Type 1 DiabetesACCESSNCT05131451
ACCESS: AI for pediatriC diabetiC Eye examS Study
A study testing Point of Care Autonomous AI diabetic retinopathy exam in people with Type 1 Diabetes and Type 2 Diabetes, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- Point of Care Autonomous AI diabetic retinopathy exam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Diabetic eye exam within the last 6 months
- Known diabetic retinopathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Pediatric Diabetes Center
Baltimore, Maryland, 21287
About this study
Official title: Autonomous AI for Diabetic Retinopathy Screening in Youth (AI-DR): A Randomized Control Trial
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.
Read the 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.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Being tested
- Point of Care Autonomous AI diabetic retinopathy exam
- Keywords
- Diabetic Retinopathy
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of Care Autonomous AI diabetic retinopathy examDiagnostic test
Also called IDx-DR
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Point of Care Autonomous AI diabetic retinopathy exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start24 Nov 2021
- Primary completion6 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Risa Wolf, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131451
- Sponsor's protocol ID
- IRB00288043
- Acronym
- ACCESS
- Status last verified
- Oct 2023
- First submitted
- 11 Nov 2021
- Last updated
- 2 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wolf RM, Channa R, Liu TYA, Zehra A, Bromberger L, Patel D, Ananthakrishnan A, Brown EA, Prichett L, Lehmann HP, Abramoff MD. Autonomous artificial intelligence increases screening and follow-up for diabetic retinopathy in youth: the ACCESS randomized control trial. Nat Commun. 2024 Jan 11;15(1):421. doi: 10.1038/s41467-023-44676-z.
PubMed 38212308
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomous AI for Diabetic Retinopathy Screening in Youth (AI-DR): A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05131451
- Acronym / sponsor ID
- ACCESS / IRB00288043
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Keywords
- Diabetic Retinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Posted 2 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Diagnostic Test: Point of Care Autonomous AI diabetic retinopathy examPoint of care (POC) Diabetic Retinopathy Exam using Autonomous AI on non-mydriatic fundus camera |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosis of Type 1 diabetes for ≥3 years, and age 11 or in puberty
- Diagnosis of Type 2 diabetes
Key exclusion criteria (2 listed)
- Diabetic eye exam within the last 6 months
- Known diabetic retinopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point of Care Autonomous AI diabetic retinopathy examAlso: IDx-DRParticipants 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. | Diagnostic test | Diabetic Retinopathy Exam |
Primary outcome
Number of Participants Who Get Screened With a Diabetic Eye Exam
Time frame: 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).
1 secondary outcome
Follow-up Rates With an Eye Care Provider
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38212308Wolf RM, Channa R, Liu TYA, Zehra A, Bromberger L, Patel D, Ananthakrishnan A, Brown EA, Prichett L, Lehmann HP, Abramoff MD. Autonomous artificial intelligence increases screening and follow-up for diabetic retinopathy in youth: the ACCESS randomized control trial. Nat Commun. 2024 Jan 11;15(1):421. doi: 10.1038/s41467-023-44676-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Risa Wolf, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point of Care Autonomous AI diabetic retinopathy exam in people with Type 1 Diabetes and Type 2 Diabetes, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Get Screened With a Diabetic Eye Exam (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05131451, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.