884-P: Duodenal Electroporation and Semaglutide Effectively Eliminate Need for Insulin in Type 2 Diabetes Patients

Introduction: Re-Cellularization via Electroporation Therapy (ReCET™) is an endoscopic ablation technique which uses electroporation of cellular membranes to elicit apoptosis of the duodenal mucosa. We aimed to eliminate insulin therapy in T2D patients by combining a single ReCET procedure with a GLP-1 receptor agonist (GLP-1RA). Methods: First-in-human study with 14 patients with T2D on basal insulin (BMI 24-40kg/m2; HbA1c≤8.0%; C-pep≥0.2nmol/l). All underwent ReCET after which semaglutide was titrated up to 1mg/week. Primary endpoints were feasibility (technical success, procedure time, GLP-1RA tolerance), safety ([S]AE, hypoglycemic events) and efficacy (off insulin at 6 months; HbA1c≤7.5%). Metabolic and glycemic data was collected throughout 24 months follow-up. Results: ReCET showed 100% technical success rate. Procedure time was 58 min. Max semaglutide dosage was tolerated by 13 patients. No device related SAEs or severe hypoglycemic events were observed. At 6 months 12 patients (86%) were off insulin and remained off insulin at 9, 12 and 18 months (24mo data available Jan 2024). Despite being off insulin, glycemic and metabolic parameters improved significantly (Table 1). Conclusion: ReCET appears to be safe and, when combined with semaglutide, can effectively eliminate the need for insulin up to 18 months in T2D patients, while improving glycemic control and metabolic health.