FDA approves professional version of CGM system

This week, the Food and Drug Administration approved a new continuous glucose monitoring system, one the manufacturer touts as the only “real-time professional” option.

The Dexcom G4 Platinum continuous glucose monitoring (CGM) system was previously approved for adult and pediatric use, but now can be used by physicians to better counsel their patients, according to the press release. In contrast to other professional systems that report retrospective, blinded data, the company reports that this system provides “real-time, unblinded feedback” for the patient and physician.

“Professional CGM provides health care practitioners and patients the necessary data to plan treatment and lifestyle decisions to keep glucose at safe levels, in the reference range found in persons without diabetes,” Lori Laffel, MD, MPH, chief of the pediatric, adolescent and young adult section, Joslin Diabetes Center, Boston, said in the release. “The ability to rapidly deploy and translate this data for the better of patients is a valuable instrument in the management of diabetes.”

The system would be owned by the medical practice and patients fitted with the system for 7 days, according to the release. Over the course of that week, patients will observe the impact of behavior and diet on their glucose levels.

The release said this CGM system should not be the basis for treatment decisions.

For more information: Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System (CGM) Receives FDA Approval