Glucotrack Announces Start Of Enrollment For Human Clinical Study Of Continuous Blood Glucose Monitor
Glucotrack Announces Start Of Enrollment For Human Clinical Study Of Continuous Blood Glucose Monitor
Feasibility study underway for the Company's novel continuous blood glucose monitor in patients with diabetes, with data expected within 6-8 weeks
公司正在进行可行性研究,针对患有糖尿病的患者使用新型连续血糖监测仪,预计数据将在6-8周内出炉。
Rutherford, NJ, Dec. 03, 2024 — 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.
新泽西州拉瑟福德,2024年12月3日 — Glucotrack, Inc.(纳斯达克:GCTK)("Glucotrack"或"公司"),是一家专注于为糖尿病患者设计、开发和商业化新技术的医疗科技公司,宣布开始进行其短期人类临床研究的患者招募。该研究将集中于公司的连续血糖监测仪("CBGM"),并将包括1型和2型糖尿病患者。该研究的数据预计将在6-8周内公布。
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.
与传统连续葡萄糖监测器测量间质液中的葡萄糖水平不同,Glucotrack的CBGM直接从血液中测量葡萄糖,旨在提供实时读数,避免通常与间质葡萄糖测量相关的滞后时间。CBGM是一种长期植入设备,没有外部组件,设计用于连续三年的准确血糖监测,提供更便捷、不那么侵入性的血糖监测解决方案。
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.
这项前瞻性、单臂研究是一项短期住院研究,CBGM传感器将在体内置入,持续四天。通过对参与者进行固定餐和葡萄糖挑战,来研究已被确诊需要葡萄糖监测和密集胰岛素治疗的糖尿病患者。
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.
该研究由首席研究员Dr. Alexandre Abizaid, MD, PhD主持进行。Abizaid博士是圣保罗圣保罗圣心医院介入心脏病学主任,以及纽约哥伦比亚大学医学中心的客座教授。他是纽约心血管研究基金会的重要成员,是一位世界知名的介入心脏病学家,在心脏病学领域进行了众多首次人体临床研究。该研究将在圣保罗大学圣保罗圣心医院的医学院临床医院进行,据《新闻周刊》报道,该医院被广泛认为是巴西和拉丁美洲最好的心脏病医院。
"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."
“在我们临床前计划取得成功后,我们很高兴达到开发我们新型CBGm的关键里程碑,” Glucotrack的总裁兼首席执行官Paul V. Goode, PhD表示。“我们相信这一突破性的早期可行性研究将展示我们实时连续血糖监测仪在为糖尿病患者提供一种真正区别化且减轻负担的血糖监测方式方面的潜力。”
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.
有关Glucotrack CBGm的更多信息,请访问 glucotrack.com. 公司网站上的信息不构成本新闻稿的一部分,也不被纳入参考。
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About Glucotrack, Inc.
关于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,Inc.(纳斯达克代码:GCTK),专注于为糖尿病患者设计、开发和商业化新技术。该公司目前正在开发一种长期可植入的连续血糖监测系统,以帮助糖尿病患者。
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 .
Glucotrack的CBGm是一种长期植入式系统,可以持续测量血糖水平,传感器寿命长达3年,无需佩戴在身上,且校准工作量最少。要了解更多信息,请访问 .
Forward-Looking Statements
前瞻性声明
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.
本新闻稿包含《1995年私人证券诉讼改革法案》(Private Securities Litigation Reform Act of 1995)规定的前瞻性声明。本新闻稿中的陈述可能会被视为前瞻性陈述。这些非历史性陈述是基于管理层的信念和管理层目前已获得的信息所做的假设。这些声明仅涉及发表声明的时间内的事件,Glucotrack无需公开更新任何前瞻性陈述,无论是因为新信息、未来事件或其他原因,除非依据法律规定。本新闻稿中所做的所有前瞻性陈述均受到这些警示性声明的限制,而且Glucotrack无法保证Glucotrack预期的实际结果将实现或即使实现了也会对我们或我们的业务或运营产生预期的后果或影响。读者应注意,某些重要因素可能会影响Glucotrack的实际结果,并导致这些结果与本新闻稿中可能做出的任何前瞻性陈述不同。可能影响Glucotrack结果的因素包括但不限于,Glucotrack筹集资金以资助其运营的能力(无论是通过公开股票或私人股票融资、债务融资、战略合作还是其他方式);有关审批的接受(和时间)的风险(包括美国食品和药物管理局的批准);有关患者登记和临床试验进行的风险;有关Glucotrack未来分销协议的风险;有关其能够聘用和留住合格人员,包括销售和分销人员的风险;以及在Glucotrack向美国证券交易委员会(SEC)提交的备案申明书中所述风险还有其他附加风险因素。
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Lisa Wilson
In-Site通讯
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E: lwilson@insitecony.com
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