Pediatric Artificial Intelligence for Retinopathy Screening in Children With Type 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-mydriatic fundus camera photography, Fundus ophtalmoscopy, Optic coherence tomography, Confocal microscopy of the retina.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes Mellitus. Basic parameters: 11 years — 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility and Effectiveness of Diabetic Retinopathy Screening Using Artificial Intelligence in Children With Type 1 Diabetes
Overview
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.
Interventions
- Diagnostic test Non-mydriatic fundus camera photography
Non-mydriatic fundus camera photography assessed by artificial intelligence software - Diagnostic test Fundus ophtalmoscopy
Fundus opthalmoscopy assessed by an experienced ophtalmologist - Diagnostic test Optic coherence tomography
Optic coherence tomography assessed by an experienced ophtalmologist - Diagnostic test Confocal microscopy of the retina
In a subset of participants over 18 years of age, confocal microscopy of the retina will be performed to assess the presence of diabetic neuropathy
Primary outcome measures
- Feasibility of AI for retinopathy screening [Time frame: Through study completion, on average 6 months.]
Secondary outcome measures (3)
- Examination satisfaction [Time frame: Through study completion, on average 6 months.]
- Prevalence of diabetic retinopathy [Time frame: Through study completion, on average 6 months.]
- Prevalence of diabetic neuropathy [Time frame: Through study completion, on average 6 months.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Czechia · 1 center
- University Hospital Motol — Prague
Identifiers
NCT: NCT07149142 · PAIRS