Use of insulin glargine during pregnancy: a case–control pilot study

Abstract

Objective To determine whether the use of insulin glargine during pregnancy is associated with an increase in the incidence of fetal macrosomia or adverse neonatal outcome.Design A matched case-control study.Setting Women's Centre, John Radcliffe Hospital, Oxford, UK.Sample Sixty-four pregnant women treated with insulin during their pregnancies, 20 with type I diabetes and 44 with gestational diabetes.Methods Two groups of women were compared in matched pairs. A study group of 32 pregnant women with diabetes treated with insulin glargine during their pregnancy and a control group of 32 pregnant women treated with an intermediate-acting human insulin (isophane or insulin zinc suspension) and matched for weight at booking, height, gestation at delivery, parity, fetal sex, duration of insulin use in pregnancy and glycaemic control during the third trimester of pregnancy (glycosylated haemoglobin [HbA 1c ] concentration and mean blood glucose concentration).Main outcome measures Birthweight, centile birthweight, the incidence of fetal macrosomia (birthweight > 90th percentile) and neonatal morbidity in the two study groups.Results There was no significant difference between the birthweight or centile birthweight of babies born to the women treated with insulin glargine during pregnancy and that of the babies born to those in the control group treated with intermediate-acting human insulin. The overall incidence of fetal macrosomia was 12/32 (37.5%) in the insulin glargine group and 13/32 (40.6%) in the control group. There was no significant difference in neonatal morbidity between the groups. ConclusionsThe results of this pilot study indicate that insulin glargine treatment during pregnancy does not appear to be associated with increased fetal macrosomia or neonatal morbidity.

Systematic Literature Review of Basal Bolus Insulin Analogue Therapy during Pregnancy

“…Birth weight and rate of congenital abnormalities were similar. Overall incidence of macrosomia was similar: 37.5% in glargine group and 40.6% in control group (p>0.05) [47].…”

“…A statistically significant improvement of mean A1c change from T1 to T3 was demonstrated by Poyhonen-Alho et al [48]. All studies reviewed, reported either no difference in the rate of maternal hypoglycemia or a significantly decreased rate compared to NPH [15,[46][47][48]50,52,53].…”

“…Price et al [47] conducted a case-control study in women with T1DM and GDM. Thirty-two women previously treated with glargine were selected (10 T1DM, 22 GDM) using either lispro or aspart for bolus therapy.…”

The use of glargine in pregnancy

“…We read with interest the article by Price et al 1 In their pilot study, Price et al investigated the use of glargine in pregnant women with type I diabetes and gestational diabetes. 1 There are concerns regarding the use of glargine in pregnancy due in part to an increase in insulin-like growth factor-I (IGF-I) receptor affinity (which the authors mention) but also to its mitogenic potency in a cell culture model that used human osteosarcoma cells 2 (which the authors does not mention).…”

“…1 There are concerns regarding the use of glargine in pregnancy due in part to an increase in insulin-like growth factor-I (IGF-I) receptor affinity (which the authors mention) but also to its mitogenic potency in a cell culture model that used human osteosarcoma cells 2 (which the authors does not mention). IGF-I has been also implicated in the development of mammary, bone and ovarian tumours and in the development of retinopathy.…”