An interventional study of Point of Care Autonomous AI diabetic retinopathy exam in Type 1 Diabetes, Type 2 Diabetes and Cystic Fibrosis-related Diabetes, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to participants aged 8 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Screening
Among 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States — 191 open to participants now, 259 under way, 17 of them phase 3. Diabetes Mellitus, Type 1 · United States.
Among the 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States, this one is the 54th largest by planned enrollment of the 1,242 interventional ones, is one of 62 that started in 2022, is one of 614 with no phase, reaches primary completion later than 69 of the 258 other live ones, and was the 1,185th registered.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 500 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →191 of the 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 411 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 257 (63%) stop at 75 or younger; 184 take children under 18; 64 take healthy volunteers.
This study: 8 Years to 21 Years · all sexes · no healthy volunteers.
The full table on the hub →1,458 studies; the count open now beside each. This study's row is marked.
First in 1983; this study’s year is marked. 62 started in 2022.
Median enrollment 40 across the 1,242 interventional studies, 64 across the 203 observational. Of the 1,117 that completed or were terminated, 562 (50%) have results posted.
398 of 1,458 have an industry lead sponsor. The 10 most frequent:
Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Johns Hopkins University has 8 studies filed under Diabetes Mellitus, Type 1 — fewer than ten, so there is no comparison to draw.
118 of the studies in Diabetes Mellitus, Type 1 with a site in United States that are under way reach primary completion within a year, 7 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06914895Phase 3Eli Lilly and CompanyA Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT06962280Phase 3Eli Lilly and CompanyA Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT07076199Phase 3Novo Nordisk A/SA Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes | 2027-01-25 |
| NCT06334133Phase 3vTv TherapeuticsCadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes | 2027-04 |
| NCT07056699Phase 3The University of Texas Health Science Center at San AntonioSGLT2i, Pioglitazone, and Ketone Production in T1D | 2027-06-01 |
Among the 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States, from their registry updates:
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, and to determine the diagnostic accuracy of the autonomous AI system in detecting diabetic retinopathy from retinal images of youth with diabetes.
This study will recruit up to 500 individuals ages 8-21 with type 1 or type 2 diabetes. In this study, participants will undergo a point-of-care diabetic eye exam using autonomous AI software on a non-mydriatic fundus camera. Participants 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.
In the AI for ChildrenS Diabetic Eye ExamS Study (ACCESS2), 398 participants will be enrolled to determine if point of care autonomous AI increases the proportion of minority and underserved youth screened for diabetic retinopathy. The autonomous AI interpretation will also be compared to consensus grading of retinal specialists to determine if there is agreement and to determine the diagnostic accuracy of the system in youth.
A cohort of youth with known diabetic retinopathy (true positives) will also be enrolled as an enriched population to determine the diagnostic accuracy of autonomous AI compared to the prognostic standard interpretation of a central reading center.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Meets American Diabetes Association (ADA) criteria for diabetic retinopathy screening:
Enriched cohort:
Exclusion Criteria:
Participants will undergo 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: Point of Care Autonomous AI diabetic retinopathy exam
Participants will undergo point-of-care diabetic retinopathy screening using autonomous artificial intelligence software to interpret retinal images taken with a non-mydriatic fundus camera and providing an immediate result.
Also known as: IDx-DR
Proportion screened for diabetic retinopathy
Equivalence in proportion screened for diabetic retinopathy of white and non-white youth with autonomous AI
Time frame: Day 1
Percentage of agreement in interpretation of retinal images
Agreement in interpretation of retinal images between autonomous AI and consensus grading by ophthalmologists
Time frame: Day 1
Sensitivity of autonomous AI vs. prognostic standard
Sensitivity of autonomous AI in detecting diabetic retinopathy in youth compared to the prognostic standard. This will be analyzed in the ACCESS2 trial cohort alone, and also in the ACCESS2 trial cohort with the enriched cohort of youth with known diabetic retinopathy.
Time frame: Day 1
Specificity of autonomous AI vs. prognostic standard
Specificity of autonomous AI in detecting diabetic retinopathy in youth compared to the prognostic standard. This will be analyzed in the ACCESS2 trial cohort alone, and also in the ACCESS2 trial cohort with the enriched cohort of youth with known diabetic retinopathy.
Time frame: Day 1
Proportion with diabetic retinopathy
Proportion of participants with diabetic retinopathy, including none, mild, moderate or severe DR.
Time frame: Day 1
Plan to share: No
Started Jul 2022 (actual). Primary completion is estimated for Dec 2026, 53 months after the start.
Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 53 months is above that.
Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.