Evaluating Safety and Effectiveness of Pulse Electric Field Ablation in Adults with Type 2 Diabetes and Poor Blood Sugar Control

What this Trial Is About

This research aims to evaluate the safety and effectiveness of a pulsed electric field ablation system in adults aged 18 to 70 with type 2 diabetes mellitus who have suboptimal blood sugar control despite medication or lifestyle changes. The study focuses on patients with glycated hemoglobin levels between 7.5% and 10.5% who have been diagnosed with type 2 diabetes for at least six months. Participants will receive treatment with the pulsed electric field ablation system and be observed over a period of up to 12 months. The study measures changes in HbA1c levels at multiple points after treatment1 month, 3 months, 6 months, and 12 monthsas well as average fasting blood glucose, weight, and the need for additional hypoglycemic medication when HbA1c exceeds 8.5%. Safety is monitored through the recording of adverse events, device performance, and instrument evaluations during the procedure. During the study, participants will attend scheduled visits for assessments including blood tests to track HbA1c and fasting glucose, weight measurements, and monitoring of medication use. The main outcome is the change in HbA1c levels six months after treatment, with additional follow-up up to 12 months to observe ongoing effects and safety. Participants must comply with visit schedules, lifestyle restrictions, and avoid blood donation during the trial.

A Preliminary Clinical Study Protocol for Evaluating the Efficacy and Safety of Pulse Electric Field Ablation Systems in Treating Adult Type 2 Diabetes Mellitus With Suboptimal Drug Control