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…
How strong is the evidence?
Evidence Hub reads this as a case report, done in people. Its evidence level is 5 of 5 (Very low · case / narrative / animal / in vitro / in silico). Case reports, narrative reviews, and animal, cell or computer-model studies give the weakest evidence for human health.
Read the paper
Related studies
- Metformin as an adjuvant in breast cancer treatment
- Metformin Lysosomal Targeting: A Novel Aspect to Be Investigated for Metformin Repurposing in Neurodegenerative Diseases?
- Aberrant HSF1 signaling activation underlies metformin amelioration of myocardial infarction in mice
- Metformin induces ZFP36 by mTORC1 inhibition in cervical cancer-derived cell lines
- Protein Interaction Network for Identifying Vascular Response of Metformin (Oral Antidiabetic)
- Preventing Long COVID With Metformin
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.