Dexcom landed FDA clearance under the de novo classification process for its Dexcom G6 continuous glucose monitor, which can be used as a standalone monitor or as a part of an automated insulin delivery system. The neatest feature of the Dexcom G6 is that the sensor doesn’t require calibration and so pricking the finger can be a thing of the past nearly completely, save for visits to the doctor’s office.
Once applied to the skin, the small sensor patch can stay on for up to ten days through sleep, showers, and most other normal activities, transmitting its readings to a smartphone, smartwatch, or its own unique receiver. The placement of the sensor is done using a new applicator that has only one button to press and that should be easy for just about anyone to work with. Of note, the system is intended for adults and children as young as two years of age.
An interesting capability of the Dexcom G6 is how it can avoid being confused by the presence of acetaminophen in the blood, which can wildly throw off the readings. It is also able to predict hypoglycemic events, warning the wearer in advance to put something sweet in the mouth.
The FDA authorization comes with a few caveats, according to Dexcom, which involve “establishing criteria, called special controls, which outline requirements for assuring CGM accuracy, reliability and clinical relevance as well as describe the type of studies and data required to demonstrate acceptable CGM performance.”