Diabetic Retinopathy Screening in General Practice

NCT05276778 | Completed

• 1 other identifier: mKrogh
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Retinopathy; Type2 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Patients' acceptance of diabetic retinopathy screenings in general practice

  Questionnaire

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

Study Arms (1)

People with type 2 diabetes

People diagnosed with type 2 diabetes age 18-70

Diagnostic Test: Diabetic Retinopathy Screening

Interventions

Diabetic Retinopathy Screening DIAGNOSTIC_TEST

Screenings are performed in the diabetes consultation in general practice

People with type 2 diabetes

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Blindness
• Cannot partake in second screening

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Malene Krogh

Aalborg, DK, 9000, Denmark

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Malene Krogh

  Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. student

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 11, 2022
• Study Start: February 28, 2022
• Primary Completion: November 14, 2023
• Study Completion: November 14, 2023
• Last Updated: May 6, 2025

Record last verified: 2023-01

Locations

DK (1)