Trial Outcomes & Findings for ACCESS: AI for pediatriC diabetiC Eye examS Study (NCT NCT05131451)

NCT ID: NCT05131451

Last Updated: 2023-11-02

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 164 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2023-11-02

Participant Flow

Participant milestones

Measure	Usual Care With Educational Reinforcement Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement	Diabetic Retinopathy Exam Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI (artificial intelligence) on non-mydriatic fundus camera Point of Care Autonomous AI diabetic retinopathy exam: 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.
Overall Study STARTED	83	81
Overall Study COMPLETED	82	81
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Usual Care With Educational Reinforcement Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement	Diabetic Retinopathy Exam Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI (artificial intelligence) on non-mydriatic fundus camera Point of Care Autonomous AI diabetic retinopathy exam: 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.
Overall Study Protocol Violation	1	0

Baseline Characteristics

ACCESS: AI for pediatriC diabetiC Eye examS Study

Baseline characteristics by cohort

Measure	Usual Care With Educational Reinforcement n=83 Participants Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement	Diabetic Retinopathy Exam n=81 Participants Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI on non-mydriatic fundus camera Point of Care Autonomous AI diabetic retinopathy exam: 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.	Total n=164 Participants Total of all reporting groups
Age, Continuous	15.1 years STANDARD_DEVIATION 2.8 • n=5 Participants	15.3 years STANDARD_DEVIATION 2.8 • n=7 Participants	15.2 years STANDARD_DEVIATION 2.8 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	49 Participants n=7 Participants	96 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	32 Participants n=7 Participants	68 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 participants n=5 Participants	6 participants n=7 Participants	10 participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Black	32 participants n=5 Participants	26 participants n=7 Participants	58 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White	42 participants n=5 Participants	44 participants n=7 Participants	86 participants n=5 Participants
Region of Enrollment United States	83 Participants n=5 Participants	81 Participants n=7 Participants	164 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

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).

Outcome measures

Measure	Usual Care With Educational Reinforcement n=82 Participants Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement	Diabetic Retinopathy Exam n=81 Participants Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI on non-mydriatic fundus camera Point of Care Autonomous AI diabetic retinopathy exam: 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.
Number of Participants Who Get Screened With a Diabetic Eye Exam	18 Participants	81 Participants

SECONDARY outcome

Timeframe: 6 months

Population: The diabetic retinopathy exam group only includes those that had an abnormal AI exam and were referred to an eye care provider for a dilated eye exam.

The number of patients that follow-up with an eye care provider (ECP), for participants in the standard of care group referred to ECP, and for participants in the AI group with an abnormal exam result that are then referred to the ECP for a dilated eye exam.

Outcome measures

Measure	Usual Care With Educational Reinforcement n=82 Participants Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement	Diabetic Retinopathy Exam n=25 Participants Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI on non-mydriatic fundus camera Point of Care Autonomous AI diabetic retinopathy exam: 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.
Follow-up Rates With an Eye Care Provider	18 Participants	16 Participants

Adverse Events

Usual Care With Educational Reinforcement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diabetic Retinopathy Exam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Risa Wolf

Johns Hopkins University

Phone: 4109556463

Email: rwolf@jhu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place