SILVER SPRING, Maryland, June 12, 2026
The U.S. Food and Drug Administration (FDA) has cleared the Dexcom Stelo Glucose Biosensor System for over-the-counter use in children aged two years and older, marking a significant milestone in pediatric diabetes management and digital health innovation. The decision expands the availability of the first OTC continuous glucose monitor (CGM) beyond adults and makes advanced glucose monitoring technology accessible to younger users who do not require insulin therapy. The FDA previously authorized Stelo for adults aged 18 years and older in 2024. With rising rates of prediabetes and Type 2 diabetes among children, healthcare experts view the expanded clearance as an important advancement that could help families better understand glucose patterns, support healthier lifestyle choices, and improve long-term metabolic health outcomes. The clearance also reflects the growing role of connected medical devices in preventive healthcare and patient-centered disease management.
Expanded Access Brings Advanced Glucose Monitoring to Pediatric Users
The Dexcom Stelo Glucose Biosensor System is designed to provide continuous, real-time glucose monitoring through a wearable sensor paired with a smartphone application. The system measures, records, analyzes, and displays glucose levels every 15 minutes, helping users and caregivers gain valuable insight into how diet, exercise, sleep, and daily activities influence blood sugar levels. Unlike traditional fingerstick testing methods, continuous glucose monitoring offers ongoing visibility into glucose trends throughout the day.
The FDA noted that the device can benefit children with diabetes who are managed using oral medications as well as individuals seeking to better understand their metabolic health. By making advanced monitoring available without a prescription, the clearance could improve access to glucose management tools for millions of families while encouraging earlier intervention and increased awareness of diabetes risk factors. Healthcare professionals believe greater glucose visibility may support better lifestyle decisions and help reduce future disease burden.
Real-World Evidence Supports FDA Regulatory Decision
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The FDA emphasized that the pediatric clearance was supported through the use of real-world evidence (RWE), highlighting the agency’s increasing reliance on real-world data to evaluate medical device performance. Regulators and Dexcom analyzed previous clinical trial results alongside real-world usage data collected from both adult and pediatric continuous glucose monitor users. This approach helped establish confidence in the device’s performance across the full 15-day sensor wear period. The system uses a compact wearable biosensor that can remain in place for up to 15 days before replacement, although wear times may vary among younger users due to physiological and behavioral factors.
Clinical data demonstrated an acceptable safety profile, with reported adverse events primarily limited to mild skin irritation, localized discomfort, or minor infections at the application site. The FDA’s use of real-world evidence in this decision highlights a broader trend toward leveraging patient-generated healthcare data to accelerate access to innovative technologies while maintaining rigorous safety standards.
Digital Health Innovation Supports Home-Based Diabetes Management
The expanded clearance aligns closely with the FDA’s Home as a Health Care Hub Initiative, which encourages the development of technologies that enable patients to manage health conditions more effectively outside traditional clinical settings. As healthcare systems increasingly adopt remote monitoring and digital health solutions, continuous glucose monitoring devices are becoming critical tools for improving disease prevention and chronic disease management. The Stelo system allows caregivers to monitor glucose information using compatible smartphones, supporting collaborative care and greater engagement in pediatric health management. However, the FDA emphasized that the device is not intended for individuals with problematic hypoglycemia, those undergoing dialysis, or users requiring automated low-glucose alerts.
The agency also recommends that patients and caregivers consult healthcare professionals before making medication changes based on CGM data. With pediatric diabetes and metabolic disorders continuing to rise globally, the expanded availability of OTC continuous glucose monitoring technology represents an important advancement in preventive healthcare, digital medicine, and patient empowerment, helping families make more informed decisions about health and wellness.
Source: FDA press release
