The Food and Drug Administration (FDA) has expanded the use of Dexcom’s G5 Mobile Continuous Glucose Monitoring (CGM) System to allow for replacement of blood glucose testing for diabetes treatment decisions in patients aged ≥2 years with diabetes.
This approval makes Dexcom’s G5 Mobile CGM System the first to be used to make diabetes treatment decisions without confirmation with a conventional fingerstick test. The CGM System was initially approved to complement fingerstick testing for diabetes treatment decisions.
The G5 Mobile CGM System consists of a small sensor wire that is inserted just under the skin that continuously measures glucose levels. The real-time data are wirelessly transmitted every 5 minutes to a receiver and compatible mobile device, such as a smartphone or tablet that is running the mobile application. Alerts indicate patients if their glucose levels are above or below the set thresholds. The G5 Mobile CGM System requires calibration at least twice a day using blood obtained from fingerstick tests but it does eliminate additional daily fingerstick tests as the real-time results can be used directly by users to make informed treatment decisions without confirmation from a fingerstick test.
The FDA reviewed data from two clinical studies on the G5 Mobile CGM System (n=130) that included patients aged ≥2 years with diabetes. Both studies included a 7-day period where the system’s readings were compared to blood glucose meter values and to a laboratory test method that measured glucose values.
Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, explained, “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.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.”
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