Diabetic Retinopathy Screening in General Practice

• Sponsor: Aalborg University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05276778
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 7.1
• Patients Per Site Per Month: 42.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy; Type2 Diabetes	Diagnostic Test: Diabetic Retinopathy Screening

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Diabetic Retinopathy Screenings in General Practice for People With Type 2 Diabetes
• Actual Study Start Date: Feb 28, 2022
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
People with type 2 diabetes People diagnosed with type 2 diabetes age 18-70	Diagnostic Test: Diabetic Retinopathy Screening; Screenings are performed in the diabetes consultation in general practice

Outcome Measures

Primary Outcome Measures

1. Patients' acceptance of diabetic retinopathy screenings in general practice [1 day (the questionnarie is fufilled one time after the retinopaty screening in general practice)]

   Questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• Diagnosed with type 2 diabetes

• Understands Danish

• Age between 18-70

Exclusion Criteria:

• Blindness

• Cannot partake in second screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Malene Krogh	Aalborg	DK	Denmark	9000

Sponsors and Collaborators

• Aalborg University

Investigators

• Principal Investigator: Malene Krogh, Center for General Practice at Aalborg University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Malene Krogh, Ph.D. student, Aalborg University
• ClinicalTrials.gov Identifier: NCT05276778
• Other Study ID Numbers: mKrogh
• First Posted: Mar 11, 2022
• Last Update Posted: Mar 11, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Malene Krogh, Ph.D. student, Aalborg University: Artificial Intelligence; Diabetic Retinopathy Screening; General practice; Primary care; Type 2 diabetes
• Additional relevant MeSH terms: Retinal Diseases; Diabetic Retinopathy; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Mar 11, 2022