Abbott Wins FDA Nod for Libre Duo Dual-Analyte Sensor

The US Food and Drug Administration (FDA) has granted Abbott de novo authorisation for the Libre Duo 10 Day, the world’s first wearable sensor that continuously measures both glucose and ketones. Announced on 25 August 2026, the authorisation covers people with diabetes ages two and up who take insulin or other glucose-lowering medications, and follows Abbott’s CE mark for the same technology in Europe in May 2026.

Libre Duo 10 Day is designed to help people with diabetes avoid diabetic ketoacidosis (DKA), a serious condition caused by a lack of insulin, by continuously tracking ketones and alerting users when levels are rising. Current guidelines call for people with diabetes to test ketones during illness or elevated glucose, but many do not have blood or urine ketone tests at home or rarely use them. The FDA reviewed six clinical studies enrolling more than 600 people aged two and older; results showed Libre Duo tracked clinically meaningful differences in ketone levels over its 10-day wear period and detected elevated ketones before DKA onset.

Uniquely, Libre Duo meets both the FDA’s integrated continuous glucose monitoring standard and a new standard for integrated continuous glucose and ketone monitoring, allowing pairing with automated insulin delivery (AID) systems. Abbott expects Libre Duo to be compatible with Beta Bionics’ iLet and Sequel Med Tech’s twiist AID systems by year-end, with integrations with Insulet, Tandem Diabetes Care and Medtronic MiniMed planned for 2027. Alisa Schiffman, Senior Medical Director for Abbott Diabetes Care, positioned the device as helping reduce hospital admissions and prevent DKA through earlier awareness.

The commercial signal is a maturing continuous glucose monitoring category evolving into a broader multi-analyte sensing platform where DKA prevention becomes a significant differentiation vector. Deep integration with the AID ecosystem provides substantial competitive lock-in. Expect Dexcom, Medtronic MiniMed, Senseonics and emerging multi-analyte specialists PercuSense and Biolinq to sharpen their own multi-analyte positioning through 2027.

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