Screening for Diabetic Retinopathy in Pharmacies With Artificial Intelligence Enhanced Retinophotography

NCT05452993 | Completed

• 1 other identifier: 2021-A01929-32
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy; Artificial Intelligence; Diabetes Mellitus

Keywords

Diabetic Retinopathy; Artificial Intelligence; Telemedicine; Pharmacy; Retinophotography; Screening; Primary care

Outcome Measures

Primary Outcomes (1)

• 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%)

  approximately one year after study start

Secondary Outcomes (5)

• patients and investigators satisfaction

  approximately one year after study start

• screening cost

  approximately one year after study start

• technical feasibility

  approximately one year after study start

• lesions stages at screening

  approximately one year after study start

• consistance between artificial intelligence and ophthalmologist re-read for doubtful images

  approximately one year after study start

Study Arms (2)

1 - Retinophotography for diabetic retinopathy screening

EXPERIMENTAL

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

Device: Analysed Retinophotography

2 - No screening

NO INTERVENTION

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

Interventions

Analysed Retinophotography DEVICE

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

1 - Retinophotography for diabetic retinopathy screening

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, France

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: July 12, 2022
• Study Start: December 16, 2022
• Primary Completion: December 5, 2023
• Study Completion: December 31, 2024
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

FR (1)