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Risk of Major Congenital Malformations or Perinatal or Neonatal Death With Insulin Detemir Versus Other Basal Insulins in Pregnant Women With Preexisting Diabetes: The Real-World EVOLVE Study

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  • Elisabeth R Mathiesen
  • Norsiah Ali
  • Amra C Alibegovic
  • Eleni Anastasiou
  • Katarzyna Cypryk
  • Harold de Valk
  • Jorge Dores
  • Fidelma Dunne
  • Mari-Anne Gall
  • Santiago Duran Garcia
  • Hélène P Hanaire
  • Lise Lotte N Husemoen
  • Marina Ivanišević
  • Hans-Peter Kempe
  • David R McCance
  • Peter Damm
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OBJECTIVE: To compare the risk of severe adverse pregnancy complications in women with preexisting diabetes.

RESEARCH DESIGN AND METHODS: Multinational, prospective cohort study to assess the prevalence of newborns free from major congenital malformations or perinatal or neonatal death (primary end point) following treatment with insulin detemir (detemir) versus other basal insulins.

RESULTS: Of 1,457 women included, 727 received detemir and 730 received other basal insulins. The prevalence of newborns free from major congenital malformations or perinatal or neonatal death was similar between detemir (97.0%) and other basal insulins (95.5%) (crude risk difference 0.015 [95% CI -0.01, 0.04]; adjusted risk difference -0.003 [95% CI -0.03, 0.03]). The crude prevalence of one or more congenital malformations (major plus minor) was 9.4% vs. 12.6%, with a similar risk difference before (-0.032 [95% CI -0.064, 0.000]) and after (-0.036 [95% CI -0.081, 0.009]) adjustment for confounders. Crude data showed lower maternal HbA1c during the first trimester (6.5% vs. 6.7% [48 vs. 50 mmol/mol]; estimated mean difference -0.181 [95% CI -0.300, -0.062]) and the second trimester (6.1% vs. 6.3% [43 vs. 45 mmol/mol]; -0.139 [95% CI -0.232, -0.046]) and a lower prevalence of major hypoglycemia (6.0% vs. 9.0%; risk difference -0.030 [95% CI -0.058, -0.002]), preeclampsia (6.4% vs. 10.0%; -0.036 [95% CI -0.064, -0.007]), and stillbirth (0.4% vs. 1.8%; -0.013 [95% CI -0.024, -0.002]) with detemir compared with other basal insulins. However, differences were not significant postadjustment.

CONCLUSIONS: Insulin detemir was associated with a similar risk to other basal insulins of major congenital malformations, perinatal or neonatal death, hypoglycemia, preeclampsia, and stillbirth.

Original languageEnglish
JournalDiabetes Care
Volume44
Issue number9
Pages (from-to)2069-2077
Number of pages9
ISSN1935-5548
DOIs
Publication statusPublished - Sep 2021

Bibliographical note

© 2021 by the American Diabetes Association.

    Research areas

  • Blood Glucose, Diabetes Mellitus, Female, Glycated Hemoglobin A/analysis, Humans, Hypoglycemic Agents/adverse effects, Infant, Newborn, Insulin Detemir/adverse effects, Insulin, Long-Acting, Perinatal Death, Pregnancy, Pregnant Women, Prospective Studies

ID: 69752864