STAT+: FDA clears first over-the-counter continuous glucose monitor
The agency Tuesday authorized Dexcom to start selling a new product, called the Stelo, to adults who do not use insulin.
For the first time, anyone in the United States will soon be able to buy a continuous glucose monitor without a prescription. The Food and Drug Administration authorized Dexcom on Tuesday to start selling a new product, called the Stelo, to adults who do not use insulin. The product is scheduled to hit the market this summer.
The Stelo product is explicitly designed for people with type 2 diabetes who are not reliant on insulin, or people without diabetes who are curious about how diet and exercise impact their blood sugar levels. The sensor will pair with a smartphone app, which will provide blood glucose measurements every 15 minutes. Dexcom has not yet released the price of the device.
The first continuous glucose monitor was approved by the FDA in 2017. Since then, people with type 1 diabetes have come to rely on the technology to noninvasively monitor their blood sugar levels and sometimes to control their insulin pump instantaneously. The space has been incredibly lucrative for companies like Dexcom and Abbott, with CGM use exploding into a $5 billion market.
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