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Can Real-World data improve diabetes care in pregnancy?

NCT ID NCT06959316

Knowledge-focused Sponsor: Jaeb Center for Health Research 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This study gathers real-world information from pregnant women with type 1 diabetes in the United States to understand how they manage their condition. Participants share data from their continuous glucose monitors and insulin pumps, and complete online surveys. The goal is to learn how diabetes is managed during pregnancy and to guide future care for better outcomes.

What this could mean

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

Active substance
Hybrid closed loop insulin delivery system (a device combining a continuous glucose monitor and an insulin pump)
What this could lead to
If successful, this could provide evidence to guide better management of type 1 diabetes during pregnancy, potentially improving outcomes for mothers and babies.
What could go wrong
This is an observational study, so it cannot prove cause and effect. The data may not represent all pregnant women with type 1 diabetes, and results depend on participant-reported outcomes.

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.

Participants

About 500 people

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

Started

Apr 2025

Expected to finish

Apr 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.

Who is studied

Pregnant adults with type 1 diabetes from across the United States who use a continuous glucose monitor.

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: 1. Age ≥18 years 2. Clinical diagnosis of presumed T1D for at least 6 months duration 3. Less than 15 weeks gestation at time of enrollment based on due date from provider 4. Planned CGM use on a regular basis (e.g., ≥10 out of 14 days) and willing to continue using CGM regularly with no plans to discontinue CGM use during the study 5. Following intensive insulin therapy regimen defined as basal-bolus delivery via an insulin pump (including a closed loop system) or multiple daily injections (MDI) 6. Have access to technology that may be required to complete study questionnaires and share diabetes device data. 7. Resident of the United States and plans to reside in the U.S. for the duration of the study 8. Comprehends written and spoken English or Spanish 9. Willing and able to provide informed consent, complete surveys and provide the device data that are part of the protocol Exclusion Criteria: 1. Multiple pregnancy 2. Current renal dialysis or plan to begin renal dialysis during the study 3. History of liver cirrhosis 4. Active cancer treatment with systemic chemotherapy 5. Current participation in other studies involving an investigational insulin delivery device or planning to participate in an investigational insulin delivery device study during pregnancy 6. Prior participation in this study

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Conditions

The condition(s) this trial relates to.

gestational diabetes Pregnancy in Diabetics type 1 diabetes mellitus type 1 diabetes mellitus 1

As listed by the trial registrant

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

Diabetes mellitus, type 1 Insulin dependent diabetes Pregnancy in diabetics Pregnancy, high risk

Contacts and locations

Locations

  • Barbara Davis Center for Diabetes & University of Colorado Health

    Aurora, Colorado, 80045, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Jaeb Center for Health Research

    Tampa, Florida, 33647, United States

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215, United States

  • Mass General Brigham

    Boston, Massachusetts, 02114, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

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