For decades, checking blood sugar meant the same routine: a lancet, a test strip, a drop of blood, and a number that told you nothing about what happened an hour ago or what might happen next. That ritual is losing its grip. The FDA has cleared the first continuous glucose monitors approved for over-the-counter sale, and the earliest of them, Dexcom’s Stelo Glucose Biosensor System, began shipping to consumers in August 2024. As of mid-2026, it remains available for direct purchase online without a prescription, putting real-time glucose data within reach of millions of adults who manage blood sugar without insulin.
What the FDA actually cleared
The Dexcom Stelo system received FDA clearance through the agency’s 510(k) premarket notification process under clearance number K234070. According to the FDA’s official announcement, the device is intended for adults 18 and older who do not use insulin. That population includes people managing Type 2 diabetes with oral medications, diet, or exercise, as well as the estimated 98 million American adults the CDC says have prediabetes, many of whom have never been formally diagnosed.
The device itself is a small adhesive patch, roughly the size of a few stacked coins, applied to the back of the upper arm. A hair-thin filament sits just beneath the skin’s surface and measures glucose concentrations in interstitial fluid, the liquid between cells. Readings transmit via Bluetooth to a paired smartphone app every few minutes, generating a continuous trend line rather than the isolated snapshots a finger-prick meter provides. Users can see, in near-real time, how a particular meal, a morning walk, or a poor night’s sleep shifts their glucose levels.
A second OTC continuous glucose monitor also appears in FDA records. Abbott’s Libre Rio Continuous Glucose Monitoring System received its own 510(k) clearance under number K233861, classified as an “Integrated Continuous Glucose Monitor for Non-Intensive Glucose Management, Over-The-Counter.” That places it in the same regulatory category as Stelo, designed for the same non-insulin-using adult population. However, as of mid-2026, Abbott has not yet launched Libre Rio at broad retail, making Stelo the only OTC CGM currently available to consumers in the United States.
What it costs and where to find it
Dexcom sells Stelo directly through its website. Each sensor lasts 15 days, and the company prices them at roughly $49 per sensor, which works out to approximately $89 to $99 per month for continuous coverage. That is a significant reduction from prescription CGM costs, which can run well above $100 per month without insurance, but it is still a recurring expense that comes entirely out of pocket for most buyers. Because the device is sold over the counter, traditional health insurance plans generally do not cover it, though some consumers have reported success using Health Savings Account or Flexible Spending Account funds.
Stelo is not yet stocked on open pharmacy shelves the way blood pressure cuffs or thermometers are. Purchasing currently happens primarily online. Whether Dexcom or Abbott will eventually place OTC monitors in brick-and-mortar pharmacies alongside other home health devices remains an open question, and neither company has publicly confirmed specific retail chain partnerships for shelf placement.
What the clearance does and does not guarantee
The 510(k) pathway requires a manufacturer to demonstrate that its device is “substantially equivalent” to a product already on the market. It does not require the large-scale, multi-year clinical trials associated with higher-risk devices such as implantable insulin pumps. Dexcom submitted performance data as part of its clearance application, and the FDA found it sufficient to authorize sale. But independent, peer-reviewed studies evaluating how accurately Stelo performs when applied at home by untrained consumers, without clinical guidance on sensor placement or skin preparation, have not yet been published in large numbers.
That distinction matters. A sensor placed in a clinical setting by a trained technician may behave differently than one stuck on by someone following a YouTube tutorial in their bathroom. Early user reports have been broadly positive, but systematic accuracy data from real-world, unsupervised use across diverse skin types, body compositions, and activity levels is still accumulating.
It is also worth noting what these devices are not designed to do. Neither Stelo nor Libre Rio is cleared for insulin dosing decisions. They do not replace prescription CGMs like Dexcom’s own G7 or Abbott’s Libre 3, which are calibrated for the tighter accuracy margins that insulin-dependent patients require. The OTC versions are monitoring tools, not treatment-guiding instruments.
The clinical question no one has answered yet
The core promise behind selling glucose monitors without a prescription is straightforward: if people can see what their blood sugar is doing throughout the day, they will make better choices about food, exercise, and when to see a doctor. It is a reasonable hypothesis, and it aligns with years of research showing that continuous glucose monitoring improves outcomes for people with Type 1 diabetes and insulin-dependent Type 2 diabetes.
But the population buying OTC monitors is different. These are people who, by definition, are not on insulin. Many have prediabetes or early-stage Type 2 diabetes. Some are wellness-oriented consumers with no diagnosis at all who simply want to understand how their bodies respond to carbohydrates. Whether continuous glucose data actually changes long-term behavior or health outcomes in these groups has not been established by published clinical research as of mid-2026.
There is also a practical question for clinicians. Doctors are already managing data streams from prescription CGMs, fitness trackers, smartwatches, and home blood pressure monitors. A new category of self-purchased glucose sensors could sharpen the picture of a patient’s metabolic health, or it could flood already-strained appointments with data that lacks clinical context. The FDA’s clearance documents address device safety and performance. They do not address how readings from an OTC monitor should be shared with a care team, interpreted alongside lab work, or acted upon in a treatment plan.
Where this leaves consumers right now
The verified facts are narrow but meaningful. Two continuous glucose monitors have received FDA clearance for over-the-counter sale to adults who do not use insulin. One of them, Dexcom Stelo, is already available for purchase without a prescription at roughly $99 per month. The second, Abbott’s Libre Rio, has regulatory clearance but has not yet reached consumers at retail. Both devices measure glucose through the skin continuously and send data to a smartphone, eliminating the need for finger pricks.
What remains unproven is whether broader access to this data will translate into fewer diabetes diagnoses, earlier interventions, or measurably better health. That evidence will take years to build. In the meantime, the technology is real, the regulatory barrier is gone, and the first patches are already on arms across the country. For the millions of Americans who have been told their blood sugar is “borderline” and handed little more than a pamphlet, that alone represents a genuine shift in how metabolic health can be tracked outside a clinic.
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*This article was researched with the help of AI, with human editors creating the final content.
