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- Aug 25, 202690% CONFIDENCEfrom the source
FDA Authorizes Abbott's Libre Duo Glucose-Ketone Sensor
- The FDA authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 and older with diabetes, the first U.S. wearable to continuously monitor ketones and the first in the world to track ketones and glucose in one device, with readings every minute sent to a smartphone and alerts when ketones reach a concerning level[2]
- The FDA granted the De Novo request (DEN250049) to Abbott Diabetes Care of Alameda, California, on 25 August 2026, creating the classification "integrated continuous glucose ketone monitoring system"; the device had Breakthrough Device designation and six clinical studies enrolled more than 600 participants[2][3]
- Abbott says it is the first system to meet both the FDA's iCGM standard and the new iCGK standard, offers up to 10 days of wear, and will launch in the United States later this year[1]
- Abbott expects the sensor to work with Beta Bionics' iLet and Sequel Med Tech's twiist automated insulin delivery systems by the end of 2026 and with Insulet and Tandem devices in 2027, plus an exclusive MiniMed integration expected in 2027[1]
- The CE Mark in May 2026 covered two systems in Europe: Libre Duo with up to 15 days of wear for adults 18 and older, and Libre Duo 10 Day for ages 2 and older[5]
- Before the decision, MedTech Dive reported that wider access to ketone data raises questions about how to interpret and act on it, and that a Breakthrough T1D-led consensus set 3 mmol/L as "urgent high"[4]
References 587% CONFIDENCE
The first entry is always the pin's source. Overall confidence is a weighted average of how firmly each reference supports the start and end times used above; a reference counts half as much for every 180 days older than the newest.
- [1]90%abbott.mediaroom.com/2026-08-25-Abbott-receives-FDA-authorization-for-worlds-first-dual-glucose-ketone-sensing-technology-for-people-with-diabetesabbott.mediaroom.com· Posted Sep 23, 2026· Starts Aug 25, 2026 ✓· 23% of score
The release is datelined "ABBOTT PARK, Ill., Aug. 25, 2026" and says Abbott "today announced U.S. Food and Drug Administration (FDA[2][3]) authorization of its Libre Duo 10 Day system"; the FDA's De Novo record gives the same decision date, 08/25/2026.
- [2]95%FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugarfda.gov· Published Aug 25, 2026· 21% of score
The FDA's[3] own press announcement of the De Novo authorization, with the clinical program, Breakthrough designation and who may use the device.
- [3]93%De Novo DEN250049: Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring Systemaccessdata.fda.gov· Published Aug 25, 2026· 21% of score
The FDA's[2] De Novo database entry: requester Abbott Diabetes Care, Alameda, decision date 08/25/2026, granted, regulation 862.1354, product code SJD.
- [4]74%5 questions on Abbott's glucose-ketone sensorsmedtechdive.com· Published Aug 19, 2026· 20% of score
MedTech Dive's pre-authorization look at how endocrinologists expect continuous ketone monitoring to be used, including the Breakthrough T1D urgent-high threshold.
- [5]80%Abbott secures CE Mark for world's first dual glucose-ketone sensing technology for people with diabetesabbott.mediaroom.com· Published May 27, 2026· 15% of score
Abbott's earlier release on the European CE Mark covering Libre Duo and Libre Duo 10 Day.[1]
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