Eversense CGMs, developed by Senseonics, offer a unique approach to continuous glucose monitoring by using implantable sensors. Senseonics has been a pioneer in long-term CGM technology, receiving FDA approval for its first Eversense CGM in 2018. Their latest models, the Eversense E3 and Eversense 365, reflect their commitment to innovation and accuracy in diabetes management.
Current CGM Offerings
Eversense E3:
- Size and Weight: Measures approximately 1.5 inches (3.81 cm) long and weighs 0.002 ounces (0.06 grams).
- Water Resistance: The sensor is water-resistant once implanted.
- Approval: Suitable for individuals aged 18 and older.
Eversense 365:
- Size and Weight: Similar dimensions and weight as the E3.
- Lifespan: Functions for up to 365 days, significantly reducing the frequency of sensor replacements.
- Water Resistance: Fully water-resistant after implantation.
- Approval: Approved for individuals aged 18 and older.
Application and Usage
Both Eversense models require a minor in-office procedure performed by a healthcare provider to implant the sensor under the skin of the upper arm. The sensors are designed for extended use:
- Eversense E3: Lasts up to 180 days (six months) with a 24-hour warm-up period.
- Eversense 365: Offers a full-year lifespan, also with a 24-hour warm-up period.
Insurance and Medicare Coverage
To qualify for Medicare or insurance coverage for Eversense CGMs, patients typically need:
- A diabetes diagnosis.
- Frequent blood glucose testing.
- Insulin therapy involving multiple daily injections or an insulin pump.
Coverage specifics may vary, so consulting healthcare providers and insurance plans is recommended.
Glucose Measurement Method Eversense CGMs use a fluorescence-based sensor to measure glucose levels in interstitial fluid. A smart transmitter worn over the sensor’s implantation site communicates with a mobile app, updating glucose data every five minutes.
Accuracy and Performance
- Eversense E3:
- MARD (Mean Absolute Relative Difference): 8.5% for high accuracy.
- Updates glucose data every five minutes.
- Certain medications, such as tetracyclines, may impact accuracy.
- Eversense 365:
- Maintains accuracy comparable to the E3 over its extended lifespan.
- Data updates every five minutes.
Glucose Measurement Range and Historical Data Both models accurately measure glucose levels between 40 and 400 mg/dL (2.2 to 22.2 mmol/L). Historical data is stored and accessible via the Eversense mobile app, offering insights into trends and patterns.
FDA Approvals
- Eversense E3: Approved by the FDA in February 2022.
- Eversense 365: Gained FDA clearance in September 2024.
Cost and Availability
- With Insurance: Many plans cover Eversense CGMs, reducing costs. Senseonics provides assistance programs for commercial insurance holders.
- Without Insurance:
- Eversense E3: Approximately $1,350 for a 180-day sensor and $700 for the transmitter. Additional costs may include implantation and removal procedures.
- Eversense 365 pricing is expected to be higher due to its extended lifespan.
These systems are available through healthcare providers trained in the implantation procedure.
Components and Training Purchasing an Eversense CGM typically includes:
- Implantable sensor.
- Smart transmitter.
- Mobile app access.
Healthcare providers offer training during implantation, with additional resources available through Senseonics.
Compatibility with Insulin Pumps and AID Systems
Currently, Eversense CGMs do not directly integrate with insulin pumps or Automated Insulin Delivery (AID) systems. However, efforts are underway to expand compatibility in the future.
Mobile App and Data Access The Eversense mobile app provides:
- Real-time and historical glucose data.
- Updates every five minutes.
- Customizable alerts for high and low glucose levels.
- Data-sharing options for caregivers and healthcare providers.
Advantages and Disadvantages
Advantages:
- Long sensor lifespan reduces the need for frequent replacements.
- High accuracy with minimal calibration.
- Water resistance and discreet design.
- Comprehensive app features for monitoring and sharing data.
Disadvantages:
- Requires an in-office procedure for implantation and removal.
- Higher upfront costs compared to other CGMs.
- Limited integration with insulin pumps and AID systems.
Conclusion Eversense CGMs, particularly the E3 and 365 models, stand out for their long-term use and accuracy. While they may not yet integrate with insulin delivery systems, their unique design and extended sensor lifespan make them an attractive choice for many individuals managing diabetes. If you’re considering a CGM, consult your healthcare provider to determine if Eversense is right for you.