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Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, said in the announcement that the clearance reflects the agency’s commitment to fostering innovation for pediatric patients.
The CGM can be used by people with diabetes or prediabetes, as long as they don’t take insulin or have a history of problematic hypoglycemia. Stelo should also not be used by people on dialysis, and people with a history of disordered eating should consult a physician before starting the device, the FDA said.
The over-the-counter sensor should be used with the supervision of an adult caregiver, according to the FDA. It shows glucose measurements and trends through a connected app that can be installed on a parent’s or caregiver’s smartphone. The sensors last for up to 15 days, although the actual wear time may be shorter in children, the FDA said.
To understand how Stelo might work for children, Dexcom used real-world evidence from current CGM users along with previous study data from children and adults. Study participants reported mild adverse events such as local infection and skin irritation.
The FDA said the device could be used by children with prediabetes. Nearly a third of adolescents in the U.S. had prediabetes in 2023, according to the Centers for Disease Control and Prevention. The product can also be used by children with diabetes who use oral medication to manage their condition.
Providing real-time glucose data can help children and their caregivers build greater glycemic awareness and track patterns in response to meals and exercise, the FDA said.
Dexcom has not shared more details about how it plans to roll out the feature for children. Currently, the company sells Stelo sensors in packages of two at about $89 or $99 per month, depending on whether users sign up for a subscription.
