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) approval for a multi-centre clinical study of its continuous blood glucose monitor (CBGM) in type 1 and type 2 diabetic patients.
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.
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Glucose spikes after a meal are extremely normal. This is your body converting food into energy, or sugar, and then releasing insulin to instruct your cells to consume that energy. Over time, a pattern of large, prolonged spikes can lower your insulin resistance and raise your risk for Type 2 diabetes and heart disease. Some research indicates that continuous glucose monitors could be a helpful tool for the early detection of prediabetes in high risk patients, but again, there is little evidence that healthy people benefit from using the technology. At a certain point, I wasn't thinking about my long-term health or sanity. I definitely wasn't thinking about the future of the American health care system. I was just trying to get a good score in the app and reduce the number of anxiety zaps. I spend a lot of time thinking about how technology makes our lives better — and worse. I've wondered the same about the American health care system, as I've gotten older and more involved in the health care decisions of my parents, kids, and myself. It's not a great comparison. After all, there is no Hippocratic oath for tech companies. In the six months I spent hooked up to every health tracker I could find, feeding my morbid curiosity, I drove myself slightly crazy. Each hit of dopamine I enjoyed by getting good scores on a health-tracking app was offset by long periods of self-doubt that came from not fully understanding how to make sense of the torrent of data without my doctor's help. I also became obsessive — checking the apps was the first thing I did in the morning and started occupying hours of my day. That's the contradiction embedded in this cutting-edge technology: It can often lead to panic rather than peace of mind. 'There's something called orthorexia, where being perfectionistically healthy can just take over your life,' Gallagher, the NYU psychologist, explained. 'You can get really rigid, maybe with what you eat and how you do things, when we typically find rigidity is not sustainable for most people.' That's the contradiction embedded in this cutting-edge technology: It can often lead to panic rather than peace of mind. I decided to take off my last biosensor as spring was turning to summer and felt a weight lifted. I put away the Whoop band, which is explicitly designed to be worn 24/7, so much so that the newest model comes with a wearable charger so that you don't have to take it off. The only thing that I kept wearing was the Oura ring when I slept. As a tired young parent, getting to see a breakdown of my sleep data somehow made me feel more in control. There was, it appeared, the right amount of data to make me feel better. But what if, instead of too much data about my body, I had almost nothing. That's the case for many people in the United States. If you're lucky enough to have regular access to health care — over 100 million Americans do not — you might get one annual visit with a primary care doctor. That might include one check of your vitals, including your blood pressure and resting heart rate. Basic bloodwork would tell me about my blood sugar and cholesterol. Your doctor might prescribe medication, like a statin, if those numbers are out of whack. This is an optimistic estimate of what health care currently looks like in America, where primary care is in crisis and many patients feel lucky to get 15 minutes of face time once a year or pay high prices to see someone right away at an urgent care center. This must be a factor in the rising popularity of wearables, such as the Oura ring and Apple Watch, as well as new health-tracking services, like Levels and Lingo. That and the simple fact that Americans love independence and immediacy. Perhaps in the absence of available professional medical advice and guidance, we're turning to these gadgets for quick and constant reassurance. Combined with googling symptoms or closely following wellness influencers, it almost feels like we're better off taking our health into our own hands. But health tracking in its current form is not a science or even an art. It's certainly not the near future of the American health care system, as some MAHA followers might make you believe. Health tracking, at its core, is a self-driven experiment in better living for those who can afford these products and have the time to spare to comb through their own data. In some ways, it's just an expensive hobby. Like running or perfecting your smoothie recipes, it can be good for you. Wearing a smart ring or a glucose monitor alone won't make you feel better.
