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1Fix the driver behind crashes, sound loss and screen glitches2Repair Windows errors before they cause bigger problems3Scan for outdated or missing drivers - takes under a minuteThe FDA cleared Dexcom Stelo on March 5, 2024, making it the first over-the-counter continuous glucose monitor (CGM) in the United States. Its original indication covered adults aged 18 and older who do not use insulin; in June 2026, the FDA expanded the indication to people aged 2 and older who do not use insulin. Stelo is a sensor-based medical device, not a glucose-measuring smartwatch, and OTC access does not remove its safety limits.
The FDA cleared Dexcom Stelo—not “approved” it—as the first OTC CGM for adults
The FDA’s March 5, 2024 action cleared Stelo through a traditional 510(k) decision based on substantial equivalence. The original clearance covered adults aged 18 and older who do not use insulin.
“Cleared” is the more precise term for this regulatory action. OTC means eligible consumers can obtain the system without a prescription; it does not mean the device is suitable for everyone or that its readings replace medical advice.
On June 12, 2026, the FDA expanded Stelo’s OTC indication to people aged 2 and older who do not use insulin. The adult-focused title describes the original clearance, while the current indication also includes eligible children.
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- HSA/FSA eligible. No prescription needed.
- 24/7 GLUCOSE TRACKING. See your glucose response to food, exercise, sleep, and other lifestyle factors via the Lingo app.
- OPTIMIZE YOUR NUTRITION. Discover which foods work for you and those that don't. The Lingo app shows you how specific meals and other factors impact your glucose, so you can learn from your insights and build healthier habits
- NAVIGATE PREDIABETES WITH A NEW VIEW OF YOU. More time in healthy glucose range is linked to lower diabetes risk. Three out of four users with prediabetes say Lingo was effective in helping to achieve their health goals¹.
- HEALTHY GLUCOSE SUPPORTS HEART HEALTH. What you eat matters to your glucose and your heart. Keeping your glucose in a healthy range (70–140 mg/dL) more often can help protect your heart from heart disease²⁻⁴.
What the FDA actually cleared
The FDA’s 510(k) record identifies the device as the Dexcom Stelo Glucose Biosensor System, number K234070, and records a substantially equivalent decision. The FDA identified Dexcom’s G7 system as the predicate device.
Stelo combines a wearable sensor, which measures glucose in interstitial fluid beneath the skin, with an app on a compatible smartphone or other smart device. The app displays glucose measurements and trends. OTC access does not change the product’s intended use, warnings, or suitability limits.
Who Stelo is for
The original adult indication covered people who are 18 or older and do not use insulin. The FDA described potential users as including people with diabetes managed without insulin, such as some people using oral medication, and people without diabetes interested in how diet and exercise affect glucose.
Stelo is not a diagnostic test for diabetes or prediabetes. A CGM can provide glucose measurements and trends, but a qualified health professional should interpret results and advise whether additional testing is appropriate.
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On June 12, 2026, the FDA cleared Stelo for OTC use in people aged 2 and older who do not use insulin. The FDA described this as the first OTC CGM clearance for children.
Rank #2
- HSA/FSA eligible. No prescription needed.
- 24/7 GLUCOSE TRACKING. See your glucose response to food, exercise, sleep, and other lifestyle factors via the Lingo app.
- OPTIMIZE YOUR NUTRITION. Discover which foods work for you and those that don't. The Lingo app shows you how specific meals and other factors impact your glucose, so you can learn from your insights and build healthier habits.
- NAVIGATE PREDIABETES WITH A NEW VIEW OF YOU. More time in healthy glucose range is linked to lower diabetes risk. Three out of four users with prediabetes say Lingo was effective in helping to achieve their health goals¹.
- HEALTHY GLUCOSE SUPPORTS HEART HEALTH. What you eat matters to your glucose and your heart. Keeping your glucose in a healthy range (70–140 mg/dL) more often can help protect your heart from heart disease²⁻⁴.
For children, the system should be used under adult supervision. A parent or caregiver may use a compatible smart device, and sensor wear time may be shorter for pediatric users. Caregivers should consult a healthcare provider before medication adjustments. The FDA also says Stelo is not for people on dialysis and advises people with a history of disordered eating to talk with a provider before use.
How the Stelo system works
Stelo is not a watch that measures glucose through the skin. Its sensor is inserted under the skin and measures glucose in interstitial fluid; the app displays the resulting information on a compatible smart device.
| Stelo detail | What the sources say |
|---|---|
| Measurement display | The FDA says the app displays glucose measurements and trends every 15 minutes. |
| Maximum sensor wear | The FDA says a sensor can be worn for up to 15 days; this is a maximum, not a guarantee for every sensor. |
| Full 15-day sensor life | Dexcom’s 2024 launch announcement said 77.9% of sensors in its cited study lasted the full 15 days. |
Check current phone, operating-system, connectivity, and app compatibility before buying. Dexcom’s 77.9% figure is from a manufacturer announcement and should not be read as a guarantee about an individual sensor.
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What OTC access does—and does not—mean
| OTC access means | OTC access does not mean |
|---|---|
| An eligible person can obtain the device without a prescription. | The device is suitable for every person with diabetes. |
| The system may be used within its labeled indications. | CGM readings diagnose diabetes or prediabetes by themselves. |
| The system remains a regulated medical device. | Users should change medication or treatment based on an app reading alone. |
| A prescription is not required to obtain it. | Medical guidance is unnecessary, especially when symptoms and readings disagree. |
Important limitations and safety warnings
The FDA says Stelo is not designed to alert users to problematic hypoglycemia and is not for people with that condition. The FDA also advises users not to make medical decisions based on the device’s output without talking to a healthcare provider. Dexcom advises consulting a provider before medication adjustments or other medical action.
If a reading does not match how you feel, do not assume either the sensor or your symptoms are correct. Consult the product instructions and a healthcare provider about what to do. Stelo’s OTC status does not make it a substitute for a prescribed monitoring plan or a clinician’s guidance.
Rank #3
- ✅ For people NOT using insulin, ages 18 years and older
- ❌ Don’t use if: On insulin, on dialysis, if you have problematic hypoglycemia, are modifying medication without HCP consultation, or if you have a history of eating disorders
- YOUR SUCCESS, OUR COMMITMENT: Should you experience an issue with your biosensor before its 15-day wear is up,[2] we’ll replace it for free. [3]
- POWERFUL FEATURES: Get AI-powered coaching, plus discover in-app nutrition & glucose insights, advanced meal and activity logging, trend summaries and deep dives, pattern insights and much more—plus, effortlessly sync your data with Apple Health, Google Health Connect, and Oura.
- PRODUCT SUPPORT: Provided by Stelo through SteloBot, which can be accessed via the Stelo app by going to Settings > Contact. SteloBot virtual support assistant is available 24/7, and live agent support available during regular business hours.
Stelo is not a glucose-measuring smartwatch
On February 21, 2024, the FDA warned consumers about smartwatches and smart rings that claim to measure or estimate glucose on their own without piercing the skin. The FDA said it had not authorized, cleared, or approved a smartwatch or smart ring intended to measure or estimate glucose independently. This is distinct from a watch or app that displays data from an authorized glucose-measuring device such as a CGM.
- Stelo: uses a sensor inserted under the skin and sends data to a compatible smart device.
- A watch displaying CGM data: can serve as a secondary screen for data generated by a glucose-measuring device.
- A watch or ring claiming to measure glucose by itself: is not equivalent to an FDA-cleared CGM.
What to compare when considering an OTC CGM
OTC products may have different indications and features. Before choosing one, check its current official labeling and compare the points below rather than assuming products are interchangeable.
| What to compare | Why it matters |
|---|---|
| Indicated age and insulin use | Eligibility depends on the product’s labeled population. |
| Hypoglycemia alerts | Stelo is not designed to alert users to problematic hypoglycemia. |
| Sensor wear period and replacement cadence | Check the labeled maximum and whether it is a guarantee. |
| Display frequency and compatible devices | Confirm how often information appears and which devices can show it. |
| Current cost and availability | Verify current terms with the manufacturer or an authorized seller; historical prices may no longer apply. |
Who should think twice before buying an OTC CGM?
Discuss Stelo with a healthcare provider if you use insulin, have problematic hypoglycemia, plan to change medication based on readings, or have symptoms that frequently do not match sensor readings. For a child, involve the care team and ensure adult supervision. The FDA also says Stelo is not for people on dialysis and recommends that people with a history of disordered eating consult a provider before use.
If you are considering a watch or ring that claims to measure glucose without a sensor, check the FDA’s warning: those claims are not equivalent to data from an FDA-cleared CGM.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.Bottom line
The FDA cleared Dexcom Stelo on March 5, 2024, as the first U.S. OTC CGM for adults aged 18 and older who do not use insulin. In June 2026, the FDA expanded its OTC indication to people aged 2 and older who do not use insulin. Stelo measures glucose with an inserted sensor; it is not a glucose-measuring smartwatch, a diagnostic test, or a system designed to alert for problematic hypoglycemia.
Rank #4
- The information below is per-pack only
- HSA/FSA eligible. No prescription needed.
- 24/7 GLUCOSE TRACKING. See your glucose response to food, exercise, sleep, and other lifestyle factors via the Lingo app.
- OPTIMIZE YOUR NUTRITION. Discover which foods work for you and those that don't. The Lingo app shows you how specific meals and other factors impact your glucose, so you can learn from your insights and build healthier habits
- NAVIGATE PREDIABETES WITH A NEW VIEW OF YOU. More time in healthy glucose range is linked to lower diabetes risk. Three out of four users with prediabetes say Lingo was effective in helping to achieve their health goals¹.
FAQ
Did the FDA approve or clear Dexcom Stelo?
The FDA cleared Stelo through a traditional 510(k) decision based on substantial equivalence. “Cleared” is the more accurate term for this action.
Who can use Stelo without a prescription?
The original March 2024 clearance covered adults aged 18 and older who do not use insulin. The FDA expanded the OTC indication on June 12, 2026, to people aged 2 and older who do not use insulin.
How long does a Stelo sensor last?
The FDA says a sensor can be worn for up to 15 days. Dexcom’s 2024 launch announcement said 77.9% of sensors in its cited study lasted the full 15 days, so the maximum is not a promise for every sensor.
Can Stelo alert me to low blood sugar?
Stelo is not designed to alert users to problematic hypoglycemia and is not for people with that condition. Ask a healthcare provider which monitoring approach is appropriate for your needs.
Is Stelo a glucose-measuring smartwatch?
No. Stelo uses a sensor inserted under the skin to measure glucose in interstitial fluid and sends information to a compatible smart device. A watch displaying CGM data is different from a watch claiming to measure glucose independently.
Crashes, No Sound, or Screen Glitches?
Random freezes, missing sound and display glitches usually trace back to one bad driver. Find and replace yours safely.Free scan · under a minutePC Slower Than It Used to Be?
A free scan shows the junk files, broken settings and background clutter dragging Windows down - then fixes them in one click.Free scan · Windows 10 & 11Can Stelo replace medical advice or a prescribed CGM?
No. The FDA says users should not make medical decisions based on Stelo output without talking to a healthcare provider. Consult a provider before medication adjustments or other medical action.
Quick Recap
Product prices and availability are accurate as of the date/time indicated and are subject to change. Any price and availability information displayed on Amazon at the time of purchase will apply.
