The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) awarded a $345,650 Project Grant under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847) to Reshape Lifesciences Inc., a small business joint venture, for the development of Targeted Dual Neuromodulation (TDN) therapy for the treatment of type 2 diabetes mellitus. The research project aims to demonstrate the feasibility of TDN therapy, which utilizes implantable pulse generators to block and stimulate specific branches of the vagus nerve in order to improve glycemic control. The key objectives of the Phase I SBIR study include validating the minimum high-frequency alternating current (HFAC) signal amplitude required to maintain glycemic control, assessing the impact of lower HFAC amplitudes on off-target effects, and evaluating changes in autonomic function through heart rate variability measurements. This research is expected to support the development of a future commercial TDN device with potential for a closed-loop system integration with continuous glucose monitoring.
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