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Dexcom’s Stelo became the first continuous glucose monitor cleared by the U.S. Food and Drug Administration for over-the-counter sale when the FDA cleared it on March 5, 2024; Dexcom announced U.S. availability on August 26, 2024. The FDA expanded the device’s age indication on June 12, 2026, to people aged 2 and older who do not use insulin. OTC access means a prescription is not required—not that Stelo is suitable for everyone or a substitute for medical advice.
What Stelo is—and what “over the counter” means
Stelo is a wearable glucose biosensor paired with an app on a compatible smartphone or other smart device. It displays glucose measurements and trends every 15 minutes, allowing users to observe changes over time. It is not a promise of a diagnosis or improved health outcomes: the FDA says it may help users better understand how lifestyle and behavior changes, including diet and exercise, affect glucose levels.
The FDA cleared Stelo for OTC marketing on March 5, 2024, calling it the first OTC continuous glucose monitor cleared in the United States. Dexcom announced that it was available for purchase in the U.S. without a prescription on August 26, 2024. The launch announcement described potential users as adults with type 2 diabetes who do not use insulin and people with prediabetes. The clearance describes who the device is indicated for; a clinician can help determine whether using it makes sense for an individual. FDA clearance announcement · Dexcom availability announcement
Who can use Stelo under the current FDA indication?
The original 2024 clearance covered adults aged 18 and older who do not use insulin. On June 12, 2026, the FDA announced a clearance expanding the indicated age range to people aged 2 and older who do not use insulin. Children should use Stelo under an adult caregiver’s supervision, and sensor wear time may be shorter for pediatric users. FDA’s 2026 pediatric clearance announcement
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- ✅ 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.
Several limitations matter when deciding whether OTC availability is appropriate:
- Problematic hypoglycemia: The FDA says Stelo is not for people with problematic hypoglycemia because it is not designed to alert users to that potentially dangerous condition.
- Dialysis: The FDA’s June 2026 notice says Stelo is not for people on dialysis.
- Eating disorders: People with a history of disordered eating or eating disorders should talk with a healthcare provider before using it.
- Medical decisions: The FDA advises users not to make medical decisions based on Stelo readings without talking with a healthcare provider.
The FDA reported study adverse events that included local infection, skin irritation, and pain or discomfort. Review the device’s current labeling and discuss personal concerns with a healthcare professional before use. FDA adult-clearance safety information · FDA pediatric-clearance information
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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.
How long sensors last and how often readings update
Each sensor is labeled for wear for up to 15 days, and the app displays measurements and trends every 15 minutes, according to the FDA. “Up to” is a maximum labeled duration, not a guarantee. Dexcom’s 2024 launch disclosure said 77.9% of sensors lasted the full 15 days in its sensor-life study; approximately 20% may not last the full 15 days, and 10% may last less than 12 days when used according to package labeling. Dexcom’s sensor-life disclosure
Price and how to check current terms
Prices have changed since launch. Dexcom’s August 2024 announcement listed a pay-as-you-go pack of two sensors for $99 and a subscription for $89 per month, which provided two sensors every 30 days. The Stelo product page reviewed October 5, 2026, displayed an $89 monthly subscription and showed $99 as the prior price. These are not a guarantee of the amount you will pay: confirm the current price, delivery schedule, and terms at Dexcom checkout. Dexcom said Stelo was FSA/HSA eligible in its launch announcement; check current eligibility and account rules before purchasing. Dexcom’s launch pricing and FSA/HSA statement · Stelo product page
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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 to consider before choosing an OTC glucose monitor
Stelo’s no-prescription access may make glucose trends easier to explore for people within its indicated population. Before buying any monitor, consider whether its intended users match your needs, whether you need alerts for low glucose, what supervision or clinician guidance is appropriate, whether your device is compatible, how long sensors actually last, and the current out-of-pocket cost. In particular, someone who needs hypoglycemia alerts should not treat Stelo as a replacement for a device or care plan designed for that need.
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- Long-Lasting, 100% Compatible with Dexcom G7 & Stelo Patch: Hold your CGM device firmly to your skin and extend its life without causing it to fall off or hang loose; designed to withstand external and physical force, our diabetic patch enables you to do all the things you care about without your sensor detaching from your skin
- Waterproof and Sweatproof, stays on through anything - Waterproof adhesive of our Dexcom g7 Patch keeps your device secure during showers, swims, and sweaty days. For best results, just blot the patch dry after water exposure.
- Comfortable, Skin-Friendly & Pre-Cut to Fit Your Device: Our breathable overpatches are made of 100% medical-grade adhesive that is zinc oxide-free, hypoallergenic, and not made with natural rubber latex, for zero irritation. Live without limits while wearing your patch.
- 4-Way Stretch, Easy Application: Our patches are ingeniously split into 5 parts for a seamless application; for best results, prep skin with an adhesive barrier solution like Skin Tac, apply the sensor, and apply the patch before bed to allow the adhesive to set well before any activities
- Commitment to Quality: We use only superior materials and adhere to high standards of quality and safety — so you can work hard and play hard without affecting your blood sugar testing
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.
