Two FDA Clearances Add Diabetes Technology Options

Miriam E. Tucker

March 07, 2023

Two diabetes management devices that aid in the precision of insulin delivery have been recently cleared by the US Food and Drug Administration (FDA).

On March 2, the FDA cleared the Android version of Bigfoot Biomedical's Unity Mobile App for use with its system of smart pen caps that are compatible with different disposable insulin pens for administering both long-acting and rapid-acting insulin.

The system, which has been compatible with iOS devices since May 2021, is "the first and only FDA-cleared smart injection system that turns CGM [continuous glucose monitoring] data into dosing recommendations displayed right on the pen cap for people using multiple daily [insulin] injection therapy," according to a company statement.

The Bigfoot app allows users to input and review provider treatment recommendations, displays current glucose ranges, and delivers real-time alerts.

Once it is commercially launched, the Android phone application will be available via the Google Play Store. "Given that 41% of US smartphone users choose Android devices, this clearance enables expanded access to a large group of people with diabetes," the company says.

Libre 2 and 3 Now Integrated Into Automated Insulin Delivery Systems

On March 6, the FDA cleared the Abbott FreeStyle Libre 2 and FreeStyle Libre 3 devices as "integrated" CGM sensors. This means that they can now be used as components in automated insulin delivery systems, along with insulin pumps and connectivity software.

Abbott is working with insulin pump manufacturers Insulet and Tandem in the United States for integration with the FreeStyle Libre versions 2 and 3. Outside the US, the Libre 3 is already authorized to work with mylife Loop from Ypsomed and CamDiab in Germany. Further launches are expected in the UK, Switzerland, and the Netherlands later this year.

The modified FreeStyle Libre 2 and FreeStyle Libre 3 sensors have been cleared for use by patients as young as age 2 years and for up to 15 days, in contrast to the previous versions, which were available for patients as young as 4 years for use up to 14 days. The FDA has cleared all Libre sensors ― 2 and 3, current and future versions ― for use by pregnant women with any type of diabetes.

The modified sensors will be available in the US later this year and will eventually replace the Libre sensors in current use, the company said in a statement.

"The FreeStyle Libre portfolio is still the most affordable CGM on the market," an Abbott representative told Medscape.

Miriam E. Tucker is a freelance journalist based in the Washington DC area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR's Shots blog, and Diabetes Forecast magazine. She is on Twitter @MiriamETucker.

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