The U.S. Food and Drug Administration authorized Abbott Diabetes Care's Libre Duo 10 Day system on Tuesday, making it the first wearable in the United States to continuously measure ketones and the first device worldwide to track ketones and glucose together. The regulator cleared it for people with diabetes aged two years and older, aiming to give patients and caregivers earlier warning of diabetic ketoacidosis, a potentially fatal complication.
The small sensor measures glucose and ketones in fluid beneath the skin every minute for up to 10 days. It sends readings wirelessly to a compatible smartphone, displays whether both measurements are rising or falling and can issue an automatic alert when ketones reach a concerning threshold. Existing blood or urine ketone tests generally provide a separate, single reading rather than a continuous trend.
Diabetic ketoacidosis develops when insufficient insulin forces the body to burn fat, producing acids called ketones that can accumulate rapidly. The Centers for Disease Control and Prevention describes the condition as life-threatening and most common in type 1 diabetes, although it can also occur in type 2 diabetes. The FDA stressed that users must interpret ketone data alongside glucose readings and symptoms rather than relying on the wearable alone.
The FDA based its decision on six clinical studies involving more than 600 participants aged two and above. According to the agency, the system tracked clinically meaningful ketone differences throughout its 10-day wear period and identified elevated levels before diabetic ketoacidosis began. The authorization used the De Novo pathway for a new type of low- to moderate-risk device, with special controls covering matters including labeling and performance testing.
The potential audience is substantial. CDC estimates show that 40.1 million people in the United States have diabetes, including about 2.1 million with diagnosed type 1 diabetes. Abbott said the system is intended particularly for people at higher risk of elevated ketones, including some insulin users and people taking SGLT2 glucose-lowering medicines, and that it plans a U.S. launch later in 2026.
The device received FDA Breakthrough Device designation before authorization and fits the agency's effort to move more patient-centered care into the home. Abbott says it is working with insulin-pump manufacturers on future connections to automated delivery systems, with some integrations planned for late 2026 and others for 2027. Authorization permits marketing, but patients will still need clinical guidance and must follow the final labeling when the product becomes available.
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