Intravenous Insulin vs Subcutaneous Insulin Infusion in Intrapartum Management of Type 1 Diabetes Mellitus

Summary

The purpose of this study is to perform a randomized trial to investigate if intrapartum insulin delivery mechanisms reduces adverse outcomes associated with type 1 diabetes in pregnancy. The investigators aim to compare subcutaneous insulin pump versus intravenous insulin infusion with regard to the primary outcome of neonatal blood sugar.

Timeline

Start

2021-03-15

Primary completion

2023-05-01

Completion

2023-05-02

Outcome

Missed primary endpoint

paper 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). PMID 37429432 ↗

Publications

• Background Feldberg D, Dicker D, Samuel N, Peleg D, Karp M, Goldman JA. Intrapartum management of insulin-dependent diabetes mellitus (IDDM) gestants. A comparative study of constant intravenous insulin infusion and continuous subcutaneous insulin infusion pump (CSIIP). Acta Obstet Gynecol Scand. 1988;67(4):333-8.
• Background Peterson C, Grosse SD, Li R, Sharma AJ, Razzaghi H, Herman WH, Gilboa SM. Preventable health and cost burden of adverse birth outcomes associated with pregestational diabetes in the United States. Am J Obstet Gynecol. 2015 Jan;212(1):74.e1-9. doi: 10.1016/j.ajog.2014.09.009. Epub 2014 Oct 28.
• Background Professional Practice Committee for the Standards of Medical Care in Diabetes-2016. Diabetes Care. 2016 Jan;39 Suppl 1:S107-8. doi: 10.2337/dc16-S018. No abstract available.
• Background Drever E, Tomlinson G, Bai AD, Feig DS. Insulin pump use compared with intravenous insulin during labour and delivery: the INSPIRED observational cohort study. Diabet Med. 2016 Sep;33(9):1253-9. doi: 10.1111/dme.13106. Epub 2016 Mar 20.
• Background Fresa R, Visalli N, Di Blasi V, Cavallaro V, Ansaldi E, Trifoglio O, Abbruzzese S, Bongiovanni M, Agrusta M, Napoli A. Experiences of continuous subcutaneous insulin infusion in pregnant women with type 1 diabetes during delivery from four Italian centers: a retrospective observational study. Diabetes Technol Ther. 2013 Apr;15(4):328-34. doi: 10.1089/dia.2012.0260. Epub 2013 Mar 28.
• Wilkie GL, Delpapa E, Leftwich HK. Intrapartum continuous subcutaneous insulin infusion vs intravenous insulin infusion among pregnant individuals with type 1 diabetes mellitus: a randomized controlled trial. Am J Obstet Gynecol. 2023 Dec;229(6):680.e1-680.e8. doi: 10.1016/j.ajog.2023.07.003. Epub 2023 Jul 8.

Drugs

Indications