Diabetic RetinopathyNCT05276778
Diabetic Retinopathy Screening in General Practice
An observational study of Diabetic Retinopathy and Type2 Diabetes, run by Aalborg University at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Retinopathy, Type2 Diabetes
- What is being tested?
- Diabetic Retinopathy Screening
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Feb 2022to 14 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosed with type 2 diabetes
- Understands Danish
- Age between 18-70
Who cannot join
- Blindness
- Cannot partake in second screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diabetic Retinopathy Screenings in General Practice for People With Type 2 Diabetes
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
- Being tested
- Diabetic Retinopathy Screening
- Keywords
- Artificial Intelligence, Diabetic Retinopathy Screening, General practice, Primary care, Type 2 diabetes
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetic Retinopathy ScreeningDiagnostic test
Screenings are performed in the diabetes consultation in general practice
| Study group | Role | What they receive |
|---|---|---|
| People with type 2 diabetes | People diagnosed with type 2 diabetes age 18-70 Receives: Diagnostic Test: Diabetic Retinopathy Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' acceptance of diabetic retinopathy screenings in general practice
Questionnaire
Measured: 1 day (the questionnarie is fufilled one time after the retinopaty screening in general practice)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start28 Feb 2022
- Primary completion14 Nov 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malene Krogh, Aalborg University
- Investigators
- Malene Krogh, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276778
- Sponsor's protocol ID
- mKrogh
- Status last verified
- Jan 2023
- First submitted
- 28 Feb 2022
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Retinopathy Screenings in General Practice for People With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05276778
- Acronym / sponsor ID
- mKrogh
- Conditions
- Diabetic Retinopathy, Type2 Diabetes
- Keywords
- Artificial Intelligence, Diabetic Retinopathy Screening, General practice, Primary care, Type 2 diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with type 2 diabetes | – | Diagnostic Test: Diabetic Retinopathy ScreeningPeople diagnosed with type 2 diabetes age 18-70 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Diagnosed with type 2 diabetes
- Understands Danish
- Age between 18-70
Key exclusion criteria (2 listed)
- Blindness
- Cannot partake in second screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetic Retinopathy ScreeningScreenings are performed in the diabetes consultation in general practice | Diagnostic test | People with type 2 diabetes |
Primary outcome
Patients' acceptance of diabetic retinopathy screenings in general practice
Time frame: 1 day (the questionnarie is fufilled one time after the retinopaty screening in general practice)
Questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Retinopathy
RecruitingPhase 2/3
Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
Diabetic Retinopathy
RecruitingPhase 2
A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy
Diabetic Retinopathy
RecruitingPhase 2
A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingObservational study
Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
Diabetic Macular Edema, Diabetic Retinopathy
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malene Krogh principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy and Type2 Diabetes, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' acceptance of diabetic retinopathy screenings in general practice (time frame: 1 day (the questionnarie is fufilled one time after the retinopaty screening in general practice)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.