Glucotrack gains HREC approval for clinical study of CBGM device
The single-arm, prospective study aims to assess the safety and performance of the device over a year, with potential extensions up to three years.
It is set to enrol up to 30 subjects needing intensive insulin therapy and glucose monitoring. With the approval in place, Glucotrack will notify Australia's Therapeutic Goods Administration (TGA) before continuing with the enrolment process.
The implantation procedure for the first subjects is expected to take place by July 2025.
The CBGM is a long-term implantable system without a wearable component, tailored for continuous blood glucose monitoring for up to three years.
It claims to directly measure glucose from blood, offering real-time readings and aiming to eliminate the lag time associated with interstitial glucose measurements.
Australia's University of Melbourne professor David O'Neal will act as the study's principal investigator and oversee the research, alongside associate professor Neale Cohen from the Baker Heart and Diabetes Institute.
The Glucotrack CBGM is limited by US federal law for investigational use only.
The device's features include three-year sensor longevity, the absence of an on-body wearable component, and minimal calibration requirements.
Glucotrack CEO and president Paul Goode said: 'Securing this approval represents a major milestone for our clinical programme and builds on the successful completion of our first-in-human study earlier this year.
'This year-long study will provide critical insights into the long-term performance, safety, and reliability of our innovative technology, which is designed to address key challenges identified by people with diabetes – including the need for extended sensor life, elimination of on-body wearables, and the benefits of direct blood glucose measurement.'
The company designs, develops and commercialises technologies for diabetic people.
In February 2025, the company completed a first-in-human study with its CGM that directly measures glucose levels from a blood vessel.
"Glucotrack gains HREC approval for clinical study of CBGM device" was originally created and published by Medical Device Network, a GlobalData owned brand.
The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
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Its subsidiaries (referred to collectively as PHC Group) include PHC Corporation, Ascensia Diabetes Care Holdings AG, Epredia Holdings Ltd., LSI Medience Corporation, Mediford Corporation, and Wemex. Together, these companies develop, manufacture, sell and service solutions across diabetes management, healthcare solutions, life sciences and diagnostics. PHC Group's consolidated net sales in FY2024 were JPY 353.9 billion with global distribution of products and services in more than 125 countries. ©2025 Ascensia Diabetes Care Holdings AG. All right reserved. Ascensia, the Ascensia Diabetes Care logo and Contour are trademarks and/or registered trademarks of Ascensia Diabetes Care Holdings AG. Forward Looking StatementsAny statements in this press release about future expectations, plans and prospects for Senseonics, including the revenue, gross margin, cash flow and global installed customer base projections, and global installed customer base and reorder assumptions, under the heading 'Full Year 2025 Financial Outlook,' statements regarding plans, timing and success of the commercial launch of the 365-day system and the adoption of, access to, or growth of use of Eversense, statements regarding future demand for Eversense, statements regarding development programs and next generation systems, statements regarding the collaboration with Sequel and the anticipated timing for commercial availability of an integrated twiistTM AID system with Eversense 365, the future regulatory approval and the potential to commercially launch Eversense 365 outside the U.S., and other statements containing the words "believe," 'expect,' 'intend,' 'may,' 'projects,' 'will,' 'planned,' and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the reliance on and execution of Ascensia Diabetes Care, the Company's commercialization partner for Eversense, uncertainties with respect to any additional commercial support that will be required for successful commercialization of Eversense, and other commercial initiatives, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties inherent in the development and registration and roll-out of new technology and solutions, uncertainties inherent in finalizing integration and commercial terms and coordination with health systems and other new collaboration partners and third parties, uncertainties inherent in the ongoing commercialization of the Eversense product and the expansion of the Eversense product and Senseonics' and its partners' activities, uncertainties relating to the current economic and regulatory/political environment, including the effects of tariffs, and such other factors as are set forth in the risk factors detailed in Senseonics' Annual Report on Form 10-K for the year ended December 31, 2024, the Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 and future reports filed with the SEC under the heading "Risk Factors." 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