Abbott received authorization from the U.S. Food and Drug Administration (FDA) for the Libre Duo 10 Day sensor, a wearable device that monitors glucose and ketones continuously for 10 days. The company plans to launch it in the United States later in 2026, targeting people with diabetes aged 2 years and older who take insulin or other glucose-lowering medications.
The device represents a notable expansion from continuous glucose monitoring to measuring two vital biomarkers in a single sensor. Abbott had received the European CE mark for the device in May, before announcing the U.S. authorization on August 25, 2026.
What Does the Sensor Monitor?
The Libre Duo 10 Day was designed to track ketone levels and issue alerts when they rise, and it can also notify users when they reach a concerning level. The importance of this function is linked to diabetic ketoacidosis (DKA), a serious condition that occurs when insulin is insufficient, causing the body to break down fat for energy and raising ketone levels in the blood.
Current guidelines recommend checking ketones during illness or when glucose is elevated, but standard testing relies on blood or urine samples. The article notes that some people do not keep these tests at home or do not use them regularly, while early signs of elevated ketones, such as fatigue, nausea and thirst, may be attributed to other illnesses.
Basis for the Authorization and Integration With Insulin Systems
The FDA said its decision was based on a review of six clinical studies involving more than 600 people aged 2 years and older, assessing the device’s accuracy in monitoring glucose and ketones. The results showed that Libre Duo could track clinically significant changes in ketone levels during the 10-day use period and detect their rise before diabetic ketoacidosis began.
According to the article, the system meets the FDA’s standard for integrated continuous glucose monitoring devices, in addition to a new standard for integrated glucose and ketone monitoring. This allows it to be paired with automated insulin delivery systems, expanding its potential role within digital diabetes-management systems rather than serving only as a standalone sensor.
Abbott expects the Libre Duo 10 Day to be compatible with Beta Bionics’ iLet and Sequel Med Tech’s twiist systems before the end of the year. It is also working on integrations with Insulet, Tandem Diabetes Care and MiniMed during 2027, including a version of the sensor that Abbott is developing exclusively for integration with MiniMed systems. The device will work with the current Libre app.
Why Does This Development Matter?
The practical shift here is from intermittent ketone testing to continuous alerts that may give users more time to take action before the condition worsens. MedTech Dive quoted Alisa Schiffman, Abbott Diabetes Care’s senior medical director, as expressing hope that the device could help reduce hospital admissions and prevent the progression of diabetic ketoacidosis by detecting rising ketones early.
However, the authorization alone does not determine how widely the product will be adopted. Abbott has not announced the price or insurance-coverage details, two factors that raised questions among experts consulted. The company said it intends to work with insurers and payers, without providing additional details so far. Therefore, the device’s practical value to users will depend on the extent to which it proves available, compatible with insulin systems and affordable.