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ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2
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.
Conditions:
🦠 Type 1 Diabetes 🦠 Type 2 Diabetes 🦠 Cystic Fibrosis-related Diabetes
🗓️ Study Start (Actual) 11 July 2022
🗓️ Primary Completion (Estimated) 1 September 2024
✅ Study Completion (Estimated) 1 October 2024
👥 Enrollment (Estimated) 500
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Baltimore, Maryland, United States

📋 Eligibility Criteria

Description

    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

    Exclusion Criteria:

    • * Known diabetic eye exam in the last 12 months
Ages Eligible for Study: 8 Years to 21 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 14 July 2022
  • First Submitted that Met QC Criteria 14 July 2022
  • First Posted 18 July 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 June 2024
  • Last Update Posted 13 June 2024
  • Last Verified June 2024
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