Driving Innovation In Diabetes Management: Glucotrack Begins Enrollment For Human Clinical Trials For Its Implantable Continuous Blood Glucose Monitor

December 05, 2024 at 10:00 AM EST

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By Joshua Enomoto, Benzinga

In the rapidly evolving medical technology sector, diabetes management specialist Glucotrack Inc. (NASDAQ: GCTK) aims to disrupt the present care framework for the benefit of patients. Thanks to its Continuous Blood Glucose Monitor (CBGM), millions of people affected by the disease may be able to access reliable, non-intrusive glucose monitoring.

Fundamentally, what distinguishes Glucotrack from its rivals is the combination of real-time accuracy without the delay associated with conventional continuous glucose monitoring systems. In addition, the medical tech specialist offers an implantable format, eliminating the hassles associated with external wearables. Even better, the system’s long sensor life facilitates convenience.

To further validate the feasibility of Glucotrack’s product under real-world conditions – and help bring the CBGM system closer to regulatory approval and commercialization – the company has recently announced the commencement of patient enrollment for its short-term human clinical study.

Clinical Study Shines Spotlight On Glucotrack’s CBGM Technology

Scheduled to be conducted at the Heart Institute (InCor) of the Clinical Hospital of the University of São Paulo – one of the most renowned cardiology hospitals in Brazil and across Latin America – the feasibility study will focus on the capabilities of Glucotrack’s CBGM.

A long-term implantable device, the CBGM features no on-body external component. Furthermore, the system is designed to provide three years of continuous, accurate blood glucose monitoring. However, the core attribute of the device is that it measures glucose levels directly from the blood as opposed to interstitial fluid, as is common among competing systems. Blood glucose measurement is the gold standard for glucose measurement. Thus, these capabilities could enable more convenient and less intrusive diabetes management.

Principal Investigator Dr. Alexandre Abizaid, MD, PhD will spearhead the study. As the director of Interventional Cardiology at the Heart Institute in São Paulo, Brazil and a visiting professor of medicine at Columbia University Medical Center in New York City, Dr. Abizaid represents one of the leading experts in interventional cardiology.

So, why is a diabetes study being performed by an interventional cardiologist? The CBGM is similar in size and form to implantable devices in the cardiovascular space. Thus, the placement procedure is recognizable and widely performed by interventional cardiologists as an outpatient procedure, under local anesthesia in a cardiac catheterization, or cath, lab. The placement procedure takes approximately 20 minutes and only requires a small, half inch incision. Not to mention, diabetes can, and often does, lead to heart disease; people with diabetes are two to four times more likely than others to develop cardiovascular disease. So, cardiologists are becoming more and more involved in patient care for people with diabetes.

Notably, the five-day study will include patients suffering from both type 1 and type 2 diabetes. First, clinical researchers will apply the CBGM sensor intravascularly (inside the blood vessel) in the study participants. Second, Glucotrack says the participants will be monitored based on the following protocol:

Observation: During this period, researchers will leverage the CBGM technology to monitor blood glucose levels in real time. This observation will provide data on how blood glucose levels fluctuate under various conditions.
Glucose challenges: Participants will be given fixed meal challenges, during which their blood glucose levels will be monitored to assess how their glucose responds to different types of food.
Comparative analysis: In addition to data collection, the study will focus on the accuracy and performance of the CBGM in measuring blood glucose levels compared to conventional glucose monitoring mechanisms.

Advancing Positive Disruption In Diabetes Management

With the announcement of the clinical study – with results expected to be available within six to eight weeks – Glucotrack has moved one step closer to positively disrupting the current paradigm in diabetes management. According to Grand View Research, the global diabetes devices market size is large, reaching a valuation of $30.31 billion last year.

“Following the success of our preclinical program, we are pleased to reach this key milestone in the development of our novel CBGM,” said Paul V. Goode, PhD, president and CEO of Glucotrack. “We believe this groundbreaking early feasibility study will demonstrate the potential for our real-time continuous blood glucose monitor to offer a truly differentiated and less burdensome approach to glucose monitoring for people with diabetes.”

Forging a path toward significantly reducing the friction and pain points of diabetes care epitomizes the essence of Glucotrack’s device. What separates the enterprise from the competition is the integration of glucose monitoring accuracy, speed and convenience — elements that are often found in disparate corporate silos, the company argues.

For instance, Abbott Laboratories (NYSE: ABT) and Dexcom (NASDAQ: DXCM) both have a strong presence in the continuous glucose monitoring (CGM) market, but their systems require frequent sensor changes, usually every 10 to 15 days, depending on the system. Reports show that some of these adhesive patch systems also suffer from wearability challenges.

In sharp contrast, Glucotrack says it addresses the shortcomings of conventional CGM devices while elevating the standard of care. Adding to the long list of advantages, the company’s CBGM system also requires minimal calibration.

Revolutionizing Diabetes Care With Cutting-Edge Glucose Monitoring

Glucotrack is striving to push boundaries in diabetes care with its approach to continuous blood glucose monitoring. With the launch of its clinical study and a focus on delivering real-time accuracy and convenience through its implantable device, the company hopes to address critical gaps in the current market. As Glucotrack advances toward regulatory approval, its technology holds the potential to redefine how diabetes is managed, hopefully offering patients a more seamless and less burdensome solution.

Featured photo by Deon Collison on Unsplash

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