Pediatric Artificial Intelligence for Retinopathy Screening in Children With Type 1 Diabetes

NCT07149142 | Not Yet Recruiting

• 1 other identifier: PAIRS
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Diabetic Retinopathy; Diabetic Neuropathy; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• Feasibility of AI for retinopathy screening

  The primary objective of this study is to test whether performing the diabetic retinopathy screening using the non-mydriatic fundus camera with AI software is feasible. The exact outcome is the percent of participants who will agree to undergo the procedure and will obtain a valid result (either positive or negative).

  Through study completion, on average 6 months.

Secondary Outcomes (3)

• Examination satisfaction

  Through study completion, on average 6 months.

• Prevalence of diabetic retinopathy

  Through study completion, on average 6 months.

• Prevalence of diabetic neuropathy

  Through study completion, on average 6 months.

Study Arms (1)

Study arm

EXPERIMENTAL

All participants will undergo 3 consecutive examinations - non-mydriatic fundus camera assessed by AI-driven software, fundus opthalmoscopy assessed by experienced opthalmologist and optic coherence tomography examination.

Diagnostic Test: Non-mydriatic fundus camera photography; Diagnostic Test: Fundus ophtalmoscopy; Diagnostic Test: Optic coherence tomography; Diagnostic Test: Confocal microscopy of the retina

Interventions

Non-mydriatic fundus camera photography DIAGNOSTIC_TEST

Non-mydriatic fundus camera photography assessed by artificial intelligence software

Study arm

Fundus ophtalmoscopy DIAGNOSTIC_TEST

Fundus opthalmoscopy assessed by an experienced ophtalmologist

Study arm

Optic coherence tomography DIAGNOSTIC_TEST

Optic coherence tomography assessed by an experienced ophtalmologist

Study arm

Confocal microscopy of the retina DIAGNOSTIC_TEST

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

Study arm

Eligibility Criteria

• Age: 11 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Unwillingness to sign a written informed consent by both the CwD and their parent/caregiver

Sponsors & Collaborators

• University Hospital, Motol: lead

Study Sites (1)

University Hospital Motol

Prague, Prague 5, 15006, Czechia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetic Retinopathy; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Vit Neuman, MD, PhD

CONTACT

+420 224 432 090; Vit.Neuman@fnmotol.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 29, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

CZ (1)