FDA Authorizes Abbott Libre Duo 10 Day Dual Glucose-Ketone Monitor via De Novo Pathway

The authorization covers a 10-day subcutaneous sensor that transmits minute-by-minute readings to a smartphone app and issues alerts when ketone thresholds are crossed. Prior devices required separate single-point ketone strips; the integrated system removes that gap for the 2.1 million U.S. type 1 diabetes patients at risk of diabetic ketoacidosis. The FDA also established special controls on labeling and performance testing that will apply to future dual-analyte monitors.

Six clinical studies supplied the evidence base, enrolling more than 600 participants across pediatric and adult cohorts. Accuracy metrics demonstrated clinically meaningful ketone detection across the 10-day wear period and identified rising levels before DKA onset. The data package earned Breakthrough Device designation, shortening review time under the Home as a Health Care Hub Initiative.

Operationally the device shifts ketone surveillance from episodic to continuous, enabling earlier intervention while glucose context remains visible. Abbott must now meet post-market performance surveillance requirements embedded in the special controls. Competitors developing similar multi-analyte sensors will face identical evidentiary thresholds for clearance.