Glucose monitoring specialist Dexcom introduced it acquired FDA clearance for its G7 15 Day steady glucose monitoring (CGM) system for individuals 18 and older with sort 1, sort 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 through a sensor with out the necessity for fingersticks or scanning.
The system has an total imply absolute relative distinction (MARD) of 8.0%. In accordance with the NIH Nationwide Library of Drugs, MARD is a parameter used to characterize the measurement efficiency of CGM techniques.
Dexcom G7 is waterproof and hands-free and has the flexibility 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 cell app is appropriate with a smartphone or pc and gives glucose patterns and statistics in addition to the means to share glucose knowledge 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 shall be appropriate with automated insulin supply techniques.
“The approval of Dexcom G7 15 Day marks one other main innovation for Dexcom,” Jake Leach, government vp and chief working officer at Dexcom, stated in an announcement.
“By listening to the wants of our customers, we’re proud to supply the longest-lasting wearable and most correct CGM, giving individuals the information to higher management their diabetes with our best-in-class expertise. This milestone units a brand new normal 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 knowledge partnership with Dexcom to combine glucose knowledge from the Dexcom G7 into its SimpleSense nanotechnology-enabled wearable.
Nanowear gives 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 knowledge circulate between Dexcom’s CGM and the Oura Ring.
Dexcom contributed $75 million to Oura’s Collection 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 knowledge from Dexcom glucose biosensors and sleep, coronary heart well being, stress, important signal and exercise knowledge 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 through a devoted Bluetooth connection.
The function offers customers the flexibility 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 sorts of diabetes.
Different firms within the CGM area embody Abbott, which in 2024 introduced its CGM system Lingo may very well be bought within the U.S. with no prescription.
Lingo accommodates a biosensor and cell app primarily based on Abbott’s FreeStyle Libre steady glucose monitoring expertise. The system is a biowearable product supposed for individuals 18 and older who are usually not taking insulin.
The system tracks glucose in actual time and gives 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 kind issue and included the Simplera CGM designed for use as a part of a Good MDI system with the InPen sensible 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’ probably shortened battery life.
The corporate notified clients that they need to monitor their MiniMed pump’s built-in alarms and alerts to maintain observe of battery standing and make contact with the corporate in the event that they discover adjustments within the pump’s battery life.
