Glucotrack Announces Ethical Approval for Long-Term Clinical Study of Continuous Blood Glucose Monitor
Glucotrack (NASDAQ: GCTK) has received ethical approval from St. Vincent's Hospital Melbourne HREC for a long-term clinical study of its continuous blood glucose monitor (CBGM) for diabetes patients. The study will enroll up to 30 participants with type 1 and type 2 diabetes mellitus, initially running for 1 year with potential extension to 3 years.
The study will be led by Professor David O'Neal and Associate Professor Neale Cohen, with first patient implants expected by July 2025. Glucotrack's CBGM is a long-term implantable system designed for up to three years of continuous monitoring, featuring no wearable components and direct blood glucose measurement, unlike traditional systems that measure from interstitial fluid.
The approval follows Glucotrack's successful first-in-human study, marking a significant advancement in their clinical program.Glucotrack (NASDAQ: GCTK) ha ottenuto l'approvazione etica dal comitato HREC dell'Ospedale St. Vincent di Melbourne per uno studio clinico a lungo termine sul suo monitor continuo della glicemia (CBGM) per pazienti diabetici. Lo studio coinvolgerà fino a 30 partecipanti affetti da diabete di tipo 1 e tipo 2, con una durata iniziale di 1 anno e possibile estensione fino a 3 anni.
Lo studio sarà guidato dal Professor David O'Neal e dal Professore Associato Neale Cohen, con i primi impianti previsti entro luglio 2025. Il CBGM di Glucotrack è un sistema impiantabile a lungo termine progettato per un monitoraggio continuo fino a tre anni, senza componenti indossabili e con misurazione diretta del glucosio nel sangue, a differenza dei sistemi tradizionali che misurano il glucosio dal fluido interstiziale.
L'approvazione arriva dopo il successo dello studio iniziale sull'uomo, rappresentando un importante progresso nel programma clinico di Glucotrack.
Glucotrack (NASDAQ: GCTK) ha recibido la aprobación ética del HREC del Hospital St. Vincent de Melbourne para un estudio clínico a largo plazo de su monitor continuo de glucosa en sangre (CBGM) para pacientes con diabetes. El estudio inscribirá hasta 30 participantes con diabetes tipo 1 y tipo 2, con una duración inicial de 1 año y posible extensión hasta 3 años.
El estudio estará dirigido por el Profesor David O'Neal y el Profesor Asociado Neale Cohen, con las primeras implantaciones previstas para julio de 2025. El CBGM de Glucotrack es un sistema implantable a largo plazo diseñado para un monitoreo continuo de hasta tres años, sin componentes portátiles y con medición directa de glucosa en sangre, a diferencia de los sistemas tradicionales que miden desde el líquido intersticial.
La aprobación sigue al exitoso estudio inicial en humanos de Glucotrack, marcando un avance significativo en su programa clínico.
Glucotrack (NASDAQ: GCTK)는 멜버른 세인트 빈센트 병원 HREC로부터 당뇨병 환자를 위한 지속 혈당 모니터(CBGM)의 장기 임상 연구에 대한 윤리 승인을 받았습니다. 이 연구는 1형 및 2형 당뇨병 환자 최대 30명을 모집하며, 초기 기간은 1년이고 최대 3년까지 연장될 수 있습니다.
연구는 데이비드 오닐 교수와 닐 코헨 부교수가 주도하며, 첫 환자 이식은 2025년 7월에 예정되어 있습니다. Glucotrack의 CBGM은 최대 3년간 지속 모니터링이 가능한 장기 이식형 시스템으로, 착용 부품이 없고 전통적인 인터스티셜 액체 측정 방식과 달리 직접 혈당을 측정합니다.
이번 승인은 Glucotrack의 첫 인간 대상 연구의 성공에 따른 것으로, 임상 프로그램에서 중요한 진전을 의미합니다.
Glucotrack (NASDAQ : GCTK) a obtenu l'approbation éthique du comité HREC de l'hôpital St. Vincent de Melbourne pour une étude clinique à long terme de son moniteur continu de glycémie (CBGM) destiné aux patients diabétiques. L'étude recrutera jusqu'à 30 participants atteints de diabète de type 1 et de type 2, pour une durée initiale d'un an avec une possible extension à trois ans.
L'étude sera dirigée par le professeur David O'Neal et le professeur associé Neale Cohen, avec les premières implantations prévues pour juillet 2025. Le CBGM de Glucotrack est un système implantable à long terme conçu pour une surveillance continue jusqu'à trois ans, sans composants portables et avec une mesure directe du glucose sanguin, contrairement aux systèmes traditionnels qui mesurent à partir du liquide interstitiel.
Cette approbation fait suite au succès de la première étude chez l'humain de Glucotrack, marquant une avancée significative dans leur programme clinique.
Glucotrack (NASDAQ: GCTK) hat von der Ethikkommission des St. Vincent's Hospital Melbourne HREC die Genehmigung für eine Langzeit-Studie seines kontinuierlichen Blutzuckermonitors (CBGM) für Diabetes-Patienten erhalten. Die Studie wird bis zu 30 Teilnehmer mit Typ-1- und Typ-2-Diabetes einschließen und zunächst 1 Jahr dauern, mit möglicher Verlängerung auf 3 Jahre.
Die Studie wird von Professor David O'Neal und Associate Professor Neale Cohen geleitet, die ersten Implantationen sind für Juli 2025 geplant. Der CBGM von Glucotrack ist ein langfristig implantierbares System, das bis zu drei Jahre kontinuierliche Überwachung ermöglicht, ohne tragbare Komponenten und mit direkter Blutzuckermessung, im Gegensatz zu traditionellen Systemen, die aus interstitieller Flüssigkeit messen.
Die Genehmigung folgt auf die erfolgreiche erste Humanstudie von Glucotrack und stellt einen bedeutenden Fortschritt im klinischen Programm dar.
- Novel technology measures glucose directly from blood instead of interstitial fluid, potentially offering more accurate real-time readings without lag time
- Device designed for up to 3 years of continuous monitoring, significantly longer than current solutions
- No wearable component required, offering more convenience for patients
- Study to be conducted by renowned diabetes technology experts
- Product is still in investigational phase with no guaranteed regulatory approval
- Limited initial study size of only 30 participants
- Additional regulatory steps required before study enrollment can begin
Insights
Glucotrack's HREC approval advances their novel implantable CBGM toward clinical validation with patient implantation expected by July.
This ethical approval from St. Vincent's Hospital Melbourne represents a critical regulatory milestone in Glucotrack's clinical development pathway. The approval enables a prospective, single-arm, multi-center study involving up to 30 participants with type 1 and type 2 diabetes requiring intensive insulin therapy. Following Australian clinical study protocols, Glucotrack still needs to notify the Therapeutic Goods Administration before proceeding with enrollment, but patient implantation is expected by July.
The study architecture is methodically designed to evaluate both safety and performance metrics over an initial 12-month period, with potential extension to 3 years pending additional regulatory submissions. Securing respected diabetes technology researchers Professor David O'Neal and Associate Professor Neale Cohen as principal investigators adds significant credibility to the trial design and execution.
What differentiates Glucotrack's technology in the competitive CGM landscape is its direct measurement of blood glucose versus interstitial fluid glucose. This distinction is technically significant as it eliminates the physiological lag time between blood and interstitial measurements, potentially offering more precise real-time glucose values—particularly important during rapid glucose fluctuations. The device's long-term implantable design (up to three years) with no external wearable component addresses two persistent barriers to CGM adoption: limited sensor longevity and wearability concerns.
This study builds upon Glucotrack's previously completed first-in-human study, following the standard medical device development sequence. While promising, the technology remains classified as an Investigational Device limited to research use, with substantial clinical validation still required before commercial availability.
Long-term clinical evaluation represents key advancement following successful first-in-human study
RUTHERFORD, N.J., May 13, 2025 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq: GCTK) (“Glucotrack” or the “Company”), a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, today announced it has received ethical approval from the St. Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC) for its long-term clinical study of the Company’s continuous blood glucose monitor (“CBGM”) in participants with type 1 and type 2 diabetes.
The prospective, single arm, multi-center study will enroll up to 30 participants with type 1 and type 2 diabetes mellitus requiring glucose monitoring and intensive insulin therapy. The study will evaluate the device's performance and safety over an initial period of 1 year. The Company may complete additional submissions to extend the study to 3 years, upon completion of the initial study period. With this approval and per the Australian clinical study process, the Company will now notify Therapeutic Goods Administration (TGA), which is Australia's regulatory authority for therapeutic goods such as medicines, medical devices, and diagnostic tests, before proceeding with enrollment. The first patients are expected to be implanted by July. The study will be conducted under Principal Investigator Professor David O’Neal (MBBS, MD, FRACP), the Director and Founder of the Diabetes Technology Research Group based at the University of Melbourne, Department of Medicine at St Vincent’s Hospital, Melbourne and Associate Professor Neale Cohen (MBBS, FRACP), Head of the Diabetes Clinical Research Laboratory at the Baker Heart and Diabetes Institute, Melbourne.
“I am excited to be bringing my expertise in leading clinical trials focused on novel diabetes technology to this important study of a device that directly measures blood glucose,” said Professor O’Neal. “This technology shows great promise for the ability to improve glycemic control and offer patients expanded choice in continuous glucose monitoring systems. The ability to directly measure glucose in blood rather than interstitial fluid could represent a significant advancement for people with diabetes seeking more accurate real-time glucose values.”
Glucotrack’s CBGM is a long-term implantable system with no wearable component, designed for up to three years of continuous, accurate blood glucose monitoring, offering a more convenient and less intrusive glucose monitoring solution. The CBGM measures glucose directly from blood, unlike traditional continuous glucose monitoring systems which measure glucose from interstitial fluid. Thus, it aims to provide real-time readings without the lag time typically associated with interstitial glucose measurements.
“Securing this approval represents a major milestone for our clinical program and builds on the successful completion of our first-in-human study earlier this year,” said Paul V. Goode, PhD, President & Chief Executive Officer. “We are honored to work with Professor O’Neal and his team on this long-term clinical study of our novel CBGM. This year-long study will provide critical insights into the long-term performance, safety and reliability of our innovative technology, which is designed to address key challenges identified by people with diabetes – including the need for extended sensor life, elimination of on-body wearables and the benefits of direct blood glucose measurement.”
The Glucotrack Continuous Blood Glucose Monitor is an Investigational Device and is limited by federal (or United States) law to investigational use.
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, 2024 as filed with the SEC on March 31, 2025.
Contacts:
Investor Relations:
investors@glucotrack.com
Media:
GlucotrackPR@icrinc.com
FAQ
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