Acute Study of Effect of Ultrasound Vagus Nerve Stimulation on Glycemia

• Written informed consent prior to any of the screening procedures
• Willingness to comply with all study procedures and available for the duration of the study
• Male or female age between 21 and 60 years old, inclusive
• Diabetes Mellitus Type 2 for at least 1 year

Exclusion Criteria:

• HbA1c greater than 10.5%
• Medical treatment regimen with insulin
• Medical treatment with antiinflammatory drugs such as Disease-Modifying Antirheumatic Drugs (DMARDs), i.e. Methotrexate and Cytokine-inhibitors, e.g. Adalimumab, and Etanercept.
• Clinically significant neuropathy in the opinion of the investigator or as documented in the subject's medical history
• Abundant fat tissue in neck, as evidenced by a neck circumference of more than 20''
• Clinically significant surgical procedure(s) or skin lesion(s) in neck that would affect subject safety or placement of device
• Prior vagotomy
• History of clinically significant vasovagal syncope or presyncope
• Use of electrically active implanted medical device
• History of heat stroke or any heat intolerance that is deemed clinically significant in the opinion of the investigator
• History of renal dysfunction or a glomerulonephropathy defined as either nephritic or nephrotic syndrome, including estimated glomerular filtration rate of \<30 mL/min
• Clinically significant cardiovascular condition or problem that in the opinion of the investigator would interfere with the study data or affect patient safety (e.g. uncontrolled hypertension, congestive heart failure, or documented evidence of prior coronary artery disease).
• Pregnancy or plans to become pregnant while participating in the study, as determined by urine pregnancy test conducted at the screening visit for women of childbearing potential. A woman of childbearing potential is defined as a premenopausal female capable of becoming pregnant. This includes women on oral, injectable, or mechanical contraception; women who are single; women whose husbands have been vasectomized or whose husbands have received or are utilizing mechanical contraceptive devices.
• Uncontrolled asthma or obstructive lung disease.
• History of sepsis
• Significant cardiac rhythm disturbances in the opinion of the investigator based on an ECG.
• GI surgery that could have lacerated any branch of the vagus nerve, i.e. cholecystectomy, gastrectomy, pancreatic surgery, etc.
• Other conditions that could impair the patient's ability to participate in the study according to the investigator's opinion.