Efficacy and Safety of Insulin Aspart vs. Human Insulin During Pregnancy by Women With Type 1 Diabetes

Inclusion Criteria: * Type 1 diabetes * Treated with insulin for at least 12 months * Either plan to become pregnant in the immediate future, willing to undertake pre pregnancy counselling, and has a screening HbA1c lesser than or equal to 12.0%, or * Pregnant with normal singleton pregnancy, gestational age for at least 10 weeks at the time of randomisation, confirmed by ultrasound scan. Exclusion Criteria: * Previous birth of child with a major congenital malformation * More than 2 previous multiple miscarriages or stillbirths * Severe hyperemesis gravidarum, requiring hospitalisation, according to Investigator judgement * Subjects being treated for infertility * Proliferative retinopathy or maculopathy requiring acute treatment * Drug or alcohol abuse * Impaired renal, hepatic or cardiac function