The U.S. Food and Drug Administration (FDA) on Friday cleared Dexcom Inc.‘s (NASDAQ:DXCM) Stelo Glucose Biosensor System for over-the-counter use in children ages 2 and older who do not use insulin, expanding access to continuous glucose monitoring for younger patients.
The FDA previously cleared Stelo for adults 18 and older in March 2024. The device is now the first over-the-counter continuous glucose monitor authorized for children in this population.
The expanded clearance comes as prediabetes affects a growing number of U.S. children, raising their risk of developing Type 2 diabetes.
Device Tracks Glucose Levels Every 15 Minutes
The device uses a wearable sensor paired with a compatible smartphone or smart device, including a parent's or caregiver's phone. It continuously measures, records, analyzes, and displays glucose readings and trends every 15 minutes.
Each sensor is designed to last up to 15 days before replacement. However, the FDA noted that wear time may be shorter in pediatric users because of physiological and behavioral differences compared with adults.
The agency advised users and caregivers to consult healthcare providers before making medication changes based on readings generated by the device.
FDA Relied On Real-World Evidence
The clearance also highlights the FDA's use of real-world evidence in regulatory decision-making.
Dexcom and the agency evaluated data from previous clinical studies involving both pediatric and adult participants, alongside real-world data from current integrated CGM users, to assess expected performance across the full 15-day wear period.
Participants in earlier studies reported mild adverse events, including local infections, skin irritation, pain, and discomfort.
DXCM Stock Price Activity: DexCom shares were down 2.2% at $73.71 at the time of publication on Monday, according to Benzinga Pro data.
Photo: Photo Nature Travel / Shutterstock.com
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