ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2 (NCT05463289) | Clinical Trial Compass
RecruitingNot Applicable
ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2
United States500 participantsStarted 2022-07-11
Plain-language summary
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.
Who can participate
Age range
8 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is using AI to screen for diabetic retinopathy instead of a traditional eye exam, how does the accuracy of this AI system compare to what my child would get from a standard visit with an eye doctor?
2My child has cystic fibrosis-related diabetes — does this study include patients like them, and would their specific type of diabetes affect how useful the AI screening results would be?
3The study is measuring how many kids actually get screened for diabetic retinopathy, so is the main goal here to test whether AI screening gets more children checked — and does that mean my child's individual eye health results would still be acted on medically?
4If my child participates and the AI screening picks up a potential problem, what happens next — would they still be referred to an ophthalmologist for follow-up care, or does this study only handle the screening step?
5Given that this is listed as Phase NA, meaning it's more of a diagnostic or screening study than a drug trial, are there any risks to my child from the screening device or process itself that we should know about before deciding whether to participate?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.