External Sensing and Neuromodulation to Assess Diabetic Pain Outcomes (XANADO)
Trial Parameters
Brief Summary
This is a prospective, longitudinal, single-center, non-randomized, open-label, post-market clinical feasibility study to assess the efficacy of neuromodulation therapies (SCS and DRG) for chronic pain patients with diabetes and investigate whether physical and physiological data collected from diabetic and pre-diabetic chronic pain patients is predictive of subjective patient-reported outcomes (PROs) and of adjustments in patient care. These assessments will be made prior to, during, and after the trial of the SCS or DRG system. The study will be carried out in the United States at a single site.
Eligibility Criteria
Inclusion Criteria: 1. Subject must provide written informed consent prior to any clinical investigation-related procedure. 2. Subject is at least 18 years of age or older at the time of enrollment. 3. Subject's scheduled trial duration for the Abbott neuromodulation system is at least 7 days. 4. Subject is scheduled to undergo trial of an Abbott neuromodulation system for chronic intractable back and/or leg pain at least 7 days after enrollment and commencement of the baseline data collection period. 5. Subject agrees to take an A1C screening test prior to study enrollment and has a confirmed HbA1C level ≥ 5.7%. 6. Subject has a baseline (with no stimulation) pain NRS of ≥ 6. 7. Subject is willing to cooperate with the study requirements including completion of all office visits. 8. Subject agrees to wear the wearable sensing devices (Fitbit® and Freestyle Libre). 9. Subject agrees to answer questionnaires regularly for the duration of the study. Exclusion Criteria: 1. Subject is enro