The US Food and Drug Administration (FDA) has approved the marketing of the first of its kind interoperable continuous glucose monitoring (iCGM) system for monitoring blood glucose levels in patients with diabetes aged 2 years and older. This device can work with different types of compatible devices gives patients the flexibility to tailor their diabetes management tools. This device’s previous model was approved in 2016 but was not compatible with other devices. This newest model comes factory calibrated so that patients will not need to use fingerstick blood measurements to adjust the sensor.
This device was approved based on 2 clinical trials including 324 adults and pediatric patients with diabetes. During the trials, no serious adverse events were reported, and the patients underwent multiple clinic visits in the 10-day study period to compare blood glucose measurements. This…
