The long-acting insulin analog glargine (IAG) is largely used as a basalbolus regimen in type 1 diabetes mellitus (T1DM), however its use is not still recommended during pregnancy. We promoted a national, multicentre, retrospective study to determine the rate of congenital malformation in a large group of offspring of mothers with T1DM who were treated with IAG before and during pregnancy. The observation’s period included all pregnancies ended before August 31 2006. We collected data on 107 TIDM pregnancies from 29 Italian centres and evaluated both maternal data and foetal outcomes. The rate of congenital malformation (CM) was compared with published data. The mean maternal age was 30.4±4.7 years, diabetes duration 15.8±7.7 years, White’s Classes B=23%, C=25%, D=35%, R=16%, RF=1%). IAG was started 10.3±6.9 months before conception as a basal-bolus regimen with an average dose of 19.2±7.5 IU/die. The pregnancy was unplanned in 92% of cases and the first diabetes assessment occurred at 8.7±4.1 weeks of pregnancy (Mean HbA1c 7.7±1.3%, range 5.3–13.8%). IAG was continued until the end of pregnancy in 38.3% of case, whereas it was stopped during the first trimester of gestation in 61.7%. Results: Glycemic control improved during the whole pregnancy with a mean HbA1c of 6.5±0.9% at the end of pregnancy. Spontaneous and elective abortions occurred in 5 and 2 women respectively. 100 babies were delivered at 36.7±2.1 week (pre-term deliveries 30.0%, caesarean sections 75.5%) with mean birth weight of 3298.0±717.4 g (LGA 42.7%). CM were reported in 5 newborns (5.0%), involving cardiovascular (n=2), genitourinary system (n=2, 1minor), and syndactylia (n=1). The rate of CM is not different from that reported in other studies regarding pregnancies of T1DM women treated with other insulins. Conclusions: Our survey, performed in a large cohort of T1DM pregnant women, suggest that insulin glargine does not seem to affect embryo-foetal development
Foetal outcomes associated with glargine's use during pregnancy: the Italian National Survey
VITACOLONNA, Ester;
2007-01-01
Abstract
The long-acting insulin analog glargine (IAG) is largely used as a basalbolus regimen in type 1 diabetes mellitus (T1DM), however its use is not still recommended during pregnancy. We promoted a national, multicentre, retrospective study to determine the rate of congenital malformation in a large group of offspring of mothers with T1DM who were treated with IAG before and during pregnancy. The observation’s period included all pregnancies ended before August 31 2006. We collected data on 107 TIDM pregnancies from 29 Italian centres and evaluated both maternal data and foetal outcomes. The rate of congenital malformation (CM) was compared with published data. The mean maternal age was 30.4±4.7 years, diabetes duration 15.8±7.7 years, White’s Classes B=23%, C=25%, D=35%, R=16%, RF=1%). IAG was started 10.3±6.9 months before conception as a basal-bolus regimen with an average dose of 19.2±7.5 IU/die. The pregnancy was unplanned in 92% of cases and the first diabetes assessment occurred at 8.7±4.1 weeks of pregnancy (Mean HbA1c 7.7±1.3%, range 5.3–13.8%). IAG was continued until the end of pregnancy in 38.3% of case, whereas it was stopped during the first trimester of gestation in 61.7%. Results: Glycemic control improved during the whole pregnancy with a mean HbA1c of 6.5±0.9% at the end of pregnancy. Spontaneous and elective abortions occurred in 5 and 2 women respectively. 100 babies were delivered at 36.7±2.1 week (pre-term deliveries 30.0%, caesarean sections 75.5%) with mean birth weight of 3298.0±717.4 g (LGA 42.7%). CM were reported in 5 newborns (5.0%), involving cardiovascular (n=2), genitourinary system (n=2, 1minor), and syndactylia (n=1). The rate of CM is not different from that reported in other studies regarding pregnancies of T1DM women treated with other insulins. Conclusions: Our survey, performed in a large cohort of T1DM pregnant women, suggest that insulin glargine does not seem to affect embryo-foetal developmentI documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
