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临床试验/NCT05261841
NCT05261841进行中(未招募)不适用

Observational Analysis and Elaboration of a Predictive Model on the Effects of Physical Activity and Individual Lifestyles in the Management of Diabetic Disease Type 2 as Part of the GATEKEEPER H2020 Project.

Casa Sollievo della Sofferenza IRCCS1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年6月26日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
试验地点
1
主要终点
Change from Baseline HbA1c at 6 and 12 months

研究概览

简要总结

This study aims to produce new evidence on the positive effects of physical activity and certain individual lifestyles in the control of type 2 diabetic disease. The goal is to build and evaluate the effectiveness of a new parsimonious risk prediction model based on the use of classical variables (blood exams), already used in other models for predicting the risk related to the disease, together with measures obtained from the use of wearable devices (steps count, sleep hours, heart rate).

详细描述

Scientific literature has shown that the use of wearable devices can improve the control of type 2 diabetes mellitus. The aim of the study is to develop a statistical model for the control of type 2 diabetes mellitus (DMT2) based on the use of "conventional" clinical parameters and the use of "unconventional" data from wearable devices. The medical outcome variable that will be used to measure diabetes control and model performance will be the Glycated Hemoglobin (HbA1c). The participant will receive a Samsung smartwatch (Galaxy Watch 3) and a Samsung smartphone (A51), (the latter only in case the participant is not in possession of a compatible smartphone) which he/she must wear during his daily activities and also during the night to measure daily activity, sleep hours and heart rate. Casa Sollievo della Sofferenza Hospital previoulsy developted the ENFORCE calculator, an inexpensive and parsimonious prediction model of 2-year all cause mortality in real life patients with T2D. In this study the investigators aim to elaborate a standardized validated risk scores similar to what has been done for ENFORCE.

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
55 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 55 years old
  • Affected by Type 2 Diabetes and monitored by Casa Sollievo della Sofferenza Hospital
  • Basic skills in using a smartphone and its apps
  • Available to use the device and its applications
  • Ability to understand the informed consent

排除标准

  • Inability to understand the informed consent
  • Low life expectancy
  • Type 1 Diabetes
  • Secondary Diabetes

结局指标

主要结局

Change from Baseline HbA1c at 6 and 12 months

时间窗: Baseline, 6 months, 12 months

Glycated Hemoglobin

次要结局

未报告次要终点

研究者

发起方
Casa Sollievo della Sofferenza IRCCS
申办方类型
Other
责任方
Sponsor

研究点 (1)

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