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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes; Pregnancy, High Risk
• Intervention / Treatment: Drug: Insulin; Drug: Insulin

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • University of Massachusetts Memorial Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
Neonatal Birthweight	Neonatal Birthweight	At Birth
Mode of Delivery	Mode of Delivery (vaginal versus cesarean)	At birth
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
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
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.	At delivery (5 minutes)
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. This is a marker for additional need for neonatal support and care after delivery.	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

Collaborators and Investigators

• Sponsor: Gianna Wilkie
• Investigators: Principal Investigator: Gianna L Wilkie, MD, UMass Memorial Health Care

Publications and helpful links

General Publications

• Peterson C, Grosse SD, Li R, Sharma AJ, Razzaghi H, Herman WH, Gilboa SM. Preventable health and cost burden of adverse birth outcomes associated with pregestational diabetes in the United States. Am J Obstet Gynecol. 2015 Jan;212(1):74.e1-9. doi: 10.1016/j.ajog.2014.09.009. Epub 2014 Oct 28.
• Professional Practice Committee for the Standards of Medical Care in Diabetes-2016. Diabetes Care. 2016 Jan;39 Suppl 1:S107-8. doi: 10.2337/dc16-S018. No abstract available.
• Feldberg D, Dicker D, Samuel N, Peleg D, Karp M, Goldman JA. Intrapartum management of insulin-dependent diabetes mellitus (IDDM) gestants. A comparative study of constant intravenous insulin infusion and continuous subcutaneous insulin infusion pump (CSIIP). Acta Obstet Gynecol Scand. 1988;67(4):333-8.
• Drever E, Tomlinson G, Bai AD, Feig DS. Insulin pump use compared with intravenous insulin during labour and delivery: the INSPIRED observational cohort study. Diabet Med. 2016 Sep;33(9):1253-9. doi: 10.1111/dme.13106. Epub 2016 Mar 20.
• Fresa R, Visalli N, Di Blasi V, Cavallaro V, Ansaldi E, Trifoglio O, Abbruzzese S, Bongiovanni M, Agrusta M, Napoli A. Experiences of continuous subcutaneous insulin infusion in pregnant women with type 1 diabetes during delivery from four Italian centers: a retrospective observational study. Diabetes Technol Ther. 2013 Apr;15(4):328-34. doi: 10.1089/dia.2012.0260. Epub 2013 Mar 28.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 2, 2023

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Pregnancy; Type 1 Diabetes; Neonatal Outcomes; Maternal Outcomes; Intrapartum Insulin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: H00021746

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes