. Each session lasts 60 minutes with pain relief starting in about 10 minutes, and often lasting 30 minutes following the end of the session. The mechanism of action is thought to relate to increased levels of endogenous opioids that act through the delta opioid receptor to block pain signal transmission in the spinal cord.

This approach to pain management offers several potential benefits. First and foremost is the benefit of on-demand relief from chronic pain. Second, it is non-narcotic, non-addictive thereby avoiding side effects that can accompany pain medications. Third, the device is controlled by a single button making it easy to configure and to use. These benefits combined with its lightweight, low profile make it convenient to wear under clothing.

Patients using SENSUS describe the stimulation as a light pressure or buzzing sensation which they can control. Patient responses include: “the first time, it only took 10 minutes before the pain went away”, “my pain level went from an ‘8 out of 10’ to a ‘2’ or ‘3’”, “I’m getting as much or more relief using SENSUS than I was taking pills”, and “I’m noticing in the morning, I’m able to get up and around much easier than I was before, without experiencing the excruciating pain…. I sometimes forget it is even there. When I activate it, I feel like I can do just about anything. It gives me a level of relief I wasn’t experiencing with anything else.”

SENSUS is a prescription product that is delivered by mail to patients. NeuroMetrix’ customer service department can address most patient questions.

The rapid pace of advancement in technology for healthcare, including the complications of diabetes such as DPN and PDN, should bring with it new and improved standards of care. DPNCheck and SENSUS are good examples of technology serving physicians to improve the lives of their patients.

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Shai N. Gozani, M.D., Ph.D. is President and Chief Executive Officer of NeuroMetrix, Inc., a medical device company focused on treatment and management of chronic pain and peripheral neuropathies.

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