Glucotrack Announces Successful Completion of Its First Human Clinical Study of Continuous Blood Glucose Monitor
04 Febbraio 2025 - 2:01PM
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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