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

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. Results: Participants received single energy application (Single Tx, n=12), double energy application (Double Tx, n=18), or the Gen 2 catheter (Gen 2, n=21)- (Figure 1). Procedure success was 100% with no related SAEs. Common AEs were sore throat (25/51) and transient diarrhea (11/51), and mostly (76%) mild. Glycemia improved post procedure with trends suggesting an energy-dose response (Figure 1). Mean (SD) HbA1c at 24 wks vs baseline was 7.2 (1.2%) vs. 8.8 (0.9)% (p<0.01) in the Gen 2 group. Gen 2 group follow up is ongoing. Durability of glycemic improvement was observed in Double Tx group at 48 wks. Conclusions: ReCET therapy is feasible and safe. Glycemic observations support further research. Disclosure D.N. O'Neal: None. A. Sartoretto: Research Support; Endogenex, Erbe Electromedizin GmbH. Advisory Panel; Bariatek. Consultant; Boston Scientific Corporation, Intuitive Surgical. E.I. Ekinci: Advisory Panel; Lilly Diabetes. Research Support; Novo Nordisk, Boehringer-Ingelheim, Eli Lilly and Company. Board Member; Eli Lilly and Company. Advisory Panel; Abbott. Research Support; Endogenex, Versanis, AstraZeneca. G. Manos: None. B. Holt: None. G. Cameron: None. S. Chandran: None. R. Vaughan: None. B.K. Abu Dayyeh: Research Support; USGI Medical, Apollo Endosurgery. Consultant; Boston Scientific Corporation, Medtronic. Other Relationship; Endogenex. Research Support; ERBE.