Screening for Diabetic Retinopathy in Pharmacies With Artificial Intelligence Enhanced Retinophotography

NCT ID: NCT05452993

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-16
• Study Completion Date: 2024-12-31

Brief 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.

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.

Conditions

Diabetic Retinopathy; Artificial Intelligence; Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

1 - Retinophotography for diabetic retinopathy screening

Patients who accepted to participate to this study and had retinophotography for diabetic retinopathy screening.

Group Type: EXPERIMENTAL

Analysed Retinophotography

Intervention Type: DEVICE

taking 2 retinophotographs per eye, and then analysed by AI software to detect Diabetic retinopathy

2 - No screening

Patients who did not meet inclusion criteria and/or refused the retinophotographies screening.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Analysed Retinophotography

taking 2 retinophotographs per eye, and then analysed by AI software to detect Diabetic retinopathy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Patient unable to read, write or give consent
• Patient refusing to share results with their general practitioner or ophthalmologist

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Caen University Hospital

Caen, , France

Countries

France

Other Identifiers

2021-A01929-32

Identifier Type: -

Identifier Source: org_study_id