Dexcom Gets FDA Green Light For 15-Day G7 CGM Sensor

Dexcom has been successful in obtaining approval from the Food and Drug Administration (FDA) for its longest-lasting continual glucose monitor, which is a 15-day variant of their flagship G7 sensor.

The new technology, which will be introduced in the U.S. in the later part of this year, will increase the wear duration from the existing 10-day lifetime. Participants with diabetes who are at least 18 years old will be able to access it.

According to the firm, the 15-day version is also a little more accurate than the normal G7. It has a mean absolute relative difference, or MARD, of 8.0%, which is a measurement of how frequently the CGM’s readings diverge from blood-drawn glucose tests. This is in comparison to the conventional G7’s MARD of 8.2%.

However, given that it is a brand-new system that has received a fresh approval from the FDA, Dexcom will need to make efforts to once again establish that it is compatible with linked insulin pumps. At this time, the G7 is able to transmit measurements of blood sugar to the Omnipod 5 from Insulet, the iLet Bionic Pancreas from Beta Bionics, as well as the Mobi and t:slim X2 solutions from Tandem Diabetes Care. The firm has said that it intends to have such linkages operational by the time the product is launched in 15 days.

In the recent past, Dexcom was able to overcome the two-week hurdle with its consumer-oriented Stelo wearable, which was first introduced as an over-the-counter sensor in the previous year. The company has made it clear that it intends to migrate all of its continuous glucose monitoring (CGM) devices onto the 15-day platform in the near future. 

The approval was a welcome development from the regulatory body, and it sent Dexcom’s shares up as much as 7%, to more than $70. This came after the organization had gotten a warning letter from the FDA about production difficulties at the beginning of the month.

The agency said that it identified insufficient methods for monitoring the sensors throughout manufacturing and for tracking changes to the CGM. Additionally, it uncovered insufficient procedures for monitoring modifications to the controller. During that time, the firm said that it had previously provided the FDA with answers and was in the process of developing further remedial steps. It was not necessary to recall any items, and the warning letter did not hold down the current assessment of the 15-day sensor or any other technologies.

This development signifies progress in diabetes control. An additional five days of sensor longevity prior to replacement minimizes waste and enhances diabetes management. 

The G7 platform includes some already existing features, such as waterproof functionality, automatic activity tracking, and streamlined reporting for meals and prescriptions. The G7 15-day will link to Apple Watches to allow patients to check glucose levels without requiring proximity to their phones.