The U.S. Food and Drug Administration has expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring (CGM) System to allow for replacement of fingerstick blood glucose testing for diabetes treatment decisions in people 2 years of age and older. This is the first FDA-approved CGM system that can be used to make diabetes treatment decisions without confirmation with a traditional fingerstick test. The system was previously approved to complement, not replace, fingerstick testing for diabetes treatment decisions.
The FDA evaluated data from two clinical studies of the G5 Mobile Continuous Glucose Monitoring System. These studies included 130 adults and children aged 2 years and older with diabetes. All studies included a seven-day period where system readings were compared to blood glucose meter values, as well as to a laboratory test method that measures glucose values. No serious adverse events were reported during the studies.
The decision to expand the indication follows the advice of FDA’s clinical chemistry and clinical toxicology advisory panel, which voted 8 to 2 in favor of the indication at a July 21 hearing.
Patients will still need to perform twice-daily finger-stick blood testing for calibration, but they will be able to base their insulin-dose calculations directly from the values displayed on the device’s receiver or smartphone app.
Dexcom’s G5 Mobile Continuous Glucose Monitoring System was approved for use by the FDA in August 2015.