Effect of VeSTAL Device in Type 2 Diabetes Mellitus

This is an interventional treatment trial for Type 2 Diabetes Read More

Inclusion Criteria:

1. Type 2 DM
2. HbA1c ≥7.0% and ≤10.0%
3. If on oral anti-diabetic medication should be stable dosage regime last 3 months
4. Males or Females. Note females of child-bearing potential must have a negative urine pregnancy test.
5. 18-80 years of age inclusive on starting the study.
6. Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with: trying to use the device on a daily basis; the hypocaloric diet weight loss program; and this provided weight loss support and mentoring.
7. Agreement not to use of prescription, or over-the-counter, weight loss preparations for the duration of the trial.
8. Agreement not to start smoking tobacco or marijuana for the duration of the study.
9. Access to Wi-Fi (to connect iPod to internet)

Exclusion Criteria:

1. History of vestibular dysfunction or other inner ear disease as indicated by the screening questions.
2. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
3. History of weight loss device implantation (e.g. VBloc Maestro or Abiliti).
4. Use of a non-invasive weight loss device (e.g. Modius)
5. Hypothyroidism requiring current treatment with levothyroxine (e.g. Levo-T, Synthroid, Thyroxine) (Other thyroid disorder patients on stable treatment for at least 3 months are acceptable).
6. Other endocrinological causes of weight gain (e.g. Cushing's disease, Cushing's syndrome or acromegaly)
7. Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working).
8. Diagnosis of liver, kidney or heart failure.
9. Tobacco or marijuana smoking in the 3 months before starting and for the duration of the study.
10. Known genetic cause of type 2 DM (e.g., Prader-Willi Syndrome).
11. Current, active member of an organized weight loss program.
12. Diagnosis of Type 1 DM.
13. Use of insulin.
14. Diagnosis of epilepsy or use of anti-epileptic medication within 3 months of starting the study (e.g. for the treatment of peripheral neuropathy)
15. Use of oral or intravenous corticosteroid medication within 3 months of starting the study.
16. Use of the beta-blockers within 3 months of starting the study.
17. Current alterations in treatment regimens of anti-depressant medication for whatever reason (including tricyclic antidepressants) (Note: stable treatment regimen for prior 6 months acceptable).
18. A myocardial infarction within the preceding year.
19. A history of stroke or severe head injury (as defined by a head injury that required craniotomy or endotracheal intubation). (In case this damaged the neurological pathways involved in vestibular stimulation).
20. Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.).
21. Untreated severe depression, schizophrenia, substance abuse, and eating disorder.
22. Current participant in another clinical trial.
23. Have a family member who is currently participating or is planning to participate in this study.
24. Pregnancy.
25. Blood transfusion within 4 months, or need for recurrent transfusions.
26. Hemolytic anemias including sickle cell, thalassemia and autoimmune varieties.
27. Hemochromatosis.
28. Use of dietary/ herbal supplements to assist with diabetic control.
29. History of migraine headaches.