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Home testing by health workers could catch diabetes in new mothers

NCT ID NCT06209411

Disease control Sponsor: Weill Medical College of Cornell University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether community health workers can help women in urban slums of India get screened for type 2 diabetes after having gestational diabetes. 330 women will either receive home-based testing or a referral to a clinic, plus diabetes education. A smaller part of the study also looks at whether a protein-fiber snack before meals helps control blood sugar.

What this could mean

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

Active substance
Community health worker home-based testing and protein-fiber food supplements
What this could lead to
If successful, this could provide a scalable model to increase early detection of type 2 diabetes in high-risk women after pregnancy, potentially preventing long-term complications.
What could go wrong
This is a relatively small trial in a specific setting, so results may not apply broadly. The supplement substudy is exploratory, and the main focus is on screening uptake, not direct treatment 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 330 people

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

Started

Jun 2024

Expected to finish

Oct 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: Pregnant Women: * Pregnant woman residing in one of pre-selected slum communities * 18 years or older * ≥ 24 weeks gestational age (as determined by self-reported last menstrual period or ultrasound) * Meet or exceed the threshold for GDM as determined by the CHW-delivered fasting OGTT * Agrees to study procedures, including in-person visits with the CHW postpartum if they are diagnosed with GDM Community Health Workers: * 18 years or older * Willingness to participate in study procedures and recruit eligible pregnant women * Agreement with goals of the study * Resides in one of the study communities * Willing to participate in surveys and interviews Clinicians: * 18 years or older * Diabetes or obstetrics physicians * In a patient-facing position for over 1 year Ministry of Health Officials * 18 years or older * Employed by the Ministry of Health and Family Welfare, Maternal Health Division Exclusion Criteria: Pregnant Women: * Preexisting diabetes diagnosis prior to current pregnancy * Unable to tolerate food/ drink and remain fasting for 8 hoursUnwilling or unable to participate in study procedures * Unwilling or unable to provide informed consent CHW, Clinicians, Ministry of Health Officials 1. Unwilling or unable to participate in study procedures 2. Unwilling or unable to provide informed consent

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Conditions

The condition(s) this trial relates to.

gestational diabetes type 2 diabetes mellitus prevention target

As listed by the trial registrant

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

Diabetes mellitus type 2 Gestational diabetes

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

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Contacts and locations

Locations

  • Deep Griha Society

    RECRUITING

    Pune, Maharashtra, 411001, India

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