Intrapartum continuous subcutaneous insulin infusion vs intravenous insulin infusion among pregnant individuals with type 1 diabetes mellitus: a randomized controlled trial

Abstract

Background: Intrapartum glucose management is critical to reducing neonatal hypoglycemia shortly after birth. Although it is known that insulin is required for all pregnant individuals with type 1 diabetes mellitus, the optimal mode of intrapartum glycemic control is not known.

Objective: This study aimed to compare the effect of intrapartum use of continuous subcutaneous insulin infusion with that of intravenous insulin infusion for glucose management among pregnant individuals with type 1 diabetes mellitus on neonatal blood glucose levels.

Study design: This was a randomized controlled trial of pregnant participants with type 1 diabetes mellitus. After written informed consent, participants were randomly allocated to 1 of 2 intrapartum insulin administration strategies: continuation of their continuous subcutaneous insulin infusion or intravenous insulin infusion. The primary outcome was the first neonatal blood glucose level.

Results: Between March 2021 and April 2023, 76 participants were approached, and 70 participants were randomized (35 participants in the intravenous insulin infusion group and 35 participants in the continuous subcutaneous insulin infusion group). The groups were similar in terms of age, race/ethnicity, pregravid body mass index, nulliparity, and gestational age at delivery. There was no statistically significant difference in the first neonatal glucose measurement between the 2 groups (50.1±23.4 vs 49.2±22.6; P=.86). In addition, there were no statistically significant differences in any secondary neonatal outcomes. Approximately 57.1% of neonates in the continuous subcutaneous insulin infusion group required either oral, intravenous, or both treatments for hypoglycemia, whereas 51.4% of neonates in the intravenous infusion group required treatment. In both groups, 28.6% of neonates required intravenous treatment for hypoglycemia.

Conclusion: Pregnant individuals with type 1 diabetes mellitus using either intravenous insulin infusion or continuation of their continuous subcutaneous insulin infusion for intrapartum insulin administration had no difference in the primary outcome of neonatal hypoglycemia. Patients should be given the option of both glycemic management strategies intrapartum.

Trial registration: ClinicalTrials.gov NCT04599075.

Keywords: continuous subcutaneous insulin infusion; insulin pump; intrapartum insulin; pregestational diabetes mellitus; type 1 diabetes mellitus.