Safety and Functional Integrity of Continuous Glucose Monitoring Sensors When Used During Radiologic Procedures Under High Exposure Conditions

Abstract

Background: We investigated wearable components of the Abbott Diabetes Care FreeStyle Libre® (continuous glucose monitoring [CGM 1), FreeStyle Libre® 2 (CGM 2), and FreeStyle Libre® 3 (CGM 3) systems in simulated diagnostic radiologic procedures. Methods: Sensors were loaded with simulated glucose data and exposed to X-ray scanning, computed tomography (CT), and magnetic resonance imaging (MRI) to simulate radiotherapeutic procedures. The exposure settings were representative of maximum in clinical settings. After the simulations, bench tests were used to assess data integrity and responsiveness of sensors to various concentrations of aqueous glucose. Results: All sensors passed all acceptance criteria following each session of X-ray, CT, and MRI exposures. During the 3 T MRI simulation, the displacement forces for the CGM 1, CGM 2, and CGM 3 sensors were 0.132, 0.109, and 0.063 N, respectively, which are more than 100× smaller than the force of 15.97 N required to dislodge the sensor from the body. Data stored in the sensors prior to the exposures remained intact. Conclusion: The sensors maintained functionality following a series of high exposure conditions in both X-ray and CT scanning systems, and the sensors were easily visible and identifiable when scanned using clinically relevant scanning parameters. Therefore, patients can continue to wear and use their sensors during and after imaging. The nonclinical MRI testing demonstrated that the sensors can be worn under the specified MRI conditions.