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临床试验/NCT06365255
NCT06365255已完成不适用

National Epidemiological Study of the Possible Impact of Stress on Glycaemic Control in Patients With Type 1 Diabetes

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète11 个研究点 分布在 1 个国家目标入组 1,344 人开始时间: 2023年1月17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
1,344
试验地点
11
主要终点
The primary endpoint is the characterisation of 4 profiles of patients with type 1 diabetes on insulin pumps.

研究概览

简要总结

The EPISTRESS2 study is a one-off cross-sectional epidemiological survey, carried out via an online form in patients with type 1 diabetes followed up by participating investigating centres.

In type 1 diabetes (T1DM), studies on stress and its impact on glycaemia have led to ambiguous results, mainly because there are no solid epidemiological or experimental data in the literature. The aim of this study was to assess the impact of perceived stress on blood glucose levels in a population of subjects with T1DM at 10 national centres.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

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

  • Patients with type 1 diabetes;
  • Do not have a psychiatric pathology;
  • At least 18 years old;
  • Affiliated to the Social Security;
  • Having read the non-opposition form and not objecting to it.

排除标准

  • Patient who has declared his opposition using the electronic non-opposition form
  • Patient with type 2 diabetes

结局指标

主要结局

The primary endpoint is the characterisation of 4 profiles of patients with type 1 diabetes on insulin pumps.

时间窗: 30 minutes

Questionnaire for Assessing the Impact of Stress on Blood Sugar Levels. This questionnaire was designed and developed by CERITD to assess the impact of perceived stress on blood glucose levels in T1DM patients.

次要结局

  • Establish and categorise the different stress factors(30 minutes)
  • Evaluation of the quality of life score obtained according to the 4 profiles and/or personalities(30 minutes)
  • Identify sub-populations of patients who feel stressed(30 minutes)
  • Establishing a relationship between personality type and the impact of stress(30 minutes)

研究者

发起方
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
申办方类型
Other
责任方
Sponsor

研究点 (11)

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