Congenital anomaly rate in offspring of mothers with diabetes treated with insulin lispro during pregnancy

Abstract

The rate of major congenital anomalies was 5.4% [95% CI (3.45%, 7.44%)] for offspring of mothers with diabetes mellitus treated with insulin lispro before and during pregnancy. The current published rates of major anomalies in infants born to mothers with diabetes treated with insulin are between 2.1 and 10.9%. This suggests that the anomaly rate with insulin lispro treatment does not differ from the published major congenital anomaly rates for other insulin treatments.

Epidemiology and Etiology of Congenital Heart Diseases

“…This excess risk is related to the level of maternal hyperglycemia during the embryonic period. The overall risk of one or more major anomalies is 6 to 7 percent, which is double the risk in the general obstetric population (Wyatt et al, 2005). Congenital heart defects increased in diabetic pregnancy include heterotaxy, TOF, TGA, septal defects, anomalous pulmonary venous return, and various defects causing left or right outflow obstruction (Lisowski et al, 2010;Corrigan et al, 2003;Wren et al, 2003).…”

Gestational Diabetes Mellitus: a review of the diagnosis, clinical implications and management

“…Human insulin is safe to be used during pregnancy, but in the last 10 years, there has been more widespread use of rapid-acting insulin analogues such as Insulin Lispro and Insulin Aspart. Studies had shown that these rapid-acting insulin analogues are safe to be used in pregnancy with no evidence of increase adverse pregnancy outcomes [40][41][42][43]. On the other hand, the safety profiles of the more long-acting insulin analogues such as Insulin Glargine and Insulin Detemir have not been fully validated for use in pregnancy.…”

Systematic Literature Review of Basal Bolus Insulin Analogue Therapy during Pregnancy

“…Two neonates had congenital malformations and 24% were LGA [18]. A retrospective cohort analysis from Wyatt et al [19] of 496 women with PGDM treated with lispro found a mean A1c value at the first prenatal visit of 8.9±4.2 to be significantly reduced to 6.2±2.4 in T3 (p<0.001). The rates of major congenital abnormalities, LGA infants, and mean birth weight were 5.4% (95% CI [3.45-7.44%]) and 23.4%, and 3464±765g, respectively [19].…”