(240) Congenital Malformations Among Offspring of Women with Type 1 Diabetes Using Insulin Pump: A Prospective Cohort Study

Friday, August 26, 2022

8:00 AM – 6:00 PM CEST

Location: Hall C

Publication Number: 571

Presenting Author(s)

Ida H. Thorius
– Novo Nordisk A/S, Center for Pregnant Women with Diabetes, Department of Endocrinology, Rigshospitalet, Frederiksberg, Hovedstaden, Denmark

Co-Author(s)

Lise Lotte N. Husemoen
– Novo Nordisk A/S, Søborg, Denmark, Denmark
Rikke B. Nordsborg
– Novo Nordisk A/S, Søborg, Denmark, Denmark
Amra C. Alibegovic
– Novo Nordisk A/S, Søborg, Denmark, Denmark
Mari-Anne Gall
– Novo Nordisk A/S, Søborg, Denmark, Denmark
Janne Petersen
– Copenhagen Phase IV unit, Department of Clinical Pharmacology and Center for Clinical research and Prevention, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark, Denmark
Elisabeth Mathiesen
– Center for Pregnant Women with Diabetes, Department of Endocrinology, Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark, Denmark

Background: Congenital malformations and perinatal mortality are 2-4 fold more frequent in offspring of women with type 1 diabetes (T1D) compared with the background population and associated with poor glycaemic control during early pregnancy. Continuous subcutaneous insulin infusion by insulin pump (pump) has proven superior to improve glycaemic control compared with conventional multiple daily insulin injection (MDI), however, whether pump treatment leads to improved pregnancy outcome regarding congenital malformations and perinatal death remain unknown.

Objectives: To evaluate the risk of severe adverse pregnancy outcomes such as malformations, perinatal and neonatal death in pregnant women with T1D treated with insulin using pump or MDI.

Methods: The present study is a secondary analysis of the EValuation Of LeVEmir in Pregnancy (EVOLVE) study cohort. In a real world setting in a prospective, multinational cohort of 2088 pregnant women with T1D insulin treated with pump (n= 750) or MDI (n=1338), odds ratios (OR) for offspring with congenital malformations, perinatal or neonatal death were analyzed using logistic regression on crude and propensity score-matched data.

Results: At enrolment (gestational week 8 (range 4-14)), pump users had higher educational level (university degree: 43.0% vs. 27.4%; P< 0.001), better glycaemic control (HbA1c: 6.8(0.9)% vs. 7.1(1.3)%; P< 0.001) and were more often reporting taking folic acid supplementation compared with MDI users (86.3% vs. 74.9%; P< 0.001). The proportion of fetuses with at least one malformation was 13.5% (pump) vs. 11.2% (MDI) (crude OR 1.23 [95%CI 0.94;1.61], P=0.13; adjusted OR 1.11 [95%CI 0.81;1.52], P=0.52). The proportion of fetuses with at least one major malformations was 2.8% vs. 3.1% (crude OR 0.89 [95%CI 0.52;1.51], P=0.66; adjusted OR 0.78 [95%CI 0.42;1.45], P=0.43), and fetuses carrying ≥1 minor malformations (but no major) were 10.7% vs. 8.1%; (crude OR 1.36 [95%CI 1.00;1.84], P=0.05; adjusted OR 1.23 [95%CI 0.87;1.75], P=0.25). The proportions of perinatal and neonatal death were 1.6% vs. 1.3% (crude OR 1.23 [95%CI 0.57;2.67], P=0.59; adjusted OR 2.02 [95%CI 0.69;5.93], P=0.20) and 0.3% vs. 0.3% (crude OR 0.90 [95%CI 0.16;4.91], P=0.90; adjusted OR 1.00 [95%CI 0.14;7.12], P=1.00), respectively.

Conclusions: Insulin pump treatment was not associated with lower risk of congenital malformations, despite better glycaemic control in early pregnancy compared with MDI. Further studies exploring the effectiveness and safety of using pump treatment during pregnancy is needed.