Diabetes (DM)FUNDUS AINCT07378891
Artificial-Intelligence-based Early Detection of Diabetic Retinopathy (FUNDUS AI)
An observational study of Diabetes (DM) and Prediabetes, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Examination of individuals with prediabetes and established diabetes for early signs of diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes (DM), Prediabetes
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2025to 15 Dec 2028
- How long will I take part?
- 1 Day
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic patients in the University Hospital Tuebingen, volunteers with prediabetes
Who may be able to join
- Voluntary adults
- Aged between 18 and 80 years
- Understanding of the study explanations and instructions
- Prediabetes (defined by elevated fasting glucose 100-125 mg/dL and/or 2-hour glucose in the oral glucose tolerance test of 140-199 mg/dL and/or HbA1c of 5.7-6.4%)
- manifest diabetes (all types of diabetes according to Ahlqvist)
Who cannot join
- participants unable to give consent
- Those who do not agree to be informed about incidentally detected pathological findings
- Uncontrolled arterial hypertension (Stage III) despite multiple antihypertensive medications
- Eye diseases that impair the interpretability of the fundus examination
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Künstliche Intelligenz (KI)-gestützte Früherkennung Der Diabetischen Retinopathie (FUNDUS-KI)
Examination of individuals with prediabetes and established diabetes for early signs of diabetic retinopathy.
Read the detailed description
Fundus images are acquired and analyzed using an AI algorithm. The fundus images are captured using two devices: a stationary fundus camera (CenterVue DRSplus) and the Optomed Aurora IQ handheld fundus camera. Retinal images are examined using AI-based image analysis.
- Conditions
- Diabetes (DM), Prediabetes
- Keywords
- Diabetic retinopathy, Prediabetes, Diabetes, EyeArt
- Medical subject headings
- Diabetes Mellitus, Prediabetic State, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prediabetes and Diabetes | Participants with prediabetes and diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of retinal changes
Assessment of retinal changes in individuals with prediabetes and diabetes, quantified using an AI algorithm.
Measured: Day 1
Secondary outcomes (3)
Image quality and comparison of the fundus cameras
The automatically assessed image quality and the comparison of stationary and mobile fundus cameras
Measured: Day 1
Influence of clinical parameters on retinal vascular changes
Influence of clinical parameters such as anthropometric measurements (WHR, blood pressure, BMI) and laboratory parameters of glucose and lipid metabolism on retinal vascular changes
Measured: Day 1
Association of medications with the ocular fundus
Association of antidiabetic and lipid-lowering medications with the ocular fundus
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 Dec 2025
- Primary completion1 Oct 2028 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes (DM)Studies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378891
- Sponsor's protocol ID
- 419/2025BO2
- Acronym
- FUNDUS AI
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Künstliche Intelligenz (KI)-gestützte Früherkennung Der Diabetischen Retinopathie (FUNDUS-KI)
- ClinicalTrials.gov ID
- NCT07378891
- Acronym / sponsor ID
- FUNDUS AI / 419/2025BO2
- Conditions
- Diabetes (DM), Prediabetes
- Keywords
- Diabetic retinopathy, Prediabetes, Diabetes, EyeArt
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 30 Jan 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.
Examination of individuals with prediabetes and established diabetes for early signs of diabetic retinopathy.
Detailed description
Fundus images are acquired and analyzed using an AI algorithm. The fundus images are captured using two devices: a stationary fundus camera (CenterVue DRSplus) and the Optomed Aurora IQ handheld fundus camera. Retinal images are examined using AI-based image analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prediabetes and Diabetes | – | –Participants with prediabetes and diabetes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients in the University Hospital Tuebingen, volunteers with prediabetes
Key inclusion criteria (5 listed)
- Voluntary adults
- Aged between 18 and 80 years
- Understanding of the study explanations and instructions
- Prediabetes (defined by elevated fasting glucose 100-125 mg/dL and/or 2-hour glucose in the oral glucose tolerance test of 140-199 mg/dL and/or HbA1c of 5.7-6.4%)
- manifest diabetes (all types of diabetes according to Ahlqvist)
Key exclusion criteria (4 listed)
- participants unable to give consent
- Those who do not agree to be informed about incidentally detected pathological findings
- Uncontrolled arterial hypertension (Stage III) despite multiple antihypertensive medications
- Eye diseases that impair the interpretability of the fundus examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of retinal changes
Time frame: Day 1
Assessment of retinal changes in individuals with prediabetes and diabetes, quantified using an AI algorithm.
3 secondary outcomes
Image quality and comparison of the fundus cameras
Time frame: Day 1
Influence of clinical parameters on retinal vascular changes
Time frame: Day 1
Association of medications with the ocular fundus
Time frame: Day 1
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 10 Feb 2026.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available
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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.
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 (DM) and Prediabetes, run by University Hospital Tuebingen at 1 site in Germany.
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 5 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 10 Feb 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 Germany. 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?
Assessment of retinal changes (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2026.