FDA clears over-the-counter glucose monitors for children 2 and older
7 reported3 unconfirmed
The Food and Drug Administration has cleared Dexcom’s Stelo continuous glucose monitor for over-the-counter marketing to children 2 and older, marking the first time such devices are available without a prescription for this age group in the United States. The FDA stated that real-time glucose data can help pediatric patients and caregivers build glycemic awareness and track patterns. However, experts have mixed views, with some clinicians seeing potential benefits for high-risk children and others warning about risks of unnecessary panic, restrictive eating, and disordered eating. The device costs $99 per month for two 15-day sensors, and its app is free. Dexcom said the device expands access for families as youth-onset type 2 diabetes rises. The American Academy of Pediatrics has not yet reached a position on over-the-counter CGM use in children.
What’s reported
The FDA cleared Dexcom’s Stelo for over-the-counter marketing to children 2 and older.
Stelo costs $99 per month for two 15-day sensors, plus applicators and adhesive patches.
The FDA said the device can help pediatric patients and caregivers build glycemic awareness and track patterns.
Some clinicians expressed tentative excitement about increased access for underserved populations.
Other experts worry about hyperfocusing on data, leading to panic, restrictive food behaviors, and disordered eating.
The American Academy of Pediatrics has not yet reached a position on over-the-counter CGM use in children.
Stelo’s website and app currently contain information related to adult users only; Dexcom did not respond to questions about pediatric-specific information.
Open questions
What normal blood sugar ranges are for children without diabetes.
How families will interpret CGM data without clinician guidance.
Whether Dexcom plans to add pediatric-specific information to its website and app.
Key figures
Wendy Schofer, pediatrician specializing in eating disorder prevention
Kristen Nadeau, pediatric endocrinologist at Children’s Hospital Colorado
Julie Wilson, clinical dietitian and certified diabetes care and education specialist at Rady Children’s Health in San Diego
Laura Burross Jackson, registered dietitian nutritionist at Children’s Hospital of The King’s Daughters in Norfolk, Va.
Robert F. Kennedy Jr., health secretary
Sources: statnews.com
