Yes, you can now buy a continuous glucose monitor without a prescription in the United States. In March 2024, the FDA cleared Dexcom Stelo as the first over-the-counter CGM, and Abbott’s Lingo and Libre Rio have since joined the OTC category. These sensors are designed for adults 18 and older who are not using insulin and are intended for metabolic awareness rather than insulin dosing.
What OTC CGMs Are and How They Differ From Prescription Devices
A continuous glucose monitor uses a small sensor with a thin filament that sits in the interstitial fluid just under the skin. The sensor measures glucose every few minutes and transmits the data to a phone app. Prescription CGMs, such as Dexcom G7 and Abbott FreeStyle Libre 3, were built for people with type 1 and insulin-using type 2 diabetes and include alarms for low and high glucose that support insulin dosing decisions.
OTC CGMs use essentially the same sensor hardware but are paired with apps tuned for a non-insulin audience. Stelo and Lingo display glucose trends, spike alerts, and sometimes a proprietary score or summary. They are not approved as aids for insulin dosing, and their default display ranges are narrower than clinical CGMs.
The FDA Pathway and Regulatory Context
The FDA authorized Dexcom Stelo through the De Novo pathway in March 2024, creating a new regulatory category for integrated CGMs intended for non-insulin users. The De Novo summary outlined accuracy testing, human factors studies for untrained users, and labeling that explicitly excludes insulin dosing. Abbott’s Lingo and Libre Rio were cleared under similar frameworks.
Users can read the formal decision at the FDA De Novo decision summary, which outlines what the device can and cannot claim. Importantly, OTC clearance does not mean the device is approved for every clinical use; labeling rules out insulin dosing and pediatric use.
Accuracy Expectations
CGM accuracy is typically reported as mean absolute relative difference, or MARD. A lower MARD means readings are closer to a lab reference. Current prescription CGMs report MARD in the high single digits, which is considered excellent. OTC versions share sensor chemistry with their prescription counterparts, so real-world accuracy is similar in adult non-insulin users.
| OTC CGM | Wear time | Typical MARD range | Intended user |
|---|---|---|---|
| Dexcom Stelo | Up to 15 days | ~8 to 9 percent | Adults 18+ not using insulin |
| Abbott Lingo | Up to 14 days | ~9 to 10 percent | Adults 18+ focused on metabolic health |
| Abbott Libre Rio | Up to 14 days | ~9 to 10 percent | Adults 18+ with type 2 diabetes not on insulin |
Real-world accuracy varies by individual. Some users may see sensor-to-sensor variability, compression lows during sleep if they lie on the sensor, or delays relative to a fingerstick, since interstitial glucose lags blood glucose by 5 to 15 minutes during rapid changes.
Who Can Benefit From an OTC CGM
An OTC CGM can be useful for people newly aware of prediabetes who want to see how specific foods, stress, or workouts affect their glucose. It can also help people with type 2 diabetes on non-insulin medications spot patterns that a weekly fingerstick would miss. For a broader picture of prediabetes risk factors, our prediabetes overview provides useful context, while our diet and nutrition hub offers meal planning ideas that can be paired with CGM data.
OTC CGMs are not substitutes for A1C testing. Our A1C levels guide explains how the two metrics work together — CGM shows the minute-to-minute picture while A1C reflects the three-month average.
Who Should Stick With a Prescription System
People using insulin, experiencing recurrent hypoglycemia, pregnant, under 18, or managing complex conditions should continue using prescription CGMs with clinician oversight. Prescription systems offer predictive low alerts, integration with insulin pumps, and customer support through a durable medical equipment supplier. They also qualify for insurance coverage, whereas most OTC CGMs are currently out-of-pocket.
Practical Use Tips
Users generally apply the sensor to the back of the upper arm using a disposable applicator. Adhesion lasts longer when the skin is clean, dry, and free of lotion. An overpatch can help keep sensors secure during exercise or showering. Data is viewed through the brand’s app, which displays current glucose, trend arrows, and a 24-hour history.
- Log meals briefly to spot food responses.
- Look for overall trends rather than reacting to every reading.
- Confirm very low or very high readings with a fingerstick if available.
- Bring data to clinician visits; many apps export PDF summaries.
Cost and Availability
OTC CGMs are typically sold directly through the manufacturer’s website or in major pharmacies. Monthly cost varies by brand and plan, and none are broadly covered by insurance at launch. Some flexible spending accounts and health savings accounts may reimburse the cost.
The Bottom Line
OTC CGMs like Dexcom Stelo, Abbott Lingo, and Libre Rio have made continuous glucose data accessible to adults who are not using insulin and not seeking a prescription. Accuracy is comparable to prescription sensors, but FDA clearance is specifically for metabolic awareness rather than insulin dosing. Paired with a clinician’s guidance and lab testing, an OTC CGM can be a practical tool for people with prediabetes or early type 2 diabetes to see how lifestyle affects their glucose in real time.
Medical disclaimer: This article is for educational purposes only and is not a substitute for advice from a qualified healthcare professional. Discuss device choices and any changes in your care with your own clinician.
