NCT04599075

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

Intravenous Insulin Versus Subcutaneous Insulin Infusion in Intrapartum Management of Pregnant Women With Type 1 Diabetes Mellitus: A Randomized Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Gianna Wilkie · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Intrapartum glucose management is critical to reducing neonatal hypoglycemia shortly after birth. Some providers are comfortable continuing patients on their subcutaneous insulin pump during labor while others transition these patients to intravenous insulin infusions. Previous literature has retrospectively shown this to be both a feasible and safe option. The investigators aim to compare subcutaneous insulin pump versus intravenous insulin infusion with regard to obstetric and neonatal outcomes.

Conditions

• Type 1 Diabetes
• Pregnancy, High Risk

Interventions

Type	Name	Description
DRUG	Insulin	IV Insulin Infusion
DRUG	Insulin	Continuous Subcutaneous Insulin Infusion (Pump)

Timeline

• Start date: 2021-03-15
• Primary completion: 2023-05-01
• Completion: 2023-05-02
• First posted: 2020-10-22
• Last updated: 2024-07-08
• Results posted: 2024-07-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study