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Could Twice-Daily insulin shots improve pregnancy outcomes for diabetic moms?

NCT ID NCT07224893

Disease control Sponsor: Eastern Virginia Medical School Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares taking insulin glargine once versus twice daily in pregnant women with type 2 diabetes who need insulin. Two hundred participants will be randomly assigned to one of the two dosing schedules, and their blood sugar levels will be tracked continuously. The goal is to see if twice-daily dosing leads to better blood sugar control and fewer pregnancy complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
insulin glargine
What this could lead to
If successful, this could show that a simple change in dosing schedule improves blood sugar control and pregnancy outcomes for women with pre-existing diabetes.
What could go wrong
This is a small, early-phase trial (200 participants) comparing two common dosing schedules, so the difference may be small or not clinically meaningful. Results may not apply to all types of diabetes or pregnancies.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 200 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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

18 years and older

Sex

Female participants only

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: * Patients older than 18 years of age; * The patient is fluent in English, physically and mentally able to understand the informed consent, and is willing to participate in this study; * Type II diabetes mellitus requiring insulin; * The patient is between 24 weeks 0 days and 28 weeks 0 days of gestation at the time of enrollment. Gestational age will be determined by last menstrual period, confirmed with a first trimester ultrasound, per the recommended guidelines by the American College of Obstetricians and Gynecologists. * Currently using or willing to use a clinically indicated continuous glucose monitor for glycemic management Exclusion Criteria: * Known allergy or reaction to insulin glargine, or concurrent medical condition where the use of insulin glargine is contraindicated; * Contraindication to CGM use, patient declines CGM use, or CGM not covered by patient's insurance; * Known or suspected fetal anomaly or aneuploidy; * Prisoners; * Ongoing prenatal care outside EVMS or planned delivery outside Sentara Norfolk General Hospital.

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Conditions

The condition(s) this trial relates to.

gestational diabetes type 2 diabetes mellitus

As listed by the trial registrant

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

Pregestational diabetes Pregnancy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sentara Norfolk General Hospital, Norfolk, Virginia 23507

    RECRUITING

    Norfolk, Virginia, 23507, United States

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