"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, PhD, 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.
Recommended medical management, training, and oversight measures to prevent patient-to-patient transmission of hepatitis viruses from diabetes-care procedures in long-term-care settings * Regularly review patient schedules for fingerstick blood glucose
sampling and insulin administration and reduce the number of percutaneous procedures to the minimum necessary for appropriate medical management of diabetes and its complications.
After the unit has been warmed and calibrated through the use of a fingerstick blood glucose
test it can provide up to six painless glucose measurements per hour for 13 hours.
Those involved were asked to demonstrate specific tasks, including coding the meter, performing quality-control testing with the standard strip, glucose-control testing and a fingerstick blood glucose