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First Continuous Glucose Monitoring System Approved for Children as Young as Age 2 — Physician’s First Watch

Medical News |
February 5, 2014

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.

Reader Comments (2)

Uzma Majid Physician, Endocrinology

I wanna know about the device.

B.Sc (Honors), MS Other Healthcare Professional, Other, Health Dept LabsI

Altho' retired, I continue to follow the newer diagnostic tests as I was involved in the development of many a new automated/ routine procedures offered to physicians

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