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.

Related Resources & Content

1. FDA, FDA, 2026 -- FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children
2. American Diabetes Association, PMC, 2026 -- Diabetes Technology: Standards of Care in Diabetes—2026
3. conexiant — Expanding CGM Access for Medicare Patients
4. The Journal of Clinical Endocrinology & Metabolism — Transforming the Oral Glucose Tolerance Test: Harnessing Real-Time Data and Enhanced Insights from Continuous Glucose Monitoring
5. The Journal of Clinical Endocrinology & Metabolism — Evaluation of Continuous Glucose Monitoring for Identifying Stages of Presymptomatic Type 1 Diabetes in Pediatric Patients
6. The Journal of Clinical Endocrinology & Metabolism — Assessment of the Feasibility, Acceptability, and Validity of an At-Home Continuous Glucose Monitoring Oral Glucose Tolerance Test in Adolescents
7. Expanding CGM Access for Medicare Patients
8. Transforming the Oral Glucose Tolerance Test: Harnessing Real-Time Data and Enhanced Insights from Continuous Glucose Monitoring
9. Evaluation of Continuous Glucose Monitoring for Identifying Stages of Presymptomatic Type 1 Diabetes in Pediatric Patients
10. Assessment of the Feasibility, Acceptability, and Validity of an At-Home Continuous Glucose Monitoring Oral Glucose Tolerance Test in Adolescents
11. FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children | FDA
12. 7. Diabetes Technology: Standards of Care in Diabetes—2026 - PMC
13. Effectiveness of Continuous Glucose Monitoring on Metrics of Glycemic Control in Type 2 Diabetes Mellitus | Endocrine Society