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

Gianna Wilkie

Status and phase: Completed; Phase 4

Conditions: Type 1 Diabetes; Pregnancy, High Risk

Treatments: Drug: Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT04599075

H00021746

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Intravenous Insulin Infusion

Experimental group

Description:

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

Treatment:

Drug: Insulin

Drug: Insulin

Continuous Subcutaneous Insulin Infusion (CSII)

Experimental group

Description:

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

Treatment:

Drug: Insulin

Drug: Insulin