Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Electrical Vestibular nerve stimulator ( Modius): non-invasive vestibular nerve stimulation is given using Modius.
Modius is the innovative headset that was created by Dr Jason McKeown
Sponsors
Neurovalance lab
Eligibility
Inclusion criteria
Inclusion criteria: Type 2 diabetes mellitus or impaired glucose tolerance (also termed pre-diabetes) 18-80 years of age inclusive on starting the study. Ability and willingness to complete all study visits and procedures. Owner of a smart phone (iOS or Android) in order to access the diet monitoring and advice app (GB Healthwatch 360), activity monitoring app called Moves, and the app that reports on the status of the stimulation devices used in the study. Agreement not to use of prescription drug therapy or the use of over-the-counter weight loss preparations for the duration of the trial. Agreement not to start smoking tobacco or marijuana for the duration of the study. Access to Wi-Fi connection at home or at workplace â?? so device can upload usage data. Stable diabetic regime for the last 3 months â?? i.e. no change in diabetic medication.
Exclusion criteria
Exclusion criteria: History of vestibular dysfunction. History of pancreatic surgery. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears, or of the head and neck. History of weight loss device implantation (e.g. VBloc Maestro or Abiliti). Untreated thyroid disorder (stable treatment for 3 months is acceptable). Other untreated endocrinological disorder that may cause hyperglycemia (e.g. Cushingâ??s disease, Cushingâ??s syndrome or acromegaly) (Stable for 6 months is acceptable) Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy, which would prevent VeNS from working).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vestibular stimulation may be effective in the management of diabetesTimepoint: Baseline values will be recorded. After one month of intervention post values will be recorded After 3 months of intervention post values will be recorded. | — |
Secondary
| Measure | Time frame |
|---|---|
| vestibular stimulation may be effective in management of autonomic measuresTimepoint: 0 day, 3 months and 6 months | — |
Countries
India
Contacts
Public ContactDr Sai Sailesh Kumar Goothy
Dr saileshs vestibular Research lab
Outcome results
None listed