Wara Samar
19th May 2025
Glucotrack Receives Green Light for Long-Term Study of Implantable Blood Glucose Monitor
Glucotrack, a medical device company advancing diabetes care through novel technologies, has announced that it has received ethical approval from the Human Research Ethics Committee (HREC) of St. Vincent’s Hospital Melbourne to conduct a long-term clinical study of its implantable continuous blood glucose monitor (CBGM). The approval marks a key step in the company’s path to evaluating the safety and performance of its system in patients with type 1 and type 2 diabetes.
The prospective, single-arm, multi-center study will enroll up to 30 participants who require intensive insulin therapy and frequent glucose monitoring. The CBGM will be assessed over an initial 12-month period, with the potential to extend the study to three years following completion of the first phase.
With ethical approval now in place, Glucotrack will proceed to notify Australia’s Therapeutic Goods Administration (TGA) as part of the clinical trial process. Patient implantation is expected to begin by July 2025.
A Novel Approach to Continuous Glucose Monitoring
Glucotrack’s CBGM offers a new approach in glucose monitoring by measuring glucose directly from the bloodstream, rather than interstitial fluid — the basis of conventional continuous glucose monitors. The implantable device, designed for use over a period of up to three years, is free of external wearable components and requires minimal calibration, offering a less intrusive and potentially more accurate option for people managing diabetes.
Professor David O’Neal, Principal Investigator of the study and Director of the Diabetes Technology Research Group at the University of Melbourne’s Department of Medicine at St Vincent’s Hospital, expressed optimism about the potential of Glucotrack’s technology.
“This technology shows great promise for the ability to improve glycemic control and offer patients expanded choice in continuous glucose monitoring systems,” said Prof. O’Neal in a statement. “The ability to directly measure glucose in blood rather than interstitial fluid could represent a significant advancement for people with diabetes seeking more accurate real-time glucose values.”
He will be joined in the study by Associate Professor Neale Cohen, Head of the Diabetes Clinical Research Laboratory at the Baker Heart and Diabetes Institute, Melbourne.
Milestone in Clinical Development
This study follows Glucotrack’s successful completion of its first-in-human study earlier this year, marking the next phase in evaluating its CBGM for long-term use. The company sees this clinical trial as a vital step toward delivering a solution that addresses persistent challenges in diabetes management, such as sensor wearability, longevity, and accuracy.
“Securing this approval represents a major milestone for our clinical program,” said Paul V. Goode, PhD, President and CEO of Glucotrack. “This year-long study will provide critical insights into the long-term performance, safety and reliability of our innovative technology, which is designed to address key challenges identified by people with diabetes.”
The Glucotrack CBGM is currently classified as an investigational device and is not yet approved for commercial use.
About Glucotrack
Glucotrack is a medical device company focused on developing and commercializing innovative technologies for people with diabetes. The company’s lead product is a long-term, implantable continuous blood glucose monitoring system with a three-year sensor lifespan, no on-body wearable component, and minimal calibration requirements.
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