The FDA has approved the first over-the-counter continuous glucose monitor designed specifically for children, marking a significant shift in how young people can track and manage their blood sugar levels at home. Dexcom Inc.'s Stelo Glucose Biosensor System received clearance for children ages two years and older who manage their condition with oral medication or want to understand how diet and exercise affect their glucose levels.

Why Is This Approval Important for Children's Health?

Prediabetes, a condition where blood sugar levels are higher than normal but not yet in the diabetic range, is increasingly affecting children in the United States, placing millions at heightened risk for progressing to type 2 diabetes. This new device addresses a critical public health gap by giving pediatric patients and their caregivers real-time glucose data without requiring a prescription.

The Stelo system works by using a wearable sensor paired with a smartphone app to continuously measure and display glucose values every 15 minutes. Each sensor lasts up to 15 days before replacement, though wear time may be shorter in children than adults due to physiological and behavioral differences.

"Children deserve access to the best tools available to manage their health. Today's clearance reflects the FDA's commitment to fostering innovation for pediatric patients and supporting the safe and effective use of medical devices where children live, learn, and play," said Michelle Tarver, M.D., Ph.D., Director of the Center for Devices and Radiological Health.

Michelle Tarver, M.D., Ph.D., Director of the Center for Devices and Radiological Health

How Can Parents and Caregivers Use This Device?

• Real-Time Monitoring: The app displays glucose measurements and trends every 15 minutes, allowing caregivers to track patterns in response to meals and exercise throughout the day.
• Informed Decision-Making: By seeing how specific foods and activities affect their child's glucose levels, families can make adjustments to support healthier long-term outcomes and better quality of life.
• Supervised Use: The device should be used under the supervision of an adult caregiver, and users should consult their health care provider before making any medication adjustments based on the device's readings.
• Lifestyle Tracking: The system helps children and families understand how diet, exercise, and other lifestyle changes affect glucose levels, building greater awareness of metabolic health.

What Are the Limitations and Safety Considerations?

While the Stelo system offers significant benefits, it is not designed for all situations. The device is not appropriate for people with problematic hypoglycemia, a condition involving dangerously low blood sugar, because it is not designed to alert users when this potentially dangerous situation occurs. It is also not suitable for people on dialysis or those with a history of disordered eating or eating disorders, who should discuss the device with their health care provider before use.

In clinical testing, participants reported mild adverse events, including local infection, skin irritation, and pain or discomfort at the sensor site. These side effects were generally manageable and did not prevent long-term use.

The FDA's approval of this device represents a significant milestone in pediatric diabetes management. By making continuous glucose monitoring available over-the-counter for children, the agency is removing barriers to access and empowering families to take a more active role in understanding and managing their children's metabolic health. The clearance also aligns with the FDA's broader "Home as a Health Care Hub" initiative, which aims to advance patient-centered devices that fit seamlessly into daily life at home.