ACCESS: AI for pediatriC diabetiC Eye examS Study

NCT05131451 | Completed Results DMC FDA Device

• 1 other identifier: IRB00288043
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if providing in clinic point-of-care autonomous AI diabetic retinopathy exams improves screening rates compared to standard of care referral to an eye care provider, in a randomized control trial in a racially and ethnically diverse cohort of youth.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Keywords

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Get Screened With a Diabetic Eye Exam

  The number of participants who get screened with a diabetic eye exam will be assessed for the AI group and the standard of care group referral to an eye care provider (ECP).

  6 months

Secondary Outcomes (1)

• Follow-up Rates With an Eye Care Provider

  6 months

Study Arms (2)

Usual care with educational reinforcement

NO INTERVENTION

Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement

Diabetic Retinopathy Exam

EXPERIMENTAL

Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI on non-mydriatic fundus camera

Diagnostic Test: Point of Care Autonomous AI diabetic retinopathy exam

Interventions

Point of Care Autonomous AI diabetic retinopathy exam DIAGNOSTIC_TEST

Participants will get a point of care diabetic retinopathy eye exam using autonomous AI. Those that test positive will be referred to Eye Care Provider for dilated eye exam.

Also known as: IDx-DR

Diabetic Retinopathy Exam

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Diabetic eye exam within the last 6 months
• Known diabetic retinopathy

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

Johns Hopkins Pediatric Diabetes Center

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications

Limitations and Caveats

Autonomous AI is not FDA cleared for use in ages 21 and under. Some participants were familiar with autonomous AI diabetic eye exams from a prior study and may have been more accepting of participation in the current study. Although pharmacologic dilation is not necessary in the pediatric population to obtain sufficient fundus imaging, this may not be applicable to adults where real-world studies have demonstrated higher rates of insufficient images without pharmacologic dilation.

Results Point of Contact

• Title: Dr. Risa Wolf
• Organization: Johns Hopkins University

rwolf@jhu.edu

4109556463

Study Officials

• Risa Wolf, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants are masked to the study arms until after randomization
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Control Arm - Standard of care referral to an eye care provider + Educational Reinforcement 2. Intervention Arm - Point of Care Diabetic Retinopathy screening using Autonomous artificial intelligence on a non-mydriatic fundus camera

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 23, 2021
• Study Start: November 24, 2021
• Primary Completion: December 6, 2022
• Study Completion: December 31, 2022
• Last Updated: November 2, 2023
• Results First Posted: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)