By VETTAPHARMA reporter – Derek Roche: The U.S. Food and Drug Administration (FDA) has cleared Dexcom’s Stelo Glucose Biosensor System for over-the-counter (OTC) use in children aged 2 years and older who do not use insulin, making it the first OTC continuous glucose monitor (CGM) authorized for pediatric use.
The expanded indication broadens access to continuous glucose monitoring for children with diabetes managed without insulin and those seeking to better understand how diet, exercise, and lifestyle affect glucose levels.
The Stelo Glucose Biosensor System was previously cleared in March 2024 for OTC use in adults aged 18 years and older. The new pediatric indication reflects the FDA’s effort to expand access to innovative home-based technologies for younger patients, particularly as prediabetes continues to affect increasing numbers of children in the United States.
The integrated CGM (iCGM) uses a wearable sensor paired with a compatible smartphone or smart device to continuously measure, analyze, and display glucose values. Each sensor is designed to last up to 15 days, although wear time may be shorter in pediatric users. The companion application updates glucose measurements and trends every 15 minutes, enabling children and caregivers to monitor glucose patterns and discuss treatment decisions with healthcare providers.
The FDA based its decision on a combination of previous clinical study data from pediatric and adult populations and real-world evidence (RWE) collected from current iCGM users. According to the agency, these data supported expected device performance throughout the intended 15-day wear period in children.
Reported adverse events were generally mild and included local infection, skin irritation, and pain or discomfort. The FDA noted that the device should be used under adult supervision in children and is not intended for people with problematic hypoglycemia, those receiving dialysis, or individuals with a history of disordered eating without consulting a healthcare provider.
The clearance also supports the FDA’s Home as a Health Care Hub Initiative, which promotes the development of patient-centered medical devices designed for use in everyday home settings.
Quick FAQs
1. What Is The Stelo Glucose Biosensor System?
The Stelo Glucose Biosensor System is an over-the-counter integrated continuous glucose monitor (iCGM) that continuously measures glucose levels using a wearable sensor paired with a compatible smartphone or smart device.
2. What Happened?
The FDA cleared Dexcom’s Stelo Glucose Biosensor System for OTC use in children aged 2 years and older who do not use insulin, making it the first OTC continuous glucose monitor approved for pediatric use.
3. What Evidence Supported The Clearance?
The FDA relied on previous pediatric and adult clinical study data together with real-world evidence (RWE) from existing iCGM users to evaluate device performance over the intended 15-day wear period.
4. Who Can Use The Device?
The device is indicated for children aged 2 years and older, including those with diabetes managed with oral medications, and individuals who want to understand how diet, exercise, and lifestyle affect their glucose levels. It is intended for people who do not use insulin.
5. What Are The Key Device Features And Safety Findings?
The wearable sensor provides glucose readings every 15 minutes and lasts for up to 15 days per sensor. Mild adverse events included local infection, skin irritation, and pain or discomfort.
6. Why Is This Important?
The clearance expands access to continuous glucose monitoring for young children without requiring a prescription, providing families with a new tool to improve glucose awareness and support healthier long-term management of diabetes and prediabetes.
