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.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
a day ago
- Business Wire
Tenovi Expands Access to Glucose Data for Remote Patient Monitoring and Cardiometabolic Programs Through Dexcom Integration
PORTSMOUTH, N.H.--(BUSINESS WIRE)-- Tenovi, a leading provider of remote patient monitoring (RPM) solutions, today announced it now supports Dexcom continuous glucose monitoring (CGM) data directly within its clinician-facing dashboard. This milestone expands Tenovi's ability to support diabetes management programs across healthcare organizations by seamlessly displaying Dexcom CGM data within its existing virtual RPM infrastructure. Through this integration, Tenovi now supports hourly average glucose data visualization for patients using Dexcom real-time CGMs. Healthcare teams using Tenovi's platform can view glucose trends alongside other vital health RPM metrics, without the need to distribute or manage physical inventory of CGM devices. 'Access to glucose insights is vital to managing chronic conditions such as diabetes,' said Iftah Mashav, Chief Growth Officer at Tenovi. 'A Dexcom and Tenovi integration allows our clients to leverage CGM data in virtual care models that are flexible, scalable, and rooted in clinical outcomes.' This expansion supports Tenovi's broader suite of telemetry solutions designed for cardiometabolic populations, an area of growing focus for health plans and employer-sponsored programs. By enabling continuous remote access to essential health data, Tenovi helps organizations improve outcomes, reduce costs, and scale value-based care. Tenovi provides secure data access via the Dexcom API, allowing health systems to onboard patients seamlessly without the burden of physical device logistics. Dexcom data access is now live on the Tenovi platform. Healthcare organizations can begin enrolling eligible patients immediately. To learn more or schedule a demo, visit About Tenovi Tenovi is a data aggregation and automation Healthcare IoT platform that connects medical device manufacturers with remote patient monitoring programs. It provides over 40 remote patient monitoring and remote therapeutic monitoring (RTM) device point solutions that integrate with its proprietary Cellular Gateway, automating the transfer of patient vitals. Tenovi's API-driven fulfillment and automation services enable seamless deployment of remote patient and therapeutic monitoring programs. For more information, visit
Yahoo
3 days ago
- Yahoo
Why This Beaten-Down Medical Device Stock Could Be Your Best Investment for the Next 5 Years
Key Points DexCom has barely scratched the surface of its niche in the diabetes market. As a result of industry challenges, the stock's valuation has now come down. But from here, the stock looks well-positioned to deliver excellent results. 10 stocks we like better than DexCom › Medical device specialist DexCom (NASDAQ: DXCM) has encountered significant headwinds in the past year. The company's financial results haven't been quite up to the market's standards, and broader market volatility caused by President Donald Trump's trade policies isn't helping either. The stock is down 26% over the trailing-12-month period. Yet even with all these challenges, DexCom could be a terrific performer in the next five years. Here's why. There's plenty of white space ahead DexCom markets continuous glucose monitoring (CGM) systems, which are devices that help track blood sugar levels in patients with diabetes. CGMs have at least two advantages: They make measurements automatically, and they make them as often as every five minutes. Consistently monitoring blood glucose levels helps people with diabetes make better health decisions. That's why CGM devices lead to improved outcomes, including less time spent in hyperglycemia. DexCom has significantly increased its installed base over the years. In 2024, it had over 2.5 million customers worldwide. However, the company remains well-positioned to capitalize on a massive global opportunity. In the U.S., DexCom estimates that there are more than 4.5 million diabetes patients on insulin therapy who aren't on CGM yet despite being eligible for third-party coverage for the technology. And that's just the U.S., one of the more advanced countries in terms of CGM penetration. DexCom has typically targeted patients who use insulin, and third-party payers have been more willing to cover these populations. However, last year, it launched Stelo, an over-the-counter CGM option for diabetes patients who aren't on insulin and for people with prediabetes. This move significantly expanded the company's addressable market. CGM penetration in the U.S. for type 2 diabetes patients not on insulin is about 5%, and for prediabetes patients less than 1%. DexCom's opportunities both within and outside the U.S. are massive. The increased adoption of CGM technology has helped its revenue and earnings grow steadily over the past decade, and this trend is likely to continue. DexCom's shares declined last year due to poor financial results; in the U.S., more patients than the company expected took advantage of rebates, leading to lower-than-expected revenue per customer. However, since there's still plenty of work to be done in the CGM market, DexCom can address that issue as it continues to make even more headway in this field. That will allow its financial results to improve. Are DexCom's shares too expensive? The stock's forward price-to-earnings ratio was recently 41.5, much higher than the healthcare sector's average of 15.8. But that forward P/E is on the low end compared to DexCom's average over the past few years: The medical device specialist has historically had steep valuation metrics, but has delivered market-beating returns anyway. In my view, DexCom can do the same in the next five to 10 years. Investors might also be concerned about DexCom's main competitor in the CGM market, Abbott Laboratories. But these rivals have battled it out for years, and there's more than enough space for both to be successful, given the large worldwide CGM opportunity. Furthermore, DexCom benefits from a network effect, as multiple companies have developed devices for diabetes patients that are compatible with its technology; these include insulin pens and pumps, third-party apps, and the Apple Watch. The more DexCom's installed base increases, the more attractive its ecosystem becomes to device or app developers looking to target a large population of patients. And as these companies launch more technologies compatible with DexCom's CGM devices, they also become more appealing to patients. This dynamic makes it likely that DexCom will remain a leader in CGM well beyond the next five years. In the meantime, the stock could rebound from its poor performance last year, and deliver superior returns through the end of the decade. Do the experts think DexCom is a buy right now? The Motley Fool's expert analyst team, drawing on years of investing experience and deep analysis of thousands of stocks, leverages our proprietary Moneyball AI investing database to uncover top opportunities. They've just revealed their to buy now — did DexCom make the list? When our Stock Advisor analyst team has a stock recommendation, it can pay to listen. After all, Stock Advisor's total average return is up 1,048% vs. just 180% for the S&P — that is beating the market by 867.59%!* Imagine if you were a Stock Advisor member when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $652,133!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $1,056,790!* The 10 stocks that made the cut could produce monster returns in the coming years. Don't miss out on the latest top 10 list, available when you join Stock Advisor. See the 10 stocks » *Stock Advisor returns as of July 15, 2025 Prosper Junior Bakiny has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Abbott Laboratories and Apple. The Motley Fool recommends DexCom and recommends the following options: long January 2027 $65 calls on DexCom and short January 2027 $75 calls on DexCom. The Motley Fool has a disclosure policy. Why This Beaten-Down Medical Device Stock Could Be Your Best Investment for the Next 5 Years was originally published by The Motley Fool
Yahoo
10-07-2025
- Yahoo
Barbie Expands Representation by Introducing First-Ever Doll With Type 1 Diabetes
Mattel, Inc. announced on July 8, 2025, that it debuted the first-ever Barbie doll with type 1 diabetes (T1D). This is the newest addition to the "Barbie Fashionistas" line, which features more than 175 looks across various skin tones, eye colors, hair textures, body types, and disabilities, including a blind Barbie doll, a Barbie doll with Down Syndrome, and a Barbie doll with hearing aids. 'Introducing a Barbie doll with type 1 diabetes marks an important step in our commitment to inclusivity and representation,' said Krista Berger, Senior Vice President of Barbie and Global Head of Dolls. 'Barbie helps shape children's early perceptions of the world, and by reflecting medical conditions like T1D, we ensure more kids can see themselves in the stories they imagine and the dolls they love.' Barbie says it partnered with type 1 diabetes research and advocacy organization, Breakthrough T1D (formerly JDRF), to ensure the doll's design accurately represented the T1D community, including the medical equipment. The doll includes: Continuous glucose monitor (CGM): CGMs are small, wearable devices that continuously measure a person's blood-sugar levels. To keep the doll's CGM in place, she uses heart-shaped medical tape, along with a phone that displays a CGM app to help track her blood sugar levels throughout the day. Insulin pump: Barbie has this small, wearable medical device that allows for automated insulin dosing as needed, attached to her waist. Blue polka dot outfit: The doll wears a stylish polka dot top and matching skirt with ruffles. Both the color blue and circle print are nods to the global symbols that represent diabetes awareness. Purse: The doll comes with a pastel blue purse, perfect for Barbie to carry any essentials, such as type 1 diabetes supplies or snacks, when she's on the go. 'We were thrilled when Barbie approached us to collaborate on the development of the Barbie doll with type 1 diabetes,' said Aaron J. Kowalski, PhD, CEO of Breakthrough T1D. 'I have lived with T1D since I was 13, and my brother since he was 3, so this partnership is deeply personal—it means the world to be part of bringing greater visibility to a condition that affects so many families. It's an honor to work with a brand that shares our commitment to showing children that a life with type 1 diabetes can be full, vibrant, and empowering.' As new generations engage with brands, it's important for brands to continue evolving with the culture. And while it's a never-ending effort, making sure all communities feel seen is a valuable part of growing up. Barbie took a step to honor type 1 diabetes advocates, Peloton Instructor Robin Arzón in the U.S. and model Lila Moss in the U.K. with their own specially-designed dolls. 'It's an absolute honor to receive a Barbie doll as a part of the brand's efforts to grow awareness and representation surrounding type 1 diabetes, so that we can help show kids that all types of challenges give us all the more reason to push forward and achieve our dreams,' Arzón said in a statement. Moss seconded the notion, with, 'I am proud to use my platform to educate around type 1 diabetes and show that being different is cool." People have already begun voicing their appreciation for what Barbie is doing with T1D dolls. "We are so excited to see the Lila Moss Barbie Doll celebrating people living with type 1 diabetes," shares Jeminee Ternus, mom to a 9-year-old daughter named Romey who has T1D. "It means so much to Romey in particular because she said 'the world is full of T1Ds, so why not show them!'" Ternus goes on to say seeing a doll like this, wearing an Omnipod (insulin pump) just like one Romey uses, gives her daughter confidence. "As a parent, I love it because instead of teaching kids that they have to fit themselves into an unrealistic mold, or [they have to hide what's] unique about them, it's embracing real kids who get to see their favorite doll showing up exactly like them," says Ternus. "If Barbie can show up brave in something that makes her different, Romey can too!" It's not only kids who are feeling represented by this initiative from Barbie. Eden Miller, DO, who's a doctor from Bend, Oregon, shares with Parents, 'I am a 54-year-old diabetes doctor who has been living with type 1 diabetes for 30 years now. Yesterday I learned about the new T1D Barbie, specifically the one-of-a-kind Barbie inspired by Lila Moss. I immediately clicked on the image and saw the Omnipod on her leg and a CGM on the back of her arm—symbols that so many of us carry with us every day. I'm not a little girl anymore, but having a T1D Barbie shows kids and adults that they are strong and beautiful.' Moss added that feeling seen is reciprocal, and something that should continue to inspire. "Receiving messages from people who see my patches and feel represented means everything to me," she says. "To be able to now see Barbie dolls with T1D, and to receive a Barbie doll that visibly looks like me even wearing her patches, is both surreal and special.' Read the original article on Parents
