Dexcom receives FDA clearance for G7 15 Day glucose monitoring system

Glucose monitoring specialist Dexcom introduced it acquired FDA clearance for its G7 15 Day steady glucose monitoring (CGM) system for folks 18 and older with kind 1, kind 2 and gestational diabetes. 

G7 15 Day, scheduled to launch within the second half of this yr, may have a 15.5-day put on time (together with a 12-hour grace interval) and final 15% longer than Dexcom G7, based on the corporate. 

The brand new system sends real-time glucose info to the Dexcom G7 app or receiver each 5 minutes by way of a sensor with out the necessity for fingersticks or scanning.

The system has an total imply absolute relative distinction (MARD) of 8.0%. In line with the NIH Nationwide Library of Drugs, MARD is a parameter used to characterize the measurement efficiency of CGM programs. 

Dexcom G7 is waterproof and hands-free and has the power to join the sensor on to an Apple Watch.

It additionally has an automatic exercise logging function that enables finish customers to enter meal and medicine info.

The Dexcom Readability cellular app is suitable with a smartphone or laptop and supplies glucose patterns and statistics in addition to the means to share glucose information with caregivers and members of the family. 

In the meantime, the corporate is working with insulin pump companions to make sure Dexcom G7 15 Day will probably be suitable with automated insulin supply programs. 

“The approval of Dexcom G7 15 Day marks one other main innovation for Dexcom,” Jake Leach, govt vice chairman and chief working officer at Dexcom, mentioned in a press release. 

“By listening to the wants of our customers, we’re proud to supply the longest-lasting wearable and most correct CGM, giving folks the information to higher management their diabetes with our best-in-class expertise. This milestone units a brand new commonplace in CGM and is a testomony to our continued management in glucose biosensing.”

THE LARGER TREND

In March, cardiometabolic digital diagnostics firm Nanowear introduced a licensing and information partnership with Dexcom to combine glucose information from the Dexcom G7 into its SimpleSense nanotechnology-enabled wearable. 

Nanowear supplies home-based, AI-enabled digital diagnostics for cardiometabolic well being. The corporate’s FDA-cleared SimpleSense wearable reads affected person vitals, together with respiration fee, coronary heart fee, blood strain, bodily exercise and lung quantity. 

In 2024, Dexcom made a $75 million strategic funding in health-tracking ring maker Oura and established a strategic partnership to allow two-way information circulate between Dexcom’s CGM and the Oura Ring.

Dexcom contributed $75 million to Oura’s Sequence D funding spherical, which introduced Oura’s valuation to greater than $5 billion.

Through the partnership, customers of each firms’ merchandise gained entry to glucose information from Dexcom glucose biosensors and sleep, coronary heart well being, stress, important signal and exercise information from the Oura Ring out there on Dexcom’s app and Oura’s app. 

That very same yr, Dexcom expanded its diabetes-management capabilities and supplied direct connectivity to the Apple Watch for its G7 CGM system by way of a devoted Bluetooth connection. 

The function offers customers the power to examine their glucose readings in actual time with out having their iPhone in hand. 

In 2022, Dexcom G7 CGM was cleared by the FDA. That mannequin was for people ages two and older with all forms of diabetes.

Different firms within the CGM area embody Abbott, which in 2024 introduced its CGM system Lingo could possibly be bought within the U.S. with out a prescription.

Lingo incorporates a biosensor and cellular app primarily based on Abbott’s FreeStyle Libre steady glucose monitoring expertise. The system is a biowearable product supposed for folks 18 and older who aren’t taking insulin. 

The system tracks glucose in actual time and supplies finish customers with private insights and training with the purpose of serving to construct wholesome habits, retrain metabolism and enhance total well being. 

That very same yr, Medtronic acquired FDA clearance for the Simplera CGM, the corporate’s first disposable, all-in-one CGM, which is half the dimensions of earlier Medtronic CGMs. 

The Simplera platform featured the corporate’s CGM type issue and included the Simplera CGM designed for use as a part of a Sensible MDI system with the InPen good insulin pen and the Simplera Sync sensor, which was designed to be built-in with the MiniMed 780G insulin system.

Final yr, Medtronic issued a voluntary recall of its MiniMed 600 and 700 sequence insulin pumps because of the pumps’ doubtlessly shortened battery life. 

The corporate notified prospects that they need to monitor their MiniMed pump’s built-in alarms and alerts to maintain monitor of battery standing and phone the corporate in the event that they discover modifications within the pump’s battery life.