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临床试验/NCT05809843
NCT05809843已完成不适用

Deep Learning in Vascular and Structural Retinal Changes in Diabetic Patients Undergoing Artificial Pancreas Device

Federico II University1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2023年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11
试验地点
1
主要终点
The measurements of retinal and choriocapillary vessel density in type 1 diabetic patients undergoing artificial pancreas device

研究概览

简要总结

This study evaluates the ability of deep learning to improve the knowledge about structural and vascular retinal changes in diabetic patients undergoing artificial pancreas device, using optical coherence tomography angiography.

详细描述

hybrid artificial pancreas systems (CSII) are able to adjust the type 1 diabetic patient's glycemic levels with insulin doses appropriate to the patient's blood glucose.

The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features.

The study evaluates the changes in optical coherence tomography angiography features in diabetic patients undergoing artificial pancreas device, elaborating these data with artificial intelligence.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • age older than 18 years
  • diagnosis of type 1 diabetes
  • treatment with artificial pancreas device
  • absence of previous ocular surgery and congenital eye diseases.
  • absence of errors of refraction
  • absence of lens opacities
  • absence of low-quality OCT and OCTA images

排除标准

  • age younger than 18 years
  • previous ocular surgery and congenital eye diseases
  • errors of refraction
  • lens opacities
  • low-quality OCT and OCTA images

结局指标

主要结局

The measurements of retinal and choriocapillary vessel density in type 1 diabetic patients undergoing artificial pancreas device

时间窗: up to 3months

The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillary vessel density matched with clinical parameters resulted from the artificial pancreas device

次要结局

未报告次要终点

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ciro Costagliola

professor

Federico II University

研究点 (1)

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