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New study tests Over-the-Counter glucose monitor for new moms with diabetes history

NCT ID NCT07356986

Knowledge-focused Sponsor: Oregon Health and Science University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study will give 50 women who had gestational diabetes a continuous glucose monitor (Stelo) to wear after giving birth. The goal is to learn how their blood sugar levels change during daily life and how well the device works. Participants will use the monitor for up to 6 weeks and provide blood samples for comparison.

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 50 people

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

Expected to start

Jan 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.

Who is studied

Postpartum individuals with pregnancies complicated by GDM.

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: * Gestational Diabetes Mellitus (GDM) diagnosis by 1- or 2-step Oral Glucose Tolerance Test (OGTT) during pregnancy or \>= 200 mg following any glucose challenge (50g, 75g, 100g) * Has a smart phone compatible to support Dexcom Stelo app * Able to read, write, and understand English * Meet Stelo Glucose Biosensor Indications for Use (IFU) per approved commercial labeling * Willing to follow all study procedures Exclusion Criteria: * Greater than 6 weeks and 6 days postpartum at enrollment * Preexisting Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D) * End-stage renal failure (on dialysis) * Heart failure * Other uncontrolled high-risk condition as determined exclusionary by site investigators * Extensive skin changes/diseases that preclude wearing the required system on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites * Known severe allergy to medical-grade adhesives * Any condition that, in the opinion of the investigator, would interfere with their participation in the trial * Obesity surgery * Insulin use prior to discharge home from the delivery admission * Current participation in another postpartum Continuous Glucose Monitoring (CGM) or lifestyle intervention trial

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Conditions

The condition(s) this trial relates to.

gestational diabetes puerperal disorder

As listed by the trial registrant

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

Gestational diabetes Postpartum

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

    Contact Email: •••••@•••••

  • Sansum Diabetes Research Institute

    Santa Barbara, California, 93105, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

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