Type 1 Diabetes, Type 2 Diabetes
Conditions
Keywords
Diabetic Retinopathy
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.
Detailed description
This study will recruit 164 individuals ages 8-21 with type 1 and type 2 diabetes. Participants will be randomized to usual care (referral to an eye care provider for a dilated eye exam) or the intervention arm and undergo a point-of-care diabetic eye exam using autonomous AI software on a non-mydriatic fundus camera. Participants in the intervention group will receive the diabetic eye exam results immediately from the autonomous AI system, and if abnormal will be referred to an eye care provider for a dilated eye exam. Participants in the standard of care group will have 6 months to complete the diabetic eye exam.
Interventions
DIAGNOSTIC_TESTPoint 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.
Sponsors
National Eye Institute (NEI)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Masking description
Participants are masked to the study arms until after randomization
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
8 Years to 21 Years
Healthy volunteers
No
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
* Diabetic eye exam within the last 6 months * Known diabetic retinopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Get Screened With a Diabetic Eye Exam | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Follow-up Rates With an Eye Care Provider | 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care With Educational Reinforcement Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement | 83 |
| Diabetic Retinopathy Exam 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. | 81 |
| Total | 164 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Usual Care With Educational Reinforcement | Diabetic Retinopathy Exam | Total |
|---|---|---|---|
| Age, Continuous | 15.1 years STANDARD_DEVIATION 2.8 | 15.3 years STANDARD_DEVIATION 2.8 | 15.2 years STANDARD_DEVIATION 2.8 |
| Race/Ethnicity, Customized Asian | 4 participants | 6 participants | 10 participants |
| Race/Ethnicity, Customized Hispanic | 5 participants | 5 participants | 10 participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 32 participants | 26 participants | 58 participants |
| Race/Ethnicity, Customized Non-Hispanic White | 42 participants | 44 participants | 86 participants |
| Region of Enrollment United States | 83 Participants | 81 Participants | 164 Participants |
| Sex: Female, Male Female | 47 Participants | 49 Participants | 96 Participants |
| Sex: Female, Male Male | 36 Participants | 32 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 83 | 0 / 81 |
| other Total, other adverse events | 0 / 83 | 0 / 81 |
| serious Total, serious adverse events | 0 / 83 | 0 / 81 |
Outcome results
Primary
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).
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care With Educational Reinforcement | Number of Participants Who Get Screened With a Diabetic Eye Exam | 18 Participants |
| Diabetic Retinopathy Exam | Number of Participants Who Get Screened With a Diabetic Eye Exam | 81 Participants |
Secondary
Follow-up Rates With an Eye Care Provider
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care With Educational Reinforcement | Follow-up Rates With an Eye Care Provider | 18 Participants |
| Diabetic Retinopathy Exam | Follow-up Rates With an Eye Care Provider | 16 Participants |