The FDA has officially cleared the Dexcom G5 continuous glucose monitor to inform treatment decisions -- without the use of a fingerstick glucometer, other than for calibration. The G5 has been cleared for a while to complement a traditional glucometer, but this non-adjunctive clearance is the first of its kind according to Dexcom and the FDA, which both released statements.
"The FDA works hard to help ensure that novel technologies, which can reduce the burden of daily disease management, are safe and accurate," Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said in a statement. "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."
The approval wasn't a total surprise. In July, an FDA advisory panel gave the non-adjunctive labeling the green light. The FDA says the decision is based on two clinical studies which included 130 adults and children with diabetes, as young as age 2.
“The expanded indication for the Dexcom G5 Mobile CGM system is an astounding milestone for people with diabetes and it is a critical step to advancing diabetes technology that will drastically change diabetes management,” Kevin Sayer, Dexcom President and CEO, said in a statement. “Now, people with diabetes who use the Dexcom G5 Mobile CGM system can make daily treatment decisions without having to perform confirmatory finger sticks. And basing their treatment decisions on a number, accompanied by information on speed and direction from the CGM, will greatly improve their decisions over the information provided by blood glucose meters.”
In addition to the added convenience and freedom from uncomfortable finger pricks for people with diabetes, the indication also paves the way for Medicare reimbursement according to Dexcom, because non-adjunctive labeling is a requirement for Medicare reimbursement.