Ultrasound Effects on Glycemic Control in T2DM

Inclusion Criteria:

1. Male or female subjects with a diagnosis of type 2 diabetes ≥ 3 months.

2. Age ≥ 21 and ≤ 75 years.

3. Currently on a stable treatment regimen of oral anti-diabetic drugs and notcurrently prescribed for medication escalation. Oral anti-diabetic drugs are limitedto one or more of the following:

• Metformin

• Sulfonylureas

• Meglitinides

• Thiazolidinediones

4. HbA1c > 7.0% and < 10% by local laboratory analysis.

5. Body Mass Index (BMI) ≥ 18 to ≤ 40.0 kg/m2.

6. Considered generally healthy upon completion of medical history, physicalexamination and biochemical investigations as judged by the Principal Investigator.

7. Female subjects must be non-pregnant and non-lactating and have a negative serumpregnancy test at screening and before the ultrasound session.

8. Ability to provide written informed consent.

Exclusion Criteria:

1. History or current diagnosis with T1DM or T2DM subjects on insulin, DPP-4inhibitors, GLP agonists.

2. A subject who is already indicated for medication escalation of their currentdiabetic therapy.

3. A subject who has manifestations of advanced complications from poorly controlled orlongstanding diabetes such as diabetic retinopathy, diabetic neuropathy andcardiovascular complications including, but not limited to coronary artery disease,peripheral vascular disease, or cerebrovascular disease such as transient ischemicattack [TIA], cerebral infarct, or cerebral hemorrhage.

4. History or current diagnosis of cardiac dysrhythmias or heart disease, defined assymptomatic heart failure (New York Heart Association class III or IV), myocardialinfarction, unstable angina requiring medication.

5. Invasive cardiovascular procedure, such as coronary artery bypass graft surgery (CABG), or angioplasty/percutaneous coronary intervention (PCI) within 6 months ofscreening.

6. History of recurrent severe hypoglycemia (more than 1 event ≤ 6 month)

7. Subjects with clinically active malignancy

8. History of renal disease or abnormal kidney function tests at Screening (glomerularfiltration rate [GFR] < 60 mL/min/1.73m2 as estimated using the MDRD equation).

9. History or active hepatic disease or clinically significant abnormal hepaticfunction tests at Screening suggestive of hepatic impairment (e.g., ALT and/or AST >2 x ULN, GGT >2 x ULN, total bilirubin > 1 x ULN).

10. Subjects with a history or presence of any psychiatric disorder that, in the opinionof the Principal Investigator, might confound the results of the trial or poseadditional risk in administering the investigational product to the subject.

11. Personal or family history of hypercoagulability or thromboembolic disease,including deep vein thrombosis and/or pulmonary embolism (PE)

12. History of surgical treatment for obesity (bariatric surgery, gastric banding, etc.)or any other gastrointestinal surgery (including appendectomy, cholecystectomy), anymalabsorption disorder, severe gastroparesis, any GI procedure for weight loss (including LAP-BAND®), as well as clinically significant gastrointestinal disorders (e.g. peptic ulcers, severe GERD) at Screening.

13. History of any major surgery within 3 months prior to screening.

14. Any nerve stimulation study or implanted stimulator, including previously orcurrently implanted vagus nerve stimulator, previously or currently implanted spinalcord stimulator, other implanted electronic medical device, such as implantedpacemaker or cardioverter/ defibrillator (AICD) or history of seizures.

15. Participation in an investigational study within 30 days prior to dosing or 5half-lives within the last dose of the investigational product given during theinvestigational study, whichever is longer.

16. Current use of any drugs (other than current treatment for diabetes mellitus) thatare known to interfere with glucose or insulin metabolism as stated below in tableprohibited medication.

17. Thyroid hormone use is not allowed unless medication is given on a stable dose forat least 3 months prior to screening.

18. Subject is unable to tolerate adhesive tape or has any unresolved adverse skinreaction in the area of the glucose sensor placement.

19. Implanted pacemaker or cardioverter/defibrillator (AICD).

20. History of any active infection, incl. COVID19 (as ruled out by negative PCR test),except mild viral disease, such as common cold, within 30 days prior to screening.

21. Known history or positive test for hepatitis B surface antigen (HBsAg), hepatitis Cantibody (HCV Ab), human immunodeficiency virus type 1 (HIV-1) or type 2 (HIV-2).

22. History of any recent traumatic injury, including intracerebral hemorrhage andvisceral injury.

23. Donation or loss of > 500 mL of blood or blood product within 2 months prior toscreening.

24. Mental incapacity, unwillingness or language barriers precluding adequateunderstanding and to follow verbal commands during the ultrasound session orcooperation.

25. An abdominal ultrasound scan or exam within 1 month prior to screening and/or anypre-planned ultrasound examinations during the study, or the need to participate inany unplanned outside ultrasound procedures during study.

26. Use of the agents listed in Prohibited Medications Table below (prescription ornonprescription) is prohibited until completion of all study activities.

27. Identification of risk of hypoglycemia or severely uncontrolled diabetes inscreening visit metabolic assessments (CGM, OGTT, and fasting blood draws)