Diabetes Dialogue: News on Abbott Readers & CMS Expansion of CGM Availability

The first half of April has been eventful for the diabetes community.

On April 16, 2023, changes to Centers for Medicare and Medicaid Services (CMS) policies ushered in a new era of continuous glucose monitoring (CGM) access. Announced in early March, the move relaxes restrictions to allow for use by insulin-treated individuals with diabetes and non-users who have a history of “problematic hypoglycemia”.¹

Abbott saw its technology placed in the spotlight during the first half of April. On April 6, 2023, the US Food and Drug Administration (FDA) announced a Class I Recall of readers used with Abbott’s FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems citing risk of overheating and fire. The most serious form of recall from the FDA, the agency stated it had received reports of 88 incidents from Abbott, including at least 7 reports of fires and 1 injury, but no deaths involving the overheating issue.²

In their own statement, Abbott noted they had begun alerting customers regarding the potential risk of overheating beginning in February 2023. The company also acknowledged this was not a physical recall and the 88 incidents represent 0.0017% of all readers sold worldwide.²

To avoid overheating, Abbott recommends users only use the provided charging equipment. Other steps for users include avoiding use of third-party charges, exposure to liquid, introduction of foreign material to ports, and improper storage.²

On April 12, 2023, the FDA updated its original announcement to note a medical device recall means a firm’s removal or correction of a medical device and, in Abbott’s case, the company was correcting the product labeling.²

Abbott would announce positive news from the FDA less than 2 weeks later on April 14, 2023, with the clearance of a reader for their FreeStyle Libre 3 integrated CGM. With the clearance of the reader in hand, the company noted plans to work with CMS to include the FreeStyle Libre 3 integrated CGM on the list of covered devices.³

In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, Diana Isaacs, PharmD, an endocrine clinical pharmacist and coordinator of the Remote Monitoring Program at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, sit down to discuss the implications of increased CGM access through CMS and take a deep dive into the latest Abbott news, including dispelling misconceptions surrounding the recall announcement.

References:

1. Isaacs D, Bellini N. Diabetes dialogue: CMS expansion ushers in new age of CGM access. HCP Live. https://www.hcplive.com/view/diabetes-dialogue-cms-expansion-ushers-in-new-age-of-cgm-access. Published March 17, 2023. Accessed April 19, 2023.
2. Campbell P. FDA issues class I recall of Abbott Freestyle Readers for risk of overheating, fire. HCP Live. https://www.hcplive.com/view/fda-issues-class-i-recall-of-abbott-freestyle-readers-for-risk-of-overheating-fire. Published April 6, 2023. Accessed April 19, 2023.
3. Campbell P. FDA clears reader for Abbott Freestyle Libre 3 System. HCP Live. https://www.hcplive.com/view/fda-clears-reader-for-abbott-freestyle-libre-3-system. Published April 17, 2023. Accessed April 19, 2023.

Relevant disclosures for Dr. Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Dr. Bellini include Abbott Diabetes Care.