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New study aims to prevent pregnancy complications with smart sugar tracking

NCT ID NCT06957028

Disease control 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether wearing a continuous glucose monitor (CGM) early in pregnancy can quickly detect and manage high blood sugar in 6,000 pregnant women. The goal is to reduce serious problems for the baby (like being too large, birth injuries, or NICU stays) and for the mother (like high blood pressure). Participants wear the CGM from early pregnancy and are followed to see if early action improves 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.

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 6,000 people

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

Started

May 2025

Expected to finish

Nov 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

Accepted

You do not need to have the condition being studied to take part.

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. Maternal age of 18 years and older 2. Singleton pregnancy 3. Gestational age up to 14w 6d of pregnancy, determined on ultrasound, for initiation of screening • Although it is preferable that ultrasound results be available prior to enrollment, if ultrasound results are not available at the time of enrollment, participant can have CGM initiated but will be dropped if not eligible after results are available 4. HbA1c \<6.5% (48 mmol/mol) since onset of pregnancy • If HbA1c result not available at time of enrollment, participant can have blinded screening CGM initiated, but results will be needed prior to randomization to verify eligibility. 5. No prior history of gestational diabetes mellitus (GDM) 6. Able to read English or Spanish Exclusion Criteria 1. Signs of abnormal fetal or placental development (suspected fetal anomaly or placenta accreta spectrum, low PAPPA) at first routine prenatal visit/ultrasound 2. Planned termination of pregnancy or any indications of miscarriage 3. Prior gastric bypass surgery 4. Pregravid diabetes (type 1 or type 2) 5. Unwillingness/inability to wear CGM sensor 6. Unwillingness to attend routine antenatal obstetric appointments 7. Use of corticosteroids by a route that can produce hyperglycemia (e.g., oral, intravenous, intramuscular, intra-articular) during the 7 days prior to initiating CGM screening or during the CGM screening • Topical and inhaled corticosteroids are acceptable 8. Use of insulin during the pregnancy prior to enrollment 9. Use of metformin within one week of the initiation of the blinded CGM sensor for screening or use of a GLP-1 or other weight-reduction medication that can affect glucose levels within 4 weeks of the initiation of the blinded CGM sensor for screening 10. Deemed unable to participate for medical reasons identified by their physician Additional Criteria for RCT Eligibility 1. Screening CGM meeting study criteria for hyperglycemia: 5% to \<25% time \>140 mg/dL 2. Randomization by 16 week 6 days of pregnancy 3. No participation in a separate intervention trial.

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Conditions

The condition(s) this trial relates to.

gestational diabetes

As listed by the trial registrant

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

Gestational diabetes mellitus in pregnancy

How to take part

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

  1. The places running it

    10 sites in 2 countries. 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

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Emory University

    RECRUITING

    Decatur, Georgia, 30033, United States

  • IDC at Park Nicollet

    RECRUITING

    Saint Louis Park, Minnesota, 55416, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Leeds Teaching Hospitals NHS Trust

    NOT_YET_RECRUITING

    Leeds, Leeds, United Kingdom

  • Norfolk and Norwich University Hospitals NHS

    NOT_YET_RECRUITING

    Norwich, Norwich, United Kingdom

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35173, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33016, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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