Electrical Vestibular Nerve Stimulation (VeNS) Compared to Sham Control As a Means of Improving Glycemic Control in Adults with Type 2 Diabetes Mellitus

Inclusion Criteria:

• Informed consent obtained before any trial-related activities. Trial-relatedactivities are any procedures that are carried out as part of the trial, includingactivities to determine suitability for the trial.

• Male or female, age ≥ 22 years and ≤ 70 years at the time of signing informedconsent. (At the US sites). The non-US sites will recruit subjects aged ≥ 18 and ≤ 70 years.

• Diagnosed with Type 2 DM ≥ 90 days prior to day of enrolment

• HbA1c (glycated hemoglobin) ≥ 6.5 and ≤ 9.5% (48-80 mmol/mol) (both inclusive).

• If taking medication to treat diabetes, a stable dose of no more than 3anti-diabetic medications for at least 90 days prior to enrolment.

• BMI ≥ 25 at non-US sites

• Must be under care of physician for follow-up of their type 2 DM (this can be aPrimary Care Physician (PCP), endocrinologist or other hospitalist).

• Must agree to continue to participate with their routine diabetes care program.

• Access to Wi-Fi.

Exclusion Criteria:

• Diagnosis of Type 1 diabetes mellitus

• Diagnosis of diabetic neuropathy

• Diagnosis of diabetic nephropathy

• Diagnosis of retinopathy

• Skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affectingthe skin behind the ears. Any disorder which in the investigator's opinion mightjeopardize subject's safety or compliance with the protocol.

• Taking beta-blockers (if previously then can enroll if off ≥ 30 days).

• Taking insulin (if previously on insulin then should be off for ≥ 90 days prior toenrolment).

• Female who is pregnant, breast-feeding or intends to become pregnant or is ofchild-bearing potential and not using an adequate contraceptive method (adequatecontraceptive measure as required by local regulation or practice)

• History of pancreatitis

• History of pancreatic surgery

• Hemochromatosis

• Either of the following within the previous year: myocardial infarction; or acutecoronary syndrome.

• History of stroke

• History of epilepsy

• Splenectomy (due to effect on red blood cell turnover)

• History of anemia (if resolved for > 90 days with treatment then can enroll)

• Blood transfusion within 90 days of enrolment (due to effect on HbA1c). (Iftransfusion occurs once enrolled then subject will be withdrawn).

• A diagnosis of a hemoglobinopathy (e.g. sickle cell disease and thalassemia,although those with sickle cell or thalassemic trait would be allowed to enroll);

• If on dietary supplements or herbal remedies, then if the subject is taking apreparation that might affect glycemic control they will be excluded. Specifically,subject will be excluded if taking biotin (vitamin B7); alpha-lipoic acid; chromium;herbal preparations marketed as being for diabetes.

• History of being diagnosed with renal, heart or liver failure

• History of active migraines with aura

• History of head injury requiring intensive care or neurosurgery.

• Change in diabetic medication within the last 90 days (prior to enrolment).

• Regular use (more than twice a month) of antihistamine medication within the last 6months. Note: If the participant is taking Fexofenadine, they can be eligible forthe trial. If the participant is on another anti-histamine medication they canvoluntarily opt to switch to Fexofenadine and enrol in the trial after a washoutperiod of 2 weeks.

• Current use of H2-receptior antagonist medication? (e.g., cimetidine, famotidine)

• History or presence of malignancy within the last year (except basal and squamouscell skin cancer and in-situ carcinomas)

• A diagnosis of myelofibrosis or a myelodysplastic syndrome.

• Previous use of Modius device

• Participation in other clinical trials sponsored by Neurovalens (e.g. Vestal study)

• Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nervestimulator etc.)

• Have a member of the same household who is currently participating in this study.

• History of vestibular dysfunction or other inner ear disease (as assessed on thescreening questionnaire)

• Failure to pass the ATMAS Flex hearing test

• Failure to demonstrate a willingness for lifestyle modification (i.e diet andexercise) if BMI is ≥25 (as assessed on the screening questionnaire)

• Failure to agree to weekly engagements with the Clinical Trial Mentors during trialparticipation

• Failure to agree to use of device daily during trial participation (no more than 2weeks usage drop without reasonable explanation)

• Use of any medication (e.g. hormonal modulators or corticosteroids) that could causeiatrogenic T2DM. (NB Topical steroid use is acceptable if judged by PI to beunrelated).

• Any other medical condition, or medication use, that in the opinion of the PI/CI islikely to make the subject refractory to VeNS.