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NCT04599075 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Type 1 Diabetes and Pregnancy, High Risk, sponsored by Gianna Wilkie.

Completed
Registry status
Phase 4
Development phase
70
Enrollment target
1
Study location

NCT04599075: Completed Phase 4 study of Type 1 Diabetes and Pregnancy, High Risk, sponsored by Gianna Wilkie.

NCT04599075 is a Phase 4 study of Type 1 Diabetes and Pregnancy, High Risk that has completed, run by Gianna Wilkie. The registered enrollment target is 70 participants, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04599075, a Phase 4 study of Type 1 Diabetes and Pregnancy, High Risk, has completed, sponsored by Gianna Wilkie.

COMPLETED
Registry status
Phase 4
Development phase
70 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

First neonatal blood sugar obtained within 2 hours of birth

Interventions

  • DRUG Insulin

Study Locations (1)

Massachusetts

  • University of Massachusetts Memorial Medical Center - Worcester

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2021-03-15
Est. Completion 2023-05-02
Phase Phase 4
Gianna Wilkie

1 total trials

What the finished NCT04599075 record still lists

NCT04599075 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (91% lower).

The record links to 2 conditions, with Type 1 Diabetes appearing as the primary indexed condition, and to 1 intervention - of which Insulin is the first listed.

NCT04599075 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT04599075 about?

NCT04599075 is a clinical study titled "Intravenous Insulin vs Subcutaneous Insulin Infusion in Intrapartum Management of Type 1 Diabetes Mellitus". 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 th...

What is the current status of trial NCT04599075?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 70 participants. The study started on 2021-03-15. Estimated completion is 2023-05-02.

What conditions does trial NCT04599075 study?

This clinical trial studies the following conditions: Type 1 Diabetes, Pregnancy, High Risk.

What interventions are being tested in trial NCT04599075?

The interventions under investigation include: Insulin (DRUG).

Who is sponsoring clinical trial NCT04599075?

This trial is sponsored by Gianna Wilkie, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04599075 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Type 1 Diabetes

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04599075's enrollment target sits among peer trials

70 68th of 198 higher than 129 of 198 other Type 1 Diabetes trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04599075, the US trial registry maintained by the National Library of Medicine. NCT04599075 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.