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The US FDA has cleared Dexcom Inc.’s Stelo over-the-counter continuous glucose monitor (CGM) for children as young as 2 years of age who do not use insulin.
The Stelo Glucose Biosensor System was initially approved in March 2024 for people ages 18 and older who have prediabetes or type 2 diabetes (T2D) and don’t use insulin.
“By providing real-time glucose data, these devices can help pediatric patients and their caregivers build greater glycemic awareness, track patterns in response to meals and exercise, and make informed adjustments to support healthier long-term outcomes and quality of life,” the FDA said in a statement.
The Stelo is indicated for children with or without diabetes who use oral medication to manage glucose levels as well as those who seek information about how food, exercise, and other factors affect their glucose levels.
It comprises a wearable sensor paired with a smartphone app, which can also connect to a parent or caregiver’s smartphone. The app displays glucose measurements and trends every 15 minutes.
Each sensor is designed to last up to 15 days before it needs to be replaced, although sensor wear time may be shorter in children than adults due to physiologic and behavioral factors, according to the FDA.
Adverse events may include local infection, skin irritation, pain, and/or discomfort.
Use in children should be under the supervision of an adult caregiver. The system should not be used in people who are prone to hypoglycemia, as it does not include alerts. It is also not for people on dialysis.
Miriam E. Tucker is a freelance journalist based in the Washington DC area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X (formerly Twitter) @MiriamETucker and BlueSky @miriametucker.bsky.social
