During February 2009, Dexcom received approval for the Seven Plus Continuous Glucose Monitor, of its new continuous glucose monitoring system from the FDA. This product received a CE mark in November 2009.
Dexcom’s first G-series CGM, the G4 Platinum, received a CE mark [1] and FDA approval in 2012 [2] for adults ages 18 and over. This new device improved hypoglycemic accuracy by 30% [3] It also offered a longer range of transmission between the sensor and receiver as well as a color LCD display. [4] The G4 Platinum was later approved by the FDA for use in patients ages 2-17 in February 2014. [5] Dexcom then received FDA approval in January 2015 for the G4 Platinum with Share, which enabled the sharing of CGM data with up to five other people using the “Share” and “Follow” smartphone apps. [6]
The Dexcom G5 was approved in August 2015 by the FDA for use as a standalone device[7], and unlike previous generations, the G5 had Bluetooth built into the transmitter, enabling it to send data to the a mobile device. [8] This allowed for use of the device without the standalone receiver. The Dexcom G5 then received a CE Mark in September 2015. [9]
The Dexcom G6 gained FDA authorization and a CE Mark in 2018. [10] The device is indicated as an integrated continuous glucose monitor (iCGM) system by the FDA for use as both a standalone CGM and for integration into automated insulin dosing (AID) systems. [11] It is the first CGM to receive the iCGM classification by the FDA. [12] [13] The G6 is worn on the abdomen and continuously measures blood glucose levels in the body’s interstitial fluid [14], sending the readings to a dedicated receiver or compatible smartphone.[15]
It is factory-calibrated and does not require routine fingersticks [16]The water-resistant sensor is approved for use for 10 days, compared to 7 days with the G5. [17] [18] It is intended for use by people with diabetes age two years and older. [19]
The Dexcom G6 Pro, which received FDA approval in October 2019 [20], is the only single use, professional CGM that gathers real-time glucose data over a 10-day period and offers both a blinded and unblinded mode. [21] In blinded mode, the healthcare provider has access to the CGM data while the patient will not have direct access. [22] In blinded mode, patients are able to review their CGM data with their healthcare provider at the end of the 10-day session. In unblinded mode, patients are able to see their glucose data throughout the 10-day duration. [23]
