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Completed

NCT Number: NCT04599075

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy, High Risk

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin

Drug

IV Insulin Infusion

Other names: Insulin via IV Infusion

Primary outcomes

  1. Neonatal Hypoglycemia

    Time frame: Within 2 hours of birth

    First neonatal blood sugar obtained within 2 hours of birth

Secondary outcomes

  1. Number of Maternal Hypoglycemic Events

    Time frame: During labor

    Number of maternal blood sugars < 60 mg/dL

  2. Development of Diabetic Ketoacidosis During Labor

    Time frame: During Labor

    Development of Diabetic Ketoacidosis during labor

  3. Mode of Delivery

    Time frame: At birth

    Mode of Delivery (vaginal versus cesarean)

  4. Neonatal Birthweight

    Time frame: At Birth

    Neonatal Birthweight

  5. Number of Participants With Shoulder Dystocia

    Time frame: At birth

    Number of participants with shoulder dystocia

  6. Number of Participants With Brachial Plexus Injury

    Time frame: At birth

    Number of participants with brachial plexus injury

  7. 5 Minute Apgar Score < 7

    Time frame: At delivery (5 minutes)

    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.

  8. Received Neonatal Intervention for Hypoglycemia

    Time frame: Within 24 hours of life

    Received intervention for hypoglycemia (any oral, IV, or both)

  9. Neonatal Intensive Care Unit Admission

    Time frame: At delivery and within first 2 day of life

    Admission to level 2 or greater neonatal ICU. This is a marker for additional need for neonatal support and care after delivery.

  10. Gestational Age at Delivery

    Time frame: At birth

    Gestational age at delivery

  11. Number of Participants With Neonatal Respiratory Distress

    Time frame: At delivery

    Requiring 2 or more hours of respiratory support or oxygen with associated diagnosis

  12. Number of Participants With Neonatal Hyperbilirubinemia

    Time frame: Within first 2 days of life

    Requiring phototherapy

Sponsors and collaborators

Lead sponsor

Gianna Wilkie

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 22, 2020
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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