Glucotrack, Inc. (Nasdaq: GCTK) has secured ethical approval from the St. Vincent's Hospital Melbourne Human Research Ethics Committee (HREC) to conduct a long-term clinical study of its innovative continuous blood glucose monitor (CBGM) in patients with diabetes, the company announced Monday.
The prospective, single-arm, multi-center study will evaluate the performance and safety of Glucotrack's implantable CBGM in up to 30 participants with type 1 and type 2 diabetes who require glucose monitoring and intensive insulin therapy. The study is initially approved for a one-year period, with the possibility of extension to three years upon completion of the initial phase.
Following this approval, Glucotrack will notify Australia's Therapeutic Goods Administration (TGA) before proceeding with participant enrollment. The company expects to begin implanting the device in the first patients by July 2025.
Novel Technology Addresses Key Challenges in Glucose Monitoring
Glucotrack's CBGM represents a significant technological advancement in diabetes management. Unlike traditional continuous glucose monitoring systems that measure glucose in interstitial fluid, the Glucotrack device directly measures glucose from blood, potentially eliminating the lag time typically associated with interstitial measurements.
The system is designed as a long-term implantable device with no external wearable component, intended to provide accurate blood glucose monitoring for up to three years with minimal calibration requirements.
"This technology shows great promise for the ability to improve glycemic control and offer patients expanded choice in continuous glucose monitoring systems," said Professor David O'Neal, the study's Principal Investigator and Director of the Diabetes Technology Research Group at the University of Melbourne. "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."
Professor O'Neal will lead the study alongside Associate Professor Neale Cohen, Head of the Diabetes Clinical Research Laboratory at the Baker Heart and Diabetes Institute in Melbourne.
Building on Previous Success
The approval follows Glucotrack's successful completion of a first-in-human study of the CBGM earlier this year, marking a significant milestone in the company's clinical program.
"Securing this approval represents a major milestone for our clinical program and builds on the successful completion of our first-in-human study earlier this year," said Paul V. Goode, PhD, President and Chief Executive Officer 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."
Goode highlighted that these challenges include "the need for extended sensor life, elimination of on-body wearables and the benefits of direct blood glucose measurement."
Addressing Unmet Needs in Diabetes Management
For the estimated 537 million adults worldwide living with diabetes, glucose monitoring is a critical component of disease management. Traditional finger-stick blood glucose testing provides only periodic snapshots of glucose levels, while current continuous glucose monitoring systems typically require replacement every 7-14 days and often include wearable components that can be inconvenient for users.
Glucotrack's technology aims to address these limitations by providing a more convenient and less intrusive monitoring solution that could potentially improve adherence and glycemic control for people with diabetes.
The Glucotrack Continuous Blood Glucose Monitor remains an investigational device limited by federal law to investigational use in the United States. The company, which is focused on the design, development, and commercialization of novel technologies for people with diabetes, trades on the Nasdaq under the symbol GCTK.
