Clinical Report: FDA Expands OTC CGM Access to Children
Overview
The FDA has cleared the Dexcom Stelo Glucose Biosensor System for over-the-counter use in children aged 2 years and older who do not use insulin. This device allows for continuous glucose monitoring.
Background
The FDA's clearance reflects a recognition of the importance of monitoring glucose levels in younger patients.
Data Highlights
The Stelo system provides glucose measurements every 15 minutes and is designed for a wear time of up to 15 days. Clinical study data supported its performance in pediatric patients.
Key Findings
The Stelo Glucose Biosensor System is indicated for children aged 2 years and older who do not use insulin.
The device is intended for those managing diabetes with oral medications and for individuals wanting to monitor lifestyle impacts on glucose levels.
Each sensor lasts up to 15 days, although wear time may be shorter in pediatric patients.
Adverse events reported include mild local infections, skin irritation, and discomfort.
The device should be used under adult supervision and is not suitable for patients with problematic hypoglycemia or those on dialysis.
Clinical Implications
The device should be used under adult supervision and is not suitable for patients with problematic hypoglycemia or those on dialysis.
Conclusion
The FDA's clearance of the Stelo system provides new options for continuous glucose monitoring.
