FDA Grants First Dual Glucose-Ketone Wearable Authorization

On August 25, 2026, the U.S. Food and Drug Administration (FDA) issued a De Novo marketing authorization for Abbott Diabetes Care’s Libre Duo 10 Day Continuous Dual Glucose-Ketone Monitoring System. The clearance makes it the first wearable in the United States—and the first worldwide—to continuously measure both blood-sugar (glucose) and ketone levels in real time. The device is cleared for anyone with diabetes aged 2 years and older.

FDA Authorizes First Wearable Device that Continuously Monitors Both Ketone Levels and Blood Sugar FDA Authorizes Libre DUO, the First CGK to Track Glucose + Ketones PharmaphorumUsNews and World Report24/7 Wall St.

Diabetic ketoacidosis (DKA) is a life-threatening emergency that can develop within hours when ketone levels rise sharply, often because of insufficient insulin. Hospital admissions for DKA have risen 55 % over the past decade, according to Abbott’s data. Yet only 18 % of people with diabetes report having a blood-ketone meter at home, and roughly one-third lack any ketone-testing supplies. Traditionally, ketones have been checked with single-point blood or urine tests, which cannot reveal whether levels are trending upward.

FDA Authorizes Libre DUO, the First CGK to Track Glucose + Ketones FDA Authorizes First Wearable Device that Continuously Monitors Both Ketone Levels and Blood Sugar UsNews and World ReportPharmaphorum

• 40.1 million Americans have diabetes (U.S. Centers for Disease Control and Prevention).

FDA Authorizes First Wearable Device that Continuously Monitors Both Ketone Levels and Blood Sugar

• 2.1 million of those have type 1 diabetes.

FDA Authorizes Libre DUO, the First CGK to Track Glucose + Ketones

• The FDA’s decision was based on six clinical studies enrolling more than 600 participants aged 2 years and older.

FDA Authorizes First Wearable Device that Continuously Monitors Both Ketone Levels and Blood Sugar

• The sensor records glucose and ketone concentrations in interstitial fluid every minute for a 10-day wear period and transmits data wirelessly to a smartphone app.

FDA Authorizes First Wearable Device that Continuously Monitors Both Ketone Levels and Blood Sugar

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• The FDA cautioned that ketone readings should always be interpreted alongside glucose numbers and the patient’s symptoms.

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• “If glucose is the speedometer, ketones are like the check engine light, providing an alert that something may need attention,” — Chris Scoggins, executive vice president of Abbott’s diabetes care business — Chris Scoggins, executive vice president of Abbott’s diabetes care business

FDA Authorizes Libre DUO, the First CGK to Track Glucose + Ketones

• “Today’s authorization is a breakthrough for the safety of children and adults living with diabetes,” — Michelle Tarver — Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health

FDA Authorizes First Wearable Device that Continuously Monitors Both Ketone Levels and Blood Sugar

Continuous dual monitoring offers a single, wearable platform that can alert users to impending DKA before symptoms become severe, potentially reducing emergency department visits and hospitalizations. By providing minute-by-minute trends, the system addresses a critical gap in diabetes self-management—real-time visibility of ketone dynamics—thereby supporting earlier clinical decision-making for both patients and caregivers.

FDA Authorizes Libre DUO, the First CGK to Track Glucose + Ketones

Abbott plans to launch the Libre Duo 10 Day in the United States later in 2026. The company is also pursuing integration with automated insulin delivery (AID) systems. Partnerships slated for the end of 2026 include Beta Bionics’ iLet and Sequel Med Tech’s twiist AID platforms; integrations with Insulet’s Omnipod and Tandem’s T:slim x2 and Mobi systems are targeted for 2027, as is a collaboration with MiniMed’s smart-dosing technology. Abbott’s CEO Robert Ford indicated that broader Medicare coverage for Type 2 patients could eventually extend the device’s reach to around 10 million beneficiaries.

FDA Authorizes Libre DUO, the First CGK to Track Glucose + Ketones

No substantive discrepancies were identified among the sources regarding the device’s authorization status, clinical performance, or intended launch timeline.

FDA Authorizes First Wearable Device that Continuously Monitors Both Ketone Levels and Blood Sugar