Glucotrack and OneTwo Analytics Present Positive Final Results of First-In-Human Study for Continuous Blood Glucose Monitor at American Diabetes Association’s 85th Scientific Sessions
Glucotrack (NASDAQ:GCTK) has announced positive final results from its first-in-human clinical study for its innovative Continuous Blood Glucose Monitor (CBGM) at the American Diabetes Association's 85th Scientific Sessions. The study demonstrated excellent accuracy with a MARD of 7.7% across 122 matched pairs and a 99% data capture rate, with no serious adverse events.
The implantable CBGM technology measures glucose directly from blood rather than interstitial fluid, eliminating typical lag time associated with traditional monitors. The study, conducted in Brazil from December 2024 to January 2025, included ten Type 1 or Type 2 diabetes patients. Analysis showed 92% of measurements in the green zone of the Diabetes Technology Society Error Grid, indicating high clinical accuracy.
The company plans to initiate a long-term early feasibility study in Q3 2025. The CBGM system is designed for a three-year sensor life with no on-body wearable component and minimal calibration requirements.
Glucotrack (NASDAQ:GCTK) ha annunciato risultati positivi definitivi dal suo primo studio clinico sull'uomo per il suo innovativo Monitor Continuo della Glicemia (CBGM) durante le 85esime Sessioni Scientifiche dell'American Diabetes Association. Lo studio ha mostrato un'eccellente accuratezza con un MARD del 7,7% su 122 coppie abbinate e un tasso di acquisizione dati del 99%, senza eventi avversi gravi.
La tecnologia CBGM impiantabile misura il glucosio direttamente dal sangue anziché dal fluido interstiziale, eliminando il tipico ritardo associato ai monitor tradizionali. Lo studio, condotto in Brasile da dicembre 2024 a gennaio 2025, ha coinvolto dieci pazienti con diabete di Tipo 1 o Tipo 2. L'analisi ha mostrato che il 92% delle misurazioni rientrava nella zona verde della Diabetes Technology Society Error Grid, indicando un'elevata accuratezza clinica.
L'azienda prevede di avviare uno studio di fattibilità precoce a lungo termine nel terzo trimestre del 2025. Il sistema CBGM è progettato per una durata del sensore di tre anni, senza componenti indossabili sul corpo e con requisiti di calibrazione minimi.
Glucotrack (NASDAQ:GCTK) ha anunciado resultados finales positivos de su primer estudio clínico en humanos para su innovador Monitor Continuo de Glucosa en Sangre (CBGM) durante las 85ª Sesiones Científicas de la American Diabetes Association. El estudio demostró una excelente precisión con un MARD del 7,7% en 122 pares emparejados y una tasa de captura de datos del 99%, sin eventos adversos graves.
La tecnología implantable CBGM mide la glucosa directamente de la sangre en lugar del fluido intersticial, eliminando el retraso típico asociado con los monitores tradicionales. El estudio, realizado en Brasil de diciembre de 2024 a enero de 2025, incluyó a diez pacientes con diabetes tipo 1 o tipo 2. El análisis mostró que el 92% de las mediciones estaban en la zona verde de la Diabetes Technology Society Error Grid, indicando alta precisión clínica.
La compañía planea iniciar un estudio de factibilidad temprana a largo plazo en el tercer trimestre de 2025. El sistema CBGM está diseñado para una vida útil del sensor de tres años, sin componentes portátiles en el cuerpo y con requisitos mínimos de calibración.
Glucotrack (NASDAQ:GCTK)가 미국 당뇨병 협회(ADA) 85차 과학 세션에서 혁신적인 연속 혈당 모니터(CBGM)에 대한 최초 인간 대상 임상 시험의 긍정적인 최종 결과를 발표했습니다. 이 연구는 122쌍의 매칭 데이터에서 MARD 7.7%의 우수한 정확도와 99% 데이터 캡처율을 보였으며, 심각한 부작용은 없었습니다.
이식형 CBGM 기술은 전통적인 모니터에서 흔히 발생하는 지연 시간을 없애기 위해 혈액에서 직접 포도당을 측정하며, 간질액이 아닌 혈액에서 측정합니다. 2024년 12월부터 2025년 1월까지 브라질에서 진행된 이 연구에는 1형 또는 2형 당뇨병 환자 10명이 참여했습니다. 분석 결과, 92%의 측정값이 당뇨병 기술 학회 오류 격자(Diabetes Technology Society Error Grid)의 녹색 구역에 속해 높은 임상 정확도를 나타냈습니다.
회사는 2025년 3분기에 장기 초기 타당성 연구를 시작할 계획입니다. CBGM 시스템은 3년간 센서 수명을 목표로 하며, 착용하는 부품 없이 최소한의 보정만 필요합니다.
Glucotrack (NASDAQ:GCTK) a annoncé des résultats finaux positifs de sa première étude clinique chez l'humain pour son moniteur continu de glycémie (CBGM) innovant lors des 85èmes sessions scientifiques de l'American Diabetes Association. L'étude a démontré une excellente précision avec un MARD de 7,7% sur 122 paires appariées et un taux de capture des données de 99%, sans événements indésirables graves.
La technologie CBGM implantable mesure le glucose directement dans le sang plutôt que dans le liquide interstitiel, éliminant ainsi le délai typique associé aux moniteurs traditionnels. L'étude, menée au Brésil de décembre 2024 à janvier 2025, a inclus dix patients atteints de diabète de type 1 ou 2. L'analyse a montré que 92% des mesures se situaient dans la zone verte de la grille d'erreur de la Diabetes Technology Society, indiquant une grande précision clinique.
L'entreprise prévoit de lancer une étude de faisabilité précoce à long terme au troisième trimestre 2025. Le système CBGM est conçu pour une durée de vie du capteur de trois ans, sans composant porté sur le corps et avec des besoins de calibration minimaux.
Glucotrack (NASDAQ:GCTK) hat positive endgültige Ergebnisse seiner ersten klinischen Studie am Menschen für seinen innovativen kontinuierlichen Blutzuckermonitor (CBGM) auf den 85. Wissenschaftlichen Sitzungen der American Diabetes Association bekannt gegeben. Die Studie zeigte eine ausgezeichnete Genauigkeit mit einem MARD von 7,7% über 122 gepaarte Messwerte und eine 99% Daten-Erfassungsrate, ohne schwerwiegende Nebenwirkungen.
Die implantierbare CBGM-Technologie misst Glukose direkt aus dem Blut und nicht aus der interstitiellen Flüssigkeit, wodurch die typische Verzögerung herkömmlicher Monitore entfällt. Die Studie, die von Dezember 2024 bis Januar 2025 in Brasilien durchgeführt wurde, umfasste zehn Patienten mit Typ-1- oder Typ-2-Diabetes. Die Analyse zeigte, dass 92% der Messungen im grünen Bereich des Diabetes Technology Society Error Grid lagen, was auf eine hohe klinische Genauigkeit hinweist.
Das Unternehmen plant, im dritten Quartal 2025 eine langfristige Frühstudie zu starten. Das CBGM-System ist für eine drei Jahre lange Sensorlebensdauer ausgelegt, ohne am Körper zu tragende Komponenten und mit minimalem Kalibrierungsaufwand.
- Excellent accuracy demonstrated with MARD of 7.7%, comparable to leading CGM systems
- High 99% data capture rate with no serious adverse events
- 92% of measurements in green zone of Error Grid, showing strong clinical accuracy
- Innovative blood-based measurement eliminates typical CGM lag time
- Long three-year sensor life potential offers competitive advantage
- Product is still in early clinical trial phase, requiring additional studies
- Limited study size of only 10 participants
- Currently restricted to investigational use only
Insights
Glucotrack's blood-based glucose monitor shows excellent 7.7% MARD in first human trial, positioning it as a potentially superior alternative to current CGMs.
Glucotrack's first-in-human study results represent a significant technological advancement in diabetes management. The achieved 7.7% MARD (Mean Absolute Relative Difference) is comparable to industry-leading CGM systems but with a crucial difference - it measures glucose directly from blood rather than interstitial fluid. This eliminates the lag time that affects traditional CGM accuracy, particularly during rapid glucose changes.
The study data is particularly compelling: 92% of measurements fell within the green zone of the Diabetes Technology Society Error Grid with zero readings in unsafe zones, indicating exceptional clinical reliability. The 99% data capture rate further demonstrates robust technical performance.
What sets this technology apart is its fully implantable design with a sensor placed in the subclavian vein connected to subcutaneous electronics. The anticipated three-year sensor life would dramatically reduce the burden of frequent sensor replacements required by current systems. The absence of external components addresses persistent issues with current CGMs - namely adhesive problems, device visibility, and replacement frequency.
The successful completion of this study enables Glucotrack to advance to a long-term early feasibility study in Q3 2025. While still in investigational stages, this technology represents a potential paradigm shift in glucose monitoring, offering a fundamentally different approach from current market leaders like Dexcom and Abbott.
Comprehensive analysis confirms safety and strong accuracy of Glucotrack's innovative blood-based continuous glucose monitoring technology, with MARD of
RUTHERFORD, N.J. and STOCKHOLM, June 25, 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 results from its completed first-in-human clinical study presented at the American Diabetes Association’s (ADA) 85th Scientific Sessions, which took place June 20-23, 2025, in Chicago.
The study met all primary and secondary endpoints, demonstrating excellent accuracy with a Mean Absolute Relative Difference (MARD) of
Glucotrack leveraged OneTwo Analytics’ next-generation artificial intelligence and machine learning-based analytics to evaluate the data and assess its clinical value. Analysis using the Diabetes Technology Society Error Grid showed that
The study, which was conducted at the Interventional Cardiology at Instituto do Coração in São Paulo, Brazil between December 13, 2024 and January 31, 2025, included ten participants with either Type 1 or Type 2 diabetes who were on intensive insulin therapy. The insertion and removal procedures were performed by interventional cardiologists using established percutaneous techniques. Following the device placement, each participant underwent inpatient observation for 4 days. During this period, frequent blood sampling and glucose tolerance tests were conducted to assess device performance. Detailed analysis showed consistent performance during glucose tolerance testing with minimal lag time compared to venous blood samples. The system successfully remained in place throughout the study period and was successfully removed at study completion, with patients then followed for 7 days post-removal.
“This study represents an important milestone validating our CBGM technology’s potential,” said Paul V. Goode, PhD, President and Chief Executive Officer of Glucotrack. “With a MARD of
Glucotrack expects to initiate a long-term early feasibility study in Q3 2025, which will evaluate safety and performance over an extended period, bringing the technology closer to its goal of providing patients with a less-intrusive alternative to continuous glucose monitoring.
Unlike traditional continuous glucose monitors, the Glucotrack CBGM is a fully implantable continuous glucose monitor, consisting of a sensor lead implanted into the subclavian vein and connected to subcutaneous electronics that communicate with a mobile application. It measures glucose directly from the blood, eliminating the lag time associated with interstitial fluid glucose monitors. Designed for a three-year sensor life with continuous, accurate blood glucose monitoring, the system offers a more convenient and less intrusive solution for people with diabetes, with no on-body wearable component and minimal calibration requirements.
“We’re proud to have applied our clinical analytics expertise to validate the performance of Glucotrack’s innovative CBGM technology,” said Lars Cederblad, Chief Executive Officer of OneTwo Analytics. “The results demonstrate excellent safety and accuracy profiles that could meaningfully improve diabetes care.”
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.
For more information about OneTwo Analytics AB, visit onetwo-analytics.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.
About OneTwo Analytics
OneTwo Analytics is a leader in AI-driven healthcare solutions, specializing in the analysis of diabetes data, real-world evidence, and clinical trial outcomes. The company develops advanced diabetes technology stacks for device manufacturers while recently launching a suite of solutions that are empowering healthcare providers and patients with data-driven intelligence to simplify diabetes disease management and improve efficiencies and outcomes.
OneTwo Analytics’ innovative tools provide healthcare professionals with valuable perspectives for personalized and efficient care, while also offering tailored solutions for stakeholders in the diabetes care sector. The company delivers a comprehensive Diabetes Technology Stack and White-Label solutions for organizations specializing in diabetes technologies.
For more information, please visit https://onetwo-analytics.com/en/.
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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