The FDA authorized Abbott's Libre Duo 10 Day, the first wearable for continuous glucose and ketone monitoring in one sensor, for people aged 2 and older.
Photo source:
Abbott's
In August 2026, the US Food and Drug
Administration (FDA) authorized the Libre Duo 10 Day, a wearable for continuous
glucose and ketone monitoring from Abbott Diabetes Care. The FDA announced it
on August 25, 2026, and says it is "the first wearable device in the U.S.
that continuously monitors ketone levels." Glucose is blood sugar, and
ketones are chemicals the liver produces for energy. The system is authorized
for people with diabetes aged 2 and older. It has not launched yet. Abbott's
page says it is "coming soon," and neither Abbott nor the FDA gives a
launch date.
The Libre Duo 10 Day is a wearable sensor that
measures ketone and glucose levels in the fluid just beneath the skin every
minute. It sends the readings wirelessly to a compatible smartphone, which
shows the current levels and whether they are rising or falling. Abbott says
ketones are tracked in the background, not through separate spot checks. If
ketones rise, the system sends an alert. Alarms arrive only when alarm settings
are on and the sensor is within 33 feet of the reading device, with nothing blocking
the signal. The FDA adds that ketone readings should be read alongside glucose
readings and symptoms.
Abbott's page presents ketone monitoring as an
early warning for diabetic ketoacidosis (DKA). DKA is a serious condition in
which ketone levels in the blood rise to dangerous levels. FDA Director
Michelle Tarver called the authorization "a breakthrough for the safety of
children and adults living with diabetes." Abbott says the system does
more than continuous glucose monitoring alone or traditional ketone testing
with urine or blood, a claim its page bases on the system's ketone alerts and
readings. The page does not give accuracy figures or the ketone levels that
trigger an alert.
Each sensor is worn for 10 days. In Abbott's
clinical studies, 84.1% of the sensors used by adults and 68.8% of those used
by children lasted the full 10 days. Readings appear in the Libre app, which
works only with certain phones and operating systems and may require
registration with LibreView. The system is authorized for children aged 2 and
older, and the FDA release says it is for people living with diabetes.
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