Over-the-counter CGM devices are continuous glucose monitors that adults in the United States can now buy without a prescription. In 2024 the FDA cleared the first ones. Here is what that clearance covers, who the devices are for, and what they do not do.
What an over-the-counter CGM is
A CGM is a small sensor worn on the body. It reads glucose in the fluid under the skin all day and night. It sends the numbers to a phone app. Until this year, people in the U.S. needed a prescription to get one.
That changed on March 5, 2024. The FDA announced that it had cleared the Dexcom Stelo Glucose Biosensor System. The agency called it the first over-the-counter CGM it had cleared. In its release, the FDA said the clearance lets people buy a CGM without the involvement of a health care provider.
Sources: FDA news release, "FDA Clears First Over-the-Counter Continuous Glucose Monitor," March 5, 2024.
Who the FDA says Stelo is for
The FDA set a clear target group. Stelo is for adults 18 and older who do not use insulin. That includes people with diabetes who manage it with pills or other non-insulin care. It also includes people without diabetes who want to see how food and exercise affect their glucose.
Stelo pairs a wearable sensor with a smartphone app. The sensor can be worn for up to 15 days. The app shows glucose readings and trends. The FDA says the system was tested in a clinical study and performed similarly to other integrated CGMs.
The FDA also listed side effects seen in the study. They included local infection, skin irritation, and pain or discomfort at the sensor site.
Sources: FDA news release, March 5, 2024.
What Stelo does not do
The limits matter as much as the clearance. The FDA says Stelo is not for people who use insulin. It is also not for people with problematic low blood sugar, which doctors call hypoglycemia.
The reason is simple. The FDA says the system is not designed to alert the user to this potentially dangerous condition. So a person who needs a low-glucose warning should not rely on it.
The agency also gave a plain rule for the numbers. Users should not make medical decisions based on the device's output without talking to their health care provider. A reading on your phone is information. It is not advice.
Sources: FDA news release, March 5, 2024.
A second option: Abbott Lingo
On June 10, 2024, Abbott announced FDA clearance for two over-the-counter systems. One is Lingo. Abbott describes it as a consumer product for adults 18 and older who want to improve their overall health and wellness. The sensor goes on the upper arm and is worn for 14 days. It sends data to a phone app that explains how food, exercise and daily stress affect glucose.
Abbott lists limits too. Lingo is for users 18 and older who are not on insulin. It is not intended for diagnosis of diseases, including diabetes. Abbott also says users should talk with a health care professional before changing their diet or exercise habits. At the time of the announcement, Abbott said people in the U.S. could sign up to be told when Lingo becomes available, so it was not yet on sale there.
The other system, Libre Rio, is cleared for adults 18 and older with type 2 diabetes who do not use insulin. Abbott called it its first over-the-counter CGM system for people with diabetes in the U.S. Abbott warns that using it other than as the label directs may cause a user to miss a severe low or high glucose event. If readings do not match symptoms, Abbott says to use a fingerstick meter value for treatment decisions.
Sources: Abbott news release, "Abbott Receives U.S. FDA Clearance for Two New Over-the-Counter Continuous Glucose Monitoring Systems," June 10, 2024.
How to read these clearances
FDA clearance means the agency reviewed a device for a stated use. That use is narrow. For these products it is adults, not on insulin, using a sensor and an app. Clearance does not turn a sensor into a doctor. It does not promise any health result.
An over-the-counter CGM can show you patterns, such as how your glucose moves after a meal or a walk. It cannot diagnose diabetes. Abbott says so directly for Lingo.
If you are thinking about one, check the label for your age and your medicines. Look at how long each sensor lasts and what the app shows. If you take insulin, or you have ever had dangerous lows, talk with your health care provider first. They can tell you whether a prescription device fits you better.
What to remember
- The FDA cleared the first over-the-counter CGM, Dexcom Stelo, on March 5, 2024.
- Abbott announced clearance for Lingo and Libre Rio on June 10, 2024.
- The devices are for adults 18 and older who do not use insulin.
- Stelo does not warn about low glucose, and none of these devices diagnose disease.
Sources: FDA news release, March 5, 2024; Abbott news release, June 10, 2024.