Glucotrack Announces Successful Completion of Its First Human Clinical Study of Continuous Blood Glucose Monitor
Glucotrack (NASDAQ: GCTK) has successfully completed its first human clinical study of a Continuous Blood Glucose Monitor (CBGM). The study, conducted over four days in a hospital setting with six diabetes patients, met its primary endpoint with no procedure or device-related serious adverse events reported.
The CBGM sensor lead was placed in the subclavian vein through a percutaneous procedure, representing the first real-time continuous blood glucose monitor placed in this location. This approach offers direct blood glucose measurement, potentially overcoming limitations of traditional monitors that measure glucose in interstitial fluid.
The device is designed for three years of continuous monitoring with no external body components. While the study focused on safety and procedural aspects rather than sensor accuracy, the system performed similarly to previous animal studies. The successful placement and removal procedures were performed by interventional cardiologists, with monitoring continuing through seven days post-removal.
Glucotrack (NASDAQ: GCTK) ha completato con successo il suo primo studio clinico umano su un Monitor Continuo della Glucosio nel Sangue (CBGM). Lo studio, condotto per quattro giorni in un contesto ospedaliero con sei pazienti diabetici, ha raggiunto il suo obiettivo principale senza segnalare eventi avversi gravi correlati alla procedura o al dispositivo.
Il sensore CBGM è stato inserito nella vena succlavia tramite una procedura percutanea, rappresentando il primo monitor continuo della glucosio nel sangue in tempo reale posizionato in questa sede. Questo approccio offre una misurazione diretta della glucosio nel sangue, superando potenzialmente le limitazioni dei monitor tradizionali che misurano la glucosio nel fluido interstiziale.
Il dispositivo è progettato per un monitoraggio continuo di tre anni senza componenti esterni. Anche se lo studio si è concentrato sulla sicurezza e sugli aspetti procedurali piuttosto che sull'accuratezza del sensore, il sistema ha mostrato prestazioni simili a quelle di studi precedenti su animali. Le procedure di posizionamento e rimozione sono state eseguite da cardiologi interventisti, con monitoraggio continuato per sette giorni dopo la rimozione.
Glucotrack (NASDAQ: GCTK) ha completado con éxito su primer estudio clínico humano de un Monitor Continuo de Glucosa en Sangre (CBGM). El estudio, realizado durante cuatro días en un entorno hospitalario con seis pacientes diabéticos, alcanzó su objetivo principal sin reportar eventos adversos graves relacionados con el procedimiento o el dispositivo.
El sensor CBGM se colocó en la vena subclavia a través de un procedimiento percutáneo, representando el primer monitor continuo de glucosa en sangre en tiempo real situado en esta ubicación. Este enfoque ofrece una medición directa de la glucosa en sangre, superando potencialmente las limitaciones de los monitores tradicionales que miden la glucosa en el líquido intersticial.
El dispositivo está diseñado para un monitoreo continuo durante tres años sin componentes externos. Si bien el estudio se centró en la seguridad y los aspectos del procedimiento en lugar de la precisión del sensor, el sistema mostró un rendimiento similar al de estudios anteriores en animales. Las exitosas procedimientos de colocación y remoción fueron realizados por cardiólogos intervencionistas, con un monitoreo continuo durante siete días después de la remoción.
글루코트랙 (NASDAQ: GCTK)가 지속적인 혈당 모니터(CBGM)에 대한 첫 번째 인간 임상 연구를 성공적으로 완료했습니다. 이 연구는 여섯 명의 당뇨병 환자와 함께 병원 환경에서 4일 동안 실시되었으며, 절차나 장치와 관련된 심각한 부작용은 보고되지 않았습니다.
CBGM 센서는 경피적 방법으로 쇄골하 정맥에 삽입되었으며, 특히 이 위치에 장착된 첫 번째 실시간 지속적인 혈당 모니터를 의미합니다. 이 접근법은 직접적인 혈당 측정을 허용하며, 간질액에서 혈당을 측정하는 전통적인 모니터의 한계를 극복할 수 있는 가능성이 있습니다.
이 장치는 외부 구성 요소 없이 3년간 지속적인 모니터링을 위해 설계되었습니다. 연구는 센서의 정확성보다는 안전성과 시술적 측면에 중점을 두었지만, 시스템은 이전 동물 연구와 유사한 성능을 보여주었습니다. 성공적인 위치 지정 및 제거 절차는 개입 심장 학자에 의해 수행되었으며, 제거 후 7일 동안 모니터링이 지속되었습니다.
Glucotrack (NASDAQ: GCTK) a réussi à achever sa première étude clinique humaine sur un Moniteur de Glucose Sanguin Continu (CBGM). L'étude, menée pendant quatre jours dans un environnement hospitalier avec six patients diabétiques, a atteint son objectif principal sans rapporter d'événements indésirables graves liés à la procédure ou à l'appareil.
Le capteur CBGM a été inséré dans la veine subclavière par une procédure percutanée, représentant le premier moniteur de glucose sanguin continu en temps réel placé à cet endroit. Cette approche offre une mesure directe de la glucose dans le sang, surmontant potentiellement les limites des moniteurs traditionnels qui mesurent la glucose dans le liquide interstitiel.
L'appareil est conçu pour un suivi continu de trois ans sans composants externes. Bien que l'étude se soit concentrée sur la sécurité et les aspects procéduraux plutôt que sur la précision du capteur, le système a présenté des performances similaires aux études précédentes sur les animaux. Les procédures de placement et de retrait réussies ont été réalisées par des cardiologues interventionnels, avec un suivi continu pendant sept jours après le retrait.
Glucotrack (NASDAQ: GCTK) hat erfolgreich seine erste klinische Studie am Menschen zum kontinuierlichen Blutzucker-Monitor (CBGM) abgeschlossen. Die Studie, die über vier Tage in einem Krankenhaus mit sechs Diabetes-Patienten durchgeführt wurde, erreichte ihr primäres Ziel, ohne dass schwerwiegende unerwünschte Ereignisse im Zusammenhang mit dem Verfahren oder dem Gerät gemeldet wurden.
Der CBGM-Sensor wurde durch einen perkutanen Eingriff in die Schlüsselbeinvene eingeführt, was den ersten kontinuierlichen Blutzucker-Monitor in Echtzeit an dieser Stelle darstellt. Dieser Ansatz ermöglicht eine direkte Blutzuckermessung und könnte potenziell die Einschränkungen traditioneller Monitore überwinden, die Glukose in interstitieller Flüssigkeit messen.
Das Gerät ist für drei Jahre kontinuierliche Überwachung ohne externe Komponenten ausgelegt. Während sich die Studie auf Sicherheits- und Verfahrensaspekte konzentrierte und nicht auf die Sensorgenauigkeit, zeigte das System ähnliche Leistungen wie frühere Tierversuche. Die erfolgreichen Platzierungs- und Entfernungsverfahren wurden von interventionellen Kardiologen durchgeführt, wobei die Überwachung sieben Tage nach der Entfernung fortgesetzt wurde.
- Successfully completed first human clinical study with no serious adverse events
- Device demonstrated similar accuracy to previous animal studies
- Technology offers potential for 3-year continuous monitoring without external components
- Successfully demonstrated placement and removal procedures
- Study was to short-term (4 days) evaluation
- Study not designed to evaluate sensor accuracy
- Small sample size of only six participants
Insights
Glucotrack's successful completion of its first human trial marks a pivotal advancement in continuous glucose monitoring technology. The study's focus on safety validation of their novel subclavian vein placement approach addresses a fundamental limitation of current CGM devices - the lag time between blood glucose changes and interstitial fluid measurements.
The trial's design, while to six participants over four days, establishes three critical elements:
- Safe placement and removal procedures by interventional cardiologists
- Functional glucose monitoring in the subclavian vein
- No serious adverse events through the 7-day post-removal period
The potential three-year monitoring duration without external components represents a significant leap forward from current CGMs that typically require replacement every 7-14 days. However, several hurdles remain before commercialization:
- Long-term safety and efficacy trials
- Accuracy validation across diverse patient populations
- FDA approval pathway navigation
While promising, investors should note that this is an early-stage validation. The path to market will require substantial clinical evidence, particularly regarding long-term safety and accuracy metrics. The absence of external components could provide a significant competitive advantage, but manufacturing scalability and cost considerations will be important factors in market penetration potential.
The study met its primary endpoint with no procedure or device related serious adverse events reported
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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