Introduction: Pregnancy in women with type 1 diabetes mellitus (T1DM) is associated with an increased risk of adverse outcomes, so pregnancy planning in order to achieve an optimal glycemic control is essential. This control has been made possible, in part, by the widespread use of insulin analogues, especially the long-acting ones, glargine and detemir. Insulin degludec, an ultra-long-acting insulin is not currently approved for pregnant women due to the lack of randomized controlled studies in this special population, although its use during pregnancy could be helpful to improve glycemic control.
Objectives: To describe obstetric and perinatal outcomes in a cohort of patients with T1DM who became pregnant while taking insulin degludec.
Material and methods: Retrospective observational study of perinatal and obstetrical data from patients who used insulin degludec in the periconceptional period and had follow-up consultations between 2016 and 2019.
Results: Data were analyzed from 12 women with T1DM (27.5±8 years old), 14.9±7.4 years of diabetes duration, a pre-pregnancy weight of 84.8±12 Kg and periconceptional HbA1c 7.8±1.5%. The insulin degludec dose at the time of conception was 0.42 UI±0.16 IU/kg and was suspended at 9.5±4.8 weeks of pregnancy. It was changed to insulin glargine in six patients, to insulin detemir in five patients and to NPH insulin in one patient. One of them was also treated with statins and angiotensin-converting enzyme inhibitors (also suspended). Two abortions occurred in the sixth and seventh week of gestation, respectively.
Up to now, 6 births (3 term and 3 pre-term) have taken place, all of them by caesarean section, with a newborn weight of 3438±690 grams. As complications, 3 patients presented pre-eclampsia and we had 3 cases of neonatal hypoglycemia. None presented neonatal jaundice, respiratory distress, congenital malformations or required admission to the neonatal intensive care unit.
Conclusions: - Causality between observed complications and insulin degludec cannot be established since insufficient perinatal metabolic control itself constitutes a risk factor of developing these complications, as well as the small sample size.
- Controlled clinical trials are needed to confirm the efficacy and safety of insulin degludec in pregnancy.
18 - 21 May 2019
European Society of Endocrinology