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Grand Rounds

Do Insulin Analogues Affect Birth Defect Risk Compared to Human Insulin?

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BACKGROUND AND PURPOSE:

  • Pregnant women with pregestational diabetes (DM type 1 or 2) will often be treated with insulin analogues, which appear to provide better control and outcomes compared to human insulin
  • However, there have been very limited data as to whether there are any associations between birth defects and use of insulin analogues in the first trimester
  • Wang et al. (BMJ Open 2018) compared the heart anomalies in fetuses exposed to either insulin analogues or human insulin in mothers with gestational diabetes mellitus

METHODS:

  • Population-based retrospective cohort study
    • Based on the EUROCAT database
  • Participants: Women with pregestational diabetes who were referred to hospitals in the region of study and were delivered between 1996 and 2012
  • Exposure (in first trimester) definition
    • Human insulin only (reference)
    • Insulin analogue only
    • Both human insulin and insulin analogue
  • Primary outcome: Risk of non-chromosomal major congenital anomaly fetus and infant
  • Secondary outcome: Congenital heart defects

RESULTS:

  • Final study cohort included 1634 pregnancies
  • During the first trimester:
    • 870 fetuses (52.4%) were exposed to human insulin only
    • 397 fetuses (23.9%) to insulin analogues only
    • 394 fetuses (23.7%) to both human insulin and insulin analogues
  • Mean HbA1c value in the first trimester were higher in human insulin group and less likely to be in the 44-53 mmol/mol (6.2% – 7.0%) range (P<0.001)
  • The risk of major congenital anomaly in fetuses exposed to insulin analogues only was lower than those exposed to human insulin only
    • Human insulin only: 70 (8.0%) fetuses
    • Insulin analogue: 15 (3.8%) fetuses
    • Both human and analogue: 19 (4.8%) fetuses
  • The relative risk for overall birth defects adjusted for glycemic control and region was 0.56 (95% CI 0.29 to 1.06) and not significant
  • However, exposure to insulin analogues only was associated with reduced risk for congenital heart defects
    • Adjusted relative risk 0.14 (95% CI 0.03 to 0.62)

CONCLUSION:

  • Exposure to insulin analogues in the first trimester did not increase the risk of major congenital anomaly compared with exposure to human insulin
  • There is possibly a lower risk of congenital heart defects among fetuses exposed to insulin analogues

Learn More – Primary Sources:

Insulin analogues use in pregnancy among women with pregestational diabetes mellitus and risk of congenital anomaly: a retrospective population-based cohort study

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Related ObG Topics:

CONCEPTT Study: Time for Continuous Glucose Monitoring for All Pregnant Women with Type 1 Diabetes?
Update from the ACP: New Hemoglobin A1c Targets for Type 2 Diabetes Mellitus

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