Clinical trial NCT05452993: Screening for Diabetic Retinopathy in Pharmacies With Artificial Intelligence Enhanced Retinophotography
Official title: Acceptability and Efficiency of Screening for Diabetic Retinopathy in Pharmacies With Artificial Intelligence Enhanced Retinophotography : a French Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Retinopathy
Artificial Intelligence
Diabetes Mellitus
Keywords: Diabetic Retinopathy
Artificial Intelligence
Telemedicine
Pharmacy
Retinophotography
Screening
Primary care
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: diabetic retinopathy screening rate
timeFrame: approximately one year after study start
Secondary outcomes:
measure: patients and investigators satisfaction
timeFrame: approximately one year after study start
measure: screening cost
timeFrame: approximately one year after study start
measure: technical feasibility
timeFrame: approximately one year after study start
measure: lesions stages at screening
timeFrame: approximately one year after study start
measure: consistance between artificial intelligence and ophthalmologist re-read for doubtful images
timeFrame: approximately one year after study start
Other outcomes:
Locations:
Study officials:
References: