> Why is that first-day margin of error acceptable for European diabetics but not American ones? Because the FDA is very conservative, in part because that con

> Why is that first-day margin of error acceptable for European diabetics but not American ones? Because the FDA is very conservative, in part because that conservatism prevented the thalidomide incident back in the day. When it comes to novel treatments, or monitoring devices, we don't know what we don't know. The FDA errs on the side of well-tested treatments and devices. Extra inaccuracy during the first day could lead people to make mistakes that could prove dangerous or fatal. You don't have no data during the first 12 hours, you just have to fall back to the fingerstick method, which the FreeStyle Libre still supports. It's possible that as more data is gathered in Europe and the US, it could be found that this extra inaccuracy is not harmful, and the European version approved in the US. Or it could be that the company is able to improve the device to improve accuracy in the first 12 hours, and get a new version approved. It seems to me that other CGMs like the Dexcom require fingerstick calibration at lest twice a day, so I would think that 12 hours of having to use a fingerstick during calibration would be preferable to twice a day fingersticks.