Dexcom, a leader in diabetes care, has introduced the Stelo Glucose Biosensor System, an over-the-counter (OTC) continuous glucose monitor (CGM) designed for individuals with type 2 diabetes not on insulin, as well as those with prediabetes. Stelo received FDA clearance as an over-the-counter glucose biosensor in March 2024.
Stelo Glucose Biosensor System Specification:
- Sensor Size and Weight: Specific dimensions and weight are not detailed, but it is described as a small, wearable sensor placed on the back of the upper arm.
- Probe Depth: The sensor measures glucose levels in the interstitial fluid beneath the skin.
- Water Resistance: Details on water resistance are not specified.
- Approved Age Range: Approved for individuals aged 18 years and older who are not on insulin.
- Glucose Measurement Method: Stelo measures glucose levels in the interstitial fluid, the fluid between cells in your tissues.
Accuracy and Data Updates
- Mean Absolute Relative Difference (MARD): Specific MARD values for Stelo are not provided.
- Data Update Frequency: The sensor takes a reading every 5 minutes.
- Impact of Substances on Accuracy: Information on the impact of substances like vitamin C is not specified.
Glucose Measurement Range and Historical Data
- Measurement Range: Designed to measure glucose levels between 70-250 mg/dL.
- Accuracy in Hypoglycemia and Hyperglycemia: Specific comparative accuracy data is not provided.
- Historical Data Retention: The app provides real-time glucose insights; details on the duration of historical data storage are not specified.
Application and Usage
- Ease of Application: The Stelo sensor is designed for easy application on the back of the upper arm.
- Usage Duration: Each sensor lasts for 15 days.
- Warm-up Time: Specific warm-up time details are not provided.
Components and Training
- Components: The system includes the sensor and access to the Stelo smartphone app.
- Training: Designed for a user-friendly application, with guidance available through the app.
Compatibility with Insulin Pumps and Automated Insulin Delivery (AID) Systems
Stelo is tailored for individuals who are not on insulin and do not integrate with insulin pumps or AID systems.
Mobile Application and Data Viewing
- Mobile Application: Yes, the Stelo app displays real-time glucose data.
- Data Display: The app provides personalized insights to help users understand their glucose patterns.
- Data Transmission Distance: Data is transmitted wirelessly to the smartphone; a typical Bluetooth range applies.
Remote Data Access and Presentation
The app offers personalized insights; details on remote data access and specific data presentation formats are not specified.
Cost and Availability
- Cost: Pricing details are not specified; checking with Dexcom or authorized retailers for current pricing is recommended.
- Availability: Available for purchase without a prescription at Stelo.com.
Medicare and Insurance Coverage
As an OTC device, Stelo is available without a prescription. Insurance coverage may vary, and it’s advisable to consult with healthcare providers or insurance companies for specific criteria.
Advantages and Disadvantages
Advantages:
- Available over-the-counter without a prescription.
- Provides continuous glucose monitoring for individuals not on insulin.
- User-friendly application and smartphone integration.
Disadvantages:
- Does not integrate with insulin pumps or AID systems.
- Limited to individuals aged 18 and older not on insulin.