FDA authorized Abbott's Libre Duo 10 Day on 25 August 2026, a wearable sensor that continuously tracks both glucose and ketones on one patch — the first device of its kind anywhere, and the first to hold continuous ketone monitoring to a new FDA standard built specifically for it.
Why ketones, and why continuously
Diabetic ketoacidosis develops when the body, starved of usable insulin, shifts to burning fat for fuel and produces ketones faster than it can clear them; unchecked, blood chemistry can turn dangerous within hours. Until now, ketone testing meant a single blood or urine reading at one point in time — useful for confirming a problem already underway, but blind to whether a level is rising, falling, or holding steady. FDA's authorization letter and Abbott's submission both frame continuous ketone tracking as closing that gap: a sensor that can flag a rising trend before it crosses into DKA territory, rather than after.
What FDA reviewed
Abbott Diabetes Care brought accuracy data from six clinical studies enrolling more than 600 participants through the De Novo pathway — the route FDA uses for novel low- to moderate-risk device types that lack an existing predicate. FDA said the data showed the sensor consistently tracked clinically meaningful shifts in ketone concentration across the full 10-day wear period, including detecting rising ketones ahead of DKA onset. The device had already secured breakthrough device designation, the program meant to speed review of technologies addressing unmet needs in serious conditions.
A standard, not just a clearance
De Novo authorizations do double duty: they clear the specific device, and they write the special controls — the performance bar — that future devices of the same type must meet to reach market through the faster 510(k) route instead of another De Novo. Libre Duo 10 Day is the first system to satisfy FDA's existing integrated continuous glucose monitoring (iCGM) special controls alongside a newly created integrated continuous glucose and ketone monitoring (iCGK) category. Any competitor building a dual glucose-ketone sensor now has a defined regulatory target instead of an open question.
Frequently asked questions
What did FDA authorize on 25 August 2026?
Abbott's Libre Duo 10 Day, the first wearable authorized to continuously monitor both ketone levels and glucose on a single sensor, worn for up to 10 days, cleared through the De Novo pathway.
Who can use it?
People aged 2 and older with type 1 or type 2 diabetes. Abbott plans a U.S. launch later in 2026.
What evidence supported the authorization?
Six clinical studies with more than 600 participants, showing the sensor tracked clinically meaningful ketone shifts through 10 days of wear, including trends preceding diabetic ketoacidosis.
Why does the new device category matter?
The De Novo grant creates an integrated continuous glucose and ketone monitoring (iCGK) special-controls category, the benchmark future dual-sensing devices will need to meet.
Sources & further reading
- FDA, “FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar”, 25 August 2026. fda.gov
- Abbott, “Abbott Receives FDA Authorization for World's First Dual Glucose-Ketone Sensing Technology for People With Diabetes”, 25 August 2026. abbott.mediaroom.com
- Same release, as syndicated via PR Newswire. prnewswire.com
Regulatory News reports on public regulatory documents. It is not legal advice, and the primary sources above govern. If we have made an error, we will say so in public: see corrections.
