Safety, feasibility, and dose‐dependent metabolic effects of endoscopic duodenal pulsed electric field therapy in adults with type 2 diabetes: Results from two multicentre proof‐of‐concept studies
Authors' conclusion
PEF-based duodenal regeneration therapy was safe, technically feasible, and associated with durable metabolic improvements over 48 weeks. These findings support further evaluation of duodenal electroporation as a novel, minimally invasive approach for managing T2D.
Study context
- Population
- Adults aged 18–70 years with uncontrolled T2D on non-insulin medications, BMI 24–40 kg/m², HbA1c 7.5%-11.0% (58–97 mmol/mol)
- Participants
- 71 adults2 studies
- Outcome
- Incidence of device- or procedure-related serious adverse events (SAEs)
Methodological detailsopen-label, multicentre, proof-of-concept, Follow-up 48 weeks
- Open-label
- Multicentre
- Proof-of-concept
- Follow-up 48 weeks
Main finding
As reported in the abstract
Device- or procedure-related SAEs · 48 weeks
- No device- or procedure-related serious adverse events (SAEs) were reported; favourable safety profile
Observational data: associations, not effects.
Further findings
Metabolic effects by dose · 48 weeks
- Higher-energy dosing, double applications and second-generation catheter yielded greater and sustained reductions in HbA1c, fasting glucose, weight and insulin resistance markers
CGM
- Sustained increases in TIR and reduced glycaemic variability
Safety
- No device- or procedure-related SAEs; favourable safety profile
Original publication
Safety, feasibility, and dose‐dependent metabolic effects of endoscopic duodenal pulsed electric field therapy in adults with type 2 diabetes: Results from two multicentre proof‐of‐concept studies. Diabetes Obes Metab. Published 9 February 2026. doi:10.
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