Dexcom Stelo
Dexcom
What it is
The first FDA-cleared over-the-counter glucose biosensor — same G7 hardware, 15-day wear, no prescription — but deliberately stripped of alarms and locked out of pumps and AID. Built for non-insulin users, NOT indicated for T1D dosing; we cover it to map the OTC CGM category.
Editorial review: .
Source dates appear in the references where available; this record has no dated citation metadata.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence behind this assessment
Key evidence notes. Study results, product eligibility and access answer different questions.
- Who was studied?
- Study populations and analysis groups vary. Product age limits alone do not describe who was studied.
- Benefit or performance
- Accuracy: Overall MARD ~8.3%, on par with the G7 it is built from; but accuracy degrades in the low range (MARD ~10% at 54–69 mg/dL, ~15% below 54 mg/dL) — and the app won't even display values under 70.[1]
- Important harms and treatment burden
- Read the safety discussion and original sources. A missing summary does not establish safety.
- Approval and country access
- Country-specific approval and access are not summarized in this record.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Read the full discussion and original sources for follow-up duration and study limitations.
This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.
Editorial score: calculation and evidence
A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.
Default calculation: 74 × 20 + 60 × 15 + 8 × 15 + 85 × 10 + 90 × 10 + 5 × 10 + 82 × 10 + 0 × 5 + 45 × 5 = 5345; divide by total weight 100. Unrounded weighted result: 53.45.
Overall MARD ~8.3%, on par with the G7 it is built from; but accuracy degrades in the low range (MARD ~10% at 54–69 mg/dL, ~15% below 54 mg/dL) — and the app won't even display values under 70.[1]
Same interstitial sensor as the G7, so the ~10–15 min physiological lag is unchanged — but the app only refreshes every 15 minutes (vs every 5 on the G7), so trends feel coarser.[1]
Deliberately closed. Firmware will only pair with the user's own smartphone — no receiver, no insulin pens, no AID systems, and no DIY loop. The opposite of what a T1D user needs.[1]
15-day wear (15.5 with a 12-hour grace period) — now matching the prescription 15-day G7 platform, so no longer a wear advantage over it.[1]
Factory-calibrated; no fingersticks, and the user cannot even enter optional calibrations.[1]
No glucose alarms at all — Urgent Low, Low, High, Rising/Falling Fast are all removed by design. Explicitly not for anyone with problematic hypoglycemia. A dealbreaker for insulin-treated T1D.[1]
Identical small all-in-one G7 wearable on the back of the upper arm; ~30-minute warm-up; showerproof.[1]
No prescription and HSA/FSA-eligible, but cash-only (a modest out-of-pocket cost per 30-day supply, no insurance billing) and US-only.[4]
The full picture
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 2024.2 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.1 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 G7.1 It is factory-calibrated — no fingersticks, and you cannot even enter an optional calibration.1
Accuracy. Overall accuracy mirrors the G7, with a MARD around 8.3%.1 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.1 The app also won't display a number below 70 or above 250 mg/dL — it just shows "Below 70" or "Above 250."1 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.1 That now matches the prescription 15-day G7 platform rather than exceeding it (see What's coming below).
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.1 It instead refreshes every 15 minutes (vs every 5 on the G7) and offers retrospective "Insights" and weekly spike reports.1 The labeling explicitly says do not use it if you have problematic hypoglycemia, because it is not designed to warn you.2
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.1 That closed design alone rules it out for AID-based T1D management.
Ketones. None — glucose only.1
Who it's for. Adults 18+ not using insulin — people with type 2 on oral medication, prediabetes, or wellness users.2 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.1
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.1
What's coming. Dexcom positions Stelo as the consumer/wellness anchor of its line, alongside the prescription 15-day G7 platform; the 2026 pediatric clearance is the most recent Stelo expansion.3 For T1D, the relevant roadmap is the prescription G7 family, not Stelo.
Sources
- [1]510(k) K234070 — Stelo Glucose Biosensor System, Substantial Equivalence Decision Summary · Regulatory decision — Primary FDA review document. Confirms OTC iCGM (product code SAF, predicate Dexcom G7 K231081), 18+/not-on-insulin indication, factory-calibration, 15-day wear, 70–250 mg/dL display, 15-min update, no alarms, no pump/AID pairing, and full per-range accuracy/MARD tables.
U.S. Food & Drug Administration. 510(k) K234070 — Stelo Glucose Biosensor System, Substantial Equivalence Decision Summary (2024).
- [2]FDA Clears First Over-the-Counter Continuous Glucose Monitor · Regulatory decision
U.S. Food & Drug Administration. FDA Clears First Over-the-Counter Continuous Glucose Monitor (5 March 2024).
- [3]FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children · Regulatory decision
U.S. Food & Drug Administration. FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children (12 June 2026).
- [4]Dexcom prices first over-the-counter glucose monitor · Science journalism
Reuter E. Dexcom prices first over-the-counter glucose monitor. MedTech Dive (2024).
- [5]Stelo Glucose Biosensor — subscription and pricing · Manufacturer
Dexcom. Stelo Glucose Biosensor — subscription and pricing. stelo.com (2026).