Dexcom Stelo

Stelo is Dexcom's over-the-counter glucose biosensor — and the first continuous glucose monitor of any kind the FDA cleared for sale without a prescription, in March 2024.¹ Under the hood it is a Dexcom G7: the FDA review lists the G7 (K231081) as the predicate and confirms the two share the same sensor, patch, applicator and transmitter hardware.² What changed is the firmware and the app — and almost every change makes Stelo less suitable for type 1 dosing, not more. We cover it here to chart the OTC category, not to recommend it for T1D.

How it works. A thin wire under the skin measures glucose in interstitial fluid via a glucose-oxidase reaction, the same method as the G7.² It is factory-calibrated — no fingersticks, and you cannot even enter an optional calibration.²

Accuracy. Overall accuracy mirrors the G7, with a MARD around 8.3%.² But the low range is weaker: in the FDA's pivotal study MARD was about 10% at 54–69 mg/dL and about 15% below 54 mg/dL.² The app also won't display a number below 70 or above 250 mg/dL — it just shows "Below 70" or "Above 250."² For someone with T1D who lives at the edges of those ranges, that is a serious blind spot.

Wear, warm-up, calibration. Each sensor lasts 15 days (15.5 with a 12-hour grace period before it shuts off), worn on the back of the upper arm, with a ~30-minute warm-up.² That is longer wear than any prescription Dexcom sensor to date.

Alerts — the big one. Stelo has no glucose alarms. The Urgent Low, Low, High, Rising Fast and Falling Fast alerts that exist on the G7 are all removed.² It instead refreshes every 15 minutes (vs every 5 on the G7) and offers retrospective "Insights" and weekly spike reports.² The labeling explicitly says do not use it if you have problematic hypoglycemia, because it is not designed to warn you.¹

What it connects to. Almost nothing. The firmware pairs only with the user's own smartphone (iOS/Android) — no receiver, no insulin pens, no automated insulin delivery systems, and no DIY loop like Loop or Trio.² That closed design alone rules it out for AID-based T1D management.

Ketones. None — glucose only.²

Who it's for. Adults 18+ not using insulin — people with type 2 on oral medication, prediabetes, or wellness users.¹ In June 2026 the FDA extended the same OTC clearance to children aged 2 and older who do not use insulin.³ It is explicitly not indicated for insulin users, problematic hypoglycemia, dialysis, or pregnancy.²

Access & cost. Sold online without a prescription in the US, launched 26 August 2024 at a modest out-of-pocket cost for a one-time 2-sensor (30-day) pack, with a slightly lower price on monthly subscription; HSA/FSA-eligible but cash-pay only.⁴⁵ At the time of writing it is US-only; no peer-reviewed independent accuracy study of Stelo specifically has yet been published, so accuracy figures here come from the FDA submission.²

What's coming. Dexcom positions Stelo as the consumer/wellness anchor of its line, alongside the 15-day G7 platform; the 2026 pediatric clearance is the most recent expansion.³ For T1D, the relevant roadmap is the prescription G7 family, not Stelo.

References

1. U.S. Food & Drug Administration. FDA Clears First Over-the-Counter Continuous Glucose Monitor (5 March 2024). https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor ↩ ↩² ↩³

2. U.S. Food & Drug Administration. 510(k) K234070 — Stelo Glucose Biosensor System, Substantial Equivalence Decision Summary (2024). https://www.accessdata.fda.gov/cdrh_docs/reviews/K234070.pdf ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹ ↩¹⁰ ↩¹¹ ↩¹² ↩¹³

3. U.S. Food & Drug Administration. FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children (12 June 2026). https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor-children ↩ ↩²

4. Reuter E. Dexcom prices first over-the-counter glucose monitor. MedTech Dive (2024). https://www.medtechdive.com/news/dexcom-sells-stelo-over-the-counter-cgm/725310/ ↩

5. Dexcom. Stelo Glucose Biosensor — subscription and pricing. stelo.com (2026). https://www.stelo.com/en-us/buy-stelo-monthly-subscription ↩