CClinicalTrials.gg
CompletedNCT05276778Updated May 6, 2025

Diabetic Retinopathy Screening in General Practice

An observational study in Diabetic Retinopathy and Type2 Diabetes, sponsored by Aalborg University. Completed at 1 site in Denmark. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-06.

Sponsored by Aalborg University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
300
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Diabetic Retinopathy is a microvascular eye complication of diabetes, which can go unnoticed until permanent vision damage has occurred - in worst-case blindness. Timely retinopathy screenings reduce the risk of sight loss since the disease can be treated if detected in time. For people with type 2 diabetes, retinopathy screenings are typically performed by specialist at private ophthalmologists' practices, and individualized screening intervals based on retinopathy level and diabetes regulation are recommended. Unfortunately, 26% of people with type 2 diabetes do not follow their screening interval, and the attendance is too low compared to the national standard of minimum 90% of patients with diabetes who ought to follow the screening program. Consequently, actions must be taken to improve screening attendance in Denmark.

The aim of this study is to investigate patients' acceptance of diabetic retinopathy screenings in general practice. Patients' acceptance is explored through a questionnaire developed for the study.

02

Conditions studied

  • Diabetic Retinopathy
  • Type2 Diabetes

Keywords

  • Artificial Intelligence
  • Diabetic Retinopathy Screening
  • General practice
  • Primary care
  • Type 2 diabetes
03

In context

Retinal Diseases

815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.

This study's enrollment of 300 is above the median of 180 across 282 observational studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

Lead sponsor

Aalborg University is the lead sponsor of 178 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population is patients diagnosed with type 2 diabetes treated in general practice within the Region of North Jutland. We are excluding patients above the age of 70 as patients at this age diagnosed with diabetes have a higher risk of developing other eye diseases, such as glaucoma or cataracts, so the general practitioners would still have to advice this patient group to schedule consultations at an ophthalmologist even though they have no sign of retinopathy.

Patients who participate in the project must fulfill all inclusion criteria and cannot fulfill any exclusion criteria listed below.

Inclusion criteria

  • Diagnosed with type 2 diabetes
  • Understands Danish
  • Age between 18-70

Exclusion criteria

Exclusion Criteria:

  • Blindness
  • Cannot partake in second screening
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
300 participants (actual)
Patient registry
No

Groups and cohorts

  • People with type 2 diabetes

    People diagnosed with type 2 diabetes age 18-70

    Diagnostic Test: Diabetic Retinopathy Screening

Interventions

  • Diagnostic testDiabetic Retinopathy Screening

    Screenings are performed in the diabetes consultation in general practice

06

What researchers measure

Primary outcomes

  1. Patients' acceptance of diabetic retinopathy screenings in general practice

    Questionnaire

    Time frame: 1 day (the questionnarie is fufilled one time after the retinopaty screening in general practice)

07

Study locations

1 site
  • Malene Krogh
    Aalborg, DK 9000, Denmark
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05276778
Lead sponsor
Aalborg University
Responsible party
Malene Krogh (Ph.D. student, Aalborg University) — Principal investigator
First posted
Mar 11, 2022
Start date
Feb 28, 2022
Primary completion
Nov 14, 2023
Completion
Nov 14, 2023
Last update
May 6, 2025

Study contacts

Malene Krogh
principal investigator · Aalborg University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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