Medtronic Paradigm 522 Guide de l'utilisateur télécharger pdf (Page 226)

Sensor accuracy

NOTE: Y

ou should review the information in this section with your healthcare professional.

The Medtronic MiniMed Paradigm 522/522K/722/722K pumps use a glucose sensor to continuously monitor

your glucose levels. The 522/522K/722/722K pumps use the same algorithm as the Guardian R

. 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.

NOTE: The Guardian R

T 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 later renamed Guardian RT.

The Medtronic Guardian RT uses a glucose sensor to continuously monitor your glucose levels. The

Guardian R

T sensor is calibrated using your home blood glucose meter. Once calibrated, the Guardian RT

reports 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 T

ype 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

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Medtronic Paradigm 522 Guide de l'utilisateur Page 226