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Could a simple test spot diabetes before it starts?

NCT ID NCT05505669

Knowledge-focused Sponsor: City of Hope Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is looking for biological markers (biomarkers) in blood, saliva, and urine that signal damage to insulin-producing beta cells in the pancreas. Researchers will compare samples from people with type 1 diabetes, type 2 diabetes, prediabetes, and healthy volunteers. The goal is to better understand how diabetes develops and find ways to diagnose it earlier.

What this could mean

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

What this could lead to
If successful, this could help doctors detect diabetes earlier and develop new treatments that protect or repair insulin-producing cells.
What could go wrong
This is an observational study, not a treatment trial. It may not find clear biomarkers, and any discoveries would need years of further research before helping patients.

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 165 people

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

Started

Mar 2022

Expected to finish

Jun 2029

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

Participants from the clinic environment/ local providers/ diabetes events, relatives/ friends of participants, employees, and normal healthy participants from the community

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

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: * Documented informed consent/ assent from the subject * ONE of the following: * Type 1 diabetes patients (including pediatric patients) -OR- * Adult type 2 diabetes patients -OR- * Volunteers who are islet auto-antibody positive (i.e. insulin, GAA, IA-2, IAA and ZnT8 antibodies) with HbA1c ≤ 5.6% (including pediatric patients)-OR- * Adult participants with clinical diagnosis of high blood sugar (i.e. HbA1c of 5.7% to 6.4%)-OR- * Adult control subjects with HbA1cc ≤ 5.6% * Weight ≥ 30 kg * Willingness to: Provide blood sample(s) and if applicable: permit medical record/ clinical laboratory result review Exclusion Criteria: * Control subjects must not have any chronic conditions or have undergone cellular, tissue or organ transplant * Sickle cell disease or anemia (exception: anemia that is corrected with treatment and source documents confirm corrected blood parameters current within 6 months of blood draw) * Active infection * Active malignancy (i.e., currently undergoing treatment) * Immunomodulatory therapy within 1 year of planned blood draw (may include immune checkpoint inhibitors, thalidomide, lenalidomide, pomalidomide, imiquimod, Bacillus Calmette-Guérin, and cytokines/ growth factors (e.g. interferons, interleukins) * Type 1 diabetes only: polyclonal regulatory T cell and/or dendritic cell therapy * Bleeding disorder * Women of childbearing potential: Pregnant/ nursing (Note: Eligibility may be deferred per blood donation timelines for pregnancy/nursing) * Diabetic patients only: Any clinical condition that might be adversely affected by the removal of up to 100 mL of blood * An employee who is under the direct/ indirect supervision of the PI/ a co-investigator/ the study manager * A direct study team member

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Conditions

The condition(s) this trial relates to.

diabetes mellitus prediabetes syndrome 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

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

    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

  • City of Hope Medical Center

    RECRUITING

    Duarte, California, 91010, United States

More trials for these conditions

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