AACE Updates Clinical Practice Guidelines for Diabetic Neuropathy

In a press statement released on October 3, 2022, the Nevro Corporation announced that the American Society of Clinical Endocrinology (AACE) updated its clinical practice guidelines for diabetic neuropathy to include high-frequency spinal cord stimulation. This update revealed that the Nevro HFX 10 kHz Therapy is the only one approved by AACE.

According to the statement, nearly 422 million people worldwide have diabetes. Of the people with diabetes, approximately 20% develop painful diabetic neuropathy. Between 140,000 and 200,000 individuals in the United States suffer from the chronic condition.

The approval is based on results from SENZA-PDN, a randomized controlled study conducted by the Nevro Corporation. This study found that 79% of patients treated with the device had substantial pain relief. Comparatively, only 5% of the participants in the control group experienced pain relief. The study, published in JAMA Neurology, found that “substantial pain relief and improved health-related quality of life sustained over six months demonstrates 10-kHz SCS can safely and effectively treat patients with refractory PDN.”

The AACE deems the Nevro HFX 10 kHz as the most effective of all existing nonpharmacological approaches.

"There is a dearth of effective medications approved by the FDA for its management, and none of these are disease-modifying. Medications which are being used are, in many cases, ineffective and/or associated with side effects. Of course, their use also necessitates life-long adherence. It was thus welcome news when the FDA approved high-frequency spinal cord stimulation for the management of PDN and also encouraging to see that its use for these patients is listed in the latest update of the AACE guideline for comprehensive care planning for diabetes,” stated Dr. George Grunberger, Chairman of the Grunberger Diabetes Institute in Bloomfield Hills, Michigan and Past President of the American Association of Clinical Endocrinologists, in the Nevro Press release.

The approval of this interventional approach by the AACE will provide physicians with an additional tool to treat painful diabetic neuropathy without pharmacological interventions.