Role of electrical stimulation of Inner ear in regulating the blood sugar in type 2 Diabetes
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2019/06/019854
- Lead Sponsor
- eurovalance lab
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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.
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method vestibular stimulation may be effective in the management of diabetesTimepoint: Baseline values will be recorded. <br/ ><br>After one month of intervention post values will be recorded <br/ ><br>After 3 months of intervention post values will be recorded.
- Secondary Outcome Measures
Name Time Method vestibular stimulation may be effective in management of autonomic measuresTimepoint: 0 day, 3 months and 6 months