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Vestibular Stimulation to Improve glycemic control in Adults with Type 2 Diabetes Clinical Trial 
 
Research Description
Study of an investigational device for improving glycemic control in adults with type 2 diabetes. It is an external headset that attaches behind the ears to deliver a small electrical current to the vestibular system – the balance system in the inner ear. Previous research suggests that activating the vestibular nerve may cause a reduction in body fat but also improve glycemic control. The aim of the study is to evaluate whether frequent use of the device, along with a lifestyle modification program, can improve glycemic control.
 
Study Procedures
This 24-week study is taking place at Various locations across the USA and Ireland
 
Study Visits: Subjects must complete 3 study visits to the study site over 24 weeks (separate screening visit may be required). The visits consist of: blood tests, vital signs, body measurements, hearing tests, completion of a number of basic questionnaires and dietary counseling with the study dietician.
 
At enrolment, subjects will be randomised, with a 1:1 chance of receiving either an active device or a control device. Subjects use their device for an hour a day, at least 5 days a week, and get a dietician prescribed diet.
 
Inclusion Criteria
  • Diagnosis of Type 2 Diabetes
  • Ages 22 to 70 (18-70 in Ireland)
  • Must be able to travel to the study site for study visits
  • Access to Wi-Fi (Study iPod Touch provided)
 
Exclusion Criteria
  • Diagnosis of Type 1 Diabetes
  • Taking insulin
  • Change in diabetic medication within the last 90 days
  • Taking beta-blocker medication 
  • Implanted device
 
Incentives
  • Compensation totalling $300 upon completion of the 24 week study (US only)
  • Travel expenses covered (Ireland and UK locations)
  • Access to weekly personalised mentoring sessions
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