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Assessment of Personalized Follow-up in Prevention of Type 2 Diabetes (Proxipart)

2022年4月5日 更新者:Ramsay Générale de Santé

In France, the overall prevalence of diabetes was estimated at 5% of population in 2016, type 2 diabetes (T2DM) corresponding to 90% of cases. However, this figure is greatly underestimated,since it does not take into account people who are untreated or not diagnosed. However,it is estimated that 20 to 30% of adults with diabetes do not are not diagnosed. Conclusions presented during the annual meeting of the european Association for the Study of diabetes (EASD-Berlin) from 2019 suggest that signs precursors of the disease would be present up to 20 years before the diagnosis.

The Diagnosis is usually made around 40-50 years. The main factor of risk of T2D is the lifestyle, in particular a diet too rich for a too sedentary daily life.

From a medico-economic point of view, chronic pathologies (including diabetes) account for 60% of insurance expenditure illness even though they concern 35% of insured persons, i.e. 20 million patients. The average annual repayment of a type 2 diabetic patient is 4890 euros.

This study is part of this context as the starting point a reflection on a different, coordinated management, to know a preventive rather than a curative approach.

研究概览

地位

招聘中

条件

详细说明

In France, the overall prevalence of diabetes was estimated at 5% of population in 2016, type 2 diabetes (T2DM) corresponding to 90% of cases. However, this figure is greatly underestimated. since it does not take into account people who are untreated or not diagnosed. However, given the silent nature of the disease, it is estimated that 20 to 30% of adults with diabetes do not are not diagnosed. This share decreases with age, falling to 13% among 55-74 year olds. Conclusions presented during the annual meeting of the european Association for the Study of diabetes (EASD-Berlin) from 2019 suggest that signs precursors of the disease would be present up to 20 years before the diagnosis.

Type 2 diabetes, or non-insulin dependent diabetes, is a metabolic disease characterized by a chronic excess of sugar in the blood, affecting both men and women. the Diagnosis is usually made around 40-50 years. The main factor of risk of T2D is the lifestyle, in particular a diet too rich for a too sedentary daily life. The direct consequences are an increase in obesity hich is itself a major risk factor for the development of T2D. Among the risk factors, we also find hyperlipidemia, high blood pressure, high blood sugar fasting, stress, smoking, heredity, family history of diabetes, or gestational diabetes.

From a medico-economic point of view, chronic pathologies (including diabetes) account for 60% of insurance expenditure illness even though they concern 35% of insured persons, i.e. 20 million patients. The average annual repayment of a type 2 diabetic patient is 4890 euros.This study is part of this context as the starting point a reflection on a different, coordinated management, to know a preventive rather than a curative approach.

研究类型

介入性

注册 (预期的)

230

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Aquitaine
      • Biarritz、Aquitaine、法国、64200
        • 招聘中
        • Clinique Aguiléra
        • 接触:
          • Aurélie LIETAER, DR

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patient, male or female, over the age of 18
  • Patient with a FINDRISC score ≥10 points
  • Beneficiary of a French health insurance system
  • Patient having been informed and having given their consent free, enlightened and written

Exclusion Criteria:

  • Patient over 75 years old
  • Patient already diagnosed with type 2 diabetes
  • Patient whose physical and/or psychological health is severely impaired, which according to the investigator may affect the compliance of the study participant.
  • Patient participating in another research
  • Patient in period of exclusion from another research always in progress at the time of inclusion.
  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by court order or administration.
  • Pregnant, breastfeeding or parturient women.
  • Patient hospitalized without consent

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:TD2 standard
Standard TD2 follow-up
Contact everay 4 months with a dedicated study nurse
实验性的:TD2+ study Nurse
Specific study nurse follow-up every 4 months in addition of standard FU.
Contact everay 4 months with a dedicated study nurse

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
FINDRISC score
大体时间:5 years
FINDRISC is a prediction tool to identify patients at risk of developing diabetes without biological analysis.
5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年3月20日

初级完成 (预期的)

2028年4月1日

研究完成 (预期的)

2028年4月1日

研究注册日期

首次提交

2022年4月5日

首先提交符合 QC 标准的

2022年4月5日

首次发布 (实际的)

2022年4月13日

研究记录更新

最后更新发布 (实际的)

2022年4月13日

上次提交的符合 QC 标准的更新

2022年4月5日

最后验证

2022年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2021-A00375-36

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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