Examining the Effects of Neuromodulation on Glucose Metabolism in Type 2 Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | June 2014 |
| End Date: | June 2015 |
Device: Investigational Study to Examine the Effects of Neuromodulation on Glucose Metabolism in Type 2 Diabetes
This is a pilot study with a single active treatment arm. The study is designed to assess
the efficacy of a portable, non-invasive neuromodulation system for the treatment of Type 2
Diabetes. In particular, the primary outcome measure is a reduction in A1c.
the efficacy of a portable, non-invasive neuromodulation system for the treatment of Type 2
Diabetes. In particular, the primary outcome measure is a reduction in 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
- GLP-1 agonist (exenatide, liraglutide, exenatide LAR)
- SGLT-2 Inhibitors (dapaglifozin, canagliflozin)
- 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.
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