External Sensing and Neuromodulation to Assess Diabetic Pain Outcomes (XANADO) (XANADO)

This is an interventional treatment trial for Chronic Pain focused on measuring ABT-CIP-10458, Chronic Pain, Neuromodulation System, SCS, Diabetic Pain, DRG Read More

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 is scheduled to undergo trial of an Abbott neuromodulation system for chronic intractable pain at least 7 days after enrollment and commencement of the baseline data collection period.
4. Subject's scheduled trial duration for the Abbott neuromodulation system is at least 7 days.
5. Subject has a baseline (with no stimulation) pain NRS of ≥ 6.
6. Subject is willing to cooperate with the study requirements including completion of all office visits.
7. Subject agrees to wear the wearable sensing devices (Apple watch®, and Oura™ Ring or Fitbit®).
8. Subject agrees to answer questionnaires regularly for the duration of the study.

Exclusion Criteria:

1. Subject is enrolled, or intends to participate, in a competing or confounding clinical study, as determined by Abbott.
2. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
3. Subject is part of a vulnerable population.
4. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
5. Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, post-herpetic neuralgia or uncontrolled diabetes mellitus.
6. Subject has, or is scheduled to receive, implantation of another neuromodulation system (e.g. DRG or SCS system or intrathecal pump) to address their chronic pain.
7. Subject engages in a profession or other activity that could be damaging to the wearable sensors, as determined by the investigator.
8. Subject has a physical condition that makes it difficult to wear the wearable sensors, as determined by the investigator.
9. Subject has tremors (e.g. Parkinson's disease or Familial tremors).
10. Subject has sleep/wake schedule that would present a challenge in completing all clinical site visits or in use of the wearable devices and engagement in the surveys via the mobile device.
11. Subject is bedridden.

Protocol-Specific Screening Exclusion Criteria

1. Subjects reports a history of allergy to any component in Ensure Surgery product or Juven Nutrition powder will be excluded from the N2 arm of the study.
2. Subject reports gastrointestinal disorder (severe chronic diarrhea, nausea, vomiting) that in the opinion of the principal investigator or physician would preclude ingestion of the study product; an obstruction of the gastrointestinal tract, inflammatory bowel disease; short bowel syndrome or other major gastrointestinal disease.