Glucotrack (Nasdaq:GCTK) announced today that it received a hospital’s ethical approval to study its continuous blood glucose monitor (CBGM).
The St. Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC) gave the nod for a long-term clinical study. It plans to include participants with both type 1 and type 2 diabetes using the CBGM.
Rutherford, New Jersey-based Glucotrack develops the CBGM implant that features no on-body external component. The company designed it for three years of continuous, accurate blood glucose monitoring for a more convenient, less intrusive solution.
Unlike traditional CGMs that measure glucose in interstitial fluid, the CBGM measures glucose levels directly from the blood. It aims to provide real-time readings without the lag time typically associated with interstitial glucose measurements.
Earlier this year, the company completed the first-in-human study of the system. By the end of this year, it expects FDA investigational device exemption (IDE) approval to conduct a long-term, multi-center pilot study for the CBGM. The study would likely help the company work toward a submission to bring the device to market in the U.S. down the line.
Glucotrack says it expects its Australian study to enroll up to 30 participants with diabetes requiring glucose monitoring and intensive insulin therapy. The study evaluates device performance and safety over an initial period of one year. Glucotrack may also complete additional submissions to extend the study to three years once it completes the initial study period. It expects the first patient implantations by July.
Commentary from Glucotrack leadership
Said Paul V. Goode, Glucotrack president and CEO:
“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. We are honored to work with [principal investigator] Professor [David] O’Neal and his team on this long-term clinical study of our novel CBGM. 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 – including the need for extended sensor life, elimination of on-body wearables and the benefits of direct blood glucose measurement.”
