Regulatory Snapshot
Device: Stelo® Glucose Biosensor System (Dexcom, Inc.)
Indication: Continuous glucose monitoring for individuals ages 2 years and older who do not use insulin, including children with diabetes managed through oral medications and individuals seeking to understand glucose responses to diet, exercise, and lifestyle factors.
Technology: Integrated Continuous Glucose Monitor (iCGM) consisting of a wearable glucose sensor paired with a smartphone application that displays glucose values and trends every 15 minutes.
Regulatory Pathway: 510(k) Clearance (Expansion of Existing Device Indication).
Notable Regulatory Feature: First Over-the-Counter (OTC) Continuous Glucose Monitor cleared for pediatric use.
Real-World Evidence: FDA incorporated real-world evidence and prior clinical study data from both pediatric and adult users to support performance expectations across the full sensor wear period.
Home Use Designation: Supports FDA’s Home as a Health Care Hub Initiative through caregiver-monitored and patient-managed glucose tracking.
Original OTC Clearance: March 5, 2024 (Adults 18+).
Pediatric Clearance: June 12, 2026 (Ages 2+).
Dexcom’s Stelo System Expands Access to Glucose Monitoring for Pediatric Patients
The U.S. Food and Drug Administration (FDA) has cleared the first over the counter (OTC) continuous glucose monitor (CGM) for children.
On June 12, 2026, FDA authorized Dexcom’s Stelo Glucose Biosensor System for use in individuals two years of age and older who do not use insulin, expanding the device’s previously authorized indication for adults.
The clearance marks an important milestone in pediatric diabetes management and consumer health technology, providing children and caregivers with direct access to continuous glucose monitoring without a prescription.
Expanded Access for Pediatric Users
The Stelo Glucose Biosensor System is an integrated continuous glucose monitor (iCGM) designed to provide real-time glucose information through a wearable sensor paired with a smartphone application.
The device is indicated for children and adults ages 2 years and older, individuals with diabetes who manage their condition without insulin, patients using oral diabetes medications, and individuals seeking to understand how diet, exercise, and lifestyle choices affect glucose levels.
The system continuously measures and records glucose levels, displaying updated glucose values and trends every 15 minutes through a compatible smartphone or smart device.
For pediatric users, caregivers may monitor glucose information directly through their own devices.
Addressing a Growing Public Health Challenge
According to FDA, prediabetes and Type 2 diabetes are increasingly affecting pediatric populations in the United States. Continuous glucose monitoring may help children and families better understand glucose patterns, recognize the impact of meals and physical activity, and support healthier long-term lifestyle decisions.
“Children deserve access to the best tools available to manage their health,” said Michelle Tarver, M.D., Ph.D., Director of FDA’s Center for Devices and Radiological Health.
FDA noted that expanded access to OTC glucose monitoring technology may help improve glycemic awareness and support earlier intervention for children at risk of developing Type 2 diabetes.
Device Features
The Stelo system consists of a wearable glucose sensor, smartphone application, continuous glucose monitoring functionality, and trend analysis and glucose tracking.
Each sensor is designed to function for up to 15 days before replacement, although FDA noted that wear time may be shorter in pediatric users because of physiological and behavioral factors.
Users should consult healthcare professionals before making medication changes based on device readings.
Real-World Evidence Supports Clearance
The clearance also highlights FDA’s growing use of real-world evidence (RWE) in regulatory decision-making. Rather than relying exclusively on traditional clinical studies, FDA and Dexcom combined previous clinical data with real-world performance information collected from current CGM users.
The agency evaluated data from both adult and pediatric populations to assess expected device performance throughout the sensor’s wear period.
The decision represents another example of FDA’s increasing acceptance of real-world data as part of medical device regulatory submissions.
Safety Considerations
Reported adverse events included mild skin irritation, localized infection, and pain or discomfort at the sensor site.
FDA emphasizes that the device should be used under adult supervision for children; is not intended for people with problematic hypoglycemia because it does not provide low-glucose alerts; is not intended for individuals on dialysis; and may not be appropriate for individuals with a history of eating disorders without healthcare provider guidance.
Regulatory Perspective
The clearance aligns with FDA’s Home as a Health Care Hub Initiative, which promotes technologies that enable patients and families to manage health conditions outside traditional healthcare settings.
By expanding access to OTC glucose monitoring for pediatric patients, FDA continues to support the development of patient-centered technologies that integrate healthcare into daily life while maintaining appropriate safety and performance standards.
MDP Perspective
This clearance represents more than an expansion of a glucose monitoring device indication.
It reflects broader regulatory trends toward increased patient self-management, expanded home-use medical technologies, greater caregiver involvement, consumer-accessible healthcare devices, and increased use of real-world evidence in regulatory submissions.
As digital health and connected medical devices continue to evolve, FDA’s willingness to leverage real-world evidence and support OTC access models will likely play an increasingly important role in accelerating innovation while expanding patient access to healthcare technologies.
Why This Matters
This clearance illustrates three important FDA regulatory trends:
Expansion of OTC medical devices into increasingly complex clinical areas.
Growing acceptance of real-world evidence (RWE) to support regulatory decision-making.
Migration of healthcare technologies into the home, allowing patients and caregivers greater access to health information without requiring prescription-only access.
Unlike many device clearances that focus solely on technological innovation, the Stelo pediatric expansion represents an evolution in how FDA approaches accessibility, home healthcare, and digital health monitoring.
