Diabetic Neuropathy Device™ 

Medicare Reimbursable (4 billing codes)

Diabetes & Neuropathy

Diabetic Neuropathy Device™ (DND) is the first FDA Cleared multi-objective painless and non-invasive tool that identifies and measures both large and small nerve fibers in peripheral extremities.

DN Accounts for More Hospitalizations than All Other Diabetes Complications Combined...

Aaron Vinik, MD, Ph.D., Endocrinologist, Diabetic Neuropathies, February 5, 2018

FREE 15-minute Patient Education Video 

*NOTE: Bookmark page for future use with patients. www.DPNtest.com

In the U.S., an estimated that up to 85% of lower extremity amputations among persons with diabetes can be prevented with improved foot care programs.

Bild DE, et al. Lower Extremity Amputations in People with Diabetes: Epidemiology and Prevention. Diabetes Care 1989; 12:24-31; CDC MMWR November 01, 1991 / 40(43);737-7

Subjective or Objective

The Diabetic Neuropathy Device™ (DND) is the only multi-objective tool that is uniquely qualified to meet the new American Diabetes Association (ADA) Diabetes screening and diagnosis recommendations with 'temperature and vibrations' under the new Diabetic Neuropathy: A Position Statement by the American Diabetes Association which recommends that screening for distal symmetric polyneuropathy (DSPN), should include a careful history and assessment of temperature (small fiber function) and vibration (large fiber function). 

Early recognition, management, and treatment of neuropathy in patients with diabetes are essential. Treatments for neuropathy must be individualized to address the particular manifestation and underlying pathogenesis of each patient's unique clinical presentation without subjecting patients to the potentially harmful side effects of opioids and other medications. Thus, reliable identification of individuals in the early stages of the neuropathic process is required to modify risk factors more rigorously, and foot care education can be implemented.

Diabetic Neuropathy (DN) is Grossly Underdiagnosed and Undertreated.

Aaron Vinik, MD, PhD, FCP, MACP, FACE, et al, Endocrinologist, Diabetic Neuropathies, February 5, 2018

Temperature (Small Fiber)

Reimbursable Foot Exams

Site-Specific Predictive Biomarkers

Vibration (Large Fiber)

Most affordable Sudomotor Function Testing (SFT) modality for lower-extremities.

The device (DND) replaces tuning forks and monofilaments...

Kazu Suzuki DPM, Medical Director of the Tower Wound Care Center at the Cedars-Sinai Medical Towers in Los Angeles, CA; Managing Neuropathy And Pain In Wound Care Patients, Podiatry Today; September 2015; 26-27.

DND eliminates false (+) and false (-) results

Importance of Specificity

Diabetic Neuropathy (DN) is often overlooked as a mortality risk because diabetics who have lower-extremity amputations have lifespans that range between 40% mortality in 1-year, 65% mortality in 3-years, and 80% mortality in 5-years. Therefore, it is critical that assessing the management of diabetic foot problems be identified through comprehensive foot screenings and exams. Diabetic Neuropathy is a serious diabetes complication affecting as many as 50% of people who suffer from pain, and another 50% may be asymptomatic - who are at the highest risk of falls, ulcerations, and amputations. Nerve damage and poor circulation are the most common causes of diabetic foot problems. One of the most underdiagnosed and untreated parts of a comprehensive foot exam is checking the loss of protective sensation (LOPS) in the feet. The diabetic large nerve fiber dysfunction, as measured by vibration, predicts foot ulcerations, amputations, and mortality. 

(Painless) Diabetic large nerve fiber dysfunction as measured by vibration Predicts foot ulceration, amputation and mortality


The purpose of a comprehensive diabetic foot exam is to gather as much clinical data about the condition of a person's normal or abnormal condition in the feet of both large and small nerve fibers. A diabetic foot exam also checks people with diabetes for infection, injury, and bone abnormalities. However, over 99% of all medical providers still use outdated and subjective tools to identify a more advanced disease. Distal Symmetric Polyneuropathy (DSPN), a glove and stocking distribution, is the most common form of Diabetic Neuropathy (DN) and is recognized as the most troublesome complication of diabetes mellitus leading to the greatest morbidity and mortality, which accounts for the most amount of hospitalizations than all other diabetic complications combined and is responsible for up to 75% of non-traumatic amputations.

(Painful) Diabetic small fiber neuropathy can only be verified with thermal thresholds or skin biopsies

Aaron Vinik, MD, Ph.D., Endocrinologist, Diabetic Neuropathies, February 5, 2018

The proper diagnosis of diabetic neuropathy should require tools to identify and measure the disorder quantitatively for the different abnormalities that occur to specific nerve fibers. Combining at least two different examinations (large and small fiber) will increase the sensitivity and specificity of detecting DPN. Currently, many medical providers are unaware of reimbursable tools that address both large fiber and small fiber neuropathy, both of which manifest in patients with diabetes. The Diabetic Neuropathy Device™ is the first FDA Cleared multi-objective tool with 15 measurements that identify both large and small nerve fibers in the upper and lower extremities.

DND Reimbursements

Up to 90-Days  Deferred Payments OAC


Zero Startup Costs

Billing Support

$199-Monthly Financed

$375 Average Reimbursements

(~30 Patients to Breakeven)

Large & Small Fibers

Nerve Fiber Types

Identifying the following nerve fibers may increase earlier awareness and interventions:

Risk Mitigation

According to the CDC, missed opportunities to diagnose neuropathy appropriately can ultimately lead to lower-extremity amputations of the toes, feet, or legs. U.S. courts have found medical institutions and physician defendants liable for medical malpractice due to their failure to adopt new technologies or procedures. Having been demonstrated in the case that set legal precedence in the U.S. Washington v. Washington Hospital (1990). Risk mitigation initiatives require clinicians to stay informed of emerging best practices based on clinical evidence. A collective refocusing on prevention and a reallocation of resources can lead to the appropriate therapy, leading to fewer inpatient and outpatient visits and improved quality of life. The Diabetic Neuropathy Device™ (DND) is a modern evidence-based tool that improves productivity, patient outcomes, and an organization's overall reputation for mitigating risks.

"...by the time a patient fails the monofilament test, he or she may have a profoundly severe neuropathy, and it may be too late to intervene."

Kazu Suzuki DPM, Medical Director of the Tower Wound Care Center at the Cedars-Sinai Medical Towers in Los Angeles, CA; Managing Neuropathy And Pain In Wound Care Patients, Podiatry Today; September 2015; 26-27.

Mechanism of Action

Skin is the largest organ of the body and helps regulate body temperatures and permits touch, heat, and cold sensations. The mechanism of action in identifying nerve fibers may be performed by testing the autonomic nervous system's sudomotor function using the sympathetic skin response (SSR). The SSR specifically tests sudomotor skin fibers that do not participate in thermoregulatory sweating. This methodology is currently performed using monofilaments and tuning forks and is recognized by multiple organizations around the U.S. including the American Diabetes Association (ADA) to diagnose autonomic dysfunction with polyneuropathies. Small fiber peripheral neuropathy primarily or exclusively affects the body, such as the skin and those that mediate pain and thermal sensation.

The sympathetic skin response is a simple, reproducible, and non-invasive test based on modifying the skin potential of peripheral nerves. Sympathetic skin response has been used to diagnose polyneuropathy, erectile dysfunction, central degenerative diseases, multiple sclerosis, brain infarction, reflex sympathetic dystrophies, spinal, and peripheral nerve lesions. The Diabetic Neuropathy Device™ is a modern tool that uses the SSR to help patients discriminate against variable temperature and vibration stimuli. 

It is imperative that we use our ability to measure quantitatively the different types of defects that occur in the disorder (DN), so the appropriate therapies can be targeted to specific nerve fiber types.

Aaron Vinik, MD, PhD, FCP, MACP, FACE, et al, Endocrinologist, Diabetic Neuropathies, February 5, 2018

Clinical References

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