The RESET System Pivotal Clinical Trial (Protocol Revision K)

Inclusion Criteria:

1. Age ≥22 years and ≤ 65 years

2. Have understood and signed the approved informed consent form

3. Diagnosis of type 2 diabetes

4. HbA1c ≥ 7.5% and ≤10%

5. BMI ≥30kg/m2 and ≤ 50kg/m2

6. Willing and able to comply with study requirements

7. Documented negative pregnancy test in women of childbearing potential

8. Women of childbearing potential not intending to become pregnant (continue to be onan approved form of birth control) for the duration of their trial participation,including post explant period. Women of child-bearing age without knownsterilization will be placed on 1 form of birth-control to prevent unwantedpregnancies

9. At least one year of medical records available, including detailed medical therapyand dosing information

10. Failed to achieve adequate HbA1c reduction (<7.5%) after dual therapy for at least 3-month stable dosage of diabetes medication(s), including insulin, metformin,SGLT-2 inhibitor, GLP-1 RA, Dual GLP-1/GIPR agonist or, other medications includingmeglitinides, sulfonylureas, thiazolidinediones, or DPP-4s.

Exclusion Criteria:

1. Previous treatment with the RESET System

2. Previous GI surgery that could preclude the ability to place the RESET Liner oraffect the function of the RESET Liner, or abnormal GI anatomical finding that couldpreclude the ability to place the RESET Liner or affect the function of the RESETLiner

3. Hypoglycemia and/or DKA/HHNK in the last 6 months requiring 3rd party assistance.

4. Known history of liver disease (e.g., viral or autoimmune etiology, METAVIR grade 2or higher fibrosis/cirrhosis from a biopsy within the past 6 months, but notincluding incidental fatty liver)

5. eGFR of less than 45 ml/min/1.73 m2

6. Prior history of an abscess requiring hospitalization, intravenous antibiotics ordrainage

7. Previous treatment for severe liver disease and/or biliary tract disease, includingbut not limited to, surgery, bile duct dilatation, and stent placement

8. Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis

9. Fasting C-peptide < 1.0 ng/mL

10. Triglyceride level > 600 mg/dL

11. Vitamin D deficiency (<20ng/ml)

12. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia withplatelet count less than 100,000/microliter, or known coagulopathy

13. Height < 5 feet (152.4 cm)

14. Current alcohol addiction, current drug addiction or usage, of drugs such as,narcotics, opiates, or benzodiazepines and other addictive tranquilizers

15. History of pancreatitis, including gallstone related pancreatitis (subsequent towhich patient has cholecystectomy)

16. Diagnosis of osteopenia or osteoporosis or currently taking denosumab,romosozumab-aqqg, bisphosphonates or teriparatide

17. Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus,scleroderma)

18. Active or recent (less than 12 months) gastroesophageal reflux disease (GERD),unless treated with H2Ras not PPI.

19. Uncontrolled thyroid disease, including a history of thyroid cancer,hyperthyroidism, or taking thyroid hormone for any reason other than primaryhypothyroidism (TSH level must be between 0.4-4)

20. Currently taking prescription antithrombotic therapy (e.g. anticoagulant orantiplatelet agent) within 10 days prior to randomization and/or there is a need orexpected need to use during the trial 9 months post implant procedure

21. Currently taking the following medications (within 30 days prior to randomization)and/or there is a need or expected need to use these medications during the trial 12months post index procedure: Restricted Medications/Supplements Systemiccorticosteroids Proton Pump Inhibitor (PPI) Drugs known to affect GI motility (e.g.metoclopramide) Prescription or over-the-counter weight loss medication(s)Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), aspirin, ibuprofen, and otheranti-inflammatory medication for study duration Medications known to causesignificant weight gain or weight loss (e.g. chemotherapeutics) Supplements that areknown or suspected to increase bleeding risk including but not limited to: Gingkobiloba Ginseng Vitamins C & E Turmeric St. John's wort Evening primrose oil FeverfewGreen Tea Extract

22. Active H. pylori

23. History of Crohn's disease, atresias or untreated stenoses

24. Abnormal pathologies or conditions of the gastrointestinal tract, including ulcersor upper gastrointestinal bleeding conditions within 3 months of randomization

25. Patients may be disqualified for study inclusion for any condition determined by thePI that places patient at undue risk.

26. Poor dentition not allowing complete chewing of food

27. Enrolled in another investigational study within 3 months of screening for thisstudy (enrollment in observational studies is permitted)

28. Residing in a location without ready access to study site medical resources

29. Documented weight loss of 5% total body weight (TBW) anytime during the 3 monthspreceding randomization

30. Positive Fecal Immunochemical Test (FIT)

31. History or observation of psychological disorder or behavior which could precludecompliance to the treatment and follow up plan

32. No access to an active telephone and internet service for provision of Follow UpSchedule calls and electronic diary

33. Having donated blood or received a blood transfusion in the 90 days prior tobaseline labs. Patients should agree not to donate blood during the study

34. Any condition that increases red cell turnover, such as thalassemia

35. Existence of (>5 cm string test) Pseudomonas aeruginosa, Stenotrophomonasmaltophilia and/or Klebsiella pneumoniae serotype K1 and K36. A known sensitivity tonickel or titanium

36. Do not meet the screening criteria for Fibroscan (i.e., Fibroscan unsafe, or Fibroscan conditional but not appropriate for the region of interest 38. History of myocardial infarction, stroke, or hospitalization for heart failure 39. History Afib and/or cardiac arrythmias 40. History of unstable angina 41.History of new or worsening signs or symptoms of CAD within the last 3 months 42.Any contraindication to general anesthesia or high risk for general anesthesia as determined by anesthesiologist (e.g., ASA score 4 or higher)