GLUCOTRACK ANNOUNCES START OF ENROLLMENT FOR HUMAN CLINICAL STUDY OF CONTINUOUS BLOOD GLUCOSE MONITOR
Glucotrack (NASDAQ: GCTK) has initiated patient enrollment for a short-term human clinical study of its continuous blood glucose monitor (CBGM). The study includes both type 1 and type 2 diabetes patients, with results expected in 6-8 weeks. The CBGM is a long-term implantable device that measures glucose directly from blood, designed to work for three years without external components. The four-day in-hospital study is being conducted at Instituto do Coração under Dr. Alexandre Abizaid, involving intravascular sensor placement and fixed meal challenges.
Glucotrack (NASDAQ: GCTK) ha avviato l'arruolamento di pazienti per uno studio clinico umano a breve termine del suo monitor glicemico continuo (CBGM). Lo studio include pazienti con diabete di tipo 1 e tipo 2, con risultati attesi in 6-8 settimane. Il CBGM è un dispositivo impiantabile a lungo termine che misura la glicemia direttamente dal sangue, progettato per funzionare per tre anni senza componenti esterni. Lo studio di quattro giorni in ospedale si sta svolgendo presso l'Istituto do Coração sotto la supervisione del Dr. Alexandre Abizaid, coinvolgendo il posizionamento di sensori intravascolari e sfide alimentari fisse.
Glucotrack (NASDAQ: GCTK) ha iniciado la inscripción de pacientes para un estudio clínico humano a corto plazo de su monitor continuo de glucosa en sangre (CBGM). El estudio incluye pacientes con diabetes tipo 1 y tipo 2, con resultados esperados en 6-8 semanas. El CBGM es un dispositivo implantable a largo plazo que mide la glucosa directamente de la sangre, diseñado para funcionar durante tres años sin componentes externos. El estudio hospitalario de cuatro días se lleva a cabo en el Instituto do Coração bajo la dirección del Dr. Alexandre Abizaid, involucrando la colocación de sensores intravasculares y desafíos alimentarios fijos.
글루코트랙 (NASDAQ: GCTK)은 지속적인 혈당 모니터 (CBGM)에 대한 단기 임상 연구를 위해 환자 등록을 시작했습니다. 이 연구는 1형 및 2형 당뇨병 환자를 포함하며, 결과는 6-8주 이내에 나올 것으로 예상됩니다. CBGM은 혈액에서 직접 혈당을 측정하는 장기 이식형 장치로, 외부 구성 요소 없이 3년 동안 작동하도록 설계되었습니다. 4일간의 병원 내 연구는 알렉상드르 아비자이드 박사 아래에서 Instituto do Coração에서 진행되며, 혈관 내 센서 배치 및 고정식 식사 도전이 포함됩니다.
Glucotrack (NASDAQ: GCTK) a lancé le recrutement de patients pour une étude clinique humaine à court terme de son moniteur de glucose sanguin continu (CBGM). L'étude comprend des patients atteints de diabète de type 1 et de type 2, avec des résultats attendus dans 6 à 8 semaines. Le CBGM est un dispositif implantable à long terme qui mesure directement le glucose dans le sang, conçu pour fonctionner pendant trois ans sans composants externes. L'étude de quatre jours à l'hôpital est dirigée par le Dr Alexandre Abizaid à l'Instituto do Coração et implique la placement de capteurs intravasculaires et des défis alimentaires fixes.
Glucotrack (NASDAQ: GCTK) hat die Patientenrekrutierung für eine kurzfristige klinische Studie mit seinem kontinuierlichen Blutzuckermonitor (CBGM) begonnen. Die Studie umfasst sowohl Patienten mit Typ-1- als auch mit Typ-2-Diabetes, wobei Ergebnisse in 6-8 Wochen erwartet werden. Das CBGM ist ein langfristig implantierbares Gerät, das den Blutzucker direkt aus dem Blut misst und dafür ausgelegt ist, drei Jahre lang ohne externe Komponenten zu funktionieren. Die viertägige klinische Studie wird unter der Leitung von Dr. Alexandre Abizaid am Instituto do Coração durchgeführt und umfasst die Platzierung von intravasalen Sensoren und festgelegte Mahlzeiten-Herausforderungen.
- Novel technology measuring glucose directly from blood instead of interstitial fluid
- Device designed for 3-year continuous monitoring without external components
- Study being conducted at a leading cardiology institution
- Results expected within short timeframe (6-8 weeks)
- Early-stage feasibility study with short duration (4 days)
- scope single-arm study design
- Results pending, no efficacy data available yet
Insights
The initiation of human clinical trials for Glucotrack's continuous blood glucose monitor represents a significant milestone. Their novel approach of measuring glucose directly from blood, rather than interstitial fluid, could address the lag time issues that plague current CGM technologies. The 4-day intravascular study with both Type 1 and Type 2 diabetes patients will provide important data on safety and efficacy.
The device's 3-year implantable design without external components could offer substantial competitive advantages over existing solutions that typically require frequent sensor replacements every 7-14 days. The selection of Dr. Alexandre Abizaid, a renowned interventional cardiologist and Instituto do Coração as the study site adds credibility to the trial. With data expected in 6-8 weeks, this feasibility study could validate the technology's potential in the
Feasibility study underway for the Company’s novel continuous blood glucose monitor in patients with diabetes, with data expected within 6-8 weeks
Rutherford, NJ, Dec. 03, 2024 (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, has announced the commencement of patient enrollment for its short-term human clinical study. The study will focus on the Company’s continuous blood glucose monitor (“CBGM”) and will include participants with both type 1 and type 2 diabetes. Data from the study is expected to be available within 6-8 weeks.
Unlike traditional continuous glucose monitors that measure glucose levels in interstitial fluid, Glucotrack’s CBGM measures glucose directly from blood, aiming to provide real-time readings without the lag time typically associated with interstitial glucose measurements. 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 prospective, single arm study is a short-term in-hospital study in which the CBGM sensor will be placed intravascularly for a period of four days. Study participants, who have been diagnosed with diabetes mellitus requiring glucose monitoring and intensive insulin therapy, will participate in several fixed meal and glucose challenges during the study period.
The study is being conducted under Principal Investigator Dr. Alexandre Abizaid, MD, PhD. Dr. Abizaid is the Director of Interventional Cardiology at Instituto do Coração in São Paulo, Brazil, and a Visiting Professor of Medicine at Columbia University Medical Center in New York City. He is a key faculty member of the Cardiovascular Research Foundation in New York and a world-renowned interventional cardiologist who has conducted numerous first in human clinical studies in the cardiology field. The study will be conducted at Instituto do Coração (InCor) of the Hospital das Clínicas of Faculdade de Medicina da Universidade de São Paulo, which is widely considered the best cardiology hospital in Brazil and Latin America, according to Newsweek.
“Following the success of our preclinical program, we are pleased to reach this key milestone in the development of our novel CBGM,” said Paul V. Goode, PhD, President & Chief Executive Officer of Glucotrack. “We believe this groundbreaking early feasibility study will demonstrate the potential for our real-time continuous blood glucose monitor to offer a truly differentiated and less burdensome approach to glucose monitoring for people with diabetes.”
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.
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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
Lisa Wilson
In-Site Communications
T: 917-543-9932
E: lwilson@insitecony.com
Media:
GlucotrackPR@icrinc.com
FAQ
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