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

Gianna Wilkie70 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Type 1 Diabetes Pregnancy, High Risk

Interventions

InsulinDRUG

IV Insulin Infusion

InsulinDRUG

Continuous Subcutaneous Insulin Infusion (Pump)

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

Outcomes

Primary Outcomes

Neonatal Hypoglycemia

First neonatal blood sugar obtained within 2 hours of birth

Time frame: Within 2 hours of birth

Secondary Outcomes

Number of Maternal Hypoglycemic Events

Number of maternal blood sugars \< 60 mg/dL

Time frame: During labor

Development of Diabetic Ketoacidosis During Labor

Development of Diabetic Ketoacidosis during labor

Time frame: During Labor

Mode of Delivery

Mode of Delivery (vaginal versus cesarean)

Time frame: At birth

Neonatal Birthweight

Time frame: At Birth

Number of Participants With Shoulder Dystocia

Number of participants with shoulder dystocia

Time frame: At birth

Number of Participants With Brachial Plexus Injury

Number of participants with brachial plexus injury

Time frame: At birth

5 Minute Apgar Score < 7

Neonatal Apgar Score: The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.

Time frame: At delivery (5 minutes)

Data from ClinicalTrials.gov

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