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, the model has no verified field deployments in the registry, 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. No verified deployments in the registry.

see evidence →

Safety record

no-incidents

No incidents on record. No verified deployments either.

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

No verified deployments on file for Stelo.

Safety record

No incidents on record. No verified deployments either, so the absence is uninformative.

Privacy

No privacy practices disclosed or on file for Stelo.

Specs

notes

[{"label":"Boundary INCLUDE (glucose-biometric + real AI)","value":"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)."},{"label":"FDA status (strongest anchor in Wave 2)","value":"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."},{"label":"Cap-flag","value":"'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)."}]

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).

formFactor

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

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?

No verified field deployments on record.

Is the Stelo safe?

No incidents on record, but with no verified field deployments either, the absence is uninformative.

How does the Stelo handle privacy?

No privacy practices disclosed or on file for 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)

Compared to

• Ultrahuman Ring (Air / Pro)by Ultrahuman · biometric
• Withings ScanWatchby Withings · biometric
• Fitbit (Charge / Sense / Versa)by Fitbit · biometric

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) · https://www.stelo.com/ ↗ · 2024-08-26