Abbott's FreeStyle Libre® 2 and 3: First Continuous Glucose Monitoring Systems Approved for Use During Medical Imaging

• Abbott's world-leading¹ FreeStyle Libre 2 and 3 systems for people living with diabetes are now the only continuous glucose monitoring sensors ² in the U.S. that users do not need to remove during common imaging procedures like X-rays, CT scans and MRIs*

ABBOTT PARK, Ill. - Oct. 30, 2024 - Abbott today announced that its FreeStyle Libre 2 and 3 systems can now be worn during common imaging procedures, such as X-rays, CT scans and MRIs*. The U.S. Food and Drug Administration (FDA) cleared the removal of the imaging contraindication, making Abbott's systems the first and only patient-applied continuous glucose monitoring (CGM) sensors approved for these screenings.

People who use FreeStyle Libre 2 and 3 systems rely on their CGM sensors to make important decisions about their diabetes, including when to take insulin. They will no longer have to remove and discard their CGM sensor before its wear time has ended, providing them with increased convenience and the potential to save money.

"For people with diabetes, especially those using insulin, removing a CGM sensor for long periods can be problematic," said Carol Wysham, M.D., clinical professor of medicine at the University of Washington School of Medicine and section head of the department of diabetes and endocrinology at Rockwood Clinic in Spokane. "Previously, patients had to remove their sensors during these procedures, resulting in several hours without critical data, especially if they didn't have a replacement sensor. The removal of the imaging contraindication from Abbott's FreeStyle Libre 2 and 3 systems is a big win for patients, allowing them to keep their sensors on and avoid lost data."

Diabetes can cause complications like cardiovascular disease, neuropathy, and infections³. Imaging procedures are often part of diabetes care: X-rays detect bone injuries, CT scans identify kidney stones and blood clots, and MRIs provide detailed images of organs and tissues to identify issues such as brain injuries, ischemic heart disease and fatty liver disease^4,5.

Abbott rigorously tested its FreeStyle Libre 2 and 3 systems sensors to ensure they remain effective after radiologic procedures*. This testing led the FDA to clear the removal of the contraindication requirement, with no changes made to the sensor.

"Continuous glucose monitoring is essential for diabetes management," said Anila Bindal, M.D., associate medical director for Abbott's diabetes care business. "We've seen first-hand how consistent use of Libre technology benefits people living with diabetes. This contraindication removal aligns with Abbott's commitment to provide easy, convenient, and affordable technology for diabetes management."

About Abbott:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube.

Important Safety Information:

Product for prescription only, for Important Safety Information, please visit https://www.freestyle.abbott/us-en/safety-information.html.

*MRI Safety Conditions: Sensor readings may be compromised during the MRI, but System function returns fully back to normal after 1 hour. Scanning between the pelvis and sternum (3T scanners) should be limited to 12 minutes maximum with a cooling period of 2 minutes in between scans. All other areas (1.5T scanners) can scan for up to 1 hour continuously without a cooling period.

¹Data on file. Abbott Diabetes Care. Data based on the number of patients assigned to each manufacturer.

²Among patient applied sensors

³American Heart Association, Diabetes Complications and Risks, accessed August 22, 2024.

⁴Radiopaedia, Diabetes mellitus: Radiology Reference Article , accessed August 22, 2024.

⁵The Diabetes Council, X-ray and Diabetes: How can it help, accessed August 22, 2024.