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FDA approves continuous glucose monitor for children
Continuous glucose monitoring system indicated for children aged 7 to 17 years.
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The Real-Time Continuous Glucose Monitor from Medtronic has been approved for use in children, and according to the company, pediatric-sized models of Medtronic systems will be available soon.
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The device is now indicated for children aged 7 to 17 and was previously only available for adults.
“It is a major step forward,” said Janet H. Silverstein, MD, chief, division of endocrinology, University of Florida, Gainesville, and a member of the Endocrine Today editorial board. “It will benefit both health care providers and their patients. The glucose trend arrows and alarms will provide a sense of comfort that hypoglycemia will not go unrecognized. It is really going to be good for parents who get up all the time because they are worried about nocturnal hypoglycemia in their children.”
The devices use directional arrows and display real-time blood glucose levels and trend graphs. Warning alarms alert parents and patients when blood glucose levels drop dangerously or rise above preset levels, even when children are sleeping.
“This technology will give us information that will allow us to make much smarter insulin dose adjustments. It is not just going to be discrete points in time, but rather a good glucose profile during the course of the day,” Silverstein said.
Silverstein envisions a gradual introduction of the pediatric continuous glucose monitors; the interest is there, but she does not foresee the device replacing fingerstick measurements just yet.
The continuous glucose monitors show the effects that diet, exercise, medication and lifestyle have on blood glucose levels, and may reduce the duration of hypoglycemic events and lower HbA1c levels by as much as two percentage points, according to Medtronic.
With a new approval, there may still be issues and barriers to overcome, such as insurance coverage. Mark A. Sperling, MD, professor, department of pediatrics, Children’s Hospital of Pittsburgh, called the FDA approval a good step, however. “This is the first step in the right direction so we can have a fully programmable closed-loop device, a so-called artificial pancreas,” said Sperling, also a member of the Endocrine Today editorial board. – by Katie Kalvaitis