search
Back to results

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

Primary Purpose

Type 1 Diabetes, Pregnancy, High Risk

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Insulin
Insulin
Sponsored by
Gianna Wilkie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Pregnancy, Type 1 Diabetes, Intrapartum Insulin, Maternal Outcomes, Neonatal Outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Massachusetts Memorial Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intravenous Insulin Infusion

Continuous Subcutaneous Insulin Infusion (CSII)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Neonatal Hypoglycemia
First neonatal blood sugar obtained within 2 hours of birth

Secondary Outcome Measures

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

Full Information

First Posted
October 16, 2020
Last Updated
May 2, 2023
Sponsor
Gianna Wilkie
search

1. Study Identification

Unique Protocol Identification Number
NCT04599075
Brief Title
Intravenous Insulin vs Subcutaneous Insulin Infusion in Intrapartum Management of Type 1 Diabetes Mellitus
Official Title
Intravenous Insulin Versus Subcutaneous Insulin Infusion in Intrapartum Management of Pregnant Women With Type 1 Diabetes Mellitus: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
May 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gianna Wilkie

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Pregnancy, High Risk
Keywords
Pregnancy, Type 1 Diabetes, Intrapartum Insulin, Maternal Outcomes, Neonatal Outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous Insulin Infusion
Arm Type
Experimental
Arm Description
Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol.
Arm Title
Continuous Subcutaneous Insulin Infusion (CSII)
Arm Type
Experimental
Arm Description
Patients will be randomized to continuation of their CSII pump intrapartum and will be managed in accordance with the CSII hospital protocol.
Intervention Type
Drug
Intervention Name(s)
Insulin
Other Intervention Name(s)
Insulin via IV Infusion
Intervention Description
IV Insulin Infusion
Intervention Type
Drug
Intervention Name(s)
Insulin
Other Intervention Name(s)
Insulin via Pump
Intervention Description
Continuous Subcutaneous Insulin Infusion (Pump)
Primary Outcome Measure Information:
Title
Neonatal Hypoglycemia
Description
First neonatal blood sugar obtained within 2 hours of birth
Time Frame
Within 2 hours of birth
Secondary Outcome Measure Information:
Title
Number of maternal intrapartum glucose measurements
Description
Number of maternal intrapartum glucose measurements
Time Frame
During Labor
Title
Maternal glucose values
Description
Each maternal glucose values obtained during labor
Time Frame
During labor
Title
Number of maternal hypoglycemic events
Description
Number of maternal blood sugars < 60 mg/dL
Time Frame
During labor
Title
Development of Diabetic Ketoacidosis during labor
Description
Development of Diabetic Ketoacidosis during labor
Time Frame
During Labor
Title
Mode of Delivery
Description
Mode of Delivery (vaginal versus cesarean)
Time Frame
At birth
Title
Neonatal Birthweight
Description
Neonatal Birthweight
Time Frame
At Birth
Title
Number of participants with shoulder dystocia
Description
Number of participants with shoulder dystocia
Time Frame
At birth
Title
Number of participants with brachial plexus injury
Description
Number of participants with brachial plexus injury
Time Frame
At birth
Title
Apgar Score
Description
Neonatal Apgar Score
Time Frame
At delivery
Title
Neonatal mean glucose level
Description
Neonatal mean glucose level in first 24 hours of life
Time Frame
Within 24 hours of life
Title
Received neonatal intervention for hypoglycemia
Description
Received intervention for hypoglycemia (any oral, IV, or both)
Time Frame
Within 24 hours of life
Title
Neonatal Intensive Care Unit Admission
Description
Admission to level 2 or greater neonatal ICU and length of stay
Time Frame
At delivery and within first 2 day of life
Title
Neonatal Intensive Care Unit Admission for hypoglycemia
Description
Admission to level 2 or greater neonatal ICU for hypoglycemia and length of stay
Time Frame
At delivery and within first 2 day of life
Title
Gestational age at delivery
Description
Gestational age at delivery
Time Frame
At birth
Title
Number of participants with neonatal respiratory distress
Description
Requiring 2 or more hours of respiratory support or oxygen with associated diagnosis
Time Frame
At delivery
Title
Number of participants with neonatal hyperbilirubinemia
Description
Requiring phototherapy
Time Frame
Within first 2 days of life
Title
Time from birth to first neonatal glucose measurement
Description
Time from birth to first neonatal glucose measurement
Time Frame
Within first 3 hours of life
Title
Maternal Care Satisfaction Survey
Description
Survey assessing satisfaction with healthcare provided
Time Frame
Postpartum, assessed within 4 days of delivery
Title
Placental Pathology
Description
Assessing for malperfusion pathology
Time Frame
At birth
Title
Umbilical Cord Blood Level of C-peptide
Description
Umbilical Cord Blood Level of C-peptide
Time Frame
At Birth
Title
Umbilical Cord Blood Level of Leptin
Description
Umbilical Cord Blood Level of Leptin
Time Frame
At Birth
Title
Umbilical Cord Blood Level of Insulin
Description
Umbilical Cord Blood Level of Insulin
Time Frame
At Birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianna L Wilkie, MD
Organizational Affiliation
UMass Memorial Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
3051881
Citation
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.
Results Reference
background
PubMed Identifier
25439811
Citation
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.
Results Reference
background
PubMed Identifier
26696673
Citation
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.
Results Reference
background
PubMed Identifier
26927202
Citation
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.
Results Reference
background
PubMed Identifier
23537417
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs