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

Completed · Phase 4

Conditions studied: Type 1 Diabetes, Pregnancy, High Risk

In brief

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.

Key facts

Study ID

NCT04599075

Run by

Gianna Wilkie

People needed

70

Starts

2021-03-15

Expected to finish

2023-05-02

Last updated by the study team

2024-07-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Pregnant women with pre-gestational diagnosis of type 1 diabetes mellitus and managed on an insulin pump in pregnancy
• Pregnancy and delivery care obtained at University of Massachusetts (UMass) Memorial Medical Center
• Patients able to provide written informed consent

You may not qualify if…

• Patients who are under the age of 18
• Patients with altered state of consciousness
• Critically ill patient requiring intensive care unit admission
• Patient at risk for suicide
• Patient refuses or is otherwise unable to participate in own care
• Patient without pump supplies
• Patients presenting with diabetic ketoacidosis on admission

Where it is running

• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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