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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 1 Diabetes, Pregnancy, High Risk

Intervention / Treatment
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* Drug: Insulin
* Drug: Insulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective, single-center, randomized study evaluating intrapartum insulin delivery management strategies among pregnant women with type 1 diabetes mellitus.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous Insulin Infusion<br>Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol. | Drug: Insulin<br>* IV Insulin Infusion<br>* Other names: Insulin via IV Infusion;|
| Experimental: Continuous Subcutaneous Insulin Infusion (CSII)<br>Patients will be randomized to continuation of their CSII pump intrapartum and will be managed in accordance with the CSII hospital protocol. | Drug: Insulin<br>* Continuous Subcutaneous Insulin Infusion (Pump)<br>* Other names: Insulin via Pump;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Hypoglycemia | First neonatal blood sugar obtained within 2 hours of birth | Within 2 hours of birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of maternal intrapartum glucose measurements | Number of maternal intrapartum glucose measurements | During Labor | 
| Maternal glucose values | Each maternal glucose values obtained during labor | During labor | 
| Number of maternal hypoglycemic events | Number of maternal blood sugars < 60 mg/dL | During labor | 
| Development of Diabetic Ketoacidosis during labor | Development of Diabetic Ketoacidosis during labor | During Labor | 
| Mode of Delivery | Mode of Delivery (vaginal versus cesarean) | At birth | 
| Neonatal Birthweight | Neonatal Birthweight | At Birth | 
| Number of participants with shoulder dystocia | Number of participants with shoulder dystocia | At birth | 
| Number of participants with brachial plexus injury | Number of participants with brachial plexus injury | At birth | 
| Apgar Score | Neonatal Apgar Score | At delivery | 
| Neonatal mean glucose level | Neonatal mean glucose level in first 24 hours of life | Within 24 hours of life | 
| Received neonatal intervention for hypoglycemia | Received intervention for hypoglycemia (any oral, IV, or both) | Within 24 hours of life | 
| Neonatal Intensive Care Unit Admission | Admission to level 2 or greater neonatal ICU and length of stay | At delivery and within first 2 day of life | 
| Neonatal Intensive Care Unit Admission for hypoglycemia | Admission to level 2 or greater neonatal ICU for hypoglycemia and length of stay | At delivery and within first 2 day of life | 
| Gestational age at delivery | Gestational age at delivery | At birth | 
| Number of participants with neonatal respiratory distress | Requiring 2 or more hours of respiratory support or oxygen with associated diagnosis | At delivery | 
| Number of participants with neonatal hyperbilirubinemia | Requiring phototherapy | Within first 2 days of life | 
| Time from birth to first neonatal glucose measurement | Time from birth to first neonatal glucose measurement | Within first 3 hours of life | 
| Maternal Care Satisfaction Survey | Survey assessing satisfaction with healthcare provided | Postpartum, assessed within 4 days of delivery | 
| Placental Pathology | Assessing for malperfusion pathology | At birth | 
| Umbilical Cord Blood Level of C-peptide | Umbilical Cord Blood Level of C-peptide | At Birth | 
| Umbilical Cord Blood Level of Leptin | Umbilical Cord Blood Level of Leptin | At Birth | 
| Umbilical Cord Blood Level of Insulin | Umbilical Cord Blood Level of Insulin | At Birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Type 1 Diabetes, Intrapartum Insulin, Maternal Outcomes, Neonatal Outcomes