User Manual

Performance Characteristics 83
Chapter 5
Performance Characteristics
NOTE - Users should have the information in this chapter reviewed by their healthcare provider.
The Medtronic MiniMed Guardian RT uses a glucose Sensor to continuously monitor your glucose levels.
The Guardian RT Sensor is “calibrated” using your home blood glucose meter. Once calibrated, the
Guardian RT reports glucose values every 5 minutes. These values were compared to reference
laboratory blood glucose measurements to check the Guardian RT’s performance characteristics in a
clinical study
1
.
Although presentations to characterize performance of the Guardian RT are given below, there is no
commonly accepted statistical approach for capturing the performance of continuous glucose monitors
such as the Guardian RT. Performance may be best characterized by viewing graphs called time-elapsed
plots. In these plots, the values from Guardian RT for one subject over time are overlaid with values at
the same time from the glucose reference method. Three representative time-elapsed plots of Sensors
that exhibited excellent performance, average performance and poor performance are shown on pp. 95-
97 (Figures 5.3-5.5).
1
Medtronic MiniMed, A Frequent Sample Accuracy Evaluation of the Medtronic MiniMed Telemetered Glucose Monitoring System
II (TGMS II) in Subjects with Type 1 Diabetes Mellitus, August 2004.