Stelo

Dexcom's Stelo is the first-ever FDA-cleared over-the-counter (no-prescription) glucose biosensor (De Novo, March 5, 2024; US launch August 26, 2024): a 15-day continuous glucose monitor for adults 18+ not on insulin (type 2 not on insulin, plus non-diabetic users tracking how diet and exercise affect glucose). It is the generative-AI end of the glucose cell: Weekly Insights run on Google Cloud's Vertex AI and Gemini, with AI photo meal-logging and personalized daily recommendations, the AI substance that carries it across the biometric boundary. Pricing is about $89 for a 2-week sensor on a biweekly subscription model (around $99/month). From DexCom (NASDAQ: DXCM), Stelo is the OTC product line, separate from the prescription G7. Cap-flag: the cleared indication is an OTC CGM for adults 18+ not on insulin; it is explicitly NOT cleared for problematic hypoglycemia and has no low-glucose alerts, so it should not be read as a diabetes-management device.

Readiness

Stelo is shipping now at $89-$99 (actual sale price), no capability claims are on file, 1 verified deployment is on file, and no incidents are on record.

Availability

shipping-now

Shipping now.

see evidence →

Price honesty

actual-sale-price

One price on file: $89-$99 (actual sale price).

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Capability honesty

no-claims

No reviewed capability claims on file for Stelo.

see evidence →

Real-world use

commercial

Maturity: commercial. 1 verified deployment in the registry.

see evidence →

Safety record

no-incidents

No incidents on record. 1 verified deployment on file.

What it claims to do

No reviewed capability claims on file.

Price

• $89-$99actual sale price · DexCom (Stelo) ↗ · as of 2024-08-26

Real-world use

• Global2024-05-01

Safety record

No incidents on record. 1 verified deployment on file.

Privacy

Privacy practices disclosed by Dexcom for Stelo, with verification status.

• Biometric storageverified

  Continuously tracks your glucose levels and provides trend analysis, spike detection, and daily and weekly summaries. The app analyzes your readings alongside meals, exercise, sleep, age, and other factors to give personalized recommendations.

  Source: https://www.stelo.com/en-us/legal/health-data-consent

• Training data useverified

  Dexcom uses your Stelo health data for internal research, bug fixes, product improvement, and regulatory compliance.

  Source: https://www.stelo.com/en-us/legal/health-data-consent

• Third-party sharingverified

  Google Play shows no data is shared with third parties, though data may be shared with affiliated companies and service providers for operations. A separate privacy policy from Edwards Health Care Services covers fulfillment data.

  Source: https://play.google.com/store/apps/datasafety?id=com.dexcom.stelo

• Data deletion controlverified

  You can request data deletion. Data is encrypted in transit. The app collects personal info including name, email, health data, crash logs, and device identifiers.

  Source: https://play.google.com/store/apps/datasafety?id=com.dexcom.stelo

Specs

notes

• Boundary INCLUDE (glucose-biometric + real AI): Glucose is in the biometric definition; Stelo clears the medical-sensor-without-meaningful-AI exclusion bar: it pairs an FDA-cleared glucose biosensor with a GENUINE generative-AI insight layer (Vertex AI/Gemini Weekly Insights, AI meal photo logging, personalized recommendations from glucose/activity/nutrition/sleep) - not a bare sensor readout. Fills the GLUCOSE cell of the biometric cohort (distinct from the HR/sleep watches+rings).
• FDA status (strongest anchor in Wave 2): First-ever FDA-cleared OTC (no-prescription) continuous glucose biosensor: De Novo clearance announced Mar 5 2024; US launch Aug 26 2024; for adults 18+ not on insulin. The FDA clearance makes it the strongest verification anchor of the Wave-2 set.
• Cap-flag: 'First generative AI platform in glucose biosensing' is Dexcom marketing framing - the CLEARANCE and the Vertex/Gemini integration are verified; the 'first' superlative is not load-bearing, don't assert it. Stelo is NOT cleared for problematic hypoglycemia / no low-glucose alerts (an indication boundary).
• Source/methodology (Phase 1A, 2026-06-04): Primary-FDA source added. Pathway cap-flag (verified-vs-claimed discrepancy): the FDA 510(k) database lists Stelo as K234070, a 510(k) (substantially-equivalent), whereas much coverage and the prior record framing described the clearance as De Novo. 'First OTC glucose biosensor' is a market-status claim that stands. The accessdata 510(k) record is the authoritative regulatory pathway; flagged here rather than force-rewriting the prose pending reconciliation.

specs

Stelo: continuous glucose monitor (CGM) biosensor, 15-day wear; first-ever FDA-cleared OTC (no-prescription) glucose biosensor (De Novo Mar 5 2024; US launch Aug 26 2024). Indication: adults 18+ NOT on insulin (type 2 not on insulin + non-diabetic users tracking diet/exercise impact); not cleared for problematic hypoglycemia (no low-glucose alerts). Generative-AI: Weekly Insights (Google Cloud Vertex AI + Gemini), AI photo meal logging, personalized daily recommendations. Company: DexCom Inc (NASDAQ: DXCM); Stelo = the OTC product line (separate from prescription G7).

battery

15 days

weight_kg

0.005

formFactor

biometric (biometric-primary GLUCOSE biosensor / OTC continuous glucose monitor + generative-AI insights)

fda_clearance

{"source":"https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor","status":"cleared","details":"FDA-cleared OTC CGM (K232990, March 2024). First over-the-counter continuous glucose monitor without prescription. For non-insulin users aged 18+.","audited_at":"2026-06-07","source_name":"FDA","health_claim":"Glucose monitoring for Type 2 diabetes management and general metabolic awareness. FDA-cleared medical device.","verification_posture":"verified"}

What's under the hood

No brain on file for Stelo.

Frequently asked questions

Is the Stelo actually available for purchase?

Yes, shipping now.Source: Stelo by Dexcom: first glucose biosensor FDA-cleared OTC (De Novo Mar 5 2024; adults 18+ not on insulin)

What does the Stelo cost?

Stelo costs $89-$99 one-time (actual sale price).Source: DexCom (Stelo)

Where is the Stelo being used?

Stelo is in use at: Global (2024-05-01).Source: Dexcom Stelo — OTC continuous glucose biosensor (FDA-authorized 2024)

Is the Stelo safe?

No incidents on record across 1 verified deployment.

How does the Stelo handle privacy?

Dexcom has disclosed 4 privacy practices for Stelo: biometric storage (Continuously tracks your glucose levels and provides trend analysis, spike detection, and daily and weekly summaries. The app analyzes yo..), training data use (Dexcom uses your Stelo health data for internal research, bug fixes, product improvement, and regulatory compliance), third-party sharing (Google Play shows no data is shared with third parties, though data may be shared with affiliated companies and service providers for ope..), and data deletion control (You can request data deletion. Data is encrypted in transit. The app collects personal info including name, email, health data, crash log..).Sources: https://www.stelo.com/en-us/legal/health-data-consent, https://play.google.com/store/apps/datasafety?id=com.dexcom.stelo

Who makes the Stelo?

Stelo is made by Dexcom, based in San Diego, California, USA.Source: Stelo by Dexcom: first glucose biosensor FDA-cleared OTC (De Novo Mar 5 2024; adults 18+ not on insulin)

Video

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Sources

1. Stelo by Dexcom: first glucose biosensor FDA-cleared OTC (De Novo Mar 5 2024; adults 18+ not on insulin) · https://investors.dexcom.com/news/news-details/2024/Stelo-by-Dexcom-First-Glucose-Biosensor-to-be-Cleared-by-FDA-as-Over-the-Counter/default.aspx ↗
2. Dexcom launches generative-AI platform for Stelo (Google Cloud Vertex AI + Gemini; Weekly Insights) · https://investors.dexcom.com/news/news-details/2024/Dexcom-Launches-the-First-Generative-AI-Platform-in-Glucose-Biosensing/default.aspx ↗
3. Dexcom gen-AI for Stelo (personalized insights; AI photo meal logging) · https://www.medtechdive.com/news/dexcom-gen-ai-feature-stelo-cgm/735918/ ↗
4. Dexcom Stelo Glucose Biosensor System 510(k) K234070 (decision Mar 5 2024; applicant Dexcom; product code SAF; OTC, adults 18+ not on insulin) · https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234070 ↗
5. Stelo Biosensor · https://www.stelo.com/en-us/buy-stelo-one-time ↗
6. Dexcom official YouTube (@dexcomCGM), embedded under standard YouTube embed terms. oEmbed author_url verified 2026-06-04. OTC consumer biosensor product video. · https://www.youtube.com/watch?v=iOpR0InsrPI ↗ · 2026-06-04
7. DexCom (Stelo) · https://www.stelo.com/ ↗ · 2024-08-26
8. Dexcom Stelo — OTC continuous glucose biosensor (FDA-authorized 2024) · https://www.dexcom.com/en-us/stelo ↗
9. FDA: Authorization of first OTC CGM (Dexcom Stelo), Mar 2024 · https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-otc-continuous-glucose-monitor ↗
10. https://www.stelo.com/en-us/legal/health-data-consent ↗
11. https://play.google.com/store/apps/datasafety?id=com.dexcom.stelo ↗