ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2
Implementing Digital Retinal Exams Into Comprehensive Pediatric Diabetes Care
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 8 Years to 21 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a special eye camera with artificial intelligence (AI) helps more young people with diabetes who have limited access to care get eye screening. It also checks how well AI finds diabetic retinopathy, which is damage to the back of the eye caused by diabetes.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- For the main group: meet American Diabetes Association rules for diabetes eye screening.
- Have type 1 diabetes for at least 3 years and be age 11 or in puberty, or have type 2 diabetes.
- For a separate group: be age 8–21, have type 1 or type 2 diabetes, and already have diabetic retinopathy.
- The separate group can join no matter when their last diabetes eye exam was.
Who can't join
- Have had a diabetes eye exam in the past 12 months. This limit does not apply to the separate group with known diabetic retinopathy.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
MD
- Johns Hopkins Pediatric Diabetes Center · Baltimore, MD 21287Risa M Wolf, MD · Study contact · 410-955-6463 · rwolf@jhu.eduMore trials in Baltimore