Delivering a breakthrough biomarker in the at-home setting
An estimated 38.4 million people in the U.S. have diabetes, according to the Centers for Disease Control and Prevention. Up to 70% of people with diabetes will be affected by diabetic peripheral neuropathy, and nearly half have no symptoms to alert them that it’s happening. This often silent condition increases the risk of foot ulcers and potential amputations. Patients with diabetic foot ulcers have a two-fold greater increase in mortality.
Unfortunately, diabetic neuropathy is often not discovered until it is well advanced when it may be irreversible. Early diagnosis of diabetic peripheral neuropathy is critical for preventing further complications, but diagnostic tools have been lacking in identifying the condition in the asymptomatic early stages.
Improving patient outcomes requires better prevention strategies
A common side effect of diabetes, peripheral autonomic neuropathy often is a result of poorly controlled blood sugar. The high blood sugar concentrations damage blood vessels, restricting their ability to deliver nutrients and oxygen to small nerves. This causes the nerves to die. Poor sweat gland function leads to drier skin and increased risk of cracking and wounds. Uncontrolled diabetes can affect circulation. The resulting poor circulation makes it more difficult for wounds to heal. In some cases, this leads to amputation.
To manage these issues, the American Diabetes Association recommends annual foot exams, but these appointments are often skipped by patients. Even when patients are compliant, their care teams have been reliant on invasive and frequently inaccurate methods of detecting diabetic peripheral neuropathy. They typically have relied on monofilament to press on the foot, which results in misdiagnosis 47% of the time.
The only other alternative was for patients to undergo painful skin biopsies, the prospect of which is not appealing to diabetic patients, who are at high risk of infections and lengthy wound healing.
Addressing the gaps in diagnosing diabetic peripheral neuropathy
Peripheral neuropathy is a common cause of diabetic foot ulcers. Early detection and appropriate treatment of foot ulcers may prevent up to 85% of amputations, according to the American Academy of Family Physicians.
That’s why it’s critical for the journey to diagnosing diabetic peripheral neuropathy to change. Addressing these serious complications much earlier will improve care teams’ ability to diagnose and provide higher quality care. Though there is no cure for diabetic peripheral neuropathy, diagnosing it early can help providers intervene and encourage patients to make lifestyle changes to slow the progression.
To provide a more reliable tool to healthcare providers, Impeto Medical – now part of Withings – invented SudoscanⓇ, a device that measures the sudomotor function. That is, the autonomic nervous systems’ control of sweat glands. Sudomotor dysfunction is one of the earliest signs of peripheral neuropathy in diabetes and other diseases. The test uses sweat production in the feet and then analyzes the body’s response.
When a patient steps on the Sudoscan, it sends a small painless current to the feet using electrodes to stimulate the sweat glands and small nerve fibers. This causes an electrochemical reaction and induces a current that produces an Electrochemical Skin Conductance score indicating the level of sweat gland function loss.
The Sudoscan provides a quantitative measure of chloride conductance, serving as a biomarker to assess sweat gland function in relation to sweat gland innervation. High conductance means no dysfunction whereas low conductance is indicative of dysfunction of sweat glands and the presence of neuropathy.
Used by hospitals for more than a decade, the Sudoscan has been proven in comparison with the existing methods. It soon became the gold standard for diagnosing diabetic peripheral neuropathy at its earliest stages. However, since it was only available at hospitals, care teams were limited to monitoring patients’ progress only once or twice a year.
Bringing the gold standard to patients’ homes
Withings embedded Sudoscan’s breakthrough technology in its Body Pro 2 cellular scale. This one-of-a-kind device complements in-hospital monitoring with the ability to track patients’ progress day to day from the convenience of their own homes. Body Pro 2, CE marked in Europe and available upon prescription in the US, has been tested to validate that it offers the same accuracy level as the Sudoscan.
With this move, Withings Health Solutions pioneered a modular approach to in-home monitoring devices, offering the Electrochemical Skin Conductance Score as its first biometric measurement in a cellular scale.
Supporting early interventions and lifestyle changes
Body Pro 2 contributes to early detection of peripheral autonomic neuropathy. The device allows for consistent remote monitoring of patients on a daily basis to identify any deterioration in sudomotor function. By facilitating easy, daily screening, it helps care teams to track patients’ risk of diabetic peripheral neuropathy, allowing for early intervention with coaching, diet and exercise changes, medications, vitamin prescriptions, and other measures to slow and hopefully prevent complications.
Similarly, if a patient has already been diagnosed with peripheral autonomic neuropathy, the device can help in the follow-up by monitoring disease progression or improvement. Patients can follow their own progress as well, helping to motivate them to continue making lifestyle changes to reduce their chances of complications.
Improving patient outcomes
Body Pro 2’s ability to support healthcare professionals better care for patients with diabetes is a major turning point for the healthcare industry. Electrochemical Skin Conductance is a breakthrough measurement that provides physicians access to the health data they need to make critical decisions about their patient’s health. Body Pro 2 will transform a traditionally underdiagnosed condition to one that can be regularly monitored from the patient’s home.
As further modules are released, care teams will be able to gain a holistic view of patients for better disease management and improved patient outcomes.