Introduction and Objective: The REGENT-1 trial evaluated the Re-Cellularization via Electroporation Therapy (ReCET™) System, which uses pulsed electric fields (PEF) to regenerate duodenal mucosa and submucosa. We examined the effect of ReCET™ across energy dose cohorts on CGM metrics.Methods: REGENT-1studied endoscopic PEF therapy at three doses in T2D adults on 1-4 non-insulin agents. Group 1) Gen 1 catheter 600V, single treatment (n=12); Group 2) Gen 1 catheter, 600V, double treatment (n=18); and Group 3) Gen 2 catheter (increased treated surface area [TSA]), double treatment 750V (n=21). CGM data were collected using Guardian 3 (Medtronic)Results: Fifty-one participants (mean age 52.9 years, BMI 31.4 kg/m², HbA1c 8.7% [72±9mmol/mol]) underwent PEF therapy. A dose-response effect was evident, with Group 3 yielding the greatest benefit in day and night glucose levels and reduced glycemic variability. Improvements in Group 3 CGM metrics emerged by week 4, peaked by week 24, and were sustained through week 48 (Figure 1). Double treatment with Gen 1 (Group 2) results were intermediate between Groups 1 and 3.Conclusion: ReCET™ treatment was followed by a dose dependent improvement in glycemia. Benefits at the highest dose appeared by week 4 and were durable. Findings highlight PEF-induced duodenal regeneration as a promising approach to improve glycemic control in T2D
D.N. O’Neal: None. J. Apostolopoulos: None. A. Sartoretto: Research Support; Endogenex. Advisory Panel; Bariatek. Research Support; Erbe Elektromedizin GmbH. Consultant; Boston Scientific Corporation. Speaker’s Bureau; Menarini. S. Chandran: None. R. Vaughan: None. B. Holt: None. G. Cameron: None. B. AbuDayyeh: Other Relationship; Endogenex. Consultant; Boston Scientific Corporation, Metronics, Olympus. R.E. Pratley: Consultant; AbbVie Inc. Stock/Shareholder; Altanine, Inc. Consultant; Amgen Inc, AstraZeneca. Other Relationship; Bayer AG, Bayer Pharmaceuticals, Inc, Biomea Fusion. Consultant; Boehringer-Ingelheim. Other Relationship; Carmot Therapeutics, Inc, Corcept Therapeutics, Dompé, Eli Lilly and Company, Endogenex. Consultant; Endogenex. Other Relationship; Fractyl Health, Inc., Gasherbrum Bio, Inc. Consultant; Genprex, Getz Pharma, Hanmi Pharm. Co., Ltd, Intas Pharmaceuticals Ltd, Lexicon Pharmaceuticals, Inc, Lilly USA LLC. Speaker’s Bureau; Lilly USA LLC. Other Relationship; Metavention, Novo Nordisk, Novo Nordisk. Speaker’s Bureau; Novo Nordisk. Other Relationship; Pfizer Inc, Poxel SA. Consultant; Regeneron Pharmaceuticals. Other Relationship; Sanofi. Consultant; Scholar Rock. Other Relationship; Sun Pharmaceutical Industries Ltd. C.H. Sorli: Employee; Endogenex. E.I. Ekinci: Research Support; Amgen Inc, Novo Nordisk, Lilly Diabetes, AstraZeneca, Endogenex, Versanis. Advisory Panel; Lilly Diabetes, Novo Nordisk.
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