On June 12, 2026, the U.S. Food and Drug Administration cleared Dexcom's Stelo Glucose Biosensor System for over-the-counter use in people 2 years of age and older who do not use insulin, and called it the first over-the-counter continuous glucose monitor (CGM) for children.[1] The FDA had first cleared Stelo for adults 18 and older in March 2024.[1]
What the FDA cleared
The clearance came through the 510(k) pathway, under number K260935.[2] Dexcom submitted it on March 20, 2026, and the FDA found the device substantially equivalent to a device already on the market, which in this case was the adult version of Stelo (K234070).[2][3] In a 510(k), the company shows that its device is as safe and effective as one that is already legally sold, and the summary says the new Stelo "does not raise different questions of safety and effectiveness."[3]
The cleared label describes Stelo as an over-the-counter integrated CGM, or iCGM, for people 2 years and older not on insulin.[3] The summary calls it interoperable, meaning it can share readings with other compatible devices and software.[3] Users under 18 need caregiver supervision.[3]
According to the FDA, the label covers children with diabetes who take oral medication, and people who want to see how diet, exercise and other lifestyle changes affect their glucose.[1]
How Stelo works
Stelo pairs a wearable sensor with an app on a compatible smartphone or other smart device, which can be a parent's or caregiver's phone.[1] The sensor sends new data every 5 minutes, and the app shows glucose values every 15 minutes.[3] The display covers 55 to 350 mg/dL.[3]
Each sensor lasts up to 15 days, plus a 12-hour grace period.[3] The FDA noted that sensors may not last as long on children as on adults.[1]
Here's what surprised us when we read the 510(k) summary: Stelo gives no glucose alerts at all.[3] That is why the FDA said it is not for people with problematic hypoglycemia (low blood sugar).[1] It is also not for people on dialysis.[1]
The same filing added a direct-to-watch feature, which shows glucose data on compatible watchOS smartwatches straight from the transmitter.[3]
The evidence behind the clearance
The FDA called this clearance an example of its use of real-world evidence.[1] Dexcom and the FDA combined earlier clinical study data from children and adults with real-world data on current iCGM use to estimate how the device would perform in children across the full 15-day wear.[1]
The 510(k) summary gives more detail. Data from a previously completed study of users ages 2 to 17 were reprocessed with the Stelo algorithm, covering wear days 1 to 10.[3] Children 7 to 17 were compared against lab blood measurements, and children 2 to 6 against capillary (fingerstick) blood glucose readings.[3] Days 11 to 15 were not studied directly in children.[3] Dexcom wrote that pediatric accuracy on those days may be comparable to adults, while sensor survival is "likely lower."[3]
Study participants reported mild side effects: local infection, skin irritation, and pain or discomfort.[1]
What this means for you
The FDA said children should use Stelo under the supervision of an adult caregiver.[1] It said users and caregivers should consult their health care provider before changing any medication based on the device's readings.[1] The agency also said people with a history of disordered eating or eating disorders should talk with their health care provider before using Stelo.[1]
Stelo is cleared only for people who do not use insulin.[3] Talk to your care team or pharmacist.