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Sensor accuracy

NOTE: You should review the information in this section with your healthcare professional.

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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 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.

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 later renamed Guardian RT.

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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 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 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.

Sensor accuracy

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