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Predicting the Risk of Diabetic Neurodegenerative Disorders by Artificial Intelligence Tools Based on Retinal Imaging

NCT06541834 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2025-03-14

No results posted yet for this study

Summary

Diabetic Retinopathy (DR) is the most frequent complication of diabetes, and its presence and severity are related to the appearance of both micro and macrovascular events.

Risk profiles have been suggested as a major direction for research in diabetes, based on non- invasive retinal imaging evaluations. There has been promising evidence that artificial intelligence (AI) based on fundus photographs can detect clinical metrics and systemic conditions invisible to expert human observers. Notably, deep-learning (DL) convolutional neural networks (CNNs) developed for retinal photographs have been shown superior performance in the detection of DR compared with human assessment.

The relationship between retinal vascular abnormalities and neurovascular complications of diabetes has been reported. The retina is a window to the body that allows a non-invasive observation of microvascular and neural tissues. However, in clinical practice there are no reported phenotypic indicators or reliable examinations to identify type 2 diabetic (T2D) patients with neurodegenerative/cognitive impairment. The presence of cognitive Impairment is a very frequent complication in diabetic patients, reported up to 60% of the diabetics when compared to only 11 % in the non-diabetics (OR of 8.78).

Furthermore, AI based on retinal imaging has never been applied before to predict the onset and worsening of neurodegenerative/cognitive impairment of T2D in a real-world setting.

The aim of this project is to develop trustworthy AI tools for predicting the risk of developing and progressing of neurodegenerative/cognitive diabetic impairment based on retinal images, in T2D population. For the development and validation of these tools, T2D patients will be enrolled from 4 well-established Italian centers.

The proposal of this study is addressed to health care systems, in order to improve their consciousness about diabetic neurodegenerative/cognitive complications and reduce the related economic burden. Since the huge majority of these disorders remain undiagnosed, DINEURET will provide new cost-effective screening strategies to identify these patients.

4 centers will be involved:

* 75 patients will be included in the IRCCS Ospedale San Raffaele, Milan;
* 75 patients will be included in the IRCCS MultiMedica, Milan;
* 50 patients will be included in the Ospedale Della Murgia "Fabio Perinei", Altamura;
* 50 patients will be included in the Azienda Ospedaliero-Universitaria (AOUI) of Cagliari, Cagliari.

Conditions

Interventions

DEVICE

Retinal imaging

Data of retinal imaging were acquired using Spectralis (Heidelberg, Germany) and California (Optos, UK).

Sponsors & Collaborators

  • Riccardo Sacconi

    collaborator UNKNOWN

  • Ilaria Zucchiatti

    collaborator UNKNOWN

  • Ospedale San Raffaele

    lead OTHER

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-30
Primary Completion
2026-04-01
Completion
2026-08-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06541834 on ClinicalTrials.gov