GE Team Reports FUS Effective for Type 2 Diabetes

by Sharena Rice, contributing editor

June 2023 issue, BioElectRx Business Report

In the evolving landscape of medical advancements, an emerging field of interest is the use of ultrasound technology for therapeutic neuromodulation. The application of ultrasound to modulate the function of peripheral nerve pathways is called peripheral focused ultrasound stimulation and is becoming a potential tool in the management of chronic diseases. A recent study by a team at GE Research, directed towards this exciting possibility, investigated its application in treating type 2 diabetes mellitus, a disease affecting millions worldwide.

This Phase 1 trial was conducted using an open label feasibility design. It assessed the potential of pFUS in enhancing the body’s glucose regulation and improving insulin resistance, a common issue in individuals with type 2 diabetes. The participants in this study had their diabetes under control, were only prescribed metformin, and had no need for medication escalation. The participants underwent an initial examination, followed by three consecutive days of pFUS therapy targeting a specific region of the liver, known as the porta hepatis. Post-treatment, a two-week period was dedicated to washout and observation. The pFUS improved cholesterol, total cholesterol to HDL cholesterol ratio, and glucagon levels, and lowered fasting insulin levels with no device-related adverse effects. The key takeaways from the study hint at pFUS as a supplemental or even an alternative method to present pharmaceutical treatments for diabetes. This could be a significant step towards revolutionizing diabetes treatment by offering an effective, non-invasive approach.

It is known that ultrasound pulses generate mechanical waves, which can activate certain ion channels sensitive to mechanical stimulation and can regulate peripheral nerve activity. Many neurons in the peripheral nervous system express these ultrasound-sensitive ion channels, such as TRPA, Peizo1/2, and MEC-4, whose activation can have site-specific effects on different anatomical structures.

One of the challenges with this trial was the need for highly-trained personnel to precisely target the hepatoportal plexus and operate the ultrasound for neuromodulation. Targeting in a more user-friendly way that does not require a sonographer to manually hold an ultrasound probe may improve in the future as medical imaging technologies advance for detection of different organs. Further, advancements in beamforming technologies may allow the focal depth of the ultrasound transducer to become more adjustable and therefore more personalized to patients. Based on several patents from Chris Puleo’s team at GE (such as US11235178 and US11602331), the company is likely pursuing fully-automated recognition of organs (such as liver) during ultrasound imaging, which may allow the use of pFUS device at home

In sum, this early-stage study suggests pFUS might pave the way for a novel, non-pharmaceutical approach to managing diabetes. This could be a game-changer, providing a noninvasive, effective alternative to existing pharmaceutical treatments. Moreover, this successful application of pFUS underscores the broader potential of noninvasive medical techniques in healthcare, improved patient outcomes and reduced healthcare expenses. This is especially the case given the feasibility of equipment for ultrasound neuromodulation to be miniaturized for use in many clinical settings and even incorporated into wearables. However, it’s worth noting that these findings stem from a Phase 1 trial and further research will build a stronger understanding of the implications of pFUS in diabetes management and its place in the realm of noninvasive medical techniques.