Diabetic RetinopathyDIABeyeIANCT05452993
Screening for Diabetic Retinopathy in Pharmacies With Artificial Intelligence Enhanced Retinophotography
A study testing Analysed Retinophotography in people with Diabetic Retinopathy and Artificial Intelligence, run by University Hospital, Caen at 1 site in France.
Trial summary
Diabetic retinopathy is frequent, potentially severe with visual threat, health costly and represents a major public health problem. However, screening compliance for retinopathy remains too low in France, approximately 40% patients with diabetes laking diabetic retinopathy screening for at least 2 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Artificial Intelligence, Diabetes Mellitus
- What is being tested?
- Analysed Retinophotography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 16 Dec 2022to 31 Dec 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with diabetes
- Ongoing diabetes treatment (oral hypoglycaemic agents, injectable GLP-1 receptor agonists and insulin)
- Regular customer of the pharmacy (at least 3 previous visits)
- Informed consent to participate to the study
Who cannot join
- Patient unable to read, write or give consent
- Patient refusing to share results with their general practitioner or ophthalmologist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability and Efficiency of Screening for Diabetic Retinopathy in Pharmacies With Artificial Intelligence Enhanced Retinophotography : a French Pilot Study
Diabetic retinopathy is frequent, potentially severe with visual threat, health costly and represents a major public health problem. However, screening compliance for retinopathy remains too low in France, approximately 40% patients with diabetes laking diabetic retinopathy screening for at least 2 years.
DIABeyeIA is a prospective pilot study evaluating the effectiveness and acceptability of diabetic retinopathy screening in 11 pharmacies in Normandy (north of France) using a non-mydriatic portable retinophotograph enhanced by artificial intelligence software. The main goal of this work is to evaluate a potential increase rate of diabetic retinopathy screening, compared to the actual rate (64% in France). Secondary goals are faisability, satisfaction and economical considerations for implementation of such a new screening program.
Read the detailed description
DIABeyeIA is a 6 months prospective study in 11 pharmacies of Normandy (a french region in north of France), to assess a systematic diabetic retinopathy screening proposed to all patients with diabetes, identified on their usual treatment, who regularly visit their pharmacy.
Participating pharmacies will offer to all their patients with diabetes the opportunity to benefit from this screening when they visit the pharmacy to pick-up their treatment.
If the patient accepts, after written consent and completion of the clinical data form, he will benefit from diabetic retinopathy screening (Arm 1) : two retinophotographies per eye will be performed by the pharmacist and will be immediately interpreted by an artificial intelligence system through an interface made available to pharmacists.
In a few seconds, the system will answer:
- (i) that there is no diabetic retinopathy. In this case, a letter is sent to the patient, reminding him of the modalities and french recommendations for diabetic retinopathy screening.
- (ii) that images are doubtful and in this case, they will be re-read by an expert ophthalmologist who will transmit his interpretation to the patient via the pharmacist. In case of threatening damage, an emergency ophthalmologist visit in the university hospital will be proposed to the patient via his pharmacist.
Patients who will not meet inclusion criteria or will refuse the study will be included on the list of refusals/impossibility to participate to the DIABeyeIA study (Arm 2).
In all cases, a letter will be given to the patient by the pharmacist, for his general practitioner and his usual ophthalmologist, in order to inform them of the screening and its result.
Clinical and therapeutic data of each participating patient will be informed by the pharmacist.
Satisfaction questionnaires will be completed by the participating pharmacists at the end of the study and by the patients at the end of the screening.
- Being tested
- Analysed Retinophotography
- Keywords
- Diabetic Retinopathy, Artificial Intelligence, Telemedicine, Pharmacy, Retinophotography, Screening, Primary care
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysed RetinophotographyDevice
taking 2 retinophotographs per eye, and then analysed by AI software to detect Diabetic retinopathy
| Study group | Role | What they receive |
|---|---|---|
| 1 - Retinophotography for diabetic retinopathy screening | Experimental | Patients who accepted to participate to this study and had retinophotography for diabetic retinopathy screening. Receives: Device: Analysed Retinophotography |
| 2 - No screening | No intervention | Patients who did not meet inclusion criteria and/or refused the retinophotographies screening. |
What is being measured
The primary outcome is the main question the study is designed to answer.
diabetic retinopathy screening rate
The screening rate for diabetic retinopathy will be assessed in the 11 participating pharmacies and then compared to literature data (actual diabetic retinopathy screening rate = 64%)
The screening rate will be calculated as follows :
Number of patients screened(Arm 1)/(number of patients screened (Arm 1) + number of patients who refused screening or failed screening (Arm2)).
We hypothesise an improvement of 10 points (≥74%)
Measured: approximately one year after study start
Secondary outcomes (5)
patients and investigators satisfaction
Measurement of patients and pharmacists' satisfaction will be assessed with specific questionnaires
Measured: approximately one year after study start
screening cost
Cost of screening per patients will be calculated, by dividing total cost of this study by the number of patient screened for diabetic retinopathy.
Measured: approximately one year after study start
technical feasibility
The rate of interpretable retinophotographies will be evaluated.
Measured: approximately one year after study start
lesions stages at screening
To assess the possibility to identify diabetic retinopathy lesions at earlier stages than the conventional screening strategy
Measured: approximately one year after study start
consistance between artificial intelligence and ophthalmologist re-read for doubtful images
To evaluate consistance between artificial intelligence and ophthalmologist re-read for doubtful images
Measured: approximately one year after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start16 Dec 2022
- Primary completion5 Dec 2023
- Study completion31 Dec 2024
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.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452993
- Sponsor's protocol ID
- 2021-A01929-32
- Acronym
- DIABeyeIA
- Status last verified
- Jul 2025
- First submitted
- 3 Jan 2022
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Efficiency of Screening for Diabetic Retinopathy in Pharmacies With Artificial Intelligence Enhanced Retinophotography : a French Pilot Study
- ClinicalTrials.gov ID
- NCT05452993
- Acronym / sponsor ID
- DIABeyeIA / 2021-A01929-32
- Keywords
- Diabetic Retinopathy, Artificial Intelligence, Telemedicine, Pharmacy, Retinophotography, Screening, Primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 12 Jul 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 frequent, potentially severe with visual threat, health costly and represents a major public health problem. However, screening compliance for retinopathy remains too low in France, approximately 40% patients with diabetes laking diabetic retinopathy screening for at least 2 years.
DIABeyeIA is a prospective pilot study evaluating the effectiveness and acceptability of diabetic retinopathy screening in 11 pharmacies in Normandy (north of France) using a non-mydriatic portable retinophotograph enhanced by artificial intelligence software. The main goal of this work is to evaluate a potential increase rate of diabetic retinopathy screening, compared to the actual rate (64% in France). Secondary goals are faisability, satisfaction and economical considerations for implementation of such a new screening program.
Detailed description
DIABeyeIA is a 6 months prospective study in 11 pharmacies of Normandy (a french region in north of France), to assess a systematic diabetic retinopathy screening proposed to all patients with diabetes, identified on their usual treatment, who regularly visit their pharmacy.
Participating pharmacies will offer to all their patients with diabetes the opportunity to benefit from this screening when they visit the pharmacy to pick-up their treatment.
If the patient accepts, after written consent and completion of the clinical data form, he will benefit from diabetic retinopathy screening (Arm 1) : two retinophotographies per eye will be performed by the pharmacist and will be immediately interpreted by an artificial intelligence system through an interface made available to pharmacists.
In a few seconds, the system will answer:
- (i) that there is no diabetic retinopathy. In this case, a letter is sent to the patient, reminding him of the modalities and french recommendations for diabetic retinopathy screening.
- (ii) that images are doubtful and in this case, they will be re-read by an expert ophthalmologist who will transmit his interpretation to the patient via the pharmacist. In case of threatening damage, an emergency ophthalmologist visit in the university hospital will be proposed to the patient via his pharmacist.
Patients who will not meet inclusion criteria or will refuse the study will be included on the list of refusals/impossibility to participate to the DIABeyeIA study (Arm 2).
In all cases, a letter will be given to the patient by the pharmacist, for his general practitioner and his usual ophthalmologist, in order to inform them of the screening and its result.
Clinical and therapeutic data of each participating patient will be informed by the pharmacist.
Satisfaction questionnaires will be completed by the participating pharmacists at the end of the study and by the patients at the end of the screening.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - Retinophotography for diabetic retinopathy screening | Experimental | Device: Analysed RetinophotographyPatients who accepted to participate to this study and had retinophotography for diabetic retinopathy screening. |
| 2 - No screening | No intervention | –Patients who did not meet inclusion criteria and/or refused the retinophotographies screening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients with diabetes
- Ongoing diabetes treatment (oral hypoglycaemic agents, injectable GLP-1 receptor agonists and insulin)
- Regular customer of the pharmacy (at least 3 previous visits)
- Informed consent to participate to the study
Key exclusion criteria (2 listed)
- Patient unable to read, write or give consent
- Patient refusing to share results with their general practitioner or ophthalmologist
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 |
|---|---|---|
| Analysed Retinophotographytaking 2 retinophotographs per eye, and then analysed by AI software to detect Diabetic retinopathy | Device | 1 - Retinophotography for diabetic retinopathy screening |
Primary outcome
diabetic retinopathy screening rate
Time frame: approximately one year after study start
The screening rate for diabetic retinopathy will be assessed in the 11 participating pharmacies and then compared to literature data (actual diabetic retinopathy screening rate = 64%) The screening rate will be calculated as follows : Number of patients screened(Arm 1)/(number of patients screened (Arm 1) + number of patients who refused screening or failed screening (Arm2)). We hypothesise an improvement of 10 points (≥74%)
5 secondary outcomes
patients and investigators satisfaction
Time frame: approximately one year after study start
screening cost
Time frame: approximately one year after study start
technical feasibility
Time frame: approximately one year after study start
lesions stages at screening
Time frame: approximately one year after study start
consistance between artificial intelligence and ophthalmologist re-read for doubtful images
Time frame: approximately one year after study start
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 25 Jul 2025.
Related trials for Diabetic Retinopathy
RecruitingObservational study
Blepharoptosis After Repeated Intravitreal Anti-VEGF Injections: A Prospective Study
Blepharoptosis, Age-Related Macular Degeneration
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
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analysed Retinophotography in people with Diabetic Retinopathy and Artificial Intelligence, run by University Hospital, Caen at 1 site in France.
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 4 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 25 Jul 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 France. 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?
diabetic retinopathy screening rate (time frame: approximately one year after study start). 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 25 Jul 2025.