Glucotrack Commences Transition From Concept To Reality With Breakthrough Clinical Trial

Associated Press

25-02-2025

NEWMEDIAWIRE) - Glucotrack, Inc. (NASDAQ: GCTK) reports it has achieved a significant milestone in its mission to transform diabetes management through three distinct advances: direct blood glucose measurement, hassle-free monitoring and the first multi-year continuous glucose monitoring (CGM) system. The company announced the successful completion of its first human clinical trial for its Continuous Blood Glucose Monitor (CBGM), a device that could eliminate both the accuracy limitations of current glucose monitors and the burden of frequent sensor changes.
Unlike existing continuous glucose monitors that measure interstitial fluid and require sensor replacement every 10 to 15 days, Glucotrack says its CBGM represents a radical shift in diabetes care through:
Direct blood measurement: By measuring glucose levels directly in the blood rather than interstitial fluid, the CBGM can provide more accurate, real-time data when it matters most for treatment decisions
Significant reduction of maintenance: With no external components to manage, the fully implantable system frees patients from the constant cycle of sensor changes, supply orders and device management that defines current diabetes care
Unsurpassed longevity: With a sensor life of three years, the CBGM moves the longevity conversation from days or weeks to number of years, much longer than any of the traditional CGMs, according to Glucotrack.
This step forward comes as the continuous glucose monitoring market is projected to reach $11.5 billion in annual revenue for 2024 (based on $2.9 billion in 1Q24, $2.9 billion in 2Q24 and $2.8 billion in 3Q24) and will continue growing at 7.19% annually, according to Close Concerns, in its publication, Closer Look. Current market leaders Dexcom Inc and Abbott Laboratories serve a growing but increasingly demanding patient population, highlighting the opportunity for innovations that address core limitations in conventional glucose monitoring.
Given the severe health risks, glucose monitoring is non-negotiable for many people with diabetes. Some rely on traditional fingerstick blood glucose monitors, which only provide one reading at a specific point in time – which makes determination of trends difficult. Many others have switched to CGMs which include a wearable component connected to a subcutaneous sensor to provide one reading every few minutes, therefore enabling the user to see trends in their glucose levels and be alerted when their glucose levels need attention. However, today's CGM systems only measure glucose in interstitial fluid, not blood, causing some lag in glucose readings that is most noticeable at times when glucose levels are rapidly changing.
Beyond this limitation on accuracy, people with diabetes must also manage frequent sensor changes, deal with adhesive issues and coordinate regular supply deliveries. While current CGMs have made important advances in diabetes care, these fundamental challenges – delayed readings, ongoing maintenance requirements and short sensor life – remain largely unaddressed until now, the company says.
Glucotrack's entry into the diabetes management ecosystem potentially marks a fundamental leap forward for patients. The CBGM doesn't merely revolve around surface-level improvements such as software integrations or reduced-size form factors. Rather, it could offer increased lifestyle freedom and represent an advancement that is potentially emblematic of an evolution in diabetes care.
The Clinical Trial: A Critical Step Toward Real-World Adoption
Building on these innovations, the company's first in-human clinical trial marks a decisive transition from theory to real-world application. The recently completed first in-human clinical study validates the safety, feasibility and procedural simplicity of the CBGM system, clearing a major hurdle in its journey toward widespread adoption, Glucotrack says.
Conducted as a short-term, in-hospital study over four days, the trial focused on the safety and procedural aspects of placing, using and removing the CBGM sensor lead. Six diabetes patients requiring glucose monitoring and intensive insulin therapy participated in the study.
The sensor lead was placed in the subclavian vein via a percutaneous procedure and connected to a prototype external sensor electronics component placed on the skin for this initial trial, though the commercial system will be fully implanted. The trial assessed whether the sensor lead could be implanted and removed without complications, while also confirming proper sensor lead placement and procedural efficiency.
Glucotrack reports that the results were a success. The study met its primary endpoint with no procedure- or device-related serious adverse events, from placement, during the four-day in-hospital stay and through the seven-day post-removal period. Importantly, the procedures were performed by three different interventional cardiologists who were already familiar with implanting similar devices and working with patients who live with diabetes. This stamp of approval from healthcare providers is an important factor for future adoption, as it could simplify integration into existing clinical workflows.
Although this initial study was not intended to measure sensor accuracy, Glucotrack noted that the system performed as expected, delivering results in line with preclinical animal studies. This reinforces confidence in the CBGM system's ability to deliver real-time, accurate glucose readings without the drawbacks of conventional CGMs.
Beyond the immediate validation of safety and procedural feasibility, this successful trial serves as a gateway to larger-scale human studies. Glucotrack says it is poised to expand clinical testing, meet regulatory requirements and advance commercialization efforts. The company plans to present these findings at an upcoming diabetes conference, providing critical exposure and engagement with key stakeholders in the medical community.
A New Path Forward
With the successful completion of its first in-human clinical study, Glucotrack has moved beyond concept and into real-world feasibility. The trial's confirmation of safety, procedural simplicity and expected performance lays the groundwork for larger clinical studies and eventual regulatory approval, bringing the CBGM system closer to patients who need a better solution.
As the diabetes management industry continues to evolve, Glucotrack stands to potentially redefine continuous glucose monitoring. The CBGM is not just another iteration of existing technology – it represents a fundamental leap forward, the company says, shifting the burden of glucose monitoring away from patients and into a less intrusive background process. With clinical validation now underway, the company says it is positioned to expand its trials, working to strengthen its market presence and redefine how diabetes care is delivered.