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New study aims to control blood sugar in diabetic pregnancies after preterm birth steroids

NCT ID NCT04542148

Disease control Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This study looks at the best way to control blood sugar in pregnant women with diabetes who receive steroids to help their baby's lungs develop before a possible early birth. About 120 women will be randomly assigned to one of three insulin strategies. The goal is to find which approach keeps blood sugar levels safest for both mother and baby.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Gestational or pregestational type 2 diabetes mellitus treated with daily insulin injection(s) or oral hypoglycemic agents such as metformin * Hospitalized for antenatal corticosteroid administration in anticipation of preterm birth * Gestational age 23 0/7 weeks - 36 5/7 weeks * Maternal age 18-50 Exclusion Criteria: * Planned delivery \< 72 hours after 1st dose of antenatal corticosteroids * More than 16 hours after 1st dose of antenatal corticosteroids * Major fetal anomaly * Triplet or higher order multiple gestation

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Conditions

The condition(s) this trial relates to.

diabetes mellitus gestational diabetes Premature Birth type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2 Diabetes, gestational Pregnancy, high risk Preterm birth

Contacts and locations

Locations

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35223, United States

  • University of South Carolina Greenville / Prisma Health-Upstate

    Greenville, South Carolina, 29605, United States

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77024, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.