User guide

Sensor accuracy
The information in this section is meant to be reviewed by you with your healthcare professional. Please
also note: The Guardian RT is not an abbreviation for the Guardian REAL-Time CGM System. The Guardian
RT is a continuous glucose monitoring system that was developed before the Guardian REAL-Time CGM
System. The Guardian RT was originally named TGMS II, and the name was changed to Guardian RT.
The Guardian REAL-Time CGM System uses a glucose sensor to continuously monitor your glucose levels.
The Guardian REAL-Time CGM System uses the same algorithm as the Guardian RT
®
. The Guardian RT was
evaluated in two clinical studies and the following information in this section describes the findings. The
remainder of this section discusses the results of this pivotal study, and uses the term Guardian RT.
The Medtronic 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
records glucose values every five minutes. These values were compared to reference laboratory blood
glucose measurements to check the Guardian RT’s performance characteristics in two clinical studies.
1, 2
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 are shown at the
end of this section of sensors that exhibited excellent performance, average performance and poor
performance.
1. Medtronic Diabetes, A Frequent Sample Accuracy Evaluation of the Medtronic Diabetes Telemetered Glucose Monitoring
System II (TGMS II) in Subjects with Type 1 Diabetes Mellitus, August 2004.
2. Medtronic Diabetes, An Accuracy Evaluation of the Medtronic Diabetes Guardian RT Glucose Monitoring System in Pediatric
Subjects with Type 1 Diabetes Mellitus, February, 2006.
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Appendix A