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临床试验/NCT04614376
NCT04614376Unknown不适用

A Machine Learning Approach to Alzheimer's Detection From Continuous Blood Glucose Monitoring Data

Bio Conscious Technologies Inc.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Blood Glucose Levels

研究概览

简要总结

The Alzheimer's and Blood Glucose Levels Study is researching the differences in blood glucose levels between people with and without Mild Cognitive Impairment or Alzheimer's disease with the aim of early detection of Alzheimer's Disease.

详细描述

This study will collect continuous glucose monitor (CGM) data from participants already using CGMs to better understand the relationship between Alzheimer's Disease and blood glucose levels. This study will use the " Endobits Companion " app for data collection. The Endobits Companion app is freely available for Android and iOS mobile devices, and was designed to keep track of patients diabetes management through a journal and relay this information with their CGM readings to their caring physician.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • For the case group: have been diagnosed with MCI or AD within the past 5 years.
  • For the control group: have not been diagnosed with MCI or AD or another major dementia disease
  • Currently using a continuous glucose monitor (CGM).
  • Willing and able to provide informed consent, and to have their data collected through the Endobits Companion app. If the participant themself is unable to provide informed consent, it will be sought from their primary caregiver.

排除标准

  • Patients younger than 50 years of age.
  • Patients with a BMI lower than 18 or higher than
  • Patients with a major psychiatric illness (e.g., major depressive disorder, schizophrenia, bipolar disorder)
  • Patients diagnosed with another major dementia disease, including vascular dementia, Lewy Body disease, Huntington's disease, Creutzfeldt-Jakob disease, and Parkinson's disease.

结局指标

主要结局

Blood Glucose Levels

时间窗: This will be measured throughout the study which is a period of up to 90 days.

All participants will use continuous glucose monitors for the period of the study. The primary outcome is to determine the difference in mean values, variability, and other patterns in blood glucose levels between the case and control groups. As there is no intervention in this study, the difference between the case and control group will be measured over the entire study period.

次要结局

未报告次要终点

研究者

发起方
Bio Conscious Technologies Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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