the health
transformation
knowledge portal
Joaquim Cardoso MSc
Founder and Chief Researcher, Editor & Strategist
March 11, 2024
What are the key points?
Introduction of Accu-Chek SmartGuide: Roche unveils its first Continuous Glucose Monitor (CGM), the Accu-Chek SmartGuide, at the ATTD conference. It incorporates predictive Artificial Intelligence (AI) and aims to provide a comprehensive solution for diabetes management.
Features and Functionality: The Accu-Chek SmartGuide CGM offers a 14-day wear time, one-step application process, and watertight properties. Users can visualize glucose data, receive predictive glucose predictions, and configure alarms and alerts through its accompanying app.
Accuracy and Performance: Roche reports a Mean Absolute Relative Difference (MARD) of 9.2% based on a 48-patient study, positioning the SmartGuide CGM among other leading CGM systems. However, some analysts express reservations about its predictive capabilities and the need for initial calibration.
Predictive AI Integration: The Accu-Chek SmartGuide integrates predictive AI algorithms to anticipate glucose trends over the next two hours. This feature aims to empower users with proactive insights, allowing them to manage their condition more effectively and reduce stress.
Future Developments and Strategy: While Roche explores potential connectivity with insulin pumps, the immediate focus is on launching the standalone CGM technology. The unveiling of the SmartGuide CGM aligns with Roche’s broader strategy to simplify life for individuals with diabetes and enhance its diabetes care portfolio.
Analysts’ Perspectives: Analysts highlight the potential differentiation of the SmartGuide CGM’s predictive capabilities within the diabetes market. However, they express cautious optimism and seek further details regarding device features, pricing, launch regions, and integration possibilities with automated insulin delivery systems.
This article was published by Drug Delivery Business News and written by Sean Whooley on March 7, 2024.
Roche today gave a presentation debuting its first continuous glucose monitor (CGM) offering that utilizes predictive AI.
The company unveiled its Accu-Chek SmartGuide in an event at the Advanced Technologies & Treatments for Diabetes (ATTD) conference in Florence, Italy. It remains an investigational device not yet authorized for sale.
Julien Boisdron, Roche Diabetes Care’s chief medical officer, called it “a solution more than a CGM” during the event. He explained that, comprised of a sensor and two applications, the offering helps visualize data and make predictions as well.
Jochen Berchtold, VP and franchise lead for insulin therapy solutions at Roche Diabetes, highlighted the power of that combination.
“We think that the combination of the strength of a CGM, plus the power of prediction, has the possibility and the potential to change the way how diabetes is managed in the future, by empowering people to take proactive actions and the depth the therapy before a problem”, he said.
About the new Roche CGM
Accu-Chek SmartGuide shares some similar properties to other CGMs on the market, like those made by Abbott and Dexcom. It features a 14-day wear time, a one-step application process and watertight properties. However, this CGM requires initial calibration, which is different from some of the latest-generation systems.
Roche aims to bring the real-time CGM to both the type 1 and type 2 diabetes populations, including for those on insulin therapy. Users can share their data with healthcare professionals and it has a differentiating predictive algorithm included.
Accu-Chek SmartGuide itself generates data, transmitting glucose values via Bluetooth directly to the app. Users can see curves in historical data, upper limits and lower limits, plus they can enter carb intakes or insulin dosing. They can also configure the system to create alarms and alerts, customizing it to their preferences.
The company reports a mean absolute relative difference (MARD) of 9.2% based on a 48-patient study, according to BTIG analysts. MARD is a measurement of accuracy for CGM, with lower percentages highlighting stronger accuracy. For instance, Dexcom’s G7 previously demonstrated a MARD of 8.2%, while Abbott’s FreeStyle Libre 3 came in at 7.6%.
Accurate glucose measurements keep patients out of hypoglycemia, which is vital for diabetes patients. Katharine Barnard-Kelly, a professor of health psychology, specializes in the psychosocial aspects of diabetes management. She explained how CGMs — including Roche’s new offering — explained that these systems buy diabetes patients time.
“It enables you to see the direction of travel so that you can act proactively rather than reactively in an emergency situation,” Barnard-Kelly said. “So, not only does it buy you time as an individual, it buys everybody else time. It enables you to be in control of disclosure around your health condition.”
Notably, she said, the predictive capabilities featured in the Roche system could prove most exciting.
Predictive AI
Accu-Chek SmartGuide provides glucose predictions showing estimated developments for different timeframes. Based on the CGM data of the person with diabetes, the system’s app shows where glucose levels might go in the next two hours at any given point in time.
“It’s more than just one sensor that generates the data,” Berchtold said. “It’s a combination of digital assets with AI-based predictive algorithms that really support the people. … We always start with an unmet need. The unmet need in this case is knowing where the glucose is heading.”
Roche designed the system with three major algorithms and a tool performing pattern recognitions. This identifies recurring behaviors at certain times that could help adapt both future behavior and therapy.
Berchtold offered an examples of giving a speech at an event or taking an exam. Someone with diabetes would be better off knowing what is happening with their glucose in the next two hours. With predictive algorithms, the user can focus on their speech or exam rather than watching their devices. Accu-Chek SmartGuide can provide this peace of mind, he said.
“It’s generating the awareness to be able to prepare, then take action subsequently,” Berchtold explained. “The aim here is to empower people with diabetes to act before the problem occurs,” Berchtold concluded. “That’s the idea.”
Insulin pump connectivity and Roche’s diabetes strategy
With the device still investigational, there is still plenty going into the development efforts at Roche. That includes the potential for connecting the CGM to insulin pumps, like other CGM makers have done.
However, for the time being, the focus remains on bringing the standalone CGM technology to people with diabetes. Berchtold said it’s another factor Roche is exploring, but there’s currently no timeline on when that feature could appear in tandem with the company’s Solo patch pump.
“Right now at the start, it’s not yet part of the launch sequence,” he said. “We know the importance of that and we are consistently improving the product.”
On the company’s diabetes strategy, he kicked off his presentation by asking, “Why are we doing this?” with regard to developing the CGM. It all folds into Roche’s efforts to make life with diabetes easy. As Barnard-Kelly pointed out, fears around complications pop up constantly, and CGM can clear the direction of travel.
Boisdron explained that this development benefits the company beyond adding to its diabetes care portfolio. Roche offers glucose strips and meters, plus digital solutions on top of the Solo pump. On top of that, the company’s pharmaceutical division is working on diabetes and obseity products as well, potentially enabling even more innovation.
“The synergies will be very interesting in the coming months and years,” Boisdron said. “The future is exciting because there are more and more innovations helping patients on the journey with this difficult-to-manage condition.”
The analysts’ view
BTIG’s Marie Thibault and Sam Eiber reported their thoughts on the unveiling of Accu-Chek SmartGuide, singling out the predictive capabilities as the potential differentiator within the diabetes market.
Another feature they pointed to is nighttime hypoglycemia risk prediction, which sends users a notification before going to bed.
In terms of the future, Roche offered no timeline on potential CE mark, and the analysts look forward to potentially getting more detail from the company’s May 22 Investor Day.
Notably, they didn’t seem blown away by this technology just yet.
“Candidly, from the presentation slides, we think the SmartGuide looks quite similar to other current generation CGMs, though the exact device footprint is not clear to us,” they wrote. While we think the longer predictive algorithm is a nice feature that can help reduce stress for patients, we are not sure how accurate this algorithm is or if most real-world users will find it a meaningful differentiator.”
Additionally, they noted the need to calibrate SmartGuide initially is a drawback, given that Dexcom and Abbott’s latest-generation CGMs did away with that aspect thanks to factory calibration.
“As it stands, we think this is a suitable CGM but we don’t see it as a major competitive threat to either [Dexcom] or [Abbott] at this point,” the analysts said. “There was nothing revealed today that surprised us nor changed our outlook on the CGM landscape.
“We remain curious on exact device footprint, pricing plans, initial geographic regions for launch, whether the CGM will appeal to MDI smart pen users and/or automated insulin delivery (AID) systems users, and any potential interest in pursuing integration with AID systems.”
To read the original publication, click here.
