Abbott’s Continuous Glucose Monitor System Obtains Highest Accuracy in a Clinical Study

After obtaining FDA approval on May 31, 2022, the next-generation continuous glucose monitor (CGM) system FreeStyle Libre 3 has garnered another major win for its manufacturer, Abbott.

Clinical data presented at the American Diabetes Association (ADA’s) annual scientific sessions in New Orleans portrayed the device’s accuracy in measuring glucose, making it the most accurate 14-day CGM currently on the market, says Abbott.

The accuracy of the FreeStyle Libre 3 system is measured by its mean absolute relative difference (MARD), the variation between a sensor’s readings and a user’s blood sugar levels confirmed with a fingerstick sample. A lower MARD represents a more accurate device.

In a cohort of 144 adults and 129 pediatric participants with Type 1 or 2 diabetes, children aged 4 or 5 years old produced an MARD of just over 10% when using the FreeStyle Libre 3 system. Those between the ages of 6 and 17 obtained an MARD of 8.7%, and adults 18 and over achieved an average of 7.6%.

When combined, the average rating shakes out to be 7.9%, marking the first and only 14-day CGM to obtain an overall accuracy score below 8%.

“In terms of the impact clinically, people with diabetes who are using the sensor can really trust the values they’re receiving and can make treatment decisions based on those,” said Mahmood Kazemi, MD, chief medical officer of Abbott’s diabetes care segment, to Fierce Medtech in an ADA conference interview.

“Being a physician myself, I can also tell you that the healthcare provider community is quite excited about the sensor because it means that they can recommend it confidently to their patients to use and rest assured that the accuracy levels are at a point where they have no worries about it at the high range, at the low range or anywhere in between,” Kazemi explained.

Abbott says this CGM sensor was designed with affordability and sustainability in mind as it has reduced the system’s total volume by more than 70%, including a 41% reduction in plastic use and a 43% decrease in carton paper, for the same cost as previous generations.

Abbott also says FreeStyle Libre 3 is the smallest and thinnest CGM sensor currently on the market, explaining that the width is approximately the height of two stacked pennies.

The discreet size, 14-day wear period, and the above-average accuracy ratings could result in greater adoption of CGMs to help with diabetes management. “For that, we can all be thankful because we’ve demonstrated that the use of CGMs does improve outcomes for people living with diabetes,” Kazemi said.

The FreeStyle Libre 3 system earned approval for use in the European market in 2020. However, the COVID-19 pandemic delayed the devices’ approval in the United States.

According to the International Diabetes Federation (IDF), 463 million adults live with diabetes worldwide, and this number is projected to balloon 51% to 700 million people by 2045, IDF data predict.

As Abbott prepares for the device’s US rollout later this year, the company is laying out plans for a new sensor that will take after the FreeStyle Libre 3 but will also monitor ketone levels. The new technology is aimed to detect signs of diabetic ketoacidosis as soon as possible since this condition can turn deadly if left untreated.

This glucose and ketone continuous monitor device is currently in clinical studies and has already obtained the FDA’s acknowledgment in the form of a breakthrough device designation, with trials expected to begin in 2023.

“It really is a breakthrough technology: There’s no continuous ketone monitoring system available, and this allows minute-by-minute measurements of both glucose and ketone levels on the same sensor, in that same teeny-tiny form factor as FreeStyle Libre 3 every minute for 14 days,” said Marc Taub, PhD, head of R&D for Abbott’s diabetes business.