EASD 2020 Highlights

Conference summaries


Risk of major congenital malformations, perinatal or neonatal death with insulin detemir vs other basal insulins in pregnant women with pre-existing diabetes: the EVOLVE study

Presented by:

Elisabeth Mathiesen, MD

  • Insulin detemir is not associated with major congenital malformations or perinatal or neonatal deaths in a large real-world analysis compared with other basal insulins.

What do we already know about this topic?

  • Women with pre-existing diabetes are at increased risk of severe pregnancy complications, such as congenital malformations and perinatal and neonatal death.1,2
  • There are limited data on the effects of the basal insulin analogue detemir on congenital malformation and perinatal death.
  • The EVOLVE study examined the risk of major congenital malformations and perinatal or neonatal deaths when using insulin detemir vs. other basal insulins in pregnant women with pre-existing diabetes.

How was this study conducted?

  • EVOLVE was a prospective, non-interventional, real-world study carried out in 92 sites in 17 countries.
  • Data were collected at conception, delivery visit, and at 1-month and 1 year after birth.
  • The primary endpoint was the number of pregnancies completing ≥22 weeks of gestation without major congenital malformations or perinatal or neonatal death.
  • 727 women were receiving insulin detemir and 730 other basal insulins.

What does this study add?

  • There were 15 major congenital malformations with insulin detemir and 17 with other basal insulins.
  • There were 6 perinatal deaths with insulin detemir and 13 with other insulins, and 1 and 0 neonatal deaths, respectively.
  • The composite primary endpoint of no major congenital malformations and no perinatal or neonatal deaths was 97.0% for insulin detemir and 95.5% for other basal insulins (adjusted risk difference -0.003, 95% CI -0.03, 0.03).
  • There were 14 induced abortions due to major congenital malformations: 5 with insulin detemir and 9 with other basal insulins.


How does this study impact clinical practice?

  • The study was designed in collaboration with the European Medicines Agency and collected real-world data covering many nationalities with broad inclusion criteria.
  • In pregnant women with pre-existing diabetes, insulin detemir was not associated with excess risk of major congenital malformations, or perinatal or neonatal deaths compared with other basal insulins.



  1. Persson M, Norman M, Hanson U. Obstetric and perinatal outcomes in type 1 diabetic pregnancies: a large, population-based study. Diabetes Care. 2009 Nov;32(11):2005-9.
  2. Eidem I, Vangen S, HanssenKF, et al. Perinatal and infant mortality in term and preterm births among women with type 1 diabetes. Diabetologia. 2011 Nov;54(11):2771-8.


Related content


This is a highlights summary of an oral session given at the EASD 2020 Virtual Meeting and presented by:

Elisabeth Mathiesen, MD
Center for Pregnant Women with Diabetes, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark; On behalf of the EVOLVE study group

The presenting authors of the original session had no part in the creation of this conference highlights summary. 

The content is produced by Infomedica. The summary text was drafted by Patrick Moore, PhD, and reviewed by Marco Gallo, MD, an independent external expert, and approved by Florian Toti, MD, the scientific editor of the program.


20 years HAPO Study: What have we learned so far?

Presented by: Patrick M. Catalano, MD
Expert commentary by Elizabeth O. Buschur, MD


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Presented by: Javed Butler, MD; Milton Packer, MD; Stefen D.Anker, MD; Gerasimos Filippatos, MD; Faiez Zannad, MD
Expert commentary by Prof. Francesco Giorgino


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