Home / Health / FDA Approves First OTC Glucose Monitor for Kids
FDA Approves First OTC Glucose Monitor for Kids
15 Jun
Summary
- Stelo is the first OTC continuous glucose monitor for children.
- FDA cleared Stelo for children aged two and older.
- Real-world evidence supported the expanded pediatric indication.
In a landmark decision, the US Food and Drug Administration (FDA) has cleared Dexcom's Stelo glucose biosensor system for pediatric use. This clearance establishes Stelo as the first over-the-counter (OTC) continuous glucose monitor (CGM) accessible to children aged two and older who do not use insulin. The expanded indication follows the system's initial FDA clearance for individuals aged 18 and above in March 2024.
The FDA's decision to expand Stelo's indication highlights the agency's innovative approach, leveraging real-world evidence (RWE) to support regulatory assessments. Dexcom collaborated with the FDA, combining clinical study data with RWE to evaluate the device's performance in younger users over its 15-day wear period.
This development is crucial for addressing prediabetes in children, a condition characterized by elevated blood sugar levels. The availability of real-time glucose data from Stelo aims to empower pediatric patients and their caregivers in managing glucose levels more effectively. The global CGM market is anticipated to reach $15.69 billion by 2035, indicating significant growth potential.
Michelle Tarver, director at the FDA's Center for Devices and Radiological Health, emphasized the agency's dedication to providing children with advanced health management tools. This clearance underscores the FDA's commitment to fostering innovation and ensuring the safe, effective use of medical devices in environments where children live, learn, and play.
