FDA Expands Access to Dexcom Stelo Glucose Biosensor for Children Aged 2 and Older
The U.S. Food and Drug Administration (FDA) has granted marketing clearance for the Dexcom Stelo Glucose Biosensor System to be used by children as young as 2 years old. This expansion allows the over-the-counter (OTC) continuous glucose monitor (CGM) to be used by pediatric patients who do not require insulin, providing a tool for families to track glucose patterns related to diet and exercise. Previously, the device was only authorized for adult use following its initial clearance in March 2024.
Who is the Stelo System for?
The Stelo system is specifically designed for individuals aged 2 and older who do not use insulin to manage their glucose levels. According to the FDA’s official guidance, the device is intended for those with diabetes who manage their condition through oral medications, as well as for individuals without diabetes who wish to monitor how their glucose levels respond to lifestyle factors such as dietary choices and physical activity. The system is not indicated for individuals who require insulin, as it lacks the high-acuity alerts necessary for managing insulin-dependent hypoglycemia.
How the Technology Works
The Stelo sensor is a wearable, integrated CGM that transmits glucose data directly to a smartphone application. The device provides a glucose reading every 15 minutes, allowing users and caregivers to observe trends over time. Each sensor is designed for a 15-day wear period, after which it must be replaced. By offering a clearer picture of how specific meals or activities influence blood sugar, the device aims to help families make informed adjustments to daily habits.
Clinical Significance for Pediatric Care
The authorization marks a shift in how non-insulin-dependent pediatric patients can monitor their metabolic health. Michelle Tarver, MD, PhD, acting director of the FDA’s Center for Devices and Radiological Health, stated that the clearance reflects a commitment to fostering innovation for pediatric patients. “Children deserve access to the best tools available to manage their health,” Tarver noted in the agency’s announcement. By bringing this technology to a younger demographic, the FDA aims to help caregivers and children build glycemic awareness that may support healthier long-term outcomes.
Comparison of CGM Access
The following table outlines the current regulatory standing for the Dexcom Stelo system compared to traditional prescription CGMs:
| Feature | Dexcom Stelo (OTC) | Prescription CGMs (e.g., Dexcom G7) |
|---|---|---|
| Target Audience | Non-insulin users | Insulin-dependent patients |
| Prescription Required | No | Yes |
| Alert Features | None (trends only) | High/Low glucose alerts |
| Age Indication | 2 years and older | Varies by specific device model |
What Happens Next
With this expanded clearance, the Stelo system will be available for purchase over the counter for pediatric use, removing the requirement for a physician’s prescription. Caregivers are encouraged to discuss the integration of CGM data with their pediatricians to ensure that the information gathered from the sensor is interpreted correctly within the context of the child’s overall health plan. As with all medical devices, users should monitor the sensor site for skin irritation and follow the manufacturer’s instructions for proper application and disposal.