The Food and Drug Administration (FDA) of the United States has announced approval for the sale of a continuous glucose monitor (CGM) in an over-the-counter format that can be purchased and used by the general public. The approved device is the Dexcom Stelo Glucose Biosensor System (Stelo).
Stelo is a sensor that attaches to the arm and continuously transmits blood sugar level data to a phone every 15 minutes. Test results have shown that Stelo is just as effective as other glucose monitoring devices on the market.
The FDA restricts the use of Stelo by not allowing it to be used by patients requiring insulin or those with hypoglycemia and low blood sugar levels. However, it may be used by individuals with diabetes or those who need to monitor blood sugar levels after exercising.
Dexcom, the manufacturer of Stelo, has stated that the device will be available on the market in the upcoming summer.
TLDR: The FDA has approved the Dexcom Stelo Glucose Biosensor System as an over-the-counter continuous glucose monitor for general public use, with restrictions on certain patient populations. Look out for its release in the coming months.
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