Dexcom wins FDA approval for next generation of glucose monitors for diabetes
San Diego’s Dexcom has won regulatory approval for its latest continuous glucose monitoring system that eliminates the need for finger pricks and is nearly one-third smaller than its current wearable sensor for diabetes patients.
The Food and Drug Administration this week gave the green light to Dexcom’s G6 system for delivering real time blood sugar readings. Expected to hit the U.S. market in the second quarter, the G6 targets Type 1 and insulin-taking Type 2 diabetes patients.
The G6 monitor is worn on the stomach. It contains a small sensor inserted just underneath the skin. The device wirelessly transmits glucose readings every five minutes to a smartphone, smartwatch, or medical device app. It will trigger an alarm when a patient’s blood sugar soars too high or drops too low.
Last fall, Abbott Labs received FDA approval for its Libre glucose monitory system for adults—challenging Dexcom’s market leadership in the U.S. The Libre doesn’t require finger pricks and sensors last for 10 days, compared with seven days for Dexcom’s previous generation monitors, the G5, which needed finger stick calibration every day or two.
With FDA approval, Dexcom can now match Libre’s features. In addition, Dexcom monitors continue to sound an alarm when patients experience blood sugar spikes or crashes—even while they’re asleep.
The Libre does not automatically warn users when blood glucose reaches dangerous levels.
Dexcom declined to disclose the price for the G6 system. Insurance firms reimburse for continuous glucose monitoring for Type 1 diabetes, where high blood sugar levels can contribute to heart disease, stroke, blindness, kidney failure and nerve damage. Low blood sugar levels can also cause dizziness, unconsciousness and, in extreme cases, death. About 1.4 million Americans are living with Type 1 diabetes, based on research estimates.
