Safety and Feasibility of a Novel Endoscopic Intervention for the Treatment of Type II Diabetes

Inclusion Criteria

• 18-70 years of age
• Current diagnosis of T2D
• History of T2D for less than or equal to 10 years, or use insulin for less or equal to 10 years
• HbA1C of 7.5-11.0%
• BMI 24-40 kg/m2
• If treated with non-insulin glucose lowering mediations, the medications (1-4 medications) should be stable for at least 12 weeks prior to baseline visit. If treated with basal insulin, the daily insulin dose should be within 20-60 IU.
• Agree not to donate blood during participation in the study.
• If treated with non-insulin glucose lowering medications, participant should have weight stability (defined as a 1 month (at any time, except for treatment of gestational diabetes) in last 2 years for those on non-insulin medications.
• Current use of multiple daily dose insulin or insulin pump
• Hypoglycemia unawareness
• History of ≥1 severe hypoglycemia (defined by needing for third-party assistance), unless a clear correctable precipitating factor can be identified, in past 6 months from the screening visit
• Known autoimmune disease, as evidenced by a positive anti-glutamic acid decarboxylase (GAD) test, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder.
• Previous GI surgery that has changed GI anatomy or could limit treatment of the duodenum, such as Billroth 2, Roux-en-Y gastric bypass, gastric band or other similar procedures or conditions.
• Known history of a structural or functional disorder of the upper GI tract that may impede passage of the device through the upper GI tract or increase risk of tissue damage during an endoscopic procedure, including esophagitis, stricture/stenosis, varices, diverticula, or other disorder of the esophagus, stomach and duodenum.
• Active H. pylori infection (Participants with active H. pylori may continue with the screening process if they are treated with an appropriate antibiotic regimen)
• History of, or gastrointestinal symptoms suggestive of gastroparesis.
• Acute gastrointestinal illness in the previous 7 days
• Known history irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease and Celiac disease
• History of chronic or acute pancreatitis.
• Known active hepatitis or active liver disease other than NASH/NAFLD.
• Alcoholic liver disease, as indicated by ANI >0
• Current use of anticoagulation therapy (such as warfarin) that cannot be discontinued for 7 days before and 14 days after the procedure.
• Current use of P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued for 14 days before and 14 days after the procedure.
• Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) during treatment through 4 weeks following the procedure. Use of acetaminophen and low dose aspirin is allowed.
• Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 12 weeks prior to the baseline visit.
• Use of drugs known to affect GI motility (e.g. Metoclopramide)
• Use of weight loss medications such as Phentermine, Meridia, Xenical, or over-the-counter weight loss medications (prescription medication)
• Persistent anemia, defined as hemoglobin 2 drinks/day regularly).
• Active malignancy within the last 5 years (excluding non-melanoma skin cancers)
• Women breast feeding
• Participating in another ongoing clinical trial of an investigational drug or device.
• Any other mental or physical condition which, in the opinion of the study investigator, makes the participant a poor candidate for clinical trial participation.
• Critically ill or has a life expectancy 11% at baseline visit
• Any severe hypoglycemic event since the screening visit
• Glucose level 270 mg/dl (>15 mmol/L) after an overnight fast or >360 mg/dl (>20 mmol/l) in a randomly performed measurement