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

NCT04599075 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: H00021746
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Pregnancy, High Risk

Keywords

Pregnancy; Type 1 Diabetes; Intrapartum Insulin; Maternal Outcomes; Neonatal Outcomes

Outcome Measures

Primary Outcomes (1)

• Neonatal Hypoglycemia

  First neonatal blood sugar obtained within 2 hours of birth

  Within 2 hours of birth

Secondary Outcomes (12)

• Number of Maternal Hypoglycemic Events

  During labor

• Development of Diabetic Ketoacidosis During Labor

  During Labor

• Mode of Delivery

  At birth

• Neonatal Birthweight

  At Birth

• Number of Participants With Shoulder Dystocia

  At birth

Study Arms (2)

Intravenous Insulin Infusion

EXPERIMENTAL

Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol.

Drug: Insulin

Continuous Subcutaneous Insulin Infusion (CSII)

EXPERIMENTAL

Patients will be randomized to continuation of their CSII pump intrapartum and will be managed in accordance with the CSII hospital protocol.

Drug: Insulin

Interventions

Insulin DRUG

IV Insulin Infusion

Also known as: Insulin via IV Infusion

Intravenous Insulin Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gianna Wilkie: lead

Study Sites (1)

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01605, United States

Location

Related Publications (6)

• 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.

  PMID: 3051881 BACKGROUND

• 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.

  PMID: 25439811 BACKGROUND

• 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.

  PMID: 26696673 BACKGROUND

• 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.

  PMID: 26927202 BACKGROUND

• 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.

  PMID: 23537417 BACKGROUND

• Wilkie GL, Delpapa E, Leftwich HK. Intrapartum continuous subcutaneous insulin infusion vs intravenous insulin infusion among pregnant individuals with type 1 diabetes mellitus: a randomized controlled trial. Am J Obstet Gynecol. 2023 Dec;229(6):680.e1-680.e8. doi: 10.1016/j.ajog.2023.07.003. Epub 2023 Jul 8.

  PMID: 37429432 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Gianna Wilkie
• Organization: University of Massachusetts Chan School of Medicine

Gianna.Wilkie@umassmemorial.org

7743642523

Study Officials

• Gianna L Wilkie, MD

  UMass Memorial Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Those assessing the outcomes from the medical chart will be blinded to the randomization process and the assigned study arm. Patients, the primary investigator, and their care providers will be aware of their treatment status.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a prospective, single-center, randomized study evaluating intrapartum insulin delivery management strategies among pregnant women with type 1 diabetes mellitus.

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 22, 2020
• Study Start: March 15, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 2, 2023
• Last Updated: July 8, 2024
• Results First Posted: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)