Glucotrack gains HREC approval for clinical study of CBGM device

Glucotrack has announced the receipt of St Vincent’s Hospital Melbourne Human Research Ethics Committee’s (HREC) support for a multi-centre objective survey of its continuous humor glucose show (CBGM) successful benignant 1 and benignant 2 diabetic patients.

The single-arm, prospective survey aims to measure the information and show of the instrumentality implicit a year, with imaginable extensions up to 3 years.

It is acceptable to enrol up to 30 subjects needing intensive insulin therapy and glucose monitoring. With the support successful place, Glucotrack volition notify Australia’s Therapeutic Goods Administration (TGA) earlier continuing with the enrolment process.

The implantation process for the archetypal subjects is expected to instrumentality spot by July 2025.

The CBGM is simply a semipermanent implantable strategy without a wearable component, tailored for continuous humor glucose monitoring for up to 3 years.

It claims to straight measurement glucose from blood, offering real-time readings and aiming to destruct the lag clip associated with interstitial glucose measurements.

Australia’s University of Melbourne prof David O’Neal volition enactment arsenic the study's main researcher and oversee the research, alongside subordinate prof Neale Cohen from the Baker Heart and Diabetes Institute.

The Glucotrack CBGM is constricted by US national instrumentality for investigational usage only.

The device's features see three-year sensor longevity, the lack of an on-body wearable component, and minimal calibration requirements.

Glucotrack CEO and president Paul Goode said: “Securing this support represents a large milestone for our objective programme and builds connected the palmy completion of our first-in-human survey earlier this year.

“This year-long survey volition supply captious insights into the semipermanent performance, safety, and reliability of our innovative technology, which is designed to code cardinal challenges identified by radical with diabetes – including the request for extended sensor life, elimination of on-body wearables, and the benefits of nonstop humor glucose measurement.”

The institution designs, develops and commercialises technologies for diabetic people.

In February 2025, the company completed a first-in-human study with its CGM that straight measures glucose levels from a humor vessel.

"Glucotrack gains HREC support for objective survey of CBGM device" was primitively created and published by Medical Device Network, a GlobalData owned brand.

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