The Stelo Glucose Biosensor System is Dexcom’s over-the-counter continuous glucose monitoring kit — the first FDA-cleared OTC CGM in the United States. The system includes the biosensor hardware, the Stelo smartphone app, and optional data-sharing tools. It is designed for adults 18 and older with type 2 diabetes not on insulin, prediabetes, or general wellness goals.
What the Stelo System Includes
The word “system” matters here: Stelo is not just a single sensor but a complete monitoring ecosystem. A typical subscription or starter kit includes:
- The biosensor: An integrated sensor-transmitter unit with adhesive patch and a single-use push-button applicator
- The Stelo smartphone app: Free download for iOS and Android that receives data via Bluetooth and displays trends, graphs, and insights
- Data sharing: Ability to export PDF summaries for your doctor or grant caregiver view access
- Educational content: In-app guidance on interpreting readings, meal logging, and lifestyle tips
Each biosensor lasts 15 days, so users on a monthly subscription receive two sensors per shipment.
How the Stelo System Works
The biosensor is applied to the back of your upper arm with the included applicator. A thin flexible filament sits just 4-5 mm under your skin, where a glucose-oxidase enzyme reacts with glucose in your interstitial fluid. Every 15 minutes the sensor transmits a glucose reading via Bluetooth Low Energy to the Stelo app on your phone.
The app displays:
- Current glucose reading with trend arrow
- 24-hour glucose graph
- Daily summary and time-in-range
- Weekly and monthly patterns
- Insights such as “This meal caused your largest spike” or “Walking lowered your glucose by 18 mg/dL”
According to the FDA’s March 2024 clearance announcement, the Stelo System was specifically cleared for non-insulin-using adults to improve access to glucose data for wellness and diabetes self-management.
Stelo System vs. Other Consumer CGM Systems
| System | Wear Time | Reading Frequency | Prescription | Monthly Cost |
|---|---|---|---|---|
| Dexcom Stelo | 15 days | Every 15 min | No | ~$99 |
| Abbott Lingo | 14 days | Every 1 min | No | ~$89 |
| Abbott Libre Rio | 14 days | Every 1 min | No | ~$89 |
| Dexcom G7 (Rx) | 10.5 days | Every 5 min | Yes | $360-540 without insurance |
Accuracy of the Stelo System
Stelo shares the sensor platform used in the Dexcom G7, the most widely used CGM in the United States. Its MARD (mean absolute relative difference) is approximately 10% for non-insulin users, which is considered clinically accurate for trend monitoring. The system is not cleared for insulin dosing, and it does not include urgent-low alerts, so it is not a replacement for a prescription CGM if you require insulin.
Who Benefits Most
The Stelo System is useful for several groups:
- Type 2 diabetes on oral meds: See meal responses, fine-tune diet, and track progress toward A1C goals. Review our A1C levels guide to relate your Stelo numbers to long-term averages.
- Prediabetes: Identify high-spike foods and behaviors, which speeds lifestyle-driven reversal. Our article on whether prediabetes is reversible explains how glucose data accelerates change.
- Wellness-focused consumers: Optimize nutrition, sleep, exercise, and stress response through real-time glucose feedback.
Setting Up the Stelo System
- Order the starter kit at Stelo.com or a participating pharmacy.
- Download the Stelo app from the App Store or Google Play and create an account.
- Clean the back of your upper arm with an alcohol wipe.
- Apply the biosensor using the push-button applicator (takes 3 seconds).
- Pair it with the app and wait 30 minutes for warm-up.
- Log meals and activities in the app for richer insights.
- Rotate arms for each new sensor to avoid skin irritation.
Privacy and Data Sharing
Dexcom follows HIPAA standards for any data shared with healthcare providers, and the app allows you to choose what, if anything, you share. You can export a 90-day PDF report to bring to your doctor, which is especially useful if you are adjusting your diet and nutrition strategy.
Limitations to Keep in Mind
- Not approved for insulin dosing or confirming hypoglycemia
- No urgent-low or predictive alerts
- 15-minute reading interval may miss very fast glucose swings
- High-dose acetaminophen, hydroxyurea, and extreme dehydration can affect readings
- Typically not covered by insurance; HSA/FSA eligible in most cases
The Bottom Line
The Stelo Glucose Biosensor System is the complete kit — sensor hardware, smartphone app, and data-sharing tools — that brings continuous glucose monitoring to adults not using insulin. Each biosensor lasts 15 days, costs about $89-99 on subscription, and delivers glucose data every 15 minutes through the Stelo app. The system is best for people with type 2 diabetes on oral medications, prediabetes, or wellness-focused glucose tracking. Discuss findings with your doctor before making any medication changes.
