Acceptability and Efficiency of Screening for Diabetic Retinopathy in Pharmacies With Artificial Intelligence Enhanced Retinophotography : a French Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- diabetic retinopathy screening rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient unable to read, write or give consent
- •Patient refusing to share results with their general practitioner or ophthalmologist
结局指标
主要结局
diabetic retinopathy screening rate
时间窗: 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%)
次要结局
- lesions stages at screening(approximately one year after study start)
- screening cost(approximately one year after study start)
- consistance between artificial intelligence and ophthalmologist re-read for doubtful images(approximately one year after study start)
- patients and investigators satisfaction(approximately one year after study start)
- technical feasibility(approximately one year after study start)