Diabetic NeuropathiesEyekonT1DNCT04608890
Eye-tracking-based Artificial Intelligence Detects Abnormalities of the Oculomotor System in Type 1 Diabetes
An observational study of Diabetic Neuropathies, run by University of Milan at 1 site in Italy.
Trial summary
Abnormalities of the oculomotor system may represent an early sign of diabetic neuropathy and are currently poorly studied. The investigators designed an eye-tracking-based test to evaluate the oculomotor function in patients with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- Eye-tracking video test
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- Child, Adult
Study population: N=40 patients with type 1 diabetes on insulin treatment N=40 healthy subjects
Who may be able to join
- Type 1 diabetes
- willing to give consent
- willing to give consent
Who cannot join
- Diabetic retinopathy and other ocular diseases
- other endocrine disease
- malignancy
- Healthy volunteers:
- Other ocular diseases
- Any endocrine disease
- Malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Abnormalities of the oculomotor system may represent an early sign of diabetic neuropathy and are currently poorly studied. The investigators designed an eye-tracking-based test to evaluate the oculomotor function in patients with type 1 diabetes.
The investigators used the SRLab -Tobii TX300 Eye tracker®, an eye-tracking device, coupled with a software that we developed to test abnormalities of the oculomotor system. The software consists in a series of screens divided in 5 classes of parameters (Resistance, Wideness, Pursuit, Velocity and Optokinetic Nystagmus [OKN]) to evaluate both smooth and saccadic movement in different directions. 40 healthy volunteers and 40 patients with long-standing type 1 diabetes will be enrolled to analyze the alterations in the oculomotor system and function.
Read the detailed description
The study will enroll 40 healthy volunteers and 40 patients with long-standing type 1 diabetes. The aim of the study is to analyze alterations in the oculomotor system function as an early sign of diabetic neuropathy. A novel eye-tracking-based test will be employed and 5 parameters will be analyzed through the use of a computer-based test which will record timeframes of eye movements towards an object, type of eye movements, time between the first eye movement, number of visualization required to recognize the object across the screen. Each of these parameter will be employed to assess whether Resistance, Wideness, Pursuit, Velocity of eye movements and movements related to the Optokinetic Nystagmus are altered in type 1 diabetes as compared to non diabetic subjects.
- Conditions
- Diabetic Neuropathies
- Being tested
- Eye-tracking video test
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye-tracking video testDiagnostic test
An eye-tracking-based test will be administered to patients. It lasts 10 minutes. It consists in several screens passing by to identify objects at a certain time by a mouse clic or touchpad.
| Study group | Role | What they receive |
|---|---|---|
| Long-standing T1D patients | Patients with long-standing type 1 diabetes Receives: Diagnostic Test: Eye-tracking video test | |
| Healthy volunteers | Healthy volunteers Receives: Diagnostic Test: Eye-tracking video test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with a change in eye movement test in each class Resistance, Velocity, Pursuit, Wideness and OKN measured by the eye-tracking based test
Percentage of all parameters tested in each class changed in patients with type 1 diabetes as compared to healthy subjects. Parameters evaluated include number of visualization required to recognize a target and time (seconds), to recognize a target moving on the screen in different directions.
Measured: End of the study (when all patients have completed all sessions of the test), an average of 6 months
Secondary outcomes (3)
Percentage of patients with a change in eye movement test in the Resistance class
Percentage of parameters tested in the Resistance class changed in patients with type 1 diabetes as compared to healthy subjects. Resistance will be measured by using number of visualization required to recognize a target and time (seconds) required to recognize a target moving on the screen in different directions. An algorithm will attribute those measurements to the specific class of Resistance.
Measured: End of the study (when all patients have completed all sessions of the test), an average of 6 months
Percentage of patients with a change in eye movement test in the Wideness class
Percentage of parameters tested in the Wideness class changed in patients with type 1 diabetes as compared to healthy subjects. Wideness will be measured by using number of visualization required to recognize a target and time (seconds) required to recognize a target moving on the screen in different directions. An algorithm will attribute those measurements to the specific class of Wideness.
Measured: End of the study (when all patients have completed all sessions of the test), an average of 6 months
Percentage of patients with a change in eye movement test in the Velocity class
Percentage of parameters tested in the Velocity class changed in patients with type 1 diabetes as compared to healthy subjects. Velocity will be measured by using number of visualization required to recognize a target and time (seconds) required to recognize a target moving on the screen in different directions. An algorithm will attribute those measurements to the specific class of Velocity.
Measured: End of the study (when all patients have completed all sessions of the test), an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start1 Dec 2020
- Primary completion1 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Collaborators
- ASST Fatebenefratelli Sacco
- Responsible party
- Principal investigator, Paolo Fiorina, MD, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608890
- Sponsor's protocol ID
- EyekonT1D
- Acronym
- EyekonT1D
- Status last verified
- May 2022
- First submitted
- 8 Oct 2020
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared under MTA agreement.
Publications
D'Addio F, Pastore I, Loretelli C, Valderrama-Vasquez A, Usuelli V, Assi E, Mameli C, Macedoni M, Maestroni A, Rossi A, Lunati ME, Morpurgo PS, Gandolfi A, Montefusco L, Bolla AM, Ben Nasr M, Di Maggio S, Melzi L, Staurenghi G, Secchi A, Bianchi Marzoli S, Zuccotti G, Fiorina P. Abnormalities of the oculomotor function in type 1 diabetes and diabetic neuropathy. Acta Diabetol. 2022 Sep;59(9):1157-1167. doi: 10.1007/s00592-022-01911-1. Epub 2022 Jun 22.
PubMed 35729357
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye-tracking-based Artificial Intelligence Detects Abnormalities of the Oculomotor System in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04608890
- Acronym / sponsor ID
- EyekonT1D / EyekonT1D
- Conditions
- Diabetic Neuropathies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- ASST Fatebenefratelli Sacco
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Abnormalities of the oculomotor system may represent an early sign of diabetic neuropathy and are currently poorly studied. The investigators designed an eye-tracking-based test to evaluate the oculomotor function in patients with type 1 diabetes.
The investigators used the SRLab -Tobii TX300 Eye tracker®, an eye-tracking device, coupled with a software that we developed to test abnormalities of the oculomotor system. The software consists in a series of screens divided in 5 classes of parameters (Resistance, Wideness, Pursuit, Velocity and Optokinetic Nystagmus [OKN]) to evaluate both smooth and saccadic movement in different directions. 40 healthy volunteers and 40 patients with long-standing type 1 diabetes will be enrolled to analyze the alterations in the oculomotor system and function.
Detailed description
The study will enroll 40 healthy volunteers and 40 patients with long-standing type 1 diabetes. The aim of the study is to analyze alterations in the oculomotor system function as an early sign of diabetic neuropathy. A novel eye-tracking-based test will be employed and 5 parameters will be analyzed through the use of a computer-based test which will record timeframes of eye movements towards an object, type of eye movements, time between the first eye movement, number of visualization required to recognize the object across the screen. Each of these parameter will be employed to assess whether Resistance, Wideness, Pursuit, Velocity of eye movements and movements related to the Optokinetic Nystagmus are altered in type 1 diabetes as compared to non diabetic subjects.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long-standing T1D patients | – | Diagnostic Test: Eye-tracking video testPatients with long-standing type 1 diabetes |
| Healthy volunteers | – | Diagnostic Test: Eye-tracking video testHealthy volunteers |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- N=40 patients with type 1 diabetes on insulin treatment N=40 healthy subjects
Key inclusion criteria (3 listed)
- Type 1 diabetes
- willing to give consent
- willing to give consent
Key exclusion criteria (7 listed)
- Diabetic retinopathy and other ocular diseases
- other endocrine disease
- malignancy
- Other ocular diseases
- Any endocrine disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye-tracking video testAn eye-tracking-based test will be administered to patients. It lasts 10 minutes. It consists in several screens passing by to identify objects at a certain time by a mouse clic or touchpad. | Diagnostic test | Healthy volunteers, Long-standing T1D patients |
Primary outcome
Percentage of patients with a change in eye movement test in each class Resistance, Velocity, Pursuit, Wideness and OKN measured by the eye-tracking based test
Time frame: End of the study (when all patients have completed all sessions of the test), an average of 6 months
Percentage of all parameters tested in each class changed in patients with type 1 diabetes as compared to healthy subjects. Parameters evaluated include number of visualization required to recognize a target and time (seconds), to recognize a target moving on the screen in different directions.
3 secondary outcomes
Percentage of patients with a change in eye movement test in the Resistance class
Time frame: End of the study (when all patients have completed all sessions of the test), an average of 6 months
Percentage of patients with a change in eye movement test in the Wideness class
Time frame: End of the study (when all patients have completed all sessions of the test), an average of 6 months
Percentage of patients with a change in eye movement test in the Velocity class
Time frame: End of the study (when all patients have completed all sessions of the test), an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Derived from this study: PubMed 35729357D'Addio F, Pastore I, Loretelli C, Valderrama-Vasquez A, Usuelli V, Assi E, Mameli C, Macedoni M, Maestroni A, Rossi A, Lunati ME, Morpurgo PS, Gandolfi A, Montefusco L, Bolla AM, Ben Nasr M, Di Maggio S, Melzi L, Staurenghi G, Secchi A, Bianchi Marzoli S, Zuccotti G, Fiorina P. Abnormalities of the oculomotor function in type 1 diabetes and diabetic neuropathy. Acta Diabetol. 2022 Sep;59(9):1157-1167. doi: 10.1007/s00592-022-01911-1. Epub 2022 Jun 22.
- Individual participant dataSharing planned: No. IPD will be shared under MTA agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Neuropathies, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with a change in eye movement test in each class Resistance, Velocity, Pursuit, Wideness and OKN measured by the eye-tracking based test (time frame: End of the study (when all patients have completed all sessions of the test), an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04608890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022; AzTrials last refreshed its copy on 31 Oct 2026.