# Stelo

Manufacturer: [Dexcom](/companies/dexcom)  
Category: biometric

## Summary

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.

## Top line

> 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.

## Readiness

- **Availability** (shipping-now): Shipping now.
- **Price honesty** (actual-sale-price): One price on file: $89-$99 (actual sale price).
- **Capability honesty** (no-claims): No reviewed capability claims on file for Stelo.
- **Real-world use** (commercial): Maturity: commercial. No verified deployments in the registry.
- **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-$99, _actual-sale-price_ ([DexCom (Stelo)](https://www.stelo.com/)) _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)](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)._

### What does the Stelo cost?

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

_Source: [DexCom (Stelo)](https://www.stelo.com/)._

### 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)](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)._

## Manufacturer

- [Dexcom (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)](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)

## Compared to

- [Ultrahuman Ring (Air / Pro)](/consumer/models/ultrahuman-ring-air)
- [Withings ScanWatch](/consumer/models/withings-scanwatch)
- [Fitbit (Charge / Sense / Versa)](/consumer/models/fitbit-tracker)

## 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

_Canonical: https://deploy.report/models/stelo_