Glucotrack to Present First-In-Human Study Results for Continuous Blood Glucose Monitor at the 2025 International Conference on Advanced Technologies & Treatment for Diabetes
Glucotrack (NASDAQ: GCTK) has announced it will present safety and performance data from its first-in-human trial of its long-term continuous blood glucose monitoring (CBGM) system at the 2025 International Conference on Advanced Technologies & Treatment for Diabetes (ATTD) in Amsterdam.
The company's CBGM technology is a long-term implantable device designed to last three years with no on-body external component. Unlike traditional monitors that measure glucose in interstitial fluid, Glucotrack's system measures glucose directly from the blood, potentially offering greater accuracy and real-time monitoring.
The presentation will feature results from an early feasibility study evaluating the intravascular CBGM in adults with diabetes mellitus. The study aims to demonstrate the safety, feasibility, and performance of the device. The company plans to advance its clinical program with an upcoming chronic implant study.
Glucotrack (NASDAQ: GCTK) ha annunciato che presenterà dati sulla sicurezza e sulle prestazioni del suo trial di prima applicazione umana del sistema di monitoraggio continuo della glicemia a lungo termine (CBGM) alla Conferenza Internazionale sulle Tecnologie Avanzate e il Trattamento per il Diabete (ATTD) del 2025 ad Amsterdam.
La tecnologia CBGM dell'azienda è un dispositivo impiantabile a lungo termine progettato per durare tre anni senza componenti esterni sul corpo. A differenza dei monitor tradizionali che misurano la glicemia nel fluido interstiziale, il sistema di Glucotrack misura la glicemia direttamente dal sangue, offrendo potenzialmente una maggiore precisione e monitoraggio in tempo reale.
La presentazione presenterà i risultati di uno studio di fattibilità iniziale che valuta il CBGM intravascolare in adulti con diabete mellito. Lo studio mira a dimostrare la sicurezza, la fattibilità e le prestazioni del dispositivo. L'azienda prevede di far avanzare il suo programma clinico con un imminente studio di impianto cronico.
Glucotrack (NASDAQ: GCTK) ha anunciado que presentará datos sobre la seguridad y el rendimiento de su ensayo de primera aplicación en humanos de su sistema de monitoreo continuo de glucosa en sangre a largo plazo (CBGM) en la Conferencia Internacional sobre Tecnologías Avanzadas y Tratamiento para la Diabetes (ATTD) 2025 en Ámsterdam.
La tecnología CBGM de la compañía es un dispositivo implantable a largo plazo diseñado para durar tres años sin componentes externos en el cuerpo. A diferencia de los monitores tradicionales que miden la glucosa en el líquido intersticial, el sistema de Glucotrack mide la glucosa directamente de la sangre, lo que potencialmente ofrece una mayor precisión y monitoreo en tiempo real.
La presentación incluirá resultados de un estudio de viabilidad inicial que evalúa el CBGM intravascular en adultos con diabetes mellitus. El estudio tiene como objetivo demostrar la seguridad, la viabilidad y el rendimiento del dispositivo. La compañía planea avanzar en su programa clínico con un próximo estudio de implante crónico.
글루코트랙 (NASDAQ: GCTK)은 암스테르담에서 열리는 2025년 국제 당뇨병 첨단 기술 및 치료 회의(ATTD)에서 장기 지속 혈당 모니터링(CBGM) 시스템의 첫 번째 인체 시험 안전성과 성능 데이터를 발표할 것이라고 발표했습니다.
회사의 CBGM 기술은 장기 이식 가능한 장치로, 외부 구성 요소 없이 3년 동안 지속되도록 설계되었습니다. 전통적인 모니터가 간질액에서 포도당을 측정하는 것과는 달리, 글루코트랙의 시스템은 혈액에서 직접 포도당을 측정하여 더 높은 정확성과 실시간 모니터링을 제공할 수 있습니다.
발표에서는 당뇨병 성인에 대한 혈관 내 CBGM을 평가하는 초기 타당성 연구의 결과가 포함될 것입니다. 이 연구는 장치의 안전성, 타당성 및 성능을 입증하는 것을 목표로 합니다. 회사는 향후 만성 이식 연구를 통해 임상 프로그램을 발전시킬 계획입니다.
Glucotrack (NASDAQ: GCTK) a annoncé qu'il présentera des données sur la sécurité et la performance de son essai de première application chez l'homme de son système de surveillance continue de la glycémie à long terme (CBGM) lors de la Conférence Internationale sur les Technologies Avancées et le Traitement du Diabète (ATTD) 2025 à Amsterdam.
La technologie CBGM de l'entreprise est un dispositif implantable à long terme conçu pour durer trois ans sans composant externe sur le corps. Contrairement aux moniteurs traditionnels qui mesurent la glycémie dans le liquide interstitiel, le système de Glucotrack mesure la glycémie directement dans le sang, offrant ainsi potentiellement une plus grande précision et un suivi en temps réel.
La présentation mettra en avant les résultats d'une étude de faisabilité précoce évaluant le CBGM intravasculaire chez des adultes atteints de diabète sucré. L'étude vise à démontrer la sécurité, la faisabilité et la performance de l'appareil. L'entreprise prévoit de faire avancer son programme clinique avec une prochaine étude d'implantation chronique.
Glucotrack (NASDAQ: GCTK) hat angekündigt, dass es Sicherheits- und Leistungsdaten aus seiner ersten klinischen Studie zum langfristigen kontinuierlichen Blutzuckerüberwachungssystem (CBGM) auf der Internationalen Konferenz über Fortgeschrittene Technologien und Behandlungen für Diabetes (ATTD) 2025 in Amsterdam präsentieren wird.
Die CBGM-Technologie des Unternehmens ist ein langfristig implantierbares Gerät, das für eine Haltbarkeit von drei Jahren ohne externe Komponenten am Körper ausgelegt ist. Im Gegensatz zu herkömmlichen Monitoren, die Glukose im interstitiellen Flüssigkeit messen, erfasst das System von Glucotrack die Glukose direkt aus dem Blut und bietet somit potenziell eine höhere Genauigkeit und Echtzeitüberwachung.
Die Präsentation wird Ergebnisse einer frühen Machbarkeitsstudie enthalten, die das intravaskuläre CBGM bei Erwachsenen mit Diabetes mellitus bewertet. Die Studie zielt darauf ab, die Sicherheit, Machbarkeit und Leistung des Geräts zu demonstrieren. Das Unternehmen plant, sein klinisches Programm mit einer bevorstehenden chronischen Implantationsstudie voranzutreiben.
- Successful completion of first-in-human trial demonstrating safety and feasibility
- Innovative technology offering direct blood glucose measurement versus interstitial fluid
- Long-term monitoring capability of 3 years without external components
- Advancement to next phase with planned chronic implant study
- Product still in investigational phase, not yet FDA approved
- No specific performance metrics or accuracy data disclosed
- Commercial launch timeline not specified
Insights
Glucotrack's announcement of first-in-human study results for their continuous blood glucose monitor (CBGM) represents a significant milestone in their clinical development program. The company's implantable CBGM technology offers three potential advantages over existing continuous glucose monitoring systems:
1. Direct blood measurement instead of interstitial fluid monitoring, potentially eliminating the lag time (typically 5-15 minutes) seen with traditional CGMs
2. No external components required on the body, improving patient convenience and eliminating adhesive-related skin issues
3. Three-year functional lifespan, which would represent a dramatic improvement over current CGMs requiring replacement every 7-14 days
The presentation at ATTD, a premier diabetes technology conference, provides valuable third-party validation that the initial safety and performance data are meaningful enough to warrant scientific presentation. However, investors should note this remains an early-stage clinical program with the device still classified as investigational. The company has not disclosed specific accuracy metrics compared to reference standards, which will be important for determining its commercial viability.
The announcement that Glucotrack is advancing to a chronic implant study suggests the first-in-human results met internal thresholds for continued development. For diabetes patients, a long-term implantable with no external components could significantly reduce the daily burden of disease management, potentially improving medication adherence and quality of life if accuracy meets clinical standards.
This clinical milestone marks important progress for Glucotrack, a micro-cap company (
The diabetes monitoring market presents both opportunity and significant competitive challenges. Current CGM leaders (Dexcom, Abbott, Medtronic) dominate with combined revenues exceeding
The three-year functional lifespan would create a compelling economic value proposition compared to traditional CGMs requiring frequent replacement. However, the regulatory pathway for long-term implantable glucose monitors remains complex, with FDA likely requiring extensive safety data given the novel implantation approach.
While the CEO characterizes the results as "promising," investors should note the absence of specific performance metrics in the announcement. The upcoming presentation will provide important data on accuracy (MARD - Mean Absolute Relative Difference) compared to reference standards, which typically need to be below
This news validates Glucotrack's technological approach has cleared an important early hurdle, though considerable clinical, regulatory, and commercial challenges remain before reaching market.
Safety and performance data from direct blood glucose measurement technology to be featured at international diabetes technology conference
RUTHERFORD, N.J., March 19, 2025 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq: GCTK), a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, today announced that safety and performance data from its first-in-human trial of its long-term continuous blood glucose monitoring (CBGM) system will be presented at the 2025 International Conference on Advanced Technologies & Treatment for Diabetes (ATTD). ATTD is an important global conference focused on technological innovations in diabetes care. The conference will be held in Amsterdam, the Netherlands, taking place March 19 – 22, 2025.
“We are pleased to be showcasing these significant results from our first-in-human trial, demonstrating the safety, feasibility and promising performance of our CBGM,” said Paul V. Goode, PhD, President and Chief Executive Officer of Glucotrack. “This ground-breaking study supports our approach to measuring glucose directly from the blood, rather than interstitial fluid, which enables real-time glucose monitoring with potentially greater accuracy and without on-body wearables, representing a potentially transformative advancement in diabetes management. We look forward to sharing detailed findings from this important study at ATTD and advancing our clinical program with our upcoming chronic implant study.”
The poster will be presented at the meeting and will be made available on the Glucotrack website following the conference.
Poster Title: Early Feasibility Study to Evaluate an Intravascular Continuous Blood Glucose Monitor in Adults with Diabetes Mellitus
Unlike traditional continuous glucose monitors, 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.
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 technology, 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
FAQ
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