Clinical Research Directory

Inclusion Criteria: * Willing and able to provide written informed consent to participate in the study * Age ≥ 22 years * BMI 30 - 50 kg/m2 * HbA1c 7.5 - 10.5% * Type 2 Diabetes treated with incretin-based medication (aka GLP-1RA agonist or GLP-1RA/GIP dual agonist) at a stable, maximal tolerated dose for a minimum of 6 months +/- any other oral glucose lowering medications AND intention to initiate insulin therapy for glycemic management * Stable weight (\< 5% TBW) within the 3 months prior to screening * Meets the indications for ESG procedure with OverStitch™ or OverStitch NXT™ Endoscopic Suturing System * Declines or is ineligible for metabolic bariatric surgery * Agrees to abstain from taking any weight loss treatments or supplements that are not part of the lifestyle modification program for a year following the ESG procedure * Willing and able to comply with the study procedure with standard of care lifestyle modification program and visit schedule. Exclusion Criteria: * Diabetes management with insulin. Prior use of insulin for gestational diabetes or short-term use (up to 1 month) in conjunction with an acute condition is acceptable. * Noncompliance with medicatio9n regime for diabetic management * History of reactive or severe hypoglycemia within the prior 1 year * History of ketoacidosis or hyperosmolar nonketotic coma within the past 1 year * Any known conditions that impact weight loss or glycemic management * Chronic systemic steroids or immunosuppressants taken at the time of enrollment or likely required during the study follow-up * CKD stage 3+, defined as eGFR \< 60 mL/min * Persistent anemia, defined as hemoglobin \< 10 g/dL * Excessive alcohol consumption, defined as meeting or exceeding sex-based heavy drinking limits * Use within the last three months prior to screening of over the counter or prescribed weight loss supplements / medications, or intent to use any weight loss medications or supplements during the study duration. * The investigator's medical judgment that the subject is not a candidate for the ESG procedure due to findings, including but not limited to psychological and nutritional evaluation results obtained in the prior 12 months. * Current pregnancy confirmed by site standard of care or planned pregnancy or breastfeeding for a year following the ESG procedure. * Vulnerable subject. * Current or planned participation in another clinical study.