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FDA Approves: Pediatric REAL-time (Medtronic)CGMS

Apr 3, 2007

The US Food and Drug Administration (FDA) has approved a pediatric model of a continuous glucose monitoring system as a stand-alone device or with a pediatric insulin pump for the management of diabetes in children aged 7 to 17 years. The system consists of a subcutaneously placed wire-like disposable sensor that continuously measures interstitial fluid glucose levels, transmitting the readings via radiofrequency transmitter to a pager-size monitor every 5 minutes for real-time display.

Unlike glucose meters that are used only at discrete intervals and yield information gaps, the system provides continuous data, trend graphs, and directional arrows regarding the effects of diet, exercise, medication, and lifestyle on glucose levels; preset alarm thresholds enable prompt intervention to reduce the frequency and severity of hypoglycemic and hyperglycemic episodes.

According to a company news release, use of the system can reduce the duration of hypoglycemic events and lower HbA1c levels by as much as 2 percentage points. Current blood glucose monitoring standards fail to detect up to 60% of hypoglycemic events, and each percentage point decrease in HbA1c is linked to a 35% reduction in the risk for complications.