FDA Approves First Over-the-Counter Glucose Monitor for Young Children

The U.S. Food and Drug Administration approved Dexcom Inc.'s Stelo Glucose Biosensor System for over-the-counter sales, marking the first continuous glucose monitor cleared for consumer purchase without a prescription.

The device carries FDA clearance for people age 2 and older who do not use insulin. It functions as an integrated continuous glucose monitor, or iCGM, a category the agency created to streamline approval of devices that measure glucose levels throughout the day.

Dexcom manufactures continuous glucose monitors, which patients wear on the skin to track blood sugar fluctuations. The company's previous CGM systems required prescriptions and primarily served people with diabetes who inject or pump insulin.

The OTC clearance expands the potential market beyond insulin users to include people managing their glucose levels through diet, exercise, or non-insulin medications. The approval reflects a shift in how regulators view glucose monitoring, positioning it as a tool for broader health management rather than exclusively for insulin-dependent patients.

The FDA's integrated CGM category allows manufacturers to seek approval through a streamlined pathway, reducing the time and cost required to bring devices to market. Under this framework, devices that meet specific performance standards and safety criteria can move through the review process faster than traditional medical devices.

Continuous glucose monitors have grown in popularity among people managing diabetes and prediabetes. The devices use a small sensor placed under the skin to measure glucose in fluid surrounding cells, transmitting readings to a receiver or smartphone app every few minutes.

Dexcom, based in San Diego, competes in a market alongside Abbott Laboratories, which makes the FreeStyle Libre system, and Medtronic, which produces Guardian. Those devices remain available primarily through prescription channels, though some insurers have expanded coverage for non-insulin users in recent years.

The Stelo approval comes as consumer interest in continuous glucose monitoring extends beyond people with diagnosed diabetes. Fitness enthusiasts, athletes, and people tracking metabolic health have driven demand for glucose-monitoring devices and apps, though the evidence supporting glucose monitoring for non-diabetic populations remains mixed among medical experts.

The FDA did not disclose specific pricing or availability details for Stelo. Dexcom has not announced retail locations or online channels through which consumers can purchase the device.