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Insulin pump during labor: a new option for moms with diabetes?

NCT ID NCT07420972

Symptom relief Sponsor: Medstar Health Research Institute 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study looks at whether it is safe and practical for pregnant women with type 1 or type 2 diabetes to continue using their insulin pump during labor, instead of switching to IV insulin. About 30 women who already use an insulin pump will be allowed to keep using it while giving birth, following a hospital safety plan. Their results will be compared to past patients who used IV insulin. The study aims to gather information for a larger future trial, not to prove one method is better.

What this could mean

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

Active substance
insulin pump (hybrid closed loop automated insulin delivery system)
What this could lead to
If successful, this could support a larger study to make insulin pump use during labor a standard option, reducing stress and improving blood sugar control for pregnant women with diabetes.
What could go wrong
This is a very small pilot study (30 people) and is not designed to prove one method is better. It may not show clear benefits, and safety concerns could still require switching to IV insulin.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

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: * Singleton gestation * Established Type 1 or 2 diabetes mellitus * Use of continuous subcutaneous insulin infusion for ≥2 months prior to delivery, -Demonstrated cognitive ability to self-manage insulin, familiarity with pump technology, availability of necessary supplies, stable clinical status * Ability to provide informed consent Exclusion Criteria: * Planned cesarean delivery without labor * Significant comorbidities affecting insulin requirements (e.g., steroid therapy) * Stillbirth prior to presenting for delivery * Known severe fetal anomalies.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus type 1 diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes Diabetes (insulin-requiring, type 1 or type 2) Pregnancy

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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