CORRELATION BETWEEN TIME IN RANGE AND GLUCOSE MANAGEMENT INDICATOR WITH THE EVERSENSE CGM SYSTEM
- Patricia Sanchez, United States of America
- Patricia Sanchez, United States of America
- Samanwoy Ghosh-dastidar, United States of America
- Katherine S. Tweden, United States of America
- Francine Kaufman, United States of America
Abstract
Background and Aims
The safety and accuracy outcomes from multiple clinical studies of the implantable Eversense CGM System allowed for CE Marking in 2016 and FDA approval in 2018. Glucometric, accuracy, and safety data from the first 205 US real-world users has been reported and shown to corroborate clinical study results.
Methods
De‐identified sensor glucose (SG) data from the Eversense data management system (DMS) from an expanded cohort of 582 real-world commercial users who reached the end of the 90‐day sensor wear period were analyzed. Correlations between Glucose Management Indicator (GMI, an SG-derived assessment of A1C) and percent of SG values between 70-180mg/dL (TIR), percent SG values >180mg/dL, and percent SG values <70mg/dL were made.
Results
As shown in the graphs, GMI had a strong negative correlation with TIR with an R2 value of 0.87. The R2 values were 0.96 for time >180mg/dL, and 0.20 for time <70mg/dL. It was calculated that a TIR increase of 10% was associated with a decrease in GMI of 0.43%.
Conclusions
Data from a large cohort of Eversense CGM system users showed a strong correlation between TIR and GMI, a mathematical assessment of A1C. Monitoring and targeting TIR, in addition to percent of SG values in the hyperglycemic range, should help patients improve diabetes long-term outcomes, particularly in between laboratory assessments of A1C. 