The technology — a dual sensor that continuously monitors glucose and ketone levels — already had FDA breakthrough device designation. Abbott said at the time that it was set for pivotal trial use in 2023, with regulatory submissions to follow.
While the sensor has yet to hit the market, it began to make waves again three years on from that initial announcement. Abbott recently agreed to implement integrations with automated insulin delivery systems offered by Sequel Med Tech, Tandem Diabetes Care, Beta Bionics, then Ypsomed and CamDiab, highlighting the interest in the sensor within the diabetes technology world even ahead of commercialization.
A future launch of the dual monitor would only bolster the company’s wide range of diabetes management options. In addition to the leading FreeStyle Libre continuous glucose monitor (CGM) platform, Abbott also recently added the over-the-counter Lingo and Libre Rio devices to its offerings.
Speaking to Drug Delivery Business News ahead of the American Diabetes Association’s 85th Scientific Sessions in Chicago, Abbott EVP of Diabetes Care Chris Scoggins, outlined the company’s excitement for the latest addition to its portfolio of CGMs and biowearable sensors.
“This is going to be a big advancement,” Scoggins said. “We’re excited to bring it to the market.”
What is the new Abbott sensor?
Much like with Lingo and Libre Rio, Abbott didn’t need to deviate from its original sensor in terms of design.
Scoggins said the new dual sensor will be built on the form factor of FreeStyle Libre 3 — which he said is the world’s smallest, thinnest sensor. FreeStyle Libre 3, the company’s latest-generation sensor, received FDA clearance in May 2022. The Libre 3 Plus, Abbott’s version of the sensor that pairs with insulin delivery systems, provides the platform for the dual sensor that will do the same.
“We’ll be leveraging that form factor,” Scoggins explained. “It has all of the recent improvements in the product that have rolled out in the last 12 months in terms of the Libre 3 Plus. We’ll be able to bring that world-class accuracy to the market whenever we look at commercializing.”
Scoggins also pointed to recent advancements on the digital side of the platform. Abbott earlier this year unveiled a new universal Libre app that enables CGM users to track glucose readings and insights. It offers several new features, including a platform for multiple generations of sensors, no need for scanning, updated alerts and alarms and more.
Users can now temporarily silence glucose alarms for up to six hours. Additionally, optional alarms can discreetly alert users to high or low glucose levels — and soon, ketone levels, too.
“[It’s important], being able to smartly alert somebody of rising ketones, but doing it in a way that leverages all of our customer insight experience on how to engage somebody to know when and where they want to be engaged, to monitor their glucose, as well as ketones going forward,” Scoggins said.
Who is the new sensor for?
According to Scoggins, Abbott has already received plenty of feedback and excitement from the patient community related to the technology. He notes that it’s “original science,” with doctors having never seen ketones measured continuously.
Current CGMs help those with diabetes identify and reduce hypoglycemia as glucose levels dip. But they don’t account for changing levels of ketones, which can lead to diabetic ketoacidosis (DKA), a life-threatening complication.
“As we look at the problem we’re solving, it’s pretty significant. Ten years ago, CGMs made major inroads in helping identify and reduce hypoglycemia,” Scoggins explained. “You’ve got this risk of rising ketones… that can happen with or without glucose rising, and certainly happens at a different rate. So, we think we’re solving a pretty significant unmet need for people with diabetes, whether they’re on insulin or a drug that can cause an increase in ketones.”
Scoggins and Abbott expect initial interest to arise from the intensively managed insulin population for the first broad application of the new sensor. Other drugs for people with diabetes can impact ketone levels, too, which could lead to interest from further communities.
The company cites early interest from the insulin pump community, as evidenced by the pre-commercial pump partnerships. Beyond that, though, Abbott anticipates a wider expansion as more people become DKA-concerned.
“It’s really kind of the healthcare professionals’ job to help evaluate the risk of somebody, whether it’s for hypoglycemia or whether it’s for DKA,” Scoggins said. “[They] choose a sensor appropriately that’s going to safeguard them against those extreme highs and lows.
“There’s real opportunity here to kind of evolve the science of diabetes management or with patients or their caregivers.”
