NCT07149142 Pediatric Artificial Intelligence for Retinopathy Screening in Children With Type 1 Diabetes
| NCT ID | NCT07149142 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Motol |
| Condition | Type 1 Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2026-07-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07149142 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 19 Years, studying Type 1 Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07149142 currently recruiting?
Yes, NCT07149142 is actively recruiting participants. Contact the research team at Vit.Neuman@fnmotol.cz for enrollment information.
Where is the NCT07149142 trial being conducted?
This trial is being conducted at Prague, Czechia.
Who is sponsoring the NCT07149142 clinical trial?
NCT07149142 is sponsored by University Hospital, Motol. The trial plans to enroll 400 participants.
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