FDA Clears First OTC Glucose Monitor for Children
The FDA has approved the first over-the-counter continuous glucose monitor for children, expanding accessibility for non-insulin users to track blood sugar.
The U.S. Food and Drug Administration (FDA) has cleared the Stelo Glucose Biosensor System by Dexcom Inc. for over-the-counter (OTC) marketing. This marks a significant milestone as it is the first OTC continuous glucose monitor (CGM) indicated for individuals two years of age and older who do not use insulin.
Traditionally, CGMs have required a prescription and were primarily used by individuals managing insulin-dependent diabetes. This new clearance expands the utility of CGM technology to a broader population, including children and adults with prediabetes, type 2 diabetes not requiring insulin, or individuals simply interested in monitoring their glucose levels for general health and wellness.
The Stelo system is an integrated CGM (iCGM), meaning it is designed to communicate with other medical devices and electronic health records, enhancing its potential for comprehensive health management.
This regulatory clearance empowers individuals, and parents of children, with unprecedented access to physiological data. Understanding glucose responses to daily activities and foods can lead to more informed health decisions, reinforcing the importance of being an active participant in one's own wellness journey.
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