User guide

Table Of Contents
Stratified Clarke Error Grid Analysis
Range of
Comparative
Glucose
Readings
(mg/dL)
Total
Count A + B A B C D E
40-80 360 (13.9%) 201
(55.8%)
141
(39.2%)
60 (16.7%) 1 (0.3%) 157
(43.6%)
1 (0.3%)
81-120 482 (18.5%) 478
(99.2%)
287
(59.5%)
191
(39.6%)
4 (0.8%) 0 (0%) 0 (0%)
121-240 1055
(40.6%)
1053
(99.8%)
782
(74.1%)
271
(25.7%)
2 (0.2%) 0 (0%) 0 (0%)
240-400 702 (27.0%) 666
(94.9%)
523
(74.5%)
143
(20.4%)
0 (0%) 36 (5.1%) 0 (0%)
Overall 2599
(100.0%)
2398
(92.3%)
1733
(66.7%)
665
(25.6%)
7 (0.3%) 193 (7.4%) 1 (0.0%)
Low and High alerts in children and adolescents
The ability of the Guardian RT to detect high and low glucose levels was measured in the same clinical
study.
11
Since it is important to set the alert levels in a conservative fashion, the Low Glucose Alert should
be set at a value slightly higher than the value of blood glucose you want to detect, and the High Glucose
Alert should be set at a value slightly lower than the value of blood glucose you want to detect.
NOTE: Please ask your healthcare professional which low and high alert setting is best for you.
The Low Glucose Alert
The Low Glucose Alert was evaluated for its ability to detect glucose levels at 70 mg/dL (3.9 mmol/L), or
below, using the blood glucose meter. As a reference, with the Low Glucose Alert set at 70 mg/dL
(3.9 mmol/L), 24% (59/244) of low glucose events were detected by the Guardian RT. Better detection of
11.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 151
Appendix A