Brain Neuromodulation via Endoscopic Gastric Implant Improves Glycemic Control in Insulin-Dependent Type-2 Diabetes: First-in-Human Feasibility and Autonomic Response Study.

Abstract

Background: A miniaturized, self-powered Brain NeuroModulator (BNM) device, endoscopically implanted under neuroleptanalgesia in the submucosal layer of the proximal lesser gastric curvature, has the potential to consistently increase parasympathetic tone as measured by heart rate variability (HRV).

Objective: Since type-2 diabetes mellitus is associated with autonomic nervous system dysfunction, we assessed whether BNM induced autonomic rebalancing translates into measurable improvement of glycemic control through a change of HRV.

Methods: The BNM device was implanted on a 69-year-old male with a 25-year history of insulin-dependent type-2 diabetes mellitus under treatment with 22 IU/night of insulin plus semaglutide and metformin. HRV was assessed before and after the procedure. After the implant, continuous glucose monitoring (CGM) with an Abbott FreeStyle Libre sensor (15-minute sampling interval) was performed.

Results: The endoscopic procedure was uneventful and lasted 15 minutes. The BNM device remained in a stable position throughout the observation period. HRV analysis confirmed increased variability. Post-implant morning HRV showed progressive parasympathetic recovery compared with baseline. Within 2 months of implantation, therapy with semaglutide and metformin was discontinued, and insulin was progressively reduced from 22 to 0 IU.

Conclusions: The BNM implant was feasible and safe, with clinically meaningful improvement in glycemic control associated with autonomic rebalancing within approximately 10 weeks of implantation. These data provide compelling preliminary evidence that correcting sympathetic dominance through vagal afferent stimulation may alter the clinical course of insulin-dependent type 2 diabetes.