FDA approved a real-time continuous glucose monitoring (CGM) system (Guardian RT, made by Medtronic, Inc.) for the management of types 1 and 2 diabetes in patients aged 18 years and older. FDA approved a real-time continuous glucose monitoring (CGM) system (Guardian RT, made by Medtronic, Inc.) for the management of types 1 and 2 diabetes in patients aged 18 years and older.
The system uses a disposable sensor that is inserted subcutaneously in the abdominal area to measure interstitial fluid glucose levels. Each sensor lasts up to three days and takes about 288 glucose readings per day.
Sensor readings are relayed via radiofrequency transmitter to a monitor and displayed in real-time every five minutes. Preset alarm thresholds alert patients to potentially dangerous glucose levels, and trend reports/charts can be analyzed after data are downloaded to a computer using therapy management software and a docking system.
Fingerstick measurements are required to calibrate the system every 12 hours and prior to adjusting insulin delivery.
Unlike glucose meters that are used only at discrete intervals and yield information gaps, the system provides continuous data regarding the effects of diet, exercise, medication, and lifestyle on glucose levels for improved disease management. The real-time display also enables prompt intervention to reduce the frequency and severity of hypoglycemic and hyperglycemic episodes for improved control.
According to a company news release, initial distribution of the device will be limited to select U.S. cities to further evaluate training, education, and reimbursement needs.
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