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

Recruiting in Palo Alto (17 mi)

Overseen by Gianna L Wilkie, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Gianna Wilkie

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Critically ill patient requiring intensive care unit admission

Patient refuses or is otherwise unable to participate in own care

Patient without pump supplies

Treatment Details

Interventions

• Insulin (Insulin)

Participant Groups

Group I: Intravenous Insulin Infusion Experimental Treatment 1 Intervention

Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol.

Group II: Continuous Subcutaneous Insulin Infusion (CSII) Experimental Treatment 1 Intervention

Patients will be randomized to continuation of their CSII pump intrapartum and will be managed in accordance with the CSII hospital protocol.

Insulin is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Insulin for:

• Diabetes mellitus

🇺🇸 Approved in United States as Insulin for:

• Diabetes mellitus

🇨🇦 Approved in Canada as Insulin for:

• Diabetes mellitus

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Massachusetts Memorial Medical Center Worcester, MA

Who Is Running the Clinical Trial?

Gianna Wilkie Lead Sponsor

References