The FDA Just Cleared the First OTC Continuous Glucose Monitor for Children
Stelo can now be marketed for children 2 years of age and older who do not use insulin.
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The US Food and Drug Administration has approved Dexcom's Stelo Glucose Biosensor System, the first over-the-counter continuous glucose monitor for children, the agency said in a press release on Friday. Stelo can now be marketed for use by people 2 years of age and older who do not use insulin, including those with diabetes who take oral medication for their condition. It should be used under the supervision of an adult caregiver.
The FDA had already approved the system for people 18 years of age and older in 2024.
Over-the-counter continuous glucose monitors are designed to help people manage diabetes and other conditions that require monitoring blood sugar levels, also known as glucose levels. They're increasingly used by people without medical conditions who are curious about how their diet,...
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