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First Continuous Glucose Monitoring System Approved for Children as Young as Age 2 — Physician’s First Watch
First Continuous Glucose Monitoring System Approved for Children as Young as Age 2
By Amy Orciari Herman
The Dexcom G4 Platinum Continuous Monitoring System, previously approved for adults with diabetes, has been approved for use in diabetic children aged 2 to 17 years, the FDA announced on Monday. It's the first continuous blood glucose monitor approved for very young children.
In a clinical trial among 176 children and adolescents who wore the sensor for 7 days, the device effectively determined patterns in glucose levels, and it alerted users when glucose was nearing hyperglycemic or hypoglycemic levels. However, the label will advise patients to:
Use a blood glucose meter (not the Dexcom monitor) to guide treatment decisions, as there were large differences between the monitor's glucose readings and patients' actual glucose levels in the pediatric trial.
Not rely on the monitor to identify low glucose, since it missed "a significant number" of hypoglycemic events in the same trial.