Blood sugar monitoring system approved for children

(HealthDay)—U.S. Food and Drug Administration approval of the Dexcom G4 Platinum Continuous Monitoring System has been expanded to include children with diabetes aged 2 years to 17 years, the agency said.

Previously approved for adults only, the device constantly monitors the user's blood sugar, checking for dangerously high or low levels, the FDA said in a news release. An estimated 25.8 million people in the United States—including 215,000 under age 20—have diabetes.

The external device, known as a continuous glucose monitor, includes a small, narrow sensor that's inserted just under the skin. That combined with a blood glucose meter can help the user's doctor decide , such as the amount of insulin to prescribe, the FDA said.

The device was evaluated in clinical studies involving 176 people ages 2 to 17. The FDA warned the device's "performance in pediatric subjects was not as accurate as the performance of the same device in adults." Nonetheless, the agency said the device is still "effective for tracking and trending to determine patterns in ," and for warning users that their had risen too high or fallen too low.

The system is produced by Dexcom Inc., based in San Diego.

More information: The FDA has more about this approval.

add to favorites email to friend print save as pdf

Related Stories

Blood-tracking device uses new technology

May 29, 2013

(HealthDay)—The first device to use Radio Frequency Identification (RFID) technology to help workers track blood products and prevent the release of unsuitable samples has been approved by the U.S. Food and Drug Administration.

FDA approves new magnet device to treat migraines

Dec 15, 2013

(HealthDay)—The U.S. Food and Drug Administration has approved the first device aimed at easing the pain of migraines preceded by aura—sensory disturbances that occur just before an attack.

Stent to treat pancreatic cysts approved

Dec 19, 2013

(HealthDay)—The Axios Stent and Delivery System has been approved by the U.S. Food and Drug Administration to treat infected pancreatic cysts that won't drain on their own and could become life threatening, the FDA said ...

Recommended for you

Viagra ads target women for first time

15 hours ago

The maker of the world's top-selling erectile dysfunction drug on Tuesday will begin airing the first Viagra TV commercial in America that targets the less-obvious sufferers of the sexual condition: women.

User comments