ABT · News · 20260825N

Libre Duo Regulatory Approval

ABBOTT LABORATORIES · 2026-08-25 · Importance 38 · Surprise 60 · In source text

Abbott received U.S. FDA De Novo authorization for Libre Duo 10 Day, the first continuous biowearable designed to monitor both glucose and ketone levels. The device is indicated for people aged 2 and older, provides up to 10 days of wear, and is designed to alert users to rising ketones associated with diabetic ketoacidosis. Libre Duo integrates with Abbott’s latest-generation Libre app and digital health ecosystem, is compatible with leading automated insulin delivery systems, and is expected to launch in the United States later in 2026, with planned Insulet and Tandem integrations in 2027.

Key facts

• The Libre Duo 10 Day is designed for compatibility with leading automated insulin delivery (AID) systems and is expected to connect with insulin delivery systems from Insulet and Tandem in 2027. source
• The Libre Duo 10 Day is expected to launch in the U.S. later in 2026. source
• Abbott announced U.S. Food and Drug Administration (FDA) authorization of its Libre Duo 10 Day system on Aug. 25, 2026. source
• The Libre Duo 10 Day is described as the world's first dual glucose‑ketone sensing technology (a dual glucose-ketone continuous monitoring system). source
• Abbott received U.S. FDA De Novo authorization for Libre Duo 10 Day. source
• The Libre Duo 10 Day alerts users to rising ketones to help prevent diabetic ketoacidosis (DKA). source
• The Libre Duo 10 Day system is indicated for individuals aged 2 and older. source
• The Libre Duo 10 Day integrates with the latest-generation Libre app and the full Libre digital health ecosystem. source

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