Poor enrollment (15 planned, only 6 enrolled)

This is an open-label, proof of concept study with a single active treatment arm designed to assess whether CVS-based stimulation has a beneficial effect on patients with type 2 diabetes. The primary outcome measure is a difference between pre and post-treatment A1c.

Inclusion Criteria

A subject is eligible for the study if all of the following criteria are met:

• Provide written informed consent prior to enrollment.

• Is male or female between 18-70 years old.

• Has been diagnosed with type II diabetes for greater than 12 months.

• Is currently either using lifestyle modification or taking one or two of the following oral antihyperglycemic agents and has been on stable doses for 90 days prior to screening:

  • metformin
  • DPP-4 inhibitors (sitagliptin, saxagliptin, alogliptin, linaglyptin)
  • Pioglitazone

• Has an A l c between 7.5 - 9.0% based upon point of care testing performed at visit 1.

• Currently performs self-monitoring blood glucose checks at least 3 times per week.

• Able to adhere to protocol requirements.

Exclusion Criteria

A subject will be excluded if any of the following criteria are met:

• Has Type 1 Diabetes or Gestational Diabetes.
• Is pregnant or planning to become pregnant during the course of the study.
• Current use OR use in the past 6 months of sulfonylureas.
• Current use OR use in the past 6 months of insulin
• History of cardiovascular disease or cerebrovascular disease.
• Any planned surgery during the course of the study.
• Current continuous renal replacement therapy.
• Current oral or injectable steroid use or use within the previous 3 months.
• Previous or current treatment with deep brain stimulation.
• Any previous known disease, injury, or surgical intervention involving the brain or central nervous system.
• Moderate or greater hearing loss.
• Presence of a cochlear implant.
• Diagnosed vestibular dysfunction.
• Eye surgery within the previous three months.
• Any history of previous ear surgery.
• Active ear infections or a perforated tympanic membrane.
• Presence of a serious or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

The study was terminated early due to poor enrollment before any of the participants could complete the end of treatment assessments and outcome results could be collected.