FDA approves glucose monitoring system to eliminate fingerstick testing
This system allows people with diabetes to avoid the additional step of fingerstick calibration, which can sometimes be painful.
(HealthDay News) — The FreeStyle Libre Flash Glucose Monitoring System has been approved by the US Food and Drug Administration, making it the first sanctioned device to monitor blood glucose in adult patients with diabetes without the need for a finger prick.
The system uses a small sensor implanted below the skin and a mobile reader to continuously monitor blood glucose, the agency said in a news release. The new device does not produce any type of alarm or alert if blood glucose levels are inappropriate, the agency noted.
"This system allows people with diabetes to avoid the additional step of fingerstick calibration, which can sometimes be painful, but still provides necessary information for treating their diabetes," said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA's Center for Devices and Radiological Health.
The system is produced by Abbott Diabetes Care, based in Alameda, California.
- FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration [press release]. US Food and Drug Administration. September 27 2017. Accessible at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm577890.htm