Another study in 322 women with type 1 diabetes, who were pregnant or planning pregnancy and therefore being at relatively high risk of severe hypoglycaemia due to very tight glycaemic control, compared insulin aspart with human insulin as meal-time insulin (with human NPH insulin as basal insulin) using an open-label, randomised, parallel-group, multicentre design. This evidence concerns the gene INS and type 1 diabetes mellitus.