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临床试验/CTRI/2024/04/065141
CTRI/2024/04/065141尚未招募不适用

A deep-learning based tool for prediction of chronic kidney disease from retinal images in people with type 2 diabetes

European Foundation for the Study of Diabetes1 个研究点 分布在 1 个国家目标入组 2,400 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
2,400
试验地点
1
主要终点
Development of deep learning algorithm for prediction of kidney disease using retinal images among type 2 diabetes

研究概览

简要总结

Background

The burden of chronic kidney disease (CKD) is increasing due to exponential increase in diabetes and hypertension globally. The association between diabetic retinopathy (DR) and diabetic kidney disease (DKD) suggests common pathways of microangiopathy.  Application of Artificial intelligence (AI) and deep learning (DL) in medicine aids early detection, disease diagnoses and predictions and enables appropriate timely intervention/ management. Retinal colour photography can be a non-invasive approach for identification of early microvascular alterations of chronic systemic complications especially CKD prior to the onset of overt clinical presentation.

Objectives:

To develop and validate a DL based algorithm to detect and prognosticate the risk for development of CKD using retinal images and clinical data in individuals with type 2 diabetes.

Methods:

Anonymized clinical metadata and corresponding retinal images of 2000 individuals with type 2 diabetes with and without DR will be utilized for development of DL model to detect CKD. Systemic parameters such as age, gender, duration of diabetes, glycated haemoglobin (HbA1c) and hypertension (HT) will be utilized along with retinal colour photographs for this model. Longitudinal data will be used for developing the prognostic tool to detect people at risk of stage 3 CKD (defined as estimated glomerular filtration rate [eGFR] < 60 ml/ min/ 1.73m2).  Convolution neural network-support vector machine (CNN-SVM) DL model will be used.  After the assessment of accuracy (sensitivity and specificity) of the DL algorithm in individuals with type 2 diabetes, the external validation will be carried out prospectively among 400 patients.

Expected outcome:

The tool would aid early detection and prediction of CKD (before it reaches stages 4 or 5), easily manageable with glycemic control and blood pressure control; hence reduce the morbidity and healthcare costs due to CKD.  Holistic screening for DR and CKD in individuals with diabetes would be possible through non-invasive retinal imaging with use of AI.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Data of individuals with type 2 diabetes aged ≥ 18 years who have provided written informed consent for use of their anonymised data.
  • Data of individuals with and without diabetic kidney disease
  • Individuals who have clear retinal images
  • Retinal images with and without diabetic retinopathy changes.

排除标准

  • 1.Unclear retinal images due to media opacities 2.Clinical and image data of those who have not provided consent for use of anonymized data.

结局指标

主要结局

Development of deep learning algorithm for prediction of kidney disease using retinal images among type 2 diabetes

时间窗: 1 year

次要结局

  • Real time validation deep learning algorithm developed for prediction of kidney disease using retinal images(6 months)

研究者

申办方类型
Other [Non profit research funding organization ]
责任方
Principal Investigator
主要研究者

Dr Viswanathan Mohan

Madras Diabetes Research Foundation

研究点 (1)

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