The FDA posted an article 3 days ago entitled “FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration” The FreeStyle Libre Flash Glucose Monitoring System is a class III device by Abbott Diabetes so it would need an IDE and a PMA. It works by using a small sensor that goes under the skins surface to continuously measure glucose levels. Patients can view results by waving a mobile reader over the sensor wire. This Device is regulated by the CDRH continuous glucose monitoring for adult patients without finger stick. The only clinical trial information I could find on this was done on individuals aged 18 and older with diabetes. They investigated the device’s performance by comparing readings obtained by the FreeStyle Libre Glucose Monitoring System to those obtained by an established laboratory method used for analysis of blood glucose. This study was done for PMA.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm577890.htm
https://www.clinicaltrials.gov/ct2/results?term=NCT02073058