Why FDA does'nt approve continuous glucose meters as stand alone devices? What is the main proplem of CGMs?
If the problem is accuracy, how accurate (+/- %) are these devices? Note: In their websites and in some publications, they claim they are as accurate as test strips. There are currently only three CGMs on the market, Dexcom, Minimed and Medtronic.
- reginachick22Lv 61 decade agoFavorite Answer
I can only guess that the FDA is scared that people may use the results from these to adjust their insulin doses, and they are not quite accurate enough to do so without a fingerstick to verify the result.
The Navigator is supposed to be the most accurate, and is due out in January.
Even if it's accurate only 90% of the time, that's the potential to have more normal BG's at least more often, which is safer any way you look at it.