USE OF INSULIN DEGLUDEC IN PREGNANCY: TWO CASE REPORTS AND A LITERATURE REVIEW

Abstract As of now, insulin Degludec has no indication for use in pregnancy, because of the lack of studies that prove its safety for foetus. However it isn't infrequent that some women conceive while treating with insulin Degludec. So, before deciding to change the type of insulin therapy during pregnancy, an evaluation of the risk associated to a possible temporary worsening of glycaemic control, due to that insulin replacement, is needed. Referring to case series reported in the scientific literature could provide a support when a clinical decision need to be taken. We report two cases of women affected by type 1 diabetes who had unplanned pregnancies during treatment with insulin Degludec. In order to avoid the risk of a possible worsening of glycaemic control due to insulin switch, we decided to continue the treatment with Degludec during their pregnancies, after obtaining the patients' written informed consent. Daily insulin requirement gradually increased for both women pregnancy progressed, and glycated haemoglobin (HbA1c) values improved from the first observation to delivery: 55 mmol/mol (7.2%) at 9 weeks to 47 mmol/mol (6.5%) at 36 weeks, in Patient 1 (P1); 44 mmol/mol (6.2%) at 8 weeks to 33 mmol/mol (5.2%) at 36 weeks, in Patient 2 (P2). P1 delivered at week 37 with a caesarean section due to failed induction. The newborn, a girl of 3398 g at birth, developed neonatal hypoglycaemia and respiratory distress (Apgar 6-6). Six days after birth she underwent colectomy because of necrotizing enterocolitis and was finally diagnosed with atypical cystic fibrosis. P2 gave birth to a healthy girl (weight 2745g at birth, Apgar 7-9) at 37 weeks, undergoing a caesarean section for maternal cervical dystocia, without neonatal complications. Our experience provides additional evidence on the safety of insulin Degludec in pregnancy without any maternal or neonatal outcome suggesting its toxicity.