Diabetes Type 1NCT07705321
Assessment of Retinal Microcirculation in Patients With Type 1 Diabetes Mellitus
An observational study of Diabetes Type 1 and Diabetic Retinopathy, run by University of Athens at 1 site in Greece.
Trial summary
Type 1 diabetes mellitus (T1DM) is associated with an increased lifetime risk of developing diabetic retinopathy, a leading cause of visual impairment among working-age adults worldwide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 1, Diabetic Retinopathy, Microvascular Circulation
- What is being tested?
- Optical Coherence Tomography Angiography (OCTA)
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jun 2025to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with Type 1 diabetes mellitus, with or without clinically diagnosed diabetic retinopathy, recruited from the 2nd Department Ophthalmology outpatient clinics with and without diabetic retinopathy.
Who may be able to join
- Adults aged 18 years or older.
- Diagnosis of Type 1 diabetes mellitus (T1DM) according to the American Diabetes Association (ADA) criteria.
- Ability and willingness to provide written informed consent.
Who cannot join
- Active uveitis or other intraocular inflammatory disease.
- Uncontrolled glaucoma
- High myopia (spherical equivalent refractive error >5.0 diopters)
- History of ocular trauma.
- History of intraocular surgery within the previous 6 months.
Trial locations and contacts
1 site in 1 country.
Greece1 site
2nd Department of Ophthalmology, Attikon University Hospital, National and Kapodistrian University of Athens
Athens, 12462
About this study
Type 1 diabetes mellitus (T1DM) is associated with an increased lifetime risk of developing diabetic retinopathy, a leading cause of visual impairment among working-age adults worldwide. Retinal assessment plays a pivotal role in the management of patients with T1DM, as the retina provides a unique, non-invasive window into the body's microvascular circulation. Early detection of retinal abnormalities is essential because structural and microvascular changes may develop years before the onset of vision-threatening diabetic retinopathy or visual symptoms. Contemporary retinal imaging techniques, enable the quantitative evaluation of retinal microvasculature allowing the identification of subclinical retinal damage.
- Conditions
- Diabetes Type 1, Diabetic Retinopathy, Microvascular Circulation, Retinal Microvascular Disease, Diabetic Complications
- Being tested
- Optical Coherence Tomography Angiography (OCTA)
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Retinopathy, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography Angiography (OCTA)Diagnostic test
A non-invasive retinal imaging technique that provides high-resolution visualization and quantitative assessment of the retinal and choroidal microvasculature, including vessel density and the foveal avascular zone, without the use of intravenous dye.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Type 1 diabetes mellitus with and without clinically diagnosed diabetic retinopathy | Not described Receives: Diagnostic Test: Optical Coherence Tomography Angiography (OCTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative assessment of retinal vessel density measured by optical coherence tomography angiography (OCTA).
Measured: Vessel density will be assessed at baseline using OCTA. This is a cross-sectional study; no follow-up assessments will be performed. Participants will be evaluated at a single study visit and classified according to the stage of diabetic retinopathy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Jun 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
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 Diabetes Type 1Studies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irini Chatziralli, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705321
- Sponsor's protocol ID
- 322/29-04-2024
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cutruzzola A, Carnevali A, Gatti V, Latella G, Lamonica L, Oliverio F, Borelli M, Parise M, Di Molfetta S, Scorcia V, Irace C, Gnasso A. Continuous Glucose Monitoring-Derived Metrics and Capillary Vessel Density in Subjects with Type 1 Diabetes without Diabetic Retinopathy. J Diabetes Res. 2023 Apr 15;2023:9516059. doi: 10.1155/2023/9516059. eCollection 2023.
PubMed 37096234
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Retinal Microcirculation in Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07705321
- Acronym / sponsor ID
- 322/29-04-2024
- Conditions
- Diabetes Type 1, Diabetic Retinopathy, Microvascular Circulation, Retinal Microvascular Disease, Diabetic Complications
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 15 Jul 2026 (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.
Type 1 diabetes mellitus (T1DM) is associated with an increased lifetime risk of developing diabetic retinopathy, a leading cause of visual impairment among working-age adults worldwide. Retinal assessment plays a pivotal role in the management of patients with T1DM, as the retina provides a unique, non-invasive window into the body's microvascular circulation. Early detection of retinal abnormalities is essential because structural and microvascular changes may develop years before the onset of vision-threatening diabetic retinopathy or visual symptoms. Contemporary retinal imaging techniques, enable the quantitative evaluation of retinal microvasculature allowing the identification of subclinical retinal damage.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Type 1 diabetes mellitus with and without clinically diagnosed diabetic retinopathy | – | Diagnostic Test: Optical Coherence Tomography Angiography (OCTA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Type 1 diabetes mellitus, with or without clinically diagnosed diabetic retinopathy, recruited from the 2nd Department Ophthalmology outpatient clinics with and without diabetic retinopathy.
Key inclusion criteria (3 listed)
- Adults aged 18 years or older.
- Diagnosis of Type 1 diabetes mellitus (T1DM) according to the American Diabetes Association (ADA) criteria.
- Ability and willingness to provide written informed consent.
Key exclusion criteria (5 listed)
- Active uveitis or other intraocular inflammatory disease.
- Uncontrolled glaucoma
- High myopia (spherical equivalent refractive error >5.0 diopters)
- History of ocular trauma.
- History of intraocular surgery within the previous 6 months.
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 |
|---|---|---|
| Optical Coherence Tomography Angiography (OCTA)A non-invasive retinal imaging technique that provides high-resolution visualization and quantitative assessment of the retinal and choroidal microvasculature, including vessel density and the foveal avascular zone, without the use of intravenous dye. | Diagnostic test | Patients with Type 1 diabetes mellitus with and without clinically diagnosed diabetic retinopathy |
Primary outcome
Quantitative assessment of retinal vessel density measured by optical coherence tomography angiography (OCTA).
Time frame: Vessel density will be assessed at baseline using OCTA. This is a cross-sectional study; no follow-up assessments will be performed. Participants will be evaluated at a single study visit and classified according to the stage of diabetic retinopathy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Background: PubMed 37096234Cutruzzola A, Carnevali A, Gatti V, Latella G, Lamonica L, Oliverio F, Borelli M, Parise M, Di Molfetta S, Scorcia V, Irace C, Gnasso A. Continuous Glucose Monitoring-Derived Metrics and Capillary Vessel Density in Subjects with Type 1 Diabetes without Diabetic Retinopathy. J Diabetes Res. 2023 Apr 15;2023:9516059. doi: 10.1155/2023/9516059. eCollection 2023.
- Individual participant dataSharing planned: No
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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 Diabetes Type 1 and Diabetic Retinopathy, run by University of Athens at 1 site in Greece.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. 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 Greece. 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?
This study is still under way. Results are not available in the source record yet.
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?
Quantitative assessment of retinal vessel density measured by optical coherence tomography angiography (OCTA). (time frame: Vessel density will be assessed at baseline using OCTA. This is a cross-sectional study; no follow-up assessments will be performed. Participants will be evaluated at a single study visit and classified according to the stage of diabetic retinopathy.). 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 NCT07705321, 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 15 Jul 2026.