Use of insulin glargine during the first weeks of pregnancy in 10 type 1 diabetic women

The long-acting analogue glargine is a new insulin with 24-hr persistence. Only a few reports have described the use of insulin glargine during human pregnancy, so its use is not recommended at present. Aim of this study was to evaluate te safety of insulin glargine on neonatal outcome in type 1 diabetic pregnant women. We retrospectively collected ten cases of use of glargine during unplanned pregnancy in three italian diabetological centries. All ten diabetic women attended their first diabetes evaluation in the period November 2002 - August 2004. They initiated glargine five to twelve months before conception as part of a basal-bolus regimen with an average dose of 26  15.4 IU/day (range: 12 – 56 IU/day) given as a single pre-dinner subcutaneous injection. The first diabetes assessment after commencement of pregnancy occurred from 6th to 12th week of gestation. Their HbA1c at that time was 8.2 1.9% (range 6.4-12). All women were informed about the lack of controlled data on the safety and efficacy of glargine in pregnant women; 8 patients were switched to NPH in the morning and bed-time, while two women decided to continue the treatment with insulin glargine. After 2 weeks of the new insulin regimen, 3 women were started on CSII because optimal control could not be attained. Spontaneous abortion occurred at 11th of gestation in one woman (age 37 years, White class F, HbA1c at conception 12%). In 9 patients strict glycemic control was achieved with an average HbA1c of 6.20.4 % at the end of pregnancy and no progression in retinophaty or other microangiopatic complication was detected. Pre-eclampsia developed in two patient at the 32nd week of gestation. Babies (3 males and 6 females) were delivered at a mean gestational age of 35.8±1.7 weeks by caesarean section in all, but two women. Mean birth weight was 3049±1021 g, with three babies large for gestational age (two over 4 Kg) and one small for gestational age ( mother aged 37 years, White Class RF, Hba1c at conception 11.4%, pre-eclampsia during pregnancy). In the other 5 babies, weight was adequate for gestational age. There was neither major nor minor congenital malformation . This experience is limited to a few subjects; nevertheless eight of the observed women used insulin glargine from the pre-conception period to 6th –12th week postconception and two women for all pregnancy. Insulin glargine does not seem to affect embryo-fetal development, moreover this as well as other observations, emphasises the need for properly planned investigations.