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Jun 11, 2024

FDA clears OTC CGMs for general public, adults with type 2 diabetes who do not use insulin

Key takeaways:

  • The Abbott Libre Rio was cleared for adults with type 2 diabetes who do not use insulin.
  • The FDA cleared the Abbott Lingo for adults who want to track glucose to improve their overall health.

The FDA granted clearance for two new over-the-counter continuous glucose monitoring systems, one for adults with type 2 diabetes who do not use insulin and another for adults without diabetes, according to an industry press release.

The FDA cleared the Abbott Libre Rio for adults aged 18 years and older with type 2 diabetes. The OTC CGM is designed for adults who do not use insulin and who manage their diabetes through lifestyle modification. The system, which is based on the Abbott FreeStyle Libre CGM, includes a biosensor worn on the back of the arm for up to 15 days along with a reader or compatible smartphone app to display glucose levels. The Libre Rio has a measurement range of 40 mg/dL to 400 mg/dL, allowing for the measurement of extremely high or extremely low glucose levels….

Read more:FDA clears OTC CGMs for general public, adults with type 2 diabetes who do not use insulin (healio.com)

Source: Healio

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