Duodenal Mucosal Recellularization via Pulsed Electric Field-Induced Electroporation (ReCET) in Type 2 Diabetes-First-in-Human Experience

Abstract

Background: ReCET utilizing an endoscope administered non-thermal pulsed electric field to stimulate duodenal cellular regeneration may correct abnormal duodenal signaling in type 2 diabetes (T2D). We report updated results from a feasibility study of ReCET therapy in T2D. Method: This multicenter, open-label, treatment-only study recruited 18-70 yr old; T2D ≤10 years; HbA1c 7.5%-11.0%; BMI 24 - 40 kg/m2; C-peptide ≥ 333 pmol/l; and on 1-4 non-insulin glucose-lowering medications (GLMs) which were unchanged post-procedure. Primary endpoint: Device/procedure-related serious adverse events (SAEs). Secondary endpoints: Changes in metabolic parameters at 24W. Result..