Duodenal Ablation Explored for Insulin Elimination in Type 2 Diabetes

For individuals with Type 2 Diabetes Mellitus (T2DM) who require insulin therapy, managing blood sugar levels can be challenging, often involving multiple daily injections and a risk of hypoglycemia. While various pharmacological treatments exist, there's a continuous search for non-pharmacological interventions that could reduce or eliminate the need for insulin. This pilot study addresses the critical knowledge gap regarding the safety, tolerability, and effectiveness of duodenal mucosal radiofrequency vapor ablation (RFVA) as a potential treatment to achieve insulin independence in these patients.

As an active pilot study, specific results are not yet available. However, the study is designed to measure key outcomes for safety and efficacy. The primary safety endpoint will assess the number of device or procedure-related serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) within 1 month post-procedure. The primary efficacy endpoint aims to determine the percentage of patients who are free of insulin at 168 days (approximately 5.5 months) following the RF vapor ablation, while maintaining an HbA1c (a measure of average blood sugar over 2-3 months) at or below 7.5% (equivalent to 58 mmol/mol).