By JE Insights, Benzinga

DETROIT, MICHIGAN - May 14, 2025 (NEWMEDIAWIRE) - Among the more challenging chronic conditions, diabetes represents both a social and economic burden, particularly for insulin-dependent cases. According to the National Diabetes Statistics Report, 38.4 million people of all ages - or 11.6% of the U.S. population – had diabetes. Of this, 1.7 million adults aged 20 years or older – or 5.7% of all U.S. adults with diagnosed diabetes – reported having the type 1 variant and using insulin.  

An autoimmune disease, type 1 diabetes impacts the body’s ability to produce insulin - the hormone the body uses to allow sugar or glucose to enter cells to produce energy - leaving the pancreas with the ability to produce only a little or no insulin at all. What makes this variant particularly vexing is that complications can affect major organs, including the heart, blood vessels, nerves, eyes and kidneys. Subsequently, normalizing blood sugar levels can lower the risk of many complications.

The CDC also reported that about 90% to 95% of the U.S. diabetic population has advanced or type 2 diabetes. If you have type 2 diabetes, cells don't respond normally to insulin. This is called insulin resistance, and many of the complications and risks are the same for both types of diabetes.

To manage these risks, patients with insulin-dependent diabetes - both type 1 and advanced type 2 - must monitor their glucose levels. However, traditional methodologies such as continuous glucose monitors (CGMs) suffer from the following pain points and challenges:

• Traditional CGMs measure interstitial fluid, not blood, thereby potentially introducing delays, especially during rapid glucose swings when interstitial glucose levels may lag blood glucose levels.

• On-body wearables - such as external patches and transmitters - are visible, cumbersome and can irritate the skin or fall off prematurely.

• Most CGMs require frequent sensor replacements (often within seven to 15 days), so managing supplies can be a hassle.

Fundamentally, it is these challenges that Glucotrack Inc. (NASDAQ: GCTK) seeks to address through a radical departure from traditional diabetes management with its intravascular Continuous Blood Glucose Monitor (CBGM). By measuring directly from the blood, the CBGM enables real-time readings, which the company says are potentially more accurate - particularly during sensitive periods such as post-meal spikes and the onset of hypoglycemia. Furthermore, the system is fully implantable and discreet, designed for a multi-year lifespan with minimal calibration requirements.

Researchers had previously only validated the underlying technology in preclinical (non-human) models – that is, until now. Thanks to an early feasibility study evaluating Glucotrack’s flagship device, the company was able to build upon earlier milestones, delivering intriguing new data that was presented at the 2025 International Conference on Advanced Technologies & Treatment for Diabetes earlier this year.

Glucotrack’s First-in-Human Study Demonstrates CBGM’s Safety And Technical Feasibility

Conducted at InCor Hospital in São Paulo, Brazil, the purpose of the Glucotrack study was to evaluate the safety, feasibility and initial performance of the company’s CBGM system, the first study to be conducted on humans. Testing occurred between December 2024 and January 2025, with the enrollment of six adult participants (five with type 1 diabetes, one with type 2). All patients were on intensive insulin therapy at the time of the study.

As part of the study design, the CBGM sensor was implanted intravascularly and connected to prototype external electronics. Following implantation of the device, study participants stayed in the hospital for a period of four days, allowing researchers to closely monitor them along with the system’s performance. Following device removal, researchers followed up on the patients to ensure no complications or delayed adverse effects.

For the study, the primary endpoint - which was achieved - was the absence of procedure or device-related serious adverse events, from sensor insertion through seven days post-removal. Minor issues, including localized pain and minor bleeding, occurred but were resolved without complications.

In addition, the study achieved its secondary endpoints, which were the validation of surgical procedures using standard catheterization techniques and tools, as well as the reliable performance of the device. Here, Glucotrack reported that the CBGM system achieved a 99% data capture rate, combined with a Mean Absolute Relative Difference (MARD) of 6.7% across matched glucose readings taken from a fingerstick blood glucose monitor – a strong early signal of effective performance.

Ultimately, the first-in-human study met its safety and feasibility objectives, with the underlying performance data supporting the CBGM system’s continued clinical development. Moving forward, the study confirms that the device is ready for long-term evaluation.

Preparing For Long-Term Evaluation Through The OUS Clinical Trial

Building upon the results of the FIH study, Glucotrack is preparing to initiate a long-term Outside-the-United States (OUS) clinical trial. Designed as a prospective, multicenter, single-arm study, the investigation will enroll up to 30 adult participants – all living with insulin-dependent diabetes and currently on intensive insulin therapy.

Unlike the early feasibility trial, this next study will assess the full commercial version of the CBGM system, including the implantable intravascular sensor, the subcutaneous electronics module and the companion mobile application. Participants will undergo continuous monitoring for an initial period of one year, offering researchers a broad dataset to evaluate the system’s extended safety, performance and usability under real-world conditions. The company may complete additional submissions to extend the study to three years, upon completion of the initial study period.

Primary endpoints will center on safety, with investigators monitoring for any procedure- or device-related serious adverse events throughout the study period. Secondary endpoints will include performance validation through matched blood glucose readings, as well as assessments of usability and reliability in everyday settings. In contrast to the earlier feasibility work, this study reflects the intended commercial configuration – a critical step in demonstrating how the system performs over time in real-world conditions.

Advancing Toward Real-World Impact

While Glucotrack had long achieved encouraging preclinical results, the company’s FIH study provided a meaningful step forward in the bid to modernize diabetes management for insulin-dependent patients. With the early human data confirming that the CBGM system can be safely implanted, monitored and removed, the resulting performance metrics justify continued investment in long-term testing.

Though still in the early stages, the transition from animal models to real patients represents a fundamental milestone for Glucotrack. Thanks to the upcoming OUS trial, the focus of the research team will now shift toward validating the durability, usability and sustained accuracy of the CBGM device – critical performance goals for overcoming the unique daily challenges of maintaining glucose control and bringing a potentially game-changing solution to market.

Featured image by Vilius Kukanauskas on Pixabay.

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