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临床试验/NCT03898076
NCT03898076已完成不适用

The Prediction of A1c Based on CGM Data Through Applying Machine Learning Approaches

Sidra Medicine1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
The difference of Predictive A1c level from CGM data with Real A1c level from EMR

研究概览

简要总结

Introduction. The hemoglobin A1C (HbA1c) reflects the average blood glucose level for last two to three months. Recent advancements in the sensor technology facilitate the daily monitoring of the blood glucose using CGM devices. The future prediction of the HbA1C based on the CGM data holds a critical significance in maintaining long term health of diabetes patients. A higher than normal value of the HbA1c greatly increases the likelihood of diabetes related cardiovascular disease.

Goal. The aim this study is to predict the HbA1c in advance by utilizing the CGM data through applying machine learning techniques. The outcomes of this research will assist in improving the health of diabetic patients.

Methods. This is a retrospective analysis. The investigators will de-identify and analyze 120 patients with T1D who using CGM sensor for last three months. Past 15 days of CGM data will be analyzed and different glucose variability features such as time in range (TIR), coefficient of variation (CV), mean amplitude of glycemic excursion (MAGE), mean of daily differences (MODD), continuous overall net glycemic action (CONGA) will be extracted. A machine learning model will calculate (predict) HbA1c in 2-3 months advance based on these 15 days of CGM data. To evaluate the performance of the proposed prediction model, predicted HbA1c will be compared with the real HbA1c.

详细描述

This is a retrospective analysis. The investigators will de-identify and analyze 120 patients with T1D using Continuous Glucose Monitoring (CGM) system for last three months. Past 15 days of CGM data will be analyzed and different glucose variability features such as time in range (TIR), coefficient of variation (CV), mean amplitude of glycemic excursion (MAGE), mean of daily differences (MODD), continuous overall net glycemic action (CONGA) will be extracted. A machine learning model will be developed to predict HbA1c in 2-3 months advance based on these 15 days of CGM data. The model is using linear regression, penalized regression (Ridge regression, Lasso regression and Elastic net regression) in combination gradient boosting to calculate predictive A1c

研究设计

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

入排标准

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

入选标准

  • Type 1 Diabetes
  • Flash glucose Monitoring system

排除标准

  • Less than 70% od CGM data in the last 90 days.

结局指标

主要结局

The difference of Predictive A1c level from CGM data with Real A1c level from EMR

时间窗: 3 months

Difference (%) between Predicted A1c and laboratory A1c from the Electronic Medical Record

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Goran Petrovski

Goran Petrovski Clinical Professor

Sidra Medicine

研究点 (1)

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