Abbott Wins FDA Authorization for First Combined Glucose and Ketone Sensor

Abbott has received US Food and Drug Administration authorization for the Libre Duo 10 Day, a wearable sensor the company describes as the first to track both glucose and ketone levels continuously, the company announced on 25 August 2026.

Ten days, two readings

Worn on the back of the upper arm, the sensor measures both analytes in the body’s interstitial fluid every minute over as long as ten days of continuous wear, sending readings to a smartphone through Abbott’s Libre app and its LibreView and LibreLinkUp platforms. It is authorised for people aged two and older with type 1 or type 2 diabetes, particularly those on insulin or glucose-lowering medications such as SGLT2 inhibitors, and those at higher risk of elevated ketones. “Libre Duo 10 Day brings both glucose and ketone levels together in a single dashboard,” said Chris Scoggins, executive vice president of Abbott’s diabetes care business.

The authorization was based on six clinical studies involving more than 600 participants, which Abbott said showed the sensor reliably tracked meaningful shifts in ketone levels throughout its full wear period, including rising concentrations that can precede diabetic ketoacidosis, a potentially life-threatening complication. The FDA reviewed the device through its De Novo pathway for new types of low- to moderate-risk devices. Abbott said hospital admissions for diabetic ketoacidosis have risen 55% over the past decade, and it plans to launch the device in the US later this year, with compatibility for other companies’ insulin delivery systems following through 2027.

Why It Matters

Diabetic ketoacidosis can develop within hours and is a leading cause of diabetes-related hospital admissions, particularly among people using newer glucose-lowering medications that can mask early warning signs. Combining glucose and ketone monitoring in a single wearable, rather than requiring separate blood or urine ketone tests, gives patients and clinicians earlier warning of a dangerous shift without adding another device to track.