Pediatric Artificial Intelligence for Retinopathy Screening in Children With Type 1 Diabetes (NCT07149142) | Clinical Trial Compass
RecruitingNot Applicable
Pediatric Artificial Intelligence for Retinopathy Screening in Children With Type 1 Diabetes
Czechia400 participantsStarted 2026-07-01
Plain-language summary
The proposed project is a clinical intervention trial testing the feasibility and effectiveness of diabetic retinopathy screening evaluated by artificial intelligence (AI) based software in children with type 1 diabetes (CwD). Another novel method, the confocal microscopy of the retina will be used to assess the early stages of diabetic neuropathy. In parallel, we aim to assess the prevalence of diabetic retinopathy and neuropathy in a well-controlled population of CwD at a tertiary diabetes care center.
Each participant will undergo an examination of diabetic retinopathy using the non-mydriatic fundus camera. The resulting photography will be evaluated by AI driven software. The participant will then follow this examinaton with fundus ophtalmoscopy in arteficial mydriasis as a standard method of diabetic retinopathy assessment. Another method, the optic coherence tomography (OCT), which is considered as the most sensitive method for diabetic retinopathy assessment, will be performed after that. The results of these methods will be compared to assess the sensitivity of each. The examination-satisfaction questionnaire will be given to the participants.
In subjects over 18 years, a confocal microscopy of the retina examination will be performed to assess the status of the corneal sub-basal nerve plexus and the presence of diabetic neuropathy will be noted.
The prevalence of diabetic retinopathy and neuropathy in this group of children with diabetes will be assessed based on the results.
Who can participate
Age range
11 Years – 19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Type 1 diabetes diagnosed according to the ADA criteria
* Age over 11.0 years or duration of diabetes over 2 years
* Signed written informed consent by both the CwD and their parent/caregiver
Exclusion Criteria:
* Unwillingness to sign a written informed consent by both the CwD and their parent/caregiver
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing whether an AI system is feasible for screening diabetic retinopathy in kids with Type 1 diabetes — does that mean my child would still get a standard eye exam, or would the AI be replacing the usual ophthalmologist review entirely?
2Since this is a feasibility study and not a treatment trial, what would actually happen if the AI screening spotted something concerning — would my child be immediately connected to follow-up care?
3How does participating in this AI screening study fit alongside my child's existing diabetes management and eye care routine, and would it add extra appointments or tests to their schedule?
4Because this trial is measuring feasibility rather than proving the AI is accurate, how confident can we be in any results the AI produces, and what are the backup plans if it misses something?
5Are there any specific ages, diabetes duration, or other criteria that would make this study a good or poor fit for my child, and is there a standard retinopathy screening approach we should be doing regardless of whether we join this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of AI for retinopathy screening
Timeframe: Through study completion, on average 6 months.