Glucotrack completed its first human clinical study of a novel continuous blood glucose monitor, demonstrating safety and procedural success.
Quiver AI Summary
Glucotrack, Inc. has announced the successful completion of its first human clinical study for a continuous blood glucose monitor (CBGM), which is uniquely placed in the subclavian vein for real-time glucose measurement. This study marks a significant advancement in diabetes monitoring technology, as it aims to overcome the limitations of traditional glucose monitors. The trial involved six participants with diabetes and focused on the safety of the sensor's placement and removal, achieving no serious adverse events reported throughout the study. Glucotrack's CEO, Dr. Paul V. Goode, expressed enthusiasm about the results, indicating that this technology brings continuous glucose monitoring closer to reality. The CBGM is designed to be a long-term implantable device without external components, allowing for three years of continuous and accurate monitoring. The promise of further development and clinical trials for this innovative system was echoed by Dr. David Klonoff, a clinical expert.
Potential Positives
- The successful completion of the first in-human clinical study marks a significant milestone in the development of continuous glucose monitoring technology.
- The new continuous blood glucose monitor (CBGM) is placed in the subclavian vein, offering a pioneering alternative to traditional monitoring methods that measure glucose levels in interstitial fluid.
- The study met its primary endpoint with no serious adverse events reported, suggesting strong safety and procedural success for the CBGM system.
- The CBGM device promises a long-term solution for glucose monitoring, with a lifespan of three years and minimal calibration needed, indicating a more convenient option for patients with diabetes.
Potential Negatives
- The clinical study was short-term and only focused on safety and procedural aspects, with no evaluation of sensor accuracy, which raises concerns about the device's practical effectiveness in real-world use.
- There is a lack of information on how the CBGM technology will perform in long-term use, given that the study only lasted four days and involved a small sample size of six participants.
- The press release emphasizes forward-looking statements, indicating possible uncertainty about future outcomes, regulatory approvals, and the need for additional capital, which could create apprehension among investors and stakeholders.
FAQ
What is the recent milestone achieved by Glucotrack, Inc.?
Glucotrack announced the successful completion of its first in human clinical study for its continuous blood glucose monitor.
How does the new CBGM differ from traditional glucose monitors?
The CBGM offers direct blood glucose measurement via subclavian vein placement, unlike traditional monitors that measure interstitial fluid.
What were the results of the clinical study?
The study confirmed the safety of the CBGM sensor lead with no serious adverse events, meeting its primary endpoint.
Who conducted the clinical study?
The study was performed by interventional cardiologists, demonstrating the successful placement and removal of the CBGM sensor lead.
What is the expected lifespan of the CBGM device?
The CBGM device is designed for three years of continuous and accurate blood glucose monitoring without an external component.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
Full Release
RUTHERFORD, N.J., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq: GCTK) (“Glucotrack” or the “Company”), a medical technology company focused on the design, development, and commercialization of novel technologies for people with diabetes, announced the successful completion of its first in human clinical study, marking a significant milestone in continuous glucose monitoring.
This study represents the first real-time, continuous blood glucose monitor (CBGM) placed in the subclavian vein, offering the potential for direct blood glucose measurement without the limitations often seen with traditional continuous glucose monitors that measure glucose levels in interstitial fluid.
“We are thrilled with the results of this first in human clinical study, which establishes safety of the placement, usage and removal of the CBGM sensor lead. While neither the study nor prototype system was designed to evaluate sensor accuracy, the system performed as expected with similar accuracy results as previously seen in our animal studies,” said Paul V. Goode, PhD, President & Chief Executive Officer of Glucotrack. “With these positive results, the promise of continuous blood glucose monitoring is one step closer to reality.”
The prospective single arm study was a short-term in-hospital study over a period of four days, focusing on the safety and procedural aspects of the CBGM sensor lead placement, use, and removal. The CBGM sensor lead was placed intravascularly via a percutaneous procedure and connected to a prototype sensor electronics component that was placed on the skin. The six study participants had been previously diagnosed with diabetes mellitus requiring glucose monitoring and intensive insulin therapy.
The study met its primary endpoint with no procedure or device related serious adverse events reported from implant through seven days post-removal of the CBGM sensor lead. The study also confirmed the function of the CBGM sensor lead in the subclavian vein. Placement and removal procedures were successfully performed by interventional cardiologists.
David Klonoff, MD, Clinical Professor of Medicine at University of California, San Francisco and Editor-in-Chief of the Journal of Diabetes Science and Technology, said "The successful completion of this first in human study with no serious adverse events is encouraging. The study suggests that this approach could offer another alternative for continuously monitoring glucose levels in diabetes, and I look forward to seeing this technology advance into long-term clinical trials."
The CBGM is a long-term implantable device with no on-body external component, designed for three years of continuous, accurate blood glucose monitoring, offering a more convenient and less intrusive glucose monitoring solution.
For more information about Glucotrack’s CBGM, visit
glucotrack.com
. Information on the Company’s website does not constitute a part of and is not incorporated by reference into this press release.
About Glucotrack, Inc.
Glucotrack, Inc. (NASDAQ: GCTK) is focused on the design, development, and commercialization of novel technologies for people with diabetes. The Company is currently developing a long-term implantable continuous blood glucose monitoring system for people living with diabetes.
Glucotrack’s CBGM is a long-term, implantable system that continually measures blood glucose levels with a sensor longevity of 3 years, no on-body wearable component and with minimal calibration. For more information, please visit
http://www.glucotrack.com
.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “believe”, “expect”, “plan” and “will” are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Glucotrack undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Glucotrack will be realized or, even if substantially realized, that they will have the expected consequences to or effects on us or our business or operations. Readers are cautioned that certain important factors may affect Glucotrack’s actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Glucotrack’s results include, but are not limited to, the ability of Glucotrack to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including U.S. Food and Drug Administration approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to Glucotrack’s future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Glucotrack’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2023 as filed with the SEC on March 28, 2024.
Contacts:
Investor Relations:
investors@glucotrack.com
Media:
GlucotrackPR@icrinc.com
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