Artificial-Intelligence-based Early Detection of Diabetic... | NCT07378891

Studies
Artificial-Intelligence-based Early Detection of Diabetic Retinopathy (FUNDUS AI)

NCT07378891

Sponsor

University Hospital Tuebingen

Status

Enrolling by invitation

Last Update Posted

Feb 10, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Diabetes (DM)
Prediabetes

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2025Actual

Primary Completion Date

Oct 1, 2028Estimated

Completion Date

Dec 15, 2028Estimated

First Submitted Date

Jan 22, 2026

First Submission Date that Met QC Criteria

Jan 22, 2026

First Posted Date

Jan 30, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2026

Last Update Posted Date

Feb 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
Prediabetes and Diabetes		Participants with prediabetes and diabetes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of retinal changes	Assessment of retinal changes in individuals with prediabetes and diabetes, quantified using an AI algorithm.	Day 1

Secondary Outcomes

Measure	Description	Time Frame
Image quality and comparison of the fundus cameras	The automatically assessed image quality and the comparison of stationary and mobile fundus cameras	Day 1
Influence of clinical parameters on retinal vascular changes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Diabetic patients in the University Hospital Tuebingen, volunteers with prediabetes

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Tuebingen, Dep. Diabetology		Tübingen		72076	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

It is not yet known if there will be a plan to make IPD available

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D011236	Prediabetic State
D003930	Diabetic Retinopathy

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided