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Second Study
 

The PRECISE II (U.S.) Trial¹

The second study (PRECISE II), performed in the United States, investigated the efficacy and safety of the Eversense CGM System during 90 days of continuous sensor wear. A total of 90 adults with Type 1 or Type 2 diabetes at 8 clinical centers were enrolled. Accuracy and safety endpoints were similar to those in the previous PRECISE study. This study also included an exercise session and durations of sensor compression.

Overall MARD value was 8.5%* (95% confidence interval: 8.1-9.3%). 91% percent of sensors were functional through day 90. Accuracy was not impacted by exercise or sensor compression. No infections or adhesive skin reactions were reported, and one related serious adverse event (1.1%) occurred during removal of a sensor.

The Eversense System detected 90% of hypoglycemic excursions detected (70mg/dL) and 98% of hyperglycemic excursions detected (180mg/dL).

 
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Study Summary

PRECISE II STUDY SUMMARY

Tested

  • Proven 90-day life
  • 100,000 days of data
  • 15,753 paired points
  • 2MM sensor readings
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Accurate

  • Overall: 8.5%
  • Euglycemia: (71-180 mg/dl) 8.5%
  • Hypoglycemia: (≤70 mg/dl) 13.6%
  • Hyperglycemia: (>180 mg/dl) 7.6%
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Safe

  • 0.0% infection rate
  • Minimally invasive
  • Efficient procedure
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Compliant

  • Proven flexibility
  • 23.4 hours of wear time per day (mean)
  • Data capture capabilities
compliant

*The MARD demonstrated in the PRECISE II study was 8.8% using the study software. The algorithm that calculates glucose values was updated after the completion of the PRECISE II study. When the updated “Software 602” algorithm was applied to the raw sensor data of the PRECISE II study, the primary endpoint was met with a demonstrated MARD of 8.5%.

Another investigation into the fluorescent glucose-indicating technology used in the Eversense CGM System showed it is not affected by the same interferents as systems using electrochemical reactions to measure glucose. The Eversense CGM System retained the ability to accurately measure glucose concentrations in the presence of acetaminophen and Vitamin C, providing a potential safety advantage to patients.2
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Sub Description

The advanced sensor technology and under-the-skin sensor help patients reach unprecedented levels of wear time, leading to improved clinical outcomes.