No Fingerstick Necessary: FDA Approves Novel CGM System for Diabetes
The FreeStyle Libre Flash continuous glucose monitoring system does not require blood sample calibration to monitor glucose levels. Image credit: Abbott Laboratories
The US Food and Drug Administration has approved the FreeStyle® Libre Flash Glucose Monitoring System (Abbott Diabetes Care, Inc.) for use in adults with diabetes.1
Device approval follows evaluation of data from 2 clinical studies2,3 of adults with either type 1 or type 2 diabetes (An Evaluation of a Novel Glucose Sensing Technology in Type 2 Diabetes [REPLACE], ClinicalTrials.gov Identifier NCT02082184; An Evaluation of Novel Glucose Sensing Technology on Hypoglycemia in Type 1 Diabetes [IMPACT], ClinicalTrials.gov Identifier NCT02232698). Performance of the FreeStyle Libre Glucose Monitoring System was compared with data collected via traditional glucose monitoring methods to establish the device's efficacy.
“This system allows people with diabetes to avoid the additional step of fingerstick calibration…but still provides necessary information for treating their diabetes — with a wave of the mobile reader,” said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health, and deputy director of new product evaluation at the FDA's Center for Devices and Radiological Health, in an FDA press release.1
The FreeStyle Libre system can be worn continuously for up to 10 days.4 After the insertion of a small sensor wire in the back of the upper arm, device users can assess their glucose levels over time by waving a mobile reader above the wire, and data tracking instances of hyperglycemia and hypoglycemia can be viewed. The FreeStyle Libre is factory calibrated, eliminating the need for daily calibration.4
The device is indicated for use in patients 18 years or older and requires a prescription. The FreeStyle Libre is anticipated to be available by the end of 2017.
FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration [news release]. Silver Springs, MD: US Food and Drug Administration. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm577890.htm. Published September 27, 2017. Accessed September 28, 2017.
Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Flash glucose-sensing technology as a replacement for blood glucose monitoring for the management of insulin-treated type 2 diabetes: a multicenter, open-label randomized controlled trial. Diabetes Ther. 2017;8(1):55-73.
Bolinder J, Antuna R, Geelhoed-Duijvestjin P, Kröger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicenter, non-masked, randomized controlled trial. Lancet. 2016;388(10057):2254-2263.
No more routine finger sticks for Americans with diabetes: Abbott's Freestyle® Libre approved in the US [news release]. Abbott Park, IL: Abbott Laboratories. http://abbott.mediaroom.com/2017-09-27-No-More-Routine-Finger-Sticks-1-for-Americans-with-Diabetes-Abbott-s-FreeStyle-R-Libre-Approved-in-the-U-S. Published September 27, 2017. Accessed September 28, 2017.