NCT07378891

Brief Summary

Examination of individuals with prediabetes and established diabetes for early signs of diabetic retinopathy.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Dec 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Dec 2025Dec 2028

Study Start

First participant enrolled

December 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2028

Last Updated

February 10, 2026

Status Verified

January 1, 2026

Enrollment Period

2.8 years

First QC Date

January 22, 2026

Last Update Submit

February 6, 2026

Conditions

Diabetes (DM)Prediabetes

Keywords

Diabetic retinopathyPrediabetesDiabetesEyeArt

Outcome Measures

Primary Outcomes (1)

  • Assessment of retinal changes

    Assessment of retinal changes in individuals with prediabetes and diabetes, quantified using an AI algorithm.

    Day 1

Secondary Outcomes (3)

  • Image quality and comparison of the fundus cameras

    Day 1

  • Influence of clinical parameters on retinal vascular changes

    Day 1

  • Association of medications with the ocular fundus

    Day 1

Study Arms (1)

Prediabetes and Diabetes

Participants with prediabetes and diabetes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diabetic patients in the University Hospital Tuebingen, volunteers with prediabetes

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Tuebingen, Dep. Diabetology

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Diabetes MellitusPrediabetic StateDiabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 30, 2026

Study Start

December 1, 2025

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

December 15, 2028

Last Updated

February 10, 2026

Record last verified: 2026-01

Locations

DE(1)