Prevalence of Post Traumatic Stress Disorder Related to Diabetes Diagnosis or Severe Hypoglycaemia in Adult With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 297
- 试验地点
- 2
- 主要终点
- To evaluate the prevalence of post-traumatic stress disorder (PTSD) in adult with Type 1 Diabetes
研究概览
简要总结
In France, the adult population living with diabetes in 2016 is estimated at more than 3.3 million patients treated. Type 1 diabetes (T1DM) represents 5.6% of diabetic patients (approximately 185,000 patients).
Numerous studies show that patients fear hypoglycemia, with an impact on their quality of life, sleep disorders and depressive symptoms. In addition, there is a metabolic impact with a problem of therapeutic compliance and an alteration of glycemic control.
This study examine the relation between Post Traumatic Stress disorder (PTSD) and diabetes diagnosis or severe hypoglycaemia in adults with Type 1 Diabetes.
The aim of this study is to evaluate the prevalence of PTSD in this population.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •18 years of age or older,
- •With type 1 diabetes,
- •Willing and able to complete all the questionnaires in French,
- •Who have given oral consent,
- •being affiliated to a social security scheme or being a beneficiary of such a scheme.
排除标准
- •Non-diabetic type 1,
- •With an unstable psychiatric pathology,
- •Pregnant or breastfeeding women,
- •Subject to a measure for the protection of justice,
- •Having opposed the research.
结局指标
主要结局
To evaluate the prevalence of post-traumatic stress disorder (PTSD) in adult with Type 1 Diabetes
时间窗: baseline
Score (\>44) measured on the Posttraumatic Stress Disorder Checklist Scale (PCL-S) for severe hypoglycemia
次要结局
- To evaluate the prevalence of post-traumatic stress disorder (PTSD). This PTSD is related to diabetes diagnosis and its initial management.(baseline)
- To evaluate the prevalence of anxiety-depressive disorder in adults with type 1 diabetes(baseline)
- To evaluate the prevalence of post-traumatic stress disorder (PTSD). This PTSD is related to at least one of the following reasons : - severe hypoglycemia - diabetes diagnosis and its initial management.(baseline)
- To demonstrate the presence of anxiety-depressive disorder related to PTSD(baseline)
- To evaluate the prevalence of post-traumatic stress disorder (PTSD) related to severe hypoglycemia.(baseline)
- To evaluate whether there is a correlation between PTSD and the patient participation to a therapeutic education program(baseline)