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NCT05463289From ClinicalTrials.govRecruiting

ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2

Implementing Digital Retinal Exams Into Comprehensive Pediatric Diabetes Care

  • Type 1 Diabetes
  • Type 2 Diabetes
  • Cystic Fibrosis-related Diabetes

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Johns Hopkins University
Enrolment target
500
Started
11 July 2022
Main results due
30 December 2026
Study sites
1
Registry updated
23 September 2026

Can you take part?

  • Ages 8 years to 21 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

The purpose of this study is to determine if use of a nonmydriatic fundus camera using autonomous artificial intelligence software at the point of care increases the proportion of underserved youth with diabetes screened for diabetic retinopathy, and to determine the diagnostic accuracy of the autonomous AI system in detecting diabetic retinopathy from retinal images of youth with diabetes.

Study sites(1)

  • Johns Hopkins Pediatric Diabetes Center

    Baltimore, Maryland, United States

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05463289. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2 | Trialion