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The Food and Drug Administration has approved a continuous glucose monitor for use in children as young as 2 years, with warnings in the label indicating that the performance of the device in children is less accurate than in adults, the agency announcedon Feb. 3.
Previously approved for use in adults aged 18 years and older, the Dexcom Platinum Continuous Monitoring System is now approved for people with diabetes aged 2-17 years, the agency said. The device has the same sensor and transmitter as the adult system, but the sensor can also be inserted into the upper buttock in addition to the abdomen, the statement said.
"The device can provide valuable glucose trend information to children with diabetes and their families, but it is important that those using this device understand the expected performance of this device compared to blood glucose meters, especially for detecting low glucose, in pediatric patients," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Devices in the FDA’s Center for Devices and Radiological Health said in the statement.
The statement summarizes the results of a pivotal study of the device in the clinic and at home in 176 patients aged 2 through 17 years, which compared glucose results provided by the continuous glucose monitoring (CGM) over 7 days of use, with results from a clinical laboratory reference method among those aged 6-17 years, and finger stick samples on a blood glucose meter among those aged 2-17 years. Performance of the device in children was less accurate than in adults, and the performance of the hypoglycemic detection alert feature of the device was "poor relative to that seen in the adult study," particularly at blood glucose levels below 70 mg/dL.
"Despite these limitations, 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," the statement added.
These results are reflected in warnings included in the CGM’s label and displayed on the device’s screen, advising that the blood glucose meter should be used for treatment decisions and that CGM alerts should not be used alone to detect low glucose.
The G4 Platinum (Pediatric) System is manufactured by Dexcom Inc.
This is the first CGM to be approved in children down to age 2 years; another CGM manufactured by Medtronic is approved for use in children after age 6 years, according to an FDA spokesperson.
Along with an insulin pump, CGMs, which measure glucose levels in the interstitial fluid, are a component of the artificial pancreas system, along with an insulin infusion pump, which is being studied in people with type 1 diabetes as a closed loop system of monitoring glucose levels and automatically dispensing the appropriate amount insulin, as determined by a computer algorithm. The CGM is calibrated periodically using the blood glucose values from a blood glucose monitor.
The Food and Drug Administration has approved a continuous glucose monitor for use in children as young as 2 years, with warnings in the label indicating that the performance of the device in children is less accurate than in adults, the agency announcedon Feb. 3.
Previously approved for use in adults aged 18 years and older, the Dexcom Platinum Continuous Monitoring System is now approved for people with diabetes aged 2-17 years, the agency said. The device has the same sensor and transmitter as the adult system, but the sensor can also be inserted into the upper buttock in addition to the abdomen, the statement said.
"The device can provide valuable glucose trend information to children with diabetes and their families, but it is important that those using this device understand the expected performance of this device compared to blood glucose meters, especially for detecting low glucose, in pediatric patients," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Devices in the FDA’s Center for Devices and Radiological Health said in the statement.
The statement summarizes the results of a pivotal study of the device in the clinic and at home in 176 patients aged 2 through 17 years, which compared glucose results provided by the continuous glucose monitoring (CGM) over 7 days of use, with results from a clinical laboratory reference method among those aged 6-17 years, and finger stick samples on a blood glucose meter among those aged 2-17 years. Performance of the device in children was less accurate than in adults, and the performance of the hypoglycemic detection alert feature of the device was "poor relative to that seen in the adult study," particularly at blood glucose levels below 70 mg/dL.
"Despite these limitations, 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," the statement added.
These results are reflected in warnings included in the CGM’s label and displayed on the device’s screen, advising that the blood glucose meter should be used for treatment decisions and that CGM alerts should not be used alone to detect low glucose.
The G4 Platinum (Pediatric) System is manufactured by Dexcom Inc.
This is the first CGM to be approved in children down to age 2 years; another CGM manufactured by Medtronic is approved for use in children after age 6 years, according to an FDA spokesperson.
Along with an insulin pump, CGMs, which measure glucose levels in the interstitial fluid, are a component of the artificial pancreas system, along with an insulin infusion pump, which is being studied in people with type 1 diabetes as a closed loop system of monitoring glucose levels and automatically dispensing the appropriate amount insulin, as determined by a computer algorithm. The CGM is calibrated periodically using the blood glucose values from a blood glucose monitor.
The Food and Drug Administration has approved a continuous glucose monitor for use in children as young as 2 years, with warnings in the label indicating that the performance of the device in children is less accurate than in adults, the agency announcedon Feb. 3.
Previously approved for use in adults aged 18 years and older, the Dexcom Platinum Continuous Monitoring System is now approved for people with diabetes aged 2-17 years, the agency said. The device has the same sensor and transmitter as the adult system, but the sensor can also be inserted into the upper buttock in addition to the abdomen, the statement said.
"The device can provide valuable glucose trend information to children with diabetes and their families, but it is important that those using this device understand the expected performance of this device compared to blood glucose meters, especially for detecting low glucose, in pediatric patients," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Devices in the FDA’s Center for Devices and Radiological Health said in the statement.
The statement summarizes the results of a pivotal study of the device in the clinic and at home in 176 patients aged 2 through 17 years, which compared glucose results provided by the continuous glucose monitoring (CGM) over 7 days of use, with results from a clinical laboratory reference method among those aged 6-17 years, and finger stick samples on a blood glucose meter among those aged 2-17 years. Performance of the device in children was less accurate than in adults, and the performance of the hypoglycemic detection alert feature of the device was "poor relative to that seen in the adult study," particularly at blood glucose levels below 70 mg/dL.
"Despite these limitations, 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," the statement added.
These results are reflected in warnings included in the CGM’s label and displayed on the device’s screen, advising that the blood glucose meter should be used for treatment decisions and that CGM alerts should not be used alone to detect low glucose.
The G4 Platinum (Pediatric) System is manufactured by Dexcom Inc.
This is the first CGM to be approved in children down to age 2 years; another CGM manufactured by Medtronic is approved for use in children after age 6 years, according to an FDA spokesperson.
Along with an insulin pump, CGMs, which measure glucose levels in the interstitial fluid, are a component of the artificial pancreas system, along with an insulin infusion pump, which is being studied in people with type 1 diabetes as a closed loop system of monitoring glucose levels and automatically dispensing the appropriate amount insulin, as determined by a computer algorithm. The CGM is calibrated periodically using the blood glucose values from a blood glucose monitor.
