FDA expands indication for continuous glucose monitoring system

 

People with diabetes have come a step closer to a life without multiple daily finger sticks. The approved use of the Dexcom G5 Mobile Continuous Glucose Monitoring System has been expanded to allow for replacement of fingerstick blood glucose testing for diabetes treatment decisions in people 2 years of age and older with diabetes, the Food and Drug Administration announced .

“Although this system still requires calibration with two daily fingersticks, it eliminates the need for any additional fingerstick blood glucose testing in order to make treatment decisions,” Alberto Gutierrez, Ph.D., director of the office of in vitro diagnostics and radiological health in the FDA’s Center for Devices and Radiological Health, said in the FDA statement.

“This may allow some patients to manage their disease more comfortably and may encourage them to have routine dialogue with their health care providers about the use of real-time continuous glucose monitoring in diabetes management.”

The FDA based its decision on data from two clinical studies of 130 adults and children aged 2 years and older with diabetes. No serious adverse events were reported during a 7-day period when system readings were compared with blood glucose meter values and lab glucose measures.

The action comes just a few months after the agency approved the MiniMed 670G by Medtronic, a hybrid closed-loop system designed to automatically monitor glucose and deliver appropriate basal insulin doses in patients aged 14 years and older. Medtronic is currently evaluating the safety and efficacy of the device in children aged 7-13 years.

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People with diabetes have come a step closer to a life without multiple daily finger sticks. The approved use of the Dexcom G5 Mobile Continuous Glucose Monitoring System has been expanded to allow for replacement of fingerstick blood glucose testing for diabetes treatment decisions in people 2 years of age and older with diabetes, the Food and Drug Administration announced .

“Although this system still requires calibration with two daily fingersticks, it eliminates the need for any additional fingerstick blood glucose testing in order to make treatment decisions,” Alberto Gutierrez, Ph.D., director of the office of in vitro diagnostics and radiological health in the FDA’s Center for Devices and Radiological Health, said in the FDA statement.

“This may allow some patients to manage their disease more comfortably and may encourage them to have routine dialogue with their health care providers about the use of real-time continuous glucose monitoring in diabetes management.”

The FDA based its decision on data from two clinical studies of 130 adults and children aged 2 years and older with diabetes. No serious adverse events were reported during a 7-day period when system readings were compared with blood glucose meter values and lab glucose measures.

The action comes just a few months after the agency approved the MiniMed 670G by Medtronic, a hybrid closed-loop system designed to automatically monitor glucose and deliver appropriate basal insulin doses in patients aged 14 years and older. Medtronic is currently evaluating the safety and efficacy of the device in children aged 7-13 years.

[email protected]

 

People with diabetes have come a step closer to a life without multiple daily finger sticks. The approved use of the Dexcom G5 Mobile Continuous Glucose Monitoring System has been expanded to allow for replacement of fingerstick blood glucose testing for diabetes treatment decisions in people 2 years of age and older with diabetes, the Food and Drug Administration announced .

“Although this system still requires calibration with two daily fingersticks, it eliminates the need for any additional fingerstick blood glucose testing in order to make treatment decisions,” Alberto Gutierrez, Ph.D., director of the office of in vitro diagnostics and radiological health in the FDA’s Center for Devices and Radiological Health, said in the FDA statement.

“This may allow some patients to manage their disease more comfortably and may encourage them to have routine dialogue with their health care providers about the use of real-time continuous glucose monitoring in diabetes management.”

The FDA based its decision on data from two clinical studies of 130 adults and children aged 2 years and older with diabetes. No serious adverse events were reported during a 7-day period when system readings were compared with blood glucose meter values and lab glucose measures.

The action comes just a few months after the agency approved the MiniMed 670G by Medtronic, a hybrid closed-loop system designed to automatically monitor glucose and deliver appropriate basal insulin doses in patients aged 14 years and older. Medtronic is currently evaluating the safety and efficacy of the device in children aged 7-13 years.

[email protected]