An observational study in Diabete Mellitus and Cognitive Impairment, sponsored by Ospedale San Raffaele. Recruiting at 1 site in Italy. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by Ospedale San Raffaele · Observational
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:
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 250 is close to the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Ospedale San Raffaele is the lead sponsor of 46 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Male or female >45 years old affected by type 2 diabetes.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Data of retinal imaging were acquired using Spectralis (Heidelberg, Germany) and California (Optos, UK).
Accuracy of AI based model
To evaluate the accuracy (sensibility and specificity) of the AI based model in the prediction of a worsening of neurodegenerative/cognitive impairment (defined as \> 2 point decrease at Montreal Cognitive Assessment scale) based on the retinal imaging acquired at the baseline.
Time frame: 30 August 2026
Reliability and reproducibility of the AI based model To characterize clinical phenotypes within T2D based on the risk of developing and worsening of cognitive decline.
To assess the reliability and reproducibility of the AI based model on different sub-samples (patients with different degrees of neurocognitive impairment).
Time frame: 30 August 2026
Clinical phenotypes of T2D patients
To select clinical phenotypes of T2D patients based on retinal imaging that are characterized by higher risk of developing and worsening of cognitive decline.
Time frame: 30 August 2026
Plan to share: Undecided
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Ospedale San Raffaele