Abbott has earned U.S. Food and Drug Administration (FDA) clearance to remove the imaging contraindication for its FreeStyle Libre 2 and 3 continuous glucose monitoring (CGM) sensors.

The CGMs can now be worn during common imaging procedures, making Abbott’s systems the first, only patient-applied CGM sensors approved for these screenings. FreeStyle Libre 2 and 3 wearers will no longer have to remove and discard their CGM sensor before its wear time has ended, increasing convenience and saving money, Abbott said.

Imaging procedures are usually part of diabetes care. This includes X-rays to spot bone injuries, CT scans to identify kidney stones and blood clots, and MRIs for detailed images of organs and tissues to detect issues like brain injury, ischemic heart disease, and fatty liver disease.

Abbott said it rigorously tested its FreeStyle Libre 2 and 3 sensors to make sure they stay effective after radiologic procedures. The company advised sensor readings may be compromised during the MRI, but function returns fully back to normal after one hour. Scanning between the pelvis and sternum (3T scanners) should be limited to 12 minutes maximum with a cooling period of two minutes in between scans. All other areas (1.5 T scanners) can scan for up to one hour continuously without a cooling period.

This testing led the FDA to clear removal of the contraindication requirement, with no changes made to the sensor.

“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.”

“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.”