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ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2

Study acronym: ACCESS2
StatusRecruiting
PhaseNot applicable
Started2022-07-11
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 30, 2026 → Dec 30, 2026
See other at-risk trials from Johns Hopkins University

Amendment history

2026-09-24
Primary completion pushed: 2026-09-30 → 2026-12-30
Completion pushed: 2026-09-30 → 2026-12-30
2026-06-30
Study Status v14
Primary completion pushed: 2026-06-30 → 2026-09-30
Completion pushed: 2026-06-30 → 2026-09-30
2026-03-25
Study Status v13
Primary completion date2026-03-30→2026-06-30
Completion date2026-03-30→2026-06-30
2025-12-22
Study Status, Study Description, Outcome Measures, Eligibility v12
Primary completion date2025-12-20→2026-03-30
Completion date2025-12-20→2026-03-30
Eligibility criteria+167 characters
[...] ears, 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
Secondary endpoints2 to 4 entries
DiagnosticSensitivity Accuracyof autonomous AI vs. prognostic standard Specificity of autonomous AI vs. prognostic standard Proportion with diabetic retinopathy
Study description+565 characters
This study will recruit up to 500 individuals ages 8-21 with type 1 andor type 2 diabetes. ParticipantsIn this study, participants will undergo a point-of-care diabetic eye exam using autono [...] be referred to an eye care provider for a dilated eye exam. In the AI for ChildrenS Diabetic Eye ExamS Study (ACCESS2), 398 participants will be enrolled to determine if point of care autonomous AI increases the proportion of minority and underserved youth screened for diabetic retinopathy. The autonomous AI interpretation will also be compared to co [...] ng of retinal specialists to determine if there is agreeme [...]
2025-10-31
Study Status v11
Primary completion date2025-10-29→2025-12-20
Completion date2025-10-29→2025-12-20
Show 10 earlier versions
2025-09-26
Study Status v10
Primary completion date2025-09-29→2025-10-29
Completion date2025-09-29→2025-10-29
2025-08-27
Study Status v9
Primary completion date2025-08-29→2025-09-29
Completion date2025-08-29→2025-09-29
2025-05-27
Study Status v8
Primary completion date2025-05-28→2025-08-29
Completion date2025-05-28→2025-08-29
2025-02-13
Study Status v7
Primary completion date2025-02-28→2025-05-28
Completion date2025-02-28→2025-05-28
2024-11-07
Study Status v6
Primary completion date2024-11-01→2025-02-28
Completion date2024-12-01→2025-02-28
2024-09-16
Study Status v5
Primary completion date2024-09-01→2024-11-01
Completion date2024-10-01→2024-12-01
2024-06-12
Study Status v4
Primary completion date2024-05-15→2024-09-01
Completion date2024-06-01→2024-10-01
2024-05-20
Study Status v3
Completion date2024-05-15→2024-06-01
2024-04-09
Study Status v2
Re-verified, no change to tracked fields
2023-04-24
Study Status, Sponsor/Collaborators, Outcome Measures v1
Secondary endpoints1 to 2 entries
Diagnostic Accuracy
Collaborators1 to 2 entries
Juvenile Diabetes Research Foundation
2022-07-14
Original filing
Johns Hopkins University
505 trials monitored
See 47 trials at risk
Diabetes
4,247 trials monitored
See 176 trials at risk
Type 2 Diabetes
2,082 trials monitored
See 101 trials at risk
Type 1 Diabetes
844 trials monitored
See 34 trials at risk
and 1 more disease
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.
Trial Details
NCT Number NCT05463289
Lead Sponsor Johns Hopkins University
Collaborators: National Eye Institute (NEI), Juvenile Diabetes Research Foundation
Conditions Type 1 Diabetes, Type 2 Diabetes, Cystic Fibrosis-related Diabetes
Enrollment 500 participants
Start Date 2022-07-11
Primary Completion 2026-12-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-23