FDA Clears Dexcom G7 15 Day Continuous Glucose Monitoring System

What You Should Know: 

– Dexcom, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System for individuals over the age of 18 with diabetes.  

– The Dexcom G7 15 Day system boasts an overall Mean Absolute Relative Difference (MARD) of 8.0% and builds upon the proven performance of Dexcom CGM technology, which has been clinically demonstrated to lower A1C, reduce hyper- and hypoglycemia, and increase time in range.

Dexcom G7 Features

The Dexcom G7 15 Day system offers up to 15.5 days of wear allowing users to benefit from fewer monthly sensors and reduced monthly waste. The waterproof CGM system provides an overall MARD of 8.0%.

Other key features of Dexcom G7 include: 

• Apple Watch Connectivity: Direct sensor connection to Apple Watch, allowing users to view glucose numbers without their iPhone.  
• Automated Logging: Automated activity logging, simplified meal logging, and new medication logging to help users understand the impact of these factors on glucose levels.  
• 12-Hour Grace Period: A 12-hour grace period for sensor replacement, ensuring a smoother transition between sessions.  
• Mobile App with Dexcom Clarity: An innovative and user-friendly mobile app with Dexcom Clarity integration for easy viewing of glucose patterns, trends, and statistics through interactive reports.  
• Remote Glucose Sharing: Ability to remotely share glucose numbers with caregivers and loved ones.  
• Customizable Alerts: Enhanced and customizable alert settings.  

“The approval of Dexcom G7 15 Day marks another major innovation for Dexcom,” said Jake Leach, executive vice president and chief operating officer at Dexcom. “By listening to the needs of our users, we’re proud to offer the longest lasting wearable and most accurate CGM, giving people the knowledge to better control their diabetes with our best-in-class technology. This milestone sets a new standard in CGM and is a testament to our continued leadership in glucose biosensing. We look forward to bringing it to market in the second half of this year, but in the meantime, we encourage our users to upgrade to our current G7 system to gain the benefits of the most connected CGM brand in the world.”

Dexcom is also working with insulin pump partners to ensure compatibility of Dexcom G7 15 Day with automated insulin delivery systems upon its launch.  

Availability

The Dexcom G7 15 Day is expected to launch in the U.S. in the second half of 2025.