Objective:

To provide access to the Dexcom Stelo Glucose Biosensor System for children aged 2 years and older who do not use insulin.

Approach:

Key Findings:

• The device is designed for children aged 2 years and older.
• Each sensor lasts up to 15 days, with potential shorter wear time in pediatric patients.
• Mild adverse events reported include local infection, skin irritation, and discomfort.

Interpretation:

The device is not suitable for patients with problematic hypoglycemia or those receiving dialysis.

Limitations:

• Does not provide alerts for low glucose levels.
• Patients with a history of disordered eating should consult a healthcare provider before use.

Conclusion:

The clearance aligns with the FDA's initiative to support home healthcare devices.

Sources:

• FDA
Source

Based on findings from:

FDA Expands OTC CGM Access to Children

Kathryn Wighton. MDSpire News, 2026.

https://news.mdspire.com/pediatrics/articles/fda-expands-otc-cgm-access-to-children/

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