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# FDA OKs 1st Integrated Glucose Monitoring System
- URL: https://www.fdaweb.com/fda-oks-1st-integrated-glucose-monitoring-system/
- Published: 2018-03-27T12:00:00.000Z
- Updated: 2026-09-14T23:55:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141079

FDA says it has allowed the marketing (*de novo* process) of the first fully interoperable continuous glucose monitoring system. Dexcom’s G6 integrated continuous glucose monitoring (iCGM) system is intended to determine blood glucose levels in children aged two and older and adults with diabetes, according to an agency [news release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm602870.htm?ref=fdaweb.com). It is used as “part of an integrated system with other compatible medical devices and electronic interfaces, which may include automated insulin dosing systems, insulin pumps, blood glucose meters or other electronic devices used for diabetes management,” it says. FDA notes that because the device went through the *de novo* process, future iCGM systems can be cleared under the 510(k) process.

“The Dexcom G6 is a patch device, about the size of a quarter, that is applied to the skin of the abdomen and contains a small sensor that continuously measures the amount of glucose in body fluid,” FDA says. It transmits real-time glucose readings every five minutes to a compatible display device and will trigger an alarm when a patient’s blood sugar enters a danger zone. When it is integrated with an automated insulin dosing system, such a reading would trigger the release of insulin from the pump, it says.