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Diabetic Neuropathy Device™
Small Fibers & Large Fibers
Diabetic Peripheral Neuropathy
Diabetic Neuropathy (DN) is often overlooked as a mortality risk and the Diabetic Neuropathy Device™ (DND) addresses this gap by being the first FDA-cleared, multi-objective, non-invasive tool that measures both large and small nerve fibers in peripheral extremities.
Temperature (Small Fiber)
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.
Site-Specific Predictive Biomarkers
Vibration (Large Fiber)
"Every medical practice should test patients with the DND before referring them to a specialist because it can help identify potential underlying conditions that may require further investigation or treatments." -J. Gonzalez MD, Neurologist
Comprehensive Foot Exams (Painful/Painless)
People with diabetes are living longer and healthier lives with fewer complications because of technological advances that facilitate earlier identification and interventions. These innovations have ben instrumental in improving the management of diabetes and enhancing patient outcomes. It is expected, if not an obligation, for medical providers to utilize the most modern and objective diagnostic tools in medicine rather than relying on subjective tools such as tuning forks (invented in 1711) and monofilaments (invented in 1938). Diabetic neuropathy is a common complication of diabetes that can lead to significant morbidities and mortalities. The epidemiology and natural history of diabetic neuropathy are clouded with uncertainty partially due to the to measure the disorder. Primary care providers are crucial in caring for patients and are often the first point of contact for individuals experiencing foot-related discomfort. We can ensure timely intervention and reduce the risk of debilitating complications by utilizing objective methods to diagnose neuropathy.
Get Reimbursed for Foot Exams
Among the various methods utilized in medical clinics, monofilament (inv. 1938) testing is an affordable and widely used technique. However, the perception that inexpensive tools like monofilaments are adequate for diagnosing neuropathy can be the highest cost of increased risk of complications. Relying on outdated and subjective tools such as monofilaments for diagnosing neuropathy may result in delayed interventions and increased risks of complications due to the possibility of false negative and false positive results. According to a study published in the Journal of Diabetes Science and Technology, the use of monofilaments as a screening tool for diabetic peripheral neuropathy has a sensitivity of only 64%, indicating that it may not be the most accurate method for diagnosis. Therefore, it is crucial to consider alternative diagnostic tools that can provide more precise and reliable results to ensure timely interventions and reduce the risk of complications.
Diabetic and Non-Diabetic
The Diabetic Neuropathy Device™ (inv. 2014) offers a significant improvement over traditional tools used to detect and measure neuropathy in diabetic patients. Clinical studies have shown that the DND provides more accurate results than tuning forks and monofilaments, which can often provide false-positive and false-negative test results. With the DND, medical providers can standardize diabetic foot exams across the United States, leading to better outcomes for patients. With the DND, medical providers can accurately diagnose and monitor diabetic neuropathy, leading to better treatment and improved patient outcomes. Its effectiveness has been hailed as the most significant innovation in diabetic neuropathy over the past 80 years, making it an essential tool for medical professionals and is eligible for reimbursements from Medicare, Medicaid, and commercial payers.
Diabetic Neuropathy Accounts for More Hospitalizations Than All Other Diabetic Complications Combined...
Aaron Vinik, MD, Ph.D., Endocrinologist, Diabetic Neuropathies, February 5, 2018
"The DND has improved the patient understanding of their disease, which is very helpful." - W. Beaton DPM
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
"We regularly use the Diabetic Neuropathy Device™ (DND) to monitor our diabetic patients who are at risk for developing diabetic neuropathy, as well as patients who are already diagnosed with diabetic neuropathy." -C. Soller NP, Endocrinology
Modern Technology
The Diabetic Neuropathy Device™ (DND) meets the new American Diabetes Association (ADA) Diabetes screening and diagnosis recommendations. It is the only tool capable of screening distal symmetric polyneuropathy (DSPN), which includes the assessment of temperature (small fiber function) and vibration (large fiber function), as recommended in the new Diabetic Neuropathy: A Position Statement by the American Diabetes Association.
Neuropathy treatments should be tailored to address each patient's unique clinical presentation and underlying pathogenesis without exposing them to the harmful side effects of opioids. For instance, if a patient with painful neuropathy is given medication to alleviate the pain, it may mask and hide the loss of protective sensation (LOPS) in their feet, increasing the risk of foot ulcers and amputation. Therefore, identifying individuals in the early stages of the neuropathic process is crucial to reducing risk factors more effectively.
Don't Change Your Workflow, Just Your Tools!
Two Major Modalities in One Simple-to-Use Handheld Device
Boris Golosarsky, MD MACP FACPI, Podiatry Management, Profiles in Excellence, January 2015
Objectively identify and measure small fiber neuropathy and large fiber neuropathy.
"We use the DND because it gives us both the small and large fiber results that we feel are important for every diabetic patient." -R. Cardenas MD, Family Practice
Morbidity and Mortalities
Neuropathy is a serious condition that, if not diagnosed properly, can lead to lower-extremity amputations of the toes, feet, or legs. Medical institutions and physicians have been found liable for medical malpractice due to their failure to adopt new technologies or procedures. This has been demonstrated in the case that set legal precedence in the U.S., Washington v. Washington Hospital (1990). Clinicians need to stay informed of emerging best practices based on clinical evidence to reduce risks. By focusing on prevention and reallocating resources, the appropriate therapy can be given, resulting in fewer inpatient and outpatient visits and improved quality of life.
"...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.
Diabetic Neuropathy (DN) is Grossly Underdiagnosed and Undertreated.
Aaron Vinik, MD, PhD, FCP, MACP, FACE, et al, Endocrinologist, Diabetic Neuropathies, February 5, 2018
Identifying the following nerve fibers may increase earlier awareness and interventions:
Aα fibers are large myelinated fibers in charge of motor functions and muscle control.
Aβ fibers are large myelinated fibers with sensory functions such as perception to touch, vibration, and position.
Aδ fibers are small myelinated fibers in charge of pain stimuli and cold perception.
C fibers can be myelinated or unmyelinated and have sensory (warm perception and pain) and autonomic functions (blood pressure and heart rate regulation, sweating, etc.).
"One of the great advantages of using the DND on our diabetic patients who have started to develop diabetic neuropathy, is that showing them their results, often makes the consequences of not taking care of themselves more realistic." -S. Erle DC, Neuropathy Centers
Importance of Specificity
Diabetics that 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. 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.
https://care.diabetesjournals.org/content/32/10/1896
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 use outdated and subjective tools (tuning fork, invented in 1711 or monofilaments, invented in 1938) to identify a progressive 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.
"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
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.
Quantitative Sensory Testing (QST) and Sympathetic Skin Response tests (SSR) are distinct diagnostic procedures employed to assess the nervous system: QST focuses on evaluating sensory function by measuring the perception of stimuli, including touch, temperature, and pressure, commonly used in neurology to assess peripheral neuropathy; whereas SSR assesses the sympathetic nervous system's activity by measuring changes in skin conductance in response to stress or stimuli, often applied in neurology to evaluate autonomic nervous system function, with key differences lying in their respective focuses, stimuli application methods, and measurements. Multiple studies have proven the value of Quantitative Sensory Testing (QST) measures in the detection of subclinical neuropathy (small fiber neuropathy), the assessment of the progression of neuropathy, and the prediction of the risk of foot ulceration (117,129,130). These standardized measures of vibration and thermal thresholds also play an important role as primary efficacy endpoints in multicenter clinical trials.
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