FDAnews
www.fdanews.com/articles/75285-fda-approves-guardian-glucose-monitoring-system

FDA APPROVES GUARDIAN GLUCOSE MONITORING SYSTEM

August 11, 2005

The FDA has approved Medtronic's Guardian RT Continuous Glucose Monitoring System for improved diabetes management.

Indicated for use in adult patients with Type 1 and/or Type 2 diabetes, the Guardian system displays real-time glucose values every five minutes and alerts patients when glucose levels become too high or too low. The system records as many as 864 glucose readings during a three-day period using a disposable glucose sensor that connects to a transmitter. Through radio frequency technology, glucose measurements are relayed every five minutes from the transmitter to the monitor, which displays the glucose values on its screen. Also, alarm thresholds can be preset to alert patients to potentially dangerous glucose levels.

The system is calibrated twice a day (every 12 hours) by entering a glucose measurement from a standard blood glucose meter into the Guardian RT's monitor. Patients can make self-management decisions after confirming with a fingerstick measurement.

(http://www.fdanews.com/ddl target=_blank)