In a significant advancement for diabetes care, the U.S. Food and Drug Administration (FDA) has granted clearance for Abbott’s FreeStyle Libre 2 and 3 continuous glucose monitoring (CGM) systems to be worn during common imaging procedures, including X-rays, CT scans, and MRIs. This development marks the first time CGM sensors can remain in place during such tests, offering enhanced convenience and continuous glucose monitoring for patients.
Implications for Healthcare Providers
As healthcare professionals, it’s essential to understand the nuances of this FDA clearance to guide patient care effectively:
- Enhanced Patient Convenience: Previously, patients were required to remove their CGM sensors before imaging procedures, leading to potential data gaps and the inconvenience of sensor replacement. With this clearance, patients using FreeStyle Libre 2 and 3 systems can maintain continuous glucose monitoring during imaging, reducing disruptions in diabetes management.
- Safety Considerations: While the sensors are now approved for use during imaging procedures, it’s crucial to note that sensor readings may be compromised during an MRI. However, system function is expected to return to normal within one hour post-procedure.
Guidance for Patient Communication
Effective communication with patients regarding this development is vital:
- Pre-Procedure Consultation: Encourage patients to inform all members of their healthcare team about their use of the FreeStyle Libre 2 or 3 systems prior to scheduling imaging procedures. This ensures coordinated care and appropriate precautions during the imaging process.
- Setting Expectations: Inform patients that while they can keep their CGM sensors on during imaging tests, there may be temporary compromises in sensor readings, especially during MRIs. Reassure them that normal sensor function typically resumes within an hour after the procedure.
- Post-Procedure Monitoring: Advise patients to closely monitor their glucose levels following imaging procedures and to report any anomalies or concerns promptly.
Operational Considerations for Healthcare Facilities
To integrate this new clearance into practice effectively:
- Staff Education: Ensure that radiology and imaging department staff are informed about the FDA clearance and understand that patients with FreeStyle Libre 2 and 3 sensors can undergo imaging without removing their devices.
- Protocol Updates: Revise existing imaging protocols to reflect this change, ensuring that all relevant personnel are aware and that patient workflows are adjusted accordingly.
- Equipment Compatibility: While the sensors are approved for use during imaging, remain vigilant about the specific conditions outlined by Abbott, especially concerning MRI procedures. Ensure that imaging equipment settings align with the recommended parameters to maintain patient safety and device integrity.
By staying informed and updating clinical practices, healthcare providers like those in radiology centers, emergency rooms and VA medical centers can enhance patient care, reduce disruptions in diabetes management, and ensure safety during imaging procedures involving CGM devices.
