Glucotrack (Nasdaq:GCTK) today announced the publication of a peer-reviewed scientific article evaluating its long-term glucose sensor.
The article, published in the Institute of Electrical and Electronics Engineers (IEEE) Sensors Journal, demonstrated the long-term in-vitro stability of the electrochemical glucose sensors used in the company’s fully implantable continuous blood glucose monitoring (CBGM) system. The company said findings represent the first year-long measurement of glucose oxidase enzyme decay reported in the literature. It says the outcomes support the feasibility of a long-life implantable continuous glucose monitor (CGM).
Currently, Senseonics produces the only long-term, implantable CGM on the market — a one-year device.
Rutherford, New Jersey-based Glucotrack’s device features no on-body external component. The company aims to offer 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.
Glucotrack Chief Science Officer Mark Tapsak outlined how the system works at the American Diabetes Association’s (ADA) 85th Scientific Sessions in Chicago in June. The company expects to submit its CBGM for FDA investigational device exemption (IDE) during the second quarter of 2026.
More on the findings from Glucotrack
The study evaluated the long-term in-vitro performance of the glucose oxidase enzyme class used in Glucotrack’s CBGM over one year. It aimed to assess sensor performance during the final year of its intended functional life. Accordingly, sensors used in the study reflected approximately two-year-old devices.
Glucotrack said its findings, published in partnership with UK-based TTP, provided higher confidence in the design of its sensor.
According to the company, the publication comes as one part of its effort to build a transparent, peer-reviewed technical foundation for the development of its implantable sensor system.
Previous first-in-human results demonstrated a highly accurate mean absolute relative difference (MARD) of 7.7% and a 99% data capture rate. Those results also included no procedure- or device-related serious adverse events.
“This work provides externally reviewed scientific evidence relevant to the design of long-life implantable glucose sensors. Peer-reviewed characterization of foundational sensor data is an important step as we continue to advance our development program and work toward clinical and regulatory milestones,” said Dr. Paul Goode, president and CEO of Glucotrack. “TTP has a strong reputation in our space, and we had a very positive experience working with their team. We anticipate that this article, among other similar projects we have in process, should serve our team well as we work towards the submission of our IDE with the FDA in the near term,” concluded Dr. Goode.
