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[IP] FDA Approves Continuous Glucose Monitor for Children



Miriam E. Tucker Disclosures
February 04, 2014

The US Food and Drug Administration (FDA) has expanded the approval of the
Dexcom G4 Platinum continuous glucose monitoring (CGM) system to include use
in children aged 2 to 17 years of age, despite reduced accuracy compared
with adults.

The G4 Platinum (Pediatric) system is the first CGM system approved for
young children. The G4 Platinum system had previously been approved only for
adults aged 18 years and older.

Another currently available CGM system, Medtronic's Enlite, is approved for
ages 16 and older but is being studied in children as young as 2 years.

As with other CGM systems, the G4 Platinum (Pediatric) system continually
displays estimated blood sugar readings and their direction and rate of
change. The sensors, inserted just under the skin, detect glucose levels in
interstitial fluid for up to 7 days before they need to be changed. With the
new pediatric version, sensors can be worn on the upper buttocks as well as
the abdomen.

The wireless system is personalized with individual glucose targets and
alerts and includes an alarm feature for when blood glucose levels fall or
rise beyond recommended thresholds.

Also, as with other CGM systems, the Dexcom G4 Platinum is not approved for
use in making insulin-dosing decisions. Finger-stick blood glucose
monitoring is still required both for calculating mealtime boluses and for
calibration of the CGM system.

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Information from Industry
In a statement, the FDA cautions that the Dexcom G4 Platinum CGM was not as
accurate as it had been in adults in studies involving 176 children aged 2
to 17 years. Moreover, the ability of the device to issue an alert at
glucose levels in the hypoglycemic range (below 70 mg/dL) was "poor"
compared with that of the same device used in adults, it states.

Warnings about these 2 limitations will be included in the product label and
will also be displayed on the receiver screen at the time a new sensor is
activated and any time an alert threshold is changed. The notices will also
include reminders about using finger-stick meters for treatment decisions
and for hypoglycemia detection.

Nonetheless, FDA says, "the study did demonstrate that the device is
effective for tracking and trending to determine patterns in glucose levels
and for alerting patients when glucose values are approaching potentially
dangerously high (hyperglycemic) and/or dangerously low (hypoglycemic)
levels."

Along with insulin pumps, CGMs are essential components of an automated
"artificial pancreas device system," currently under development by several
manufacturers
.
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