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AI eye test could revolutionize diabetes care

NCT ID NCT04624737

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether artificial intelligence (AI) can help doctors better predict how diabetic retinopathy (an eye disease from diabetes) will progress. Over 3,000 adults with diabetes were followed for about 2 years. The goal was to create a smarter system that uses eye images and patient data to improve treatment decisions.

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

3,183 people

The number who actually took part.

Started

Dec 2020

Finished

Dec 2025

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

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: * patient with type 1 or type 2 diabetes or other, * aged 18 years or more, * diabetes duration greater than 10 years for type 1 diabetes, * patient affiliated to social security, * women of childbearing potential who are unwilling or unable to use a method to avoid pregnancy; women who are pregnant or breastfeeding can be included in the study. Exclusion Criteria: * ungradable fundus photography or OCT/OCTA imaging in both eyes, * previous treatment with vitrectomy in both eyes, * participant is unable or unwilling to comply with study procedures (including foreign language speakers who are not assisted by a native language speaker), * Gestational diabetes vulnerable participants (minors, legally detained), * patients under legal protection (guardianship), * prisoners or subjects who are involuntarily incarcerated, * patients with untreated or treated proliferative DR and macular edema involving the center of the macula in both eyes or with panretinal photocoagulation and untreated or treated macular edema involving the center of the macula in both eyes.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus diabetic retinopathy

As listed by the trial registrant

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

Diabetic retinopathy

Contacts and locations

Locations

  • CHU de NICE HÔPITAL PASTEUR 2

    Nice, CS 51069_06001, Nice cedex1, France

  • Centre Broca / Mutuelle Generale

    Paris, 75013, France

  • Chic Creteil

    Créteil, 94010, France

  • Chu Avicenne

    Bobigny, 93000, France

  • Chu Bordeaux

    Bordeaux, 33000, France

  • Chu Brest

    Brest, 29200, France

  • Chu Dijon

    Dijon, 21000, France

  • Chu Lariboisiere

    Paris, 75010, France

  • Chu Lyon Croix Rousse

    Lyon, 69317, France

  • Chu Pitie Salpetriere

    Paris, 75013, France

  • Clinique Monticelli

    Marseille, 13008, France

  • Clinique ophtalmologique du CHU de Nantes

    Nantes, 44000, France

  • Fondation Rothschild

    Paris, 75019, France

  • Hôpital des 15-20

    Paris, 75571, France

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