Recall, expanded indication for different CGMs
Some sensors for the Freestyle Libre 3 continuous glucose monitor (CGM) were recalled, and an interoperable automated glycemic controller was approved for insulin-dependent type 2 diabetes.
The FDA took two recent actions related to continuous glucose monitors for diabetes.
On Sept. 5, it announced the recall of certain FreeStyle Libre 3 sensors, a component of a continuous glucose monitoring (CGM) system, because they may provide incorrect high glucose readings. Use of the affected product may cause serious adverse health consequences, including severe hypoglycemia. There have been two reported injuries. Users should check their sensor's serial numbers online to find out if it is in the affected lot.
On Aug. 26, the FDA approved an expanded indication for the Insulet SmartAdjust technology, an interoperable automated glycemic controller previously indicated for the management of type 1 diabetes, to also include management of type 2 diabetes. An interoperable automated glycemic controller is software that automatically adjusts insulin delivery by connecting to an alternate controller-enabled insulin pump and integrated CGM. In a study of 289 diverse patients with type 2 diabetes on insulin who used the technology for 13 weeks, blood glucose control improved across all demographic groups compared to before the study. Adverse events included hyperglycemia, hypoglycemia, and skin irritation.