Efficacy Study of the DIAMOND System to Treat Type 2 Diabetes Mellitus

Exclusion Criteria

• •Injectable anti-diabetic therapy within the last 3 months (such as insulin and/or GLP-1 receptor agonists)
• •Taking medications known to affect gastric motility such as narcotics (chronic use) and anticholinergics/antispasmodics
• •Any gastric or upper GI surgery
• •Experiencing severe and progressing diabetic complications (i.e. retinopathy not stabilized, nephropathy with macroalbuminuria)
• •Prior wound healing problems
• •Diagnosed with past or current psychiatric condition that may impair his or her ability to comply with the study procedures
• •Use of anti-psychotic medications
• •Diagnosed with an eating disorder such as bulimia or binge eating
• •Obesity due to an endocrinopathy (e.g. Cushing disease, Hypothyroidism not treated)
• •Hiatal hernia requiring surgical repair or a paraesophageal hernia
• •Pregnant or lactating
• •Diagnosed with impaired liver function (liver enzymes 3 times greater than normal)
• •Any prior bariatric surgery
• •Any history of pancreatitis
• •Any history of peptic ulcer disease within 10 years of enrollment
• •Diagnosed with Gastroparesis or other GI motility disorder
• •Use of active medical devices (either implantable or external) such as ICD, pacemaker, drug infusion device, or neurostimulator (either implanted or worn). Subjects using an external active device who are able and willing to avoid use of the device during the study may be enrolled.
• •Cardiac history that physician /surgeon feels should exclude the subject from the study.
• •Use of another investigational device or agent in the 30 days prior to enrollment
• •A history of life-threatening disease within 5 years of enrollment
• •Any additional condition(s) that in the Investigator"s opinion would warrant exclusion from the study or prevent the subject from completing the study