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

NCT04599075 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-07-08

Study results available
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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

Interventions

DRUG

Insulin

IV Insulin Infusion

DRUG

Insulin

Continuous Subcutaneous Insulin Infusion (Pump)

Sponsors & Collaborators

  • Gianna Wilkie

    lead OTHER

Principal Investigators

  • Gianna L Wilkie, MD · UMass Memorial Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-15
Primary Completion
2023-05-01
Completion
2023-05-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04599075 on ClinicalTrials.gov