Are Continuous Glucose Monitors Available OTC? Plus, Answers to 6 Other FAQs
Key takeaways:
In March 2024, the FDA cleared Dexcom’s Stelo Glucose Biosensor System. It was the first over-the-counter (OTC) continuous glucose monitor (CGM). Since then, other OTC CGMs, such as Abbott’s Lingo, have also become available for purchase without a prescription.
Dexcom’s Stelo is FDA cleared for use in adults with or without diabetes who don’t use insulin. Stelo is not safe for people who are prone to hypoglycemia (low blood sugar). That's because it doesn’t alert for low or high glucose levels.
Abbott’s Lingo is FDA cleared for adults as a general health and wellness tool. Lingo is not cleared for use for those with diabetes. Like Stelo, this CGM doesn’t alert for out-of-range glucose values.
Table of contents
People living with diabetes typically check their glucose (sugar) every day — sometimes several times per day. There are two at-home devices to do this with: glucometers and continuous glucose monitors (CGMs).
Rather than doing fingerstick checks throughout the day, many people wear a CGM instead. Glucometers provide limited information. They can only tell you what your blood glucose is at that moment. On the other hand, a CGM automatically provides glucose data every few minutes along with trends and patterns over time.
In the past, CGMs have required a prescription to purchase. This made it tough for people who are at risk for developing (but don’t currently have) diabetes to access these devices. But that’s not the case anymore. Because like glucometers, some CGMs are now available over the counter (OTC).
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1. Are there any OTC continuous glucose monitors (CGMs)?
Yes, there are a few OTC CGMs. In March 2024, the FDA cleared Dexcom’s Stelo Glucose Biosensor System for OTC use. This made headlines, as it was the first CGM to be cleared for OTC purchase. Then in June 2024, Abbott received FDA clearance for two OTC CGMs: Lingo and Libre Rio.
Stelo and Lingo are currently available for purchase. Libre Rio hasn't been commercially launched yet.
Dexcom and Abbott are well-known CGM manufacturers. Dexcom makes the prescription-only G6 and G7 CGMs. Abbott makes the FreeStyle Libre line of prescription CGMs.
Good to know: “FDA cleared” is a term used to describe medical devices that the FDA has reviewed for safety and effectiveness. Many people use the terms “FDA cleared” and “FDA approved” interchangeably. But FDA approval is a different process, and it’s typically only used to review medications and vaccines.
2. How do CGMs work?
CGMs are wearable devices that measure the glucose in the fluid underneath your skin 24 hours a day. They don’t measure blood glucose. This means there might be a few minutes of “lag time” between when your blood glucose changes and when your CGM senses it.
CGMs have three main components, which include:
A sensor that detects glucose levels. Most CGMs use a self-inserted microneedle that provides regular measurements. But there are also implantable CGMs that are placed beneath the skin by a healthcare professional.
A transmitter that sends glucose readings from the sensor to a receiver. Some CGMs come with the transmitter pre-attached to the sensor. Others require you to attach the transmitter to the sensor before you can use the device.
A receiver that displays glucose readings taken by the sensor. Depending on the CGM, you’ll have the option of using a smartphone app or a touchscreen reader.
OTC CGMs should be placed on the back of your upper arm. Directions for inserting sensors vary brand to brand. So be sure to read your user manual before inserting your first sensor.
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How long an OTC sensor lasts and how often it provides readings also varies between brands:
Dexcom’s Stelo’s sensor takes readings every 15 minutes and lasts for up to 15 days.
Abbott’s Lingo’s sensors take readings every minute and last for up to 14 days.
Because Abbott’s Libre Rio hasn’t launched yet, we don’t have information on its exact specifications. But it’s expected to be similar to Lingo.
3. Can anyone use OTC CGMs?
Many people will be eligible to use OTC CGMs. This includes people without diabetes who are interested in using a device for general health and wellness. Or for those who may be at risk of developing diabetes or were recently diagnosed with Type 2 diabetes, whose insurance plan may not cover a CGM.
While CGMs are available without a prescription, they aren’t right for everyone. For example, you shouldn’t use Dexcom’s Stelo if you:
Use insulin
Are under 18 years old
Receive dialysis
Have problematic hypoglycemia (two or more episodes of severe low blood glucose in the past year)
Stelo doesn’t alert for hyperglycemia (high blood glucose) or hypoglycemia (low blood glucose). These events, especially hypoglycemia, can become life-threatening. So people who have a higher risk of experiencing it shouldn’t use Stelo.
Lingo is a wellness CGM for adults. It’s not FDA cleared to help manage diabetes. So if you have diabetes, don’t use it. It can’t alert you to high or low glucose levels and has a narrower range of glucose levels it can read.
For example, Lingo can only measure glucose levels between 55 mg/dL and 200 mg/dL. People with diabetes sometimes have glucose levels outside of this range. That’s why it shouldn’t be used for diabetes management. To compare, Dexcom’s Stelo can measure levels between 40 mg/dL and 400 mg/dL, which is similar to prescription-only CGMs.
If you’re living with diabetes, it’s a good idea to discuss with your healthcare team whether using an OTC CGM is right for you. Depending on your personal risks and health history, they may recommend that you use a prescription-only CGM.
4. Are OTC CGMs good for people with prediabetes?
Yes, OTC CGMs can be helpful for people with prediabetes. Lifestyle changes, such as following a prediabetes-friendly diet and exercising regularly, are an essential part of managing prediabetes. And CGMs can help you be more aware of how these lifestyle changes affect your glucose levels.
Studies on the benefits of CGM use with prediabetes are limited. But experts believe these devices may help people discover they have prediabetes earlier. And earlier awareness helps guide changes to prevent Type 2 diabetes.
5. How do OTC and prescription CGMs compare?
All CGMs are generally similar, but they have differences in their advanced features. A few notable comparisons between OTC and prescription CGMs include:
Recommended age ranges: OTC CGMs are only FDA cleared to be used by adults 18 and older. Many prescription CGMs, such as the Dexcom G7, are cleared for use by children, sometimes as young as 2 years old.
How often they take readings: As mentioned earlier, Stelo takes readings every 15 minutes. Lingo and many prescription CGMs, such as the FreeStyle Libre 3, take readings more frequently — sometimes as often as every minute.
Alert capabilities: OTC CGMs don’t provide alerts for out-of-range glucose levels. Only prescription CGM models have this capability.
Insulin pump compatibility: Stelo isn’t cleared for use by people who are prescribed insulin. That’s why it’s not compatible with smart insulin pens, insulin pumps, or automated insulin delivery (AID) systems. Many prescription CGMs are compatible with these insulin delivery devices.
6. How much do OTC CGMs cost?
The available OTC CGMs cost about the same.
As of December 2024, Dexcom’s Stelo costs $89 per month if you sign up for a monthly subscription. A one-time order of 2 sensors (a 1-month supply) costs $99. A 3-month subscription plan costs $252, which comes out to $84 per month.
Abbott’s Lingo has different options. You can purchase a one-time 2-week supply (1 sensor) for $49 or 4-week supply (2 sensors) for $89. They also offer a 12-week (about 3 months) subscription plan, which costs $249 every 12 weeks. This works out to $83 per month.
7. Where can you purchase an OTC CGM?
Unlike prescription CGMs, you won’t find OTC CGMs in community pharmacies. Both Stelo and Lingo are only available to purchase through their manufacturers’ websites. After you order, the product will be shipped directly to you.
The bottom line
In March 2024, the FDA cleared the first over-the-counter (OTC) continuous glucose monitor (CGM) — Dexcom’s Stelo. A few months later, Abbott’s Lingo and Libre Rio were also cleared for OTC use. Since then, Stelo and Lingo have launched and are available to buy without a prescription. Libre Rio isn’t available for purchase yet.
OTC CGMs aren’t for everyone. Stelo is cleared to help manage diabetes in adults who don’t use insulin and aren't prone to hypoglycemia (low blood glucose). It can also be used as a lifestyle tool if you don’t have diabetes. On the other hand, Lingo isn’t cleared for use in diabetes. It’s a general health and wellness tool for use in adults.
Having CGMs available OTC makes these devices more widely accessible. For those living with diabetes, it’s best to discuss CGM use with your healthcare team to determine what the safest option is for you.
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References
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Abbott. (2024). Hello, Lingo: Next-gen health coach is FDA-cleared.
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Choudhary, P., et al. (2015). Evidence-informed clinical practice recommendations for treatment of Type 1 diabetes complicated by problematic hypoglycemia. Diabetes Care.
Dexcom. (n.d.). Stelo glucose biosensor - one-time purchase.
Dexcom, Inc. (2024). Stelo glucose biosensor essentials.
Dexcom, Inc. (2024). Stelo user guide.
diaTribe Learn. (n.d.). Continuous glucose monitoring: What is CGM, how does it work, and which device is right for me?
Klonoff, D. C., et al. (2022). Use of continuous glucose monitors by people without diabetes: An idea whose time has come? Journal of Diabetes Science and Technology.
Lingo. (n.d.). Is Lingo the same as Freestyle Libre?
Lingo. (n.d.). Select your plan.
National Institute of Diabetes and Digestive and Kidney Diseases. (2023). Continuous glucose monitoring. National Institutes of Health.
U.S. Food and Drug Administration. (n.d.). 510(k) Substantial equivalence determination decision summary: Assay and instrument.
U.S. Food and Drug Administration. (2024). FDA clears first over-the-counter continuous glucose monitor.
