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a)Do not use the Guardian Connect System for pediatric patients until you have thoroughly reviewed (with your Healthcare Professional), the system alert performance in the Guardian Connect Application User Guide and the sensor accuracy performance in the Guardian Sensor (3) Performance document. Discuss with your Healthcare Professional how to best set up your Guardian Connect System alerts to reduce the risk of missing low blood glucose or high blood glucose events.
b)In the pediatric clinical study (3-18 years of age), larger differences were observed between the Guardian Connect System and actual blood glucose values compared to those differences observed in the adolescent/adult clinical study (14-75 years of age), particularly at low glucose levels.
c)In the pediatric clinical study, a significant percentage of low glucose events were not detected by the Guardian Connect System. Do not rely solely on the Guardian Connect System alerts to detect low glucose.
d)In the pediatric clinical study, the Guardian Connect System triggered a high percentage of false low glucose and false high glucose alerts. The Guardian Connect System is not intended to make therapy adjustments: always check your capillary blood glucose before making therapy adjustments.
e)In the pediatric clinical study, enabling the ‘Alert Before Low’ and ‘Alert Before High’ predicted alerts significantly reduced the percentage of missed low blood glucose and missed high blood glucose events, but also significantly increased the percentage of false low glucose and false high glucose alerts. Do not ignore alerts from your Guardian Connect System. Always follow your treatment instructions from your Healthcare Professional when responding to an alert from your Guardian Connect System.