PERIPHERAL NEUROPATHY is a highly prevalent condition in people living with Type 2 diabetes and patients frequently suffer from pain or are asymptomatic, which are at the highest risk of falls, ulcerations, and amputations. Often overlooked as a mortality risk, Distal Symmetric Polyneuropathy (DSPN), a glove and stocking distribution, is the most common form of Diabetic Peripheral Neuropathy (DPN) 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 50-75% of non-traumatic amputations.

The ongoing lack of objective tools and the inability to unify patient data surrounding diabetes care has been a major factor in the mortality and morbidity of patients living with diabetes but nothing more important than diabetic neuropathy (DN). More sophisticated tools and methods of detecting neuropathy may help establish the true nature of the disorder. Subjective tools used in diabetic foot exams today may also prevent advanced therapeutic interventions from occurring promptly. Despite the medical advances over the last 100-years, older subjective tools are still used in approximately 99% of today's diabetic foot exams. Measuring peripheral neuropathy sets a patient's baseline and standardizes screenings because it overcomes the deficiency and lack of uniformity from one medical provider's subjective interpretation to another.

Medical providers may be underdiagnosing diabetic neuropathy due to poorly defined criteria and a lack of standardized methodologies to evaluate the disease. According to the Center for Disease Control (CDC), the International Diabetes Foundation (IDF), and the World Health Organization (WHO), it is estimated that 85% of Diabetes-Related Lower-Extremity Amputations (DRLEAs) are preventable with improved foot care programs. The Diabetic Neuropathy Device™ (DND) performs all of the above without disrupting the existing workflow for foot exams. Adding the Diabetic Neuropathy Device™ to any diabetes foot screening or fall-risk assessment meets the newest screening and diagnosis recommendations by the American Diabetes Association (ADA) by using temperatures and vibrations to measure a patient's level's risk for neuropathy, which are:

• Monofilament Testing

The DuPont company invented nylon in 1938, and in 1939 it began marketing nylon fishing lines and later repurposed as a medical tool.

• Vibration Testing (128 Hz)

The tuning fork's invention is credited to the British musician John Shore in 1711 for music purposes and has traditionally been used to tune musical instruments.

• Temperature Testing

The Diabetic Neuropathy Device™ (DND) was FDA Cleared in 2014 and was explicitly designed as a medical device with 5-variable vibrations and 10-variable temperatures.

The proper diagnosis for diabetic neuropathy requires tools with the ability to measure the disorder quantitatively for the different types of abnormalities that occur to specific nerve fibers. According to the ADA, assessments should follow the typical DPN pattern, starting distally (the dorsal aspect of the hallux) on both sides and move proximally until a sensory threshold is identified. Combining a minimum of at least two different examinations (large fiber and small fiber) will increase the sensitivity and specificity of detecting DPN.

The DND Eliminates False-Positive and False-Negative Results

Pain is the reason for 40% of patient visits in a primary care setting and about 20% of the presenting patients have had pain for greater than 6 months. Persistent neuropathic pain interferes significantly with quality of life (QOL), impairing sleep and recreation; it also significantly impacts emotional well-being and is associated with, if not the cause of depression, anxiety, loss of sleep, and noncompliance with treatment. Therefore, early stages of DSPN or a painful small fiber neuropathy with or without minimal deficits can only be verified using more sophisticated tests such as thermal thresholds or skin biopsies.

Site-Specific Biomarkers

Distal Symmetric Polyneuropathy (DSPN) causes nerve damage to peripheral extremities, including the hands, arms, legs, and feet. Utilizing an objective and functional tool that measures large fiber and small fiber nerves for all peripheral extremities may also improve the quality of life for people living with diabetes. A prognostic biomarker provides information about a patient's overall disease outcome (e.g. tuning forks on the hallux), while a predictive biomarker provides information about the effect of therapeutic intervention; a predictive biomarker can be a target for therapy. Therefore, it is imperative to educate medical providers to use objective tools that identify the specific nerve fiber type so that the appropriate therapies may be targeted toward the particular nerve fibers.

Primary Care's clinical incentives follow recommendations by the American Diabetes Association (ADA) and identify neuropathy in people with diabetes or other idiopathic neuropathies. Using the Diabetic Neuropathy Device™ with a monofilament can enhance patient outcomes. The Diabetic Neuropathy Device™ meets the CMS Medicare Advantage Star Ratings.

Site-Specific Biomarkers

The current lack of uniformity from the various tools used by multiple medical providers to identify and measure neurological conditions can leave medical providers frustrated, especially in patients with DPN. The need to help a practitioner to overcome the deficiency and inconsistency of foot exams throughout all medical environments remains paramount. A physician designed the Diabetic Neuropathy Device™ due to the disappointment of neuropathic patients not being diagnosed promptly and the absence of foot exam uniformity from one practitioner to another.

Diabetic Neuropathy May be Silent and Go Undetected while Exercising its Ravages

Loss of protective sensation (LOPS) is one of the major causes of a podiatrist's visit. Missed opportunity to diagnose LOPS can ultimately lead to toe and foot amputation. The correct diagnosis and treatment of neuropathy in patients with diabetes are imperative. The clinical benefits of offering preventive medical testing with predictive biomarkers on the foot or other extremities validate why early detection and early intervention can reduce patient mortality and morbidity rates. A foot ulcer precedes eighty-five percent (85%) of diabetes-related lower extremity amputations (DRLEA). More importantly, the percentage rates for recurrent diabetic foot ulcers (RDFUs) is roughly 40% within 1-year, almost 60% within 3-years, and 65% within 5-years.

Fall Risk Management

STAR Ratings are Directly Related to the Percentage of HEDIS Measures Met like Fall Risk Managment (FRM). Our tool helps patients enrolled in CMS and Medicare Advantage (MA) plans. It is widely agreed that some costly re-admissions could be prevented with better care management and represent inefficient care delivery. Identifying any potential complications and addressed in the Annual Wellness Exams can improve the overall metrics. These exams are performed under a medical provider's supervision and the assessments may be done in the clinic or at a patient's home by trained and certified staff. The HEDIS domains of care are for patients include the following risk assessments:

• Amputations Prevention

• Blood Pressure Control

• Blood Sugar Control

• Fall Risks

• Medication Management

Medical providers often prescribe medications to manage many of these conditions. However, consider that our state-of-the-art technology is also reimbursable and provides a value-based outcome at the point-of-care, while increasing revenue and enhancing an organization's overall reputation for mitigating risks.

Medicare Advantage STAR Ratings and HEDIS Measures Directly Affect the Bottom Line.

Diabetic neuropathy and its progressive loss of proprioception diminished sensation, and weakness may lead to an imbalance with a more significant fall probability. Risk mitigation and the failure to diagnose lower-extremity diabetic neuropathy directly affect a patient's safety and mortality. DPN is a substantial contributor to falls and fractures through more advanced small-fiber and large-fiber dysfunction, loss of sensory, proprioception, temperature discrimination, and pain, ultimately leading to an increased risk of falls. Recent studies suggest that subjective tools may be the most significant causative factor preventing therapeutic interventions from occurring promptly. The most important risk factors of DSPN and neuropathic pain in these surveys were age, obesity, and low physical activity, while the predominant co-morbidity was a peripheral arterial disease, highlighting the paramount role of cardiovascular risk factors and diseases in prevalent DSPN.

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.