INDIANA — The U.S. Food and Drug Administration (FDA) has officially cleared Dexcom Inc.’s Stelo Glucose Biosensor System for over-the-counter (OTC) marketing to children, marking the first time an OTC continuous glucose monitor (CGM) has been approved for pediatric use.
The integrated CGM (iCGM) system is now indicated for individuals two years of age and older who do not use insulin. The federal agency previously cleared the Stelo system for OTC use in adults aged 18 and older in March 2024.
“Children deserve access to the best tools available to manage their health,” said Michelle Tarver, M.D., Ph.D., Director of the FDA’s Center for Devices and Radiological Health. “Today’s clearance reflects the FDA’s commitment to fostering innovation for pediatric patients and supporting the safe and effective use of medical devices where children live, learn, and play.”
Addressing the Rise of Pediatric Prediabetes
The expanded clearance comes at a critical time, as prediabetes increasingly impacts children across the United States, placing millions of youth at a heightened risk for progressing to Type 2 diabetes.
For pediatric users who do not require insulin, OTC continuous glucose monitors are expected to play a vital public health role. By offering real-time glucose data, the Stelo system allows pediatric patients and their caregivers to develop greater glycemic awareness, track trends in response to physical activity and meals, and make proactive lifestyle changes to support long-term health outcomes.
The device is specifically indicated for children—including those diagnosed with diabetes—who manage their condition via oral medications, as well as individuals who simply want to monitor how diet, exercise, and other behavioral factors influence their blood sugar levels.
How the Technology Works
The Stelo Glucose Biosensor System consists of two primary components:
- A Wearable Sensor: Applied directly to the skin to continuously measure, record, and analyze glucose values.
- A Smart Application: Paired via a compatible smartphone or smart device—such as a parent’s or caregiver’s phone—to display updated glucose measurements and trend lines every 15 minutes.
Each sensor is designed to last for up to 15 days before replacement is necessary. However, the FDA notes that actual sensor wear time may be shorter in pediatric users than in adults due to a combination of physiological and behavioral factors unique to children.
Safety Guidelines and Limitations
The FDA emphasized several critical parameters and exclusions regarding the safe use of the device:
- Caregiver Supervision Required: For pediatric users, the device must be utilized under the direct supervision of an adult caregiver.
- Not for Insulin Users or Hypoglycemia: The system is not designed for individuals with problematic hypoglycemia (low blood sugar) because it lacks an alert system to warn users when dangerously low levels occur.
- Medical Consultations: Users and caregivers are strongly advised to consult a healthcare provider before making any medication adjustments based on the device’s data.
- Other Exclusions: The system is not approved for individuals on dialysis. Additionally, anyone with a history of disordered eating or eating disorders should speak with a medical professional before using the Stelo system.
In previous clinical tracking, participants reported only mild adverse events, which included localized skin irritation, pain or discomfort, and minor local infections where the sensor was applied.
Real-World Evidence Fuels Fast Innovation
The expansion into pediatric care was heavily supported by the FDA’s utilization of real-world evidence (RWE) to guide regulatory decisions. Dexcom and the FDA evaluated existing clinical study data alongside RWE gathered from real-world data on current iCGM use across both adult and pediatric populations. This allowed regulators to safely project device performance and accuracy across the full 15-day pediatric wear window.
This regulatory clearance also aligns with the FDA’s broader “Home as a Health Care Hub Initiative.” The program focuses on advancing the development of innovative, patient-centered technologies that fit seamlessly into a family’s daily lifestyle at home rather than relying strictly on clinical environments.
