FDA Authorizes Marketing of First Integrated Continuous Glucose Monitoring System

The FDA has authorized for marketing an integrated continuous glucose monitoring system (iCGM) for determining blood glucose levels for patients with diabetes who are aged 2 years and older. The Dexcom G6 is the first type of continuous glucose monitoring system (CGM) permitted by the FDA to be used as part of an integrated system with other compatible medical devices and electronic interfaces.

A patch device, the Dexcom G6 contains a small sensor that continuously measures the amount of glucose in body fluid. It transmits real-time glucose readings every 5 minutes to a compatible display device, such as a mobile medical application, an automated insulin dosing system, an insulin pump, a blood glucose meter, or other electronic devices used for diabetes management, and it triggers an alarm when a patient’s blood sugar enters dangerously high or low levels. The Dexcom G6 device, whose approval for marketing by Dexcom Inc. was announced Wednesday, is about the size of a quarter and is applied to the skin of the abdomen.

“The ability of this device to work with different types of compatible devices gives patients the flexibility to tailor their diabetes management tools to best meet personal preferences,” Donald St. Pierre, acting 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.

An earlier version of the iCGM technology, the Dexcom G5, received the agency’s approval in 2016, but it was not designed as an integrated system to be used with compatible devices, according to the FDA. The Dexcom G6 iCGM is intended as a more seamless integration with other diabetes devices than previously marketed CGM systems.

Prior to approving the marketing of the Dexcom G6, the FDA evaluated the data from 2 clinical studies of the device. The studies included 324 adults and children, aged 2 and older, with diabetes. Both studies included multiple clinical visits with a 10-day period, where system readings were compared with laboratory tests that measured blood glucose levels, according to the FDA.

In a statement, the FDA said that no serious adverse events were reported during the clinical studies. Risks associated with the use of the Dexcom G6 system may include hypoglycemia or hyperglycemia, in cases where hardware set-up issues disable alarms and alerts or where information provided by the device is inaccurate and used to make treatment decisions. Patients may also experience redness or skin irritation around the device’s adhesive patch, according to the FDA.

Along with authorization for marketing the Dexcom G6, the FDA said that it is establishing criteria, or special controls, that will outline requirements for assuring the accuracy of iCGM devices, as well as clinical relevance and reliability. The special controls will also describe the type of studies and data required to demonstrate acceptable iCGM performance.

“The FDA has taken steps to expedite the review process for similar, integrated CGMs and make these types of systems available to patients as quickly as possible, while also helping to ensure their safety and reliability,” St. Pierre said in the statement.

Nearly 10% of Americans are patients with diabetes, according to the FDA. The disease impairs the body’s ability to make or properly use the blood glucose-regulating hormone insulin, and patients must regularly monitor their blood sugar levels. Continuously high blood sugar levels can lead to heart disease, stroke, blindness, kidney failure and nerve damage, which can lead to the amputation of toes, feet or legs. Blood sugars that fall too law can cause dizziness, confusion, unconsciousness and, in extreme cases, death.

Reference

FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices [news release]. FDA. March 27, 2018.fda.gov/newsevents/newsroom/pressannouncements/ucm602870.htm. Accessed March 28, 2018.