Intravenous Insulin vs Subcutaneous Insulin Infusion in Intrapartum Management of Type 1 Diabetes Mellitus
- Registration Number
- NCT04599075
- Lead Sponsor
- Gianna Wilkie
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 70
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continuous Subcutaneous Insulin Infusion (CSII) Insulin Patients will be randomized to continuation of their CSII pump intrapartum and will be managed in accordance with the CSII hospital protocol. Intravenous Insulin Infusion Insulin Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol.
- Primary Outcome Measures
Name Time Method Neonatal Hypoglycemia Within 2 hours of birth First neonatal blood sugar obtained within 2 hours of birth
- Secondary Outcome Measures
Name Time Method Gestational Age at Delivery At birth Gestational age at delivery
Number of Maternal Hypoglycemic Events During labor Number of maternal blood sugars \< 60 mg/dL
Development of Diabetic Ketoacidosis During Labor During Labor Development of Diabetic Ketoacidosis during labor
Number of Participants With Neonatal Hyperbilirubinemia Within first 2 days of life Requiring phototherapy
Number of Participants With Shoulder Dystocia At birth Number of participants with shoulder dystocia
Number of Participants With Brachial Plexus Injury At birth Number of participants with brachial plexus injury
Received Neonatal Intervention for Hypoglycemia Within 24 hours of life Received intervention for hypoglycemia (any oral, IV, or both)
Neonatal Intensive Care Unit Admission 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.
Mode of Delivery At birth Mode of Delivery (vaginal versus cesarean)
Neonatal Birthweight At Birth Neonatal Birthweight
5 Minute Apgar Score < 7 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.
Number of Participants With Neonatal Respiratory Distress At delivery Requiring 2 or more hours of respiratory support or oxygen with associated diagnosis
Trial Locations
- Locations (1)
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States