US-based glucose biosensing company DexCom has received approval from the US Food and Drug Administration (FDA) for its Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System for adults with diabetes.
The system, which has an overall Mean Absolute Relative Difference (MARD) of 8.0%, builds on the performance of the Dexcom CGM, which has been shown to lower A1C, decrease hyper- and hypoglycaemia incidents, and increase time within the target glucose range.
Dexcom executive vice president and COO Jake Leach said: “The approval of Dexcom G7 15 Day marks another major innovation for 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.”
The Dexcom G7 15 Day offers several features designed to enhance diabetes management. It is the sole waterproof continuous glucose monitor, allowing users to maintain connectivity.
The sensor can be linked directly to an Apple Watch, enabling glucose monitoring without an iPhone.
The system also includes automated logging for activities, simplified meal tracking, and new medication logging, aiding users in understanding the immediate effects of lifestyle choices on glucose levels.
A 12-hour grace period is provided for sensor replacement, facilitating a smooth transition between sessions.
The system’s mobile app, integrated with Dexcom Clarity, offers interactive reports to track glucose patterns and trends.
Users can share glucose data remotely with caregivers and family members for additional support. The system also features customizable alert settings for increased discretion.
Leach added: “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.”
The company is actively working with insulin pump partners to ensure that the Dexcom G7 15 Day will be compatible with automated insulin delivery systems when it launches in the US, expected in the latter half of 2025.
