A Sensor That Watches Your Ketones
A Sensor That Watches Your Ketones
The FDA has cleared the first wearable that reads glucose and ketones at the same time. Here is what the agency reviewed, and what nobody has shown yet.
The FDA authorized Abbott’s Libre Duo 10 Day on August 25, according to the agency’s announcement. It is a wearable sensor that reads glucose and ketones at the same time, for people age 2 and up, and the FDA cleared it through the De Novo pathway — the route used when a device has no existing category to fit into. The agency built the category as part of the authorization.
The ketone half is the new part. Ketones have always been a snapshot: a strip, a stick, a meter you hope is not expired, checked at the moment you already suspect something has gone wrong. This turns them into a line that moves.
Abbott says the U.S. launch comes later this year. Before that, it is worth seeing how the category arrived, because the guardrails were written before the device existed.
What the FDA reviewed, and what it did not
According to the FDA’s announcement, the review covered six clinical studies enrolling more than 600 participants age 2 and older. The agency reported that the sensor tracked clinically meaningful differences in ketone levels across the full wear period, including picking up elevated ketones before ketoacidosis set in. Michelle Tarver, who directs the FDA’s device center, said having that information in real time “can be the difference between early intervention and a life-threatening emergency.”
Read that again, because it describes accuracy. The question the agency answered is whether the sensor measures ketones well enough to be relied on. The question it did not answer is whether wearing one lowers anybody’s odds of ending up in a hospital bed. Those are different studies, and the second kind has not been reported. Abbott designed the device, ran the studies, and wrote the release; the release also quotes Jennifer Sherr of Yale, a co-author of the Lancet panel that set the thresholds, and Aaron Kowalski of Breakthrough T1D, which led that same paper. It is a small field. None of that makes the work wrong. It is just worth knowing who is standing where.
The part nobody has shown yet
Finding out sooner only matters if the extra time changes what happens next. That is the claim underneath this entire category, and it is the claim that has not been put to a trial.
There are two reasonable ways to think about it. Both are still arguments.
The most honest sentence available here belongs to the panel itself. Its members wrote that they met “in the absence of substantial evidence” able to identify the right ketone thresholds for this technology. The thresholds now sitting inside an authorized device were set by expert judgment, because there was nothing sturdier to set them with.
What this changes for you
Nothing this week. Abbott has not announced a price or any insurance coverage, and the product is not on shelves. According to reporting in MedTech Dive, compatibility with Beta Bionics and Sequel Med Tech pumps is expected near the end of the year, with Insulet, Tandem, and MiniMed following the year after. For now this is a thing that exists, not a thing you can wear.
When it does arrive, the dull advice is the durable advice: keep the blood ketone meter. The expert panel recommends exactly that, for the times when how you feel does not match what the sensor says, and Abbott’s own published safety language allows that the urgent high ketones alarm may not detect every instance of ketones above 3.0 mmol/L. The company’s wear-duration study also reported that roughly 16 percent of adult sensors and 31 percent of pediatric sensors did not last the full ten days. None of that is disqualifying. It is the difference between a tool and a promise. The sick day plan is still what does the work — the sensor can move the moment you find out, but it cannot tell you what to do about it. Build that plan with your doctor before you need it, not during.
The authorization. U.S. Food and Drug Administration. FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar. FDA news release, August 25, 2026. Device details, quotes, alarm limitations and sensor wear-duration figures also come from Abbott’s press release of the same date. Abbott makes the device and funded the studies supporting it.
Ketone thresholds and how to use them. Dhatariya K, Bergenstal RM, Sherr J, et al. Continuous ketone monitoring for people with diabetes: international expert recommendations on the application of a new technology. The Lancet Diabetes & Endocrinology, 2026;14(1):82–92. Expert consensus, published as a Personal View and endorsed by ISPAD. Led by Breakthrough T1D.
DKA hospitalization trend. Benoit SR, Zhang Y, Geiss LS, Gregg EW, Albright A. Trends in Diabetic Ketoacidosis Hospitalizations and In-Hospital Mortality — United States, 2000–2014. MMWR Morb Mortal Wkly Rep, 2018;67:362–365. National surveillance data.
Continuous ketone sensing against blood. Haas NL, Korley FK, Schneider RM, et al. Continuous Ketone Monitoring in Diabetic Ketoacidosis: Prospective Multicenter Method-Comparison and Feasibility Study. Diabetes Technology & Therapeutics, 2026. A 34-participant feasibility study of a different manufacturer’s sensor, not Abbott’s.
Euglycemic DKA and SGLT inhibitors. Danne T, Garg S, Peters AL, et al. International Consensus on Risk Management of Diabetic Ketoacidosis in Patients With Type 1 Diabetes Treated With Sodium–Glucose Cotransporter (SGLT) Inhibitors. Diabetes Care, 2019;42(6):1147–1154.
Launch and pump-integration timing. MedTech Dive, August 2026 trade reporting.
How to read this evidence. The FDA review is a regulatory accuracy assessment, not an outcomes trial. The Lancet recommendations are expert consensus, and the panel states plainly that trial evidence for its thresholds does not yet exist. The emergency department comparison is a 34-participant feasibility study of a different manufacturer’s sensor, so it supports the idea that continuous ketone sensing can be accurate — not any claim about this particular product. The CDC hospitalization figures are surveillance data. They describe how often something happened, not why, and the most recent published national trend ends in 2014. Libre Duo 10 Day is authorized but not yet for sale in the United States, and no price or insurance coverage has been announced. Nothing here describes what any individual should do.
Disclosure. The Juicebox Podcast is sponsored by, among others, Dexcom, Omnipod, Tandem, MiniMed, twiist and Eversense — several of which are named above. Abbott is not a Juicebox sponsor. This post was not solicited, reviewed, or paid for by any company.
This post is for educational purposes only and is not medical advice. Nothing here is a recommendation to start, stop, or change any medication. Talk with your doctor before making any changes to your care.
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