Implementing Digital Retinal Exams Into Comprehensive Pediatric Diabetes Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Proportion screened for diabetic retinopathy
研究概览
简要总结
The purpose of this study is to determine if use of a nonmydriatic fundus camera using autonomous artificial intelligence software at the point of care increases the proportion of underserved youth with diabetes screened for diabetic retinopathy, and to determine the diagnostic accuracy of the autonomous AI system in detecting diabetic retinopathy from retinal images of youth with diabetes.
详细描述
This study will recruit up to 500 individuals ages 8-21 with type 1 or type 2 diabetes. In this study, participants will undergo a point-of-care diabetic eye exam using autonomous AI software on a non-mydriatic fundus camera. Participants will receive the diabetic eye exam results immediately from the autonomous AI system, and if abnormal will be referred to an eye care provider for a dilated eye exam.
In the AI for ChildrenS Diabetic Eye ExamS Study (ACCESS2), 398 participants will be enrolled to determine if point of care autonomous AI increases the proportion of minority and underserved youth screened for diabetic retinopathy. The autonomous AI interpretation will also be compared to consensus grading of retinal specialists to determine if there is agreement and to determine the diagnostic accuracy of the system in youth.
A cohort of youth with known diabetic retinopathy (true positives) will also be enrolled as an enriched population to determine the diagnostic accuracy of autonomous AI compared to the prognostic standard interpretation of a central reading center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
All participants will undergo point-of-care diabetic retinopathy screening. Participants will know that they will undergo point-of-care diabetic retinopathy screening at the time of consenting.
入排标准
- 年龄范围
- 8 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets American Diabetes Association (ADA) criteria for diabetic retinopathy screening:
- •Diagnosis of Type 1 diabetes for ≥3 years, and age 11 or in puberty
- •Diagnosis of Type 2 diabetes
- •Enriched cohort:
- •Patients with Type 1 or Type 2 diabetes,
- •8-21 years of age with known diabetic retinopathy (true positives).
- •No time limit on last diabetic eye exam.
排除标准
- •Known diabetic eye exam in the last 12 months
研究组 & 干预措施
Diabetic Retinopathy Exam at the point of care
Participants will undergo a point of care diabetic retinopathy eye exam using autonomous AI. Those that test positive will be referred to Eye Care Provider for dilated eye exam.
干预措施: Point of Care Autonomous AI diabetic retinopathy exam (Diagnostic Test)
结局指标
主要结局
Proportion screened for diabetic retinopathy
时间窗: Day 1
Equivalence in proportion screened for diabetic retinopathy of white and non-white youth with autonomous AI
次要结局
- Percentage of agreement in interpretation of retinal images(Day 1)
- Sensitivity of autonomous AI vs. prognostic standard(Day 1)
- Specificity of autonomous AI vs. prognostic standard(Day 1)
- Proportion with diabetic retinopathy(Day 1)