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

• Sponsor: Gianna Wilkie (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04599075
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 27.5
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes; Pregnancy, High Risk	Drug: Insulin; Drug: Insulin	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a prospective, single-center, randomized study evaluating intrapartum insulin delivery management strategies among pregnant women with type 1 diabetes mellitus.This is a prospective, single-center, randomized study evaluating intrapartum insulin delivery management strategies among pregnant women with type 1 diabetes mellitus.
• Masking: Single (Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Intravenous Insulin Versus Subcutaneous Insulin Infusion in Intrapartum Management of Pregnant Women With Type 1 Diabetes Mellitus: A Randomized Trial
• Actual Study Start Date: Mar 15, 2021
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

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
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; Continuous Subcutaneous Insulin Infusion (Pump); Other Names: Insulin via Pump

Outcome Measures

Primary Outcome Measures

1. Neonatal Hypoglycemia [Within 2 hours of birth]

   First neonatal blood sugar obtained within 2 hours of birth

Secondary Outcome Measures

1. Number of maternal intrapartum glucose measurements [During Labor]

   Number of maternal intrapartum glucose measurements

2. Maternal glucose values [During labor]

   Each maternal glucose values obtained during labor

3. Number of maternal hypoglycemic events [During labor]

   Number of maternal blood sugars < 60 mg/dL

4. Development of Diabetic Ketoacidosis during labor [During Labor]

   Development of Diabetic Ketoacidosis during labor

5. Mode of Delivery [At birth]

   Mode of Delivery (vaginal versus cesarean)

6. Neonatal Birthweight [At Birth]

   Neonatal Birthweight

7. Number of participants with shoulder dystocia [At birth]

   Number of participants with shoulder dystocia

8. Number of participants with brachial plexus injury [At birth]

   Number of participants with brachial plexus injury

9. Apgar Score [At delivery]

   Neonatal Apgar Score

10. Neonatal mean glucose level [Within 24 hours of life]

    Neonatal mean glucose level in first 24 hours of life

11. Received neonatal intervention for hypoglycemia [Within 24 hours of life]

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

12. Neonatal Intensive Care Unit Admission [At delivery and within first 2 day of life]

    Admission to level 2 or greater neonatal ICU and length of stay

13. Neonatal Intensive Care Unit Admission for hypoglycemia [At delivery and within first 2 day of life]

    Admission to level 2 or greater neonatal ICU for hypoglycemia and length of stay

14. Gestational age at delivery [At birth]

    Gestational age at delivery

15. Number of participants with neonatal respiratory distress [At delivery]

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

16. Number of participants with neonatal hyperbilirubinemia [Within first 2 days of life]

    Requiring phototherapy

17. Time from birth to first neonatal glucose measurement [Within first 3 hours of life]

    Time from birth to first neonatal glucose measurement

18. Maternal Care Satisfaction Survey [Postpartum, assessed within 4 days of delivery]

    Survey assessing satisfaction with healthcare provided

19. Placental Pathology [At birth]

    Assessing for malperfusion pathology

20. Umbilical Cord Blood Level of C-peptide [At Birth]

    Umbilical Cord Blood Level of C-peptide

21. Umbilical Cord Blood Level of Leptin [At Birth]

    Umbilical Cord Blood Level of Leptin

22. Umbilical Cord Blood Level of Insulin [At Birth]

    Umbilical Cord Blood Level of Insulin

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts	United States	01605

Sponsors and Collaborators

• Gianna Wilkie

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Gianna Wilkie, Principal Investigator, University of Massachusetts, Worcester
• ClinicalTrials.gov Identifier: NCT04599075
• Other Study ID Numbers: H00021746
• First Posted: Oct 22, 2020
• Last Update Posted: May 10, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Gianna Wilkie, Principal Investigator, University of Massachusetts, Worcester: Pregnancy; Type 1 Diabetes; Intrapartum Insulin; Maternal Outcomes; Neonatal Outcomes
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Insulin; Insulin, Globin Zinc

Study Results

No Results Posted as of May 10, 2022