In March 2024, the FDA approved the Dexcom Stelo Glucose Biosensor System as the first over-the-counter (OTC) CGM. It is expected to be available during the summer of 2024. The Dexcom Stelo is cleared for use in adults 18 years or older with or without diabetes who do not use insulin. It can also be used for individuals with diabetes treating their condition with oral medications or those without diabetes who want to understand better how diet and exercise may impact blood sugar levels. The system is available without a prescription.
The Stelo system has the sensor placed on the back of the upper arm and takes glucose readings every 15 minutes. Stelo does not have an alert signal to indicate glucose levels that are too high or too low. In addition, the system is not FDA-cleared for use with insulin delivery systems or insulin pumps.
OTC CGMs will soon become more readily available to people without diabetes. They could benefit individuals with prediabetes and those without diabetes who might have difficulty obtaining a prescription for a CGM. In addition, they could help people who were recently diagnosed with type 2 diabetes and whose insurance plan may not cover a CGM.
On the other hand, an OTC CGM may not be used if an insulin user is under 18 years old or might have problematic hypoglycemia (two or more episodes of severely low blood sugar in the past year). The Stelo system is not designed to alert individuals with hypoglycemia.
