Diabetes technology

Evaluation of Accuracy and Safety of the 365-Day Implantable Eversense Continuous Glucose Monitoring System: The ENHANCE Study

Diabetes Technol TherPublished Prospective multicentre single-arm accuracy and safety 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 modelValueConfirmed alert detection rate at 70 mg/dLConfirmed alert detection rate at 180 mg/dL
Eversense 365 CGMoverall 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

OutcomeValues
Sensor survival · 365 daysEversense 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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