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<h3>Objective:</h3> To evaluate the long-term safety and effectiveness of 10 kHz spinal cord stimulation (SCS) for the treatment of painful diabetic neuropathy (PDN). <h3>Background:</h3> Approximately 37 million Americans have diabetes,1 and ~ 25% of these patients experience PDN.2 Conventional medical management (CMM), which includes pharmacotherapies, is ineffective for many PDN patients.2 Here we report outcomes through 24-month (24M) follow-up for high-frequency (10 kHz) SCS treatment of PDN. <h3>Design/Methods:</h3> In this RCT, patients had PDN symptoms ≥12M refractory to medications, lower limb pain intensity ≥5cm (0–10cm visual analog scale [VAS]), and hemoglobin A1c ≤10%. Patients (n=216) were randomized 1:1 to 10 kHz SCS plus CMM or CMM alone, with optional treatment crossover at 6M. <h3>Results:</h3> At 6M, patients receiving 10 kHz SCS experienced average pain relief of 76%, while patients receiving CMM alone experienced average pain increase of 2%. At 6M, no 10 kHz SCS patients crossed over to CMM, while 93% of eligible CMM patients elected to cross over to 10 kHz SCS. Pain relief with 10 kHz SCS was durable as patients experienced average pain relief of 80% at 24M. At 6M, clinician-assessed neurological improvements were observed in 62% of patients in the 10 kHz SCS arm and 3% in the CMM arm. Neurological improvements were durable as 66% of patients receiving 10 kHz SCS had improvement at 24M. There were no device explants due to lack of efficacy. There were eight (5.2%) study-related infections (n=3 resolved; n=5 (3.2%) explanted), which is within the range reported across all/non-diabetic SCS patients (2.5–10%).3 <h3>Conclusions:</h3> The results demonstrate that 10 kHz SCS provides durable pain relief with acceptable safety. The improvements in neurological function highlight the unique disease-modifying potential of 10 kHz SCS for PDN. <b>Disclosure:</b> Erika Petersen has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Nevro. Erika Petersen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbott Neuromodulation. Erika Petersen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Medtronic. Erika Petersen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Vertos. Erika Petersen has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for American Society of Pain and Neurosciences. Erika Petersen has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for SynerFuse. Erika Petersen has stock in SynerFuse. Erika Petersen has stock in neuro.42. The institution of Erika Petersen has received research support from Saluda. The institution of Erika Petersen has received research support from Nevro. The institution of Erika Petersen has received research support from ReNeuron. The institution of Erika Petersen has received research support from Neuros. Erika Petersen has received intellectual property interests from a discovery or technology relating to health care. Thomas Stauss has nothing to disclose. James Scowcroft has received research support from Nevro . Dr. Jaasma has received personal compensation for serving as an employee of Nevro Corp. Dr. Jaasma has received personal compensation for serving as an employee of Bone Health Technologies, Inc.. Dr. Jaasma has stock in Bone Health Technologies. Dr. Jaasma has received intellectual property interests from a discovery or technology relating to health care. Judith White has received personal compensation for serving as an employee of Synexus Research. An immediate family member of Judith White has received personal compensation for serving as an employee of synexus Research. Judith White has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lilly Inc. Shawn Sills has nothing to disclose. Kasra Amirdelfan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Nevro. Kasra Amirdelfan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Saluda. Kasra Amirdelfan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. Kasra Amirdelfan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vertiflex. Kasra Amirdelfan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Nevro. Kasra Amirdelfan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Saluda. Kasra Amirdelfan has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biotronik. Dr. Argoff has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Argoff has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vertex. Dr. Argoff has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nevro. Dr. Argoff has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for XGene. Dr. Argoff has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Vertex. Dr. Argoff has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan/Abbvie. Dr. Argoff has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Argoff has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lilly. Dr. Argoff has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Argoff has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Pain Medicine (Oxford University Press). The institution of Dr. Argoff has received research support from Lilly. Dr. Argoff has received publishing royalties from a publication relating to health care. Rod Taylor has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Nevro. Rod Taylor has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Medtronic. Rod Taylor has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Saluda. David Caraway has received personal compensation for serving as an employee of Nevro. Dr. Mekhail has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allograft. Dr. Mekhail has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Saluda. Dr. Mekhail has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nevro. Dr. Mekhail has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vertos. Dr. Mekhail has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Spinal Modulation. Dr. Mekhail has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sollis Therapeutics. Dr. Mekhail has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Relievant Medsystems. The institution of Dr. Mekhail has received research support from Mesoblast. The institution of Dr. Mekhail has received research support from Avanos "Halyard". The institution of Dr. Mekhail has received research support from Neuros Medical.