INS and type 1 diabetes mellitus: In 2012, insulin detemir received US Food and Drug Administration approval for reclassification to pregnancy category B from pregnancy category C. This was based on the results of small observational studies and, mostly, of a randomized control trial (RCT) comparing insulin detemir and NPH in 310 pregnant women with type 1 diabetes mellitus (T1DM) [6–9].