In an exciting breakthrough for patients with diabetes, the US Food and Drug Administration (FDA) has authorized the marketing of the Dexcom G6 integrated continuous glucose monitoring system (iCGM). The latest version of the continuous glucose monitoring system is indicated for use by patients with diabetes aged two and up. Furthermore, the device can be used as a stand-alone CGM or it can be integrated into automated insulin dosing systems, making it first CGM to receive this classification from the FDA.
Those familiar with previous versions of the Dexcom CGM systems will find a number of features are still present in the new device, such as the ability to automatically send glucose readings to a Dexcom receiver or compatible smart device, support for sharing results with up to five people, and customizable alarms and alerts to notify users of pending dangerous highs or lows in blood sugar readings.
However, the new device brings a host of new features not found in older versions of the Dexcom systems. Unlike earlier generations, no fingerstick calibration is needed as the devices are factory calibrated. The sensor applicator is easier to apply and is of a smaller, more discreet design. An important addition is acetaminophen blocking, which improves the accuracy of readings and minimizes interference with readings as a result of taking this form of medication. Other new features include a predictive low alert, which forecasts hypoglycemia and makes it easier to avoid dangerous lows, and an extended 10-day sensor, which can be used for up to 43 percent longer than previous generations of the device.
Diabetes affects more than nine percent of Americans, which equates to around 30.3 million people across the country, according to the Centers for Disease Control and Prevention’s National Diabetes Statistics Report 2017. It found that of the 23.1 million whose condition was diagnosed, around 132,000 were children and adolescents under 18 years of age. Type 2 diabetes accounts for the majority of diabetes in the United States, accounting for an estimated 95 percent of cases.
The FDA granted a De Novo request for the Dexcom G6 CGM system. This classification is granted using a risk-based strategy for new and novel devices that are previously unclassified. It grants the device status as a new device type, along with classification, regulation, necessary controls, and a product code. It is also eligible to serve as a predicate for new devices. This means future iCGMs that meet special control criteria will be able to go through a more streamlined premarket review, known as 510(k) clearance.
Approval for the device was granted following evaluation of data from two clinical studies involving 324 patients with diabetes aged two and above. “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,” said 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.
His comments echoed those of Daniel DeSalvo, MD, pediatric endocrinologist at Texas Children’s Hospital in Houston, Texas, who described the device as “transformative for people with diabetes”. In a press release for Dexcom, he stated: ““I can tell you as someone who has type 1 diabetes myself, with all of its features and benefits, the Dexcom G6 is the CGM device I have been anticipating for the last twenty years. This CGM system will help to alleviate the burden of diabetes management while improving the lives of people with diabetes”.
For more information on the Dexcom G6 visit: https://www.dexcom.com/g6-cgm-system