Over-the-Counter CGM(OTC CGM)
Definition
A continuous glucose monitor that can be purchased directly by consumers without a prescription, representing a new regulatory category established by the FDA in 2024. Over-the-counter CGMs are intended for general wellness and glucose awareness in people without diabetes, not for insulin dosing decisions. The Dexcom Stelo and Abbott Lingo were among the first OTC CGMs to reach the market, priced between $89 and $99 per month without insurance, and they cannot be used with insulin pumps or for closed-loop systems.
Why “Over-the-Counter CGM” Matters for Glucose Monitoring
Understanding over-the-counter cgm is essential for anyone using or evaluating a continuous glucose monitor. This concept directly affects how CGM devices are designed, how glucose data is interpreted, and how clinical decisions about blood sugar management are made. Regulatory classifications determine which CGMs you can buy without a prescription, which devices can be used for insulin dosing, and how insurance coverage is determined.
This term is particularly relevant to 2 CGM products in our database. Understanding OTC CGM helps you compare devices more effectively and choose the right continuous glucose monitor for your specific needs.
Related Terms
The regulatory approval pathway for CGM devices in the United States, typically through the FDA's 510(k) process, which requires the manufacturer to demonstrate that a new device is substantially equivalent to an existing legally marketed device.
A wearable medical device that tracks glucose levels in interstitial fluid 24 hours a day through a tiny sensor inserted just under the skin.
A regulatory classification that determines whether a CGM can be used as the sole basis for treatment decisions.