Aims: This post hoc analysis of the real-world EVOLVE study investigated safety and effectiveness of insulin aspart (IAsp) vs. other bolus insulins in pregnant women with pre-existing type 1 diabetes.

Methods: Maternal, pregnancy and infant outcomes were assessed in women receiving bolus insulins on enrolment and during pregnancy in a prospective cohort, by estimating risk differences following adjustment for potential confounders using propensity score matching.

Results: Insulin treatment in early pregnancy and maternal, pregnancy and infant outcomes are presented (Table) . In total, 1434 women were treated with IAsp and 4with other bolus insulins on enrolment. Significantly lower mean A1c values in the third trimester were observed with IAsp vs. other bolus insulins (adjusted % point difference -0.16% [95% CI -0.28;-0.05]; p=0.005) . No significant differences were seen with IAsp vs. other bolus insulins in the risk of adverse maternal-fetal outcomes including major maternal hypoglycemia, abortion, pre-term delivery, pre-eclampsia, birthweight large for gestational age, major congenital malformations and perinatal or neonatal death, in the matched dataset.

Conclusion: Compared with other bolus insulins, IAsp was associated with significantly lower A1c during the third trimester and a similar risk of adverse pregnancy outcomes.


E.Mathiesen: Consultant; Novo Nordisk A/S, Speaker's Bureau; Novo Nordisk A/S. On behalf of the evolve study group: n/a. A.Alibegovic: Employee; Novo Nordisk A/S, Novo Nordisk A/S. G.Anil: Employee; Novo Nordisk Global Business Services. F.P.Dunne: None. T.Halasa: Employee; Novo Nordisk A/S. M.Ivanisevic: None. D.R.Mccance: None. R.Baastrup nordsborg: Employee; Novo Nordisk A/S, Stock/Shareholder; Novo Nordisk A/S. P.Damm: Advisory Panel; Novo Nordisk A/S.


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