Ron Brazg, United States of America
Rainier Clinical Research Center EndocrinologyPresenter of 1 Presentation
PERFORMANCE OF THE GUARDIAN™ SENSOR 3 CONTINUOUS GLUCOSE MONITORING SYSTEM WITH NO CALIBRATION
- Ron Brazg, United States of America
- Timothy Bailey, United States of America
- Bruce W. Bode, United States of America
- Kristin Castorino, United States of America
- Mark Christiansen, United States of America
- Satish K. Garg, United States of America
- Kevin Kaiserman, United States of America
- Yogish Kudva, United States of America
- David Liljenquist, United States of America
- Dorothy Shulman, United States of America
- Robert Slover, United States of America
- Scott W. Lee, United States of America
- John Shin, United States of America
- Suiying Huang, United States of America
- Andrew Rhinehart, United States of America
- Robert A. Vigersky, United States of America
Abstract
Background and Aims
Continuous glucose monitoring (CGM) is becoming an important tool for glycemic management and is an integral part of automated insulin delivery (AID) systems. Medtronic developed a new sensor algorithm for use with the Guardian™ Sensor 3 (GS3) glucose sensor that requires no calibration, and the present study assessed its performance.
Methods
There were 160 subjects (aged 18-80 years, ~64% with T1D) who wore GS3 sensors in the arm and abdomen. Data were compared with Yellow Springs Instrument (YSI) values and processed using the Zeus algorithm and incorporating different calibration schemes. The primary endpoint was determination of overall sensor glucose (SG) values within 20% of YSI reference, or ±20 mg/dL when SG was <80 mg/dL (20%/20). Other endpoints included overall mean absolute relative difference (MARD) between system and reference values, ±15 mg/dL at SG <70 mg/dL, and Consensus Error Grid (CEG) analyses.
Results
For no calibrations and the arm location, 20%/20 and ±15 mg/dL agreement rates were 88.0% (N=20,612 paired data points) and 89.6% (N=2456 paired data points), respectively. For the abdomen, the rates were 88.0% (N=18,423) and 92.1% (N=1963), respectively. MARD was 10.64% for the arm and 10.78% for the abdomen. MARD for the <70 mg/dL SG range was 12.61% for the arm and 14.78% for the abdomen. The CEG analyses determined 99.9% of points within the A+B range for both the arm (N=20,590) and abdomen (N=18,409) locations.
Conclusions
These data on the performance of the no-calibration Guardian™ Sensor 3 system may support non-adjunctive insulin dosing in standalone CGM and AID systems.