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AI eye scans could help underserved youth with diabetes avoid vision loss

NCT ID NCT05463289

Diagnosis Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tests whether using an AI-driven retinal camera during regular diabetes checkups can increase the number of young people screened for diabetic retinopathy, a leading cause of blindness. Researchers will enroll 500 youth with type 1, type 2, or cystic fibrosis-related diabetes, focusing on underserved groups. The goal is to see if this point-of-care approach is accurate and helps close racial gaps in screening rates.

What this could mean

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

Active substance
IDx-DR autonomous AI software for diabetic retinopathy screening
What this could lead to
If successful, this could make diabetic retinopathy screening faster and more accessible for young people with diabetes, especially those in underserved communities.
What could go wrong
This is an early-stage implementation study, not a treatment trial. The AI's accuracy in youth is still being tested, and it may not work as well as in adults.

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 500 people

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

Started

Jul 2022

Expected to finish

Sep 2026

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

8 to 21 years

Sex

Anyone

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: Meets American Diabetes Association (ADA) criteria for diabetic retinopathy screening: * Diagnosis of Type 1 diabetes for ≥3 years, and age 11 or in puberty * Diagnosis of Type 2 diabetes Enriched cohort: * Patients with Type 1 or Type 2 diabetes, * 8-21 years of age with known diabetic retinopathy (true positives). * No time limit on last diabetic eye exam. Exclusion Criteria: * Known diabetic eye exam in the last 12 months

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Conditions

The condition(s) this trial relates to.

cystic fibrosis-related diabetes diabetic retinopathy 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.

Cystic fibrosis-related diabetes Type 1 diabetes Type 2 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

  • Johns Hopkins Pediatric Diabetes Center

    RECRUITING

    Baltimore, Maryland, 21287, United States

More trials for these conditions

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