Evaluation of Accuracy and Safety of the 365-Day Implantable Eversense Continuous Glucose Monitoring System: The ENHANCE Study
Authors' conclusion
The Eversense 365 CGM was shown to be safe and accurate through 1 year with primarily one calibration per week.
Study context
- Population
- Adults with diabetesimplanted
- Participants
- 110 adults
- Comparison
- Eversense 365 Continuous Glucose Monitoring (CGM) vs Yellow Springs Instrument reference glucose
- Eversense 365 CGMn = 110
- Outcome
- Accuracy and safety of the Eversense 365 CGM system
- Follow-up
- 1 year
Methodological detailsmulticenter, 14 in-clinic visits comparing CGM with Yellow Springs Instrument reference glucose, including hyperglycemia and hypoglycemia challenges
- Multicenter
- 14 in-clinic visits comparing CGM with Yellow Springs Instrument reference glucose, including hyperglycemia and hypoglycemia challenges
Performance
As reported in the abstract
Accuracy (MARD vs reference glucose) · through 1 year
| Test or model | Value | Confirmed alert detection rate at 70 mg/dL | Confirmed alert detection rate at 180 mg/dL |
|---|---|---|---|
| Eversense 365 CGM | overall mean absolute relative difference 8.8% | 96.6% | 97.9% |
Eversense 365 CGM
Valueoverall mean absolute relative difference 8.8%
Confirmed alert detection rate at 70 mg/dL96.6%
Confirmed alert detection rate at 180 mg/dL97.9%
Further findings
| Outcome | Values |
|---|---|
| Sensor survival · 365 days | Eversense 365 CGM 90% |
Safety
Related serious AEs · 1 year
- No related serious AEs were reported
Original publication
Evaluation of Accuracy and Safety of the 365-Day Implantable Eversense Continuous Glucose Monitoring System: The ENHANCE Study. Diabetes Technol Ther. Published 27 January 2025. doi:10. 1089/ dia. 2024. 0592
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