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临床试验/NCT05482958
NCT05482958已完成不适用

Delivering Evidence Based Care Using Artificial Intelligence to Patients With Diabetes and CardioVascular Comorbidities: The DECIDE-CV Innovation Project

McGill University Health Centre/Research Institute of the McGill University Health Centre1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2022年7月29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
210
试验地点
1
主要终点
Presence or absence of T2DM

研究概览

简要总结

The purpose of this study is to identify digital biomarkers associated with type 2 diabetes mellitus (T2DM) by combining sensor data from a wrist-worn wearable and clinical data. This will be done by recruiting patients with and without diabetes within the cardio-metabolic clinics a the MUHC. Consented patients will be provided with a HOP Technologies (HOP) watch in this project across two observation periods. The Watch-HOP platform facilitates the development of predictive algorithms built with data collected in a clinical setting or at home in a passive (sensors) and active (self-assessments) way. Data from the Watch-Hop will be analyzed using machine learning strategies to determine associations with clinical measures of T2DM.

详细描述

The epidemic of type 2 diabetes mellitus (T2DM) continues to increase. Sensor technologies and artificial intelligence present us with an opportunity to identify patients suffering from T2DM and to optimize their treatment.

Specifically, our primary objective is to identify digital biomarkers associated with T2DM by combining sensor data from a wrist-worn wearable and clinical data.

研究设计

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

入排标准

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

入选标准

  • Age > 18 years
  • Able to follow-up with study protocol schedule
  • Life expectancy > 1 year
  • Case group only a. HbA1c >= 6.5% or is diagnosed with T2DM

排除标准

  • Any person who does not meet the above criteria or who refuses to participate
  • Undergoing chemotherapy or dialysis
  • Currently in palliative care
  • Any person who does not have an email address
  • Control group only a. HbA1c >= 6.5% or is diagnosed with T2DM

结局指标

主要结局

Presence or absence of T2DM

时间窗: Cross sectional based on a single clinic visit with device worn for an estimated 24 hours

As defined by HbA1c \> 6.5 %, known history of T2DM, or on antihyperglycemic therapies

Glycemic control amongst people with established T2DM.

时间窗: Cross sectional based on a single clinic visit with device worn for an estimated 24 hours

As defined by HbA1c %

次要结局

  • Glycemic control.(Cross sectional based on a single clinic visit with device worn for an estimated 24 hours)
  • Change in glycemic control.(On average the change will be evaluated over 3-6 months)

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Abhinav Sharma

Assistant Professor

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (1)

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