RECET: A Multicenter, Double-blind, Sham-controlled Study for Assessing the Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals with Type 2 Diabetes

Study Purpose: To study changes in blood glucose control and weight loss in Type II Diabetics using Nutrition and Lifestyle Counseling combined with an investigational device called the ReCET Intestinal Cellular Regeneration System To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the following criteria: Study Duration: ~15 months Study Commitment: 1 Screening Visit 1 Baseline Visit 1 Procedure Visit 17 Follow Up Visits Phone Calls Age: 22-70 years old Sex: Male & Female Conditions/Eligibility: T2D, at least 6 months Treated with diabetes medications but have not achieved an optimal blood sugar level BMI 27-40 kg/m2 No major GI disorders/diseases Generally healthy, additional safety screening criteria upon first visits Study Procedures: Nutrition & Lifestyle Counseling ReCET Procedure Medical History review, Physical exams Vital Signs Bloodwork, Pregnancy testing Weight, Height, Waist measurements Blood glucose monitoring sensors (CGM) & diaries Questionnaires Compensation: up to $5400