Study of the Changes in Glycemic Control and Psychological Distress in Diabetic Patients After the Confinement Period Related to the COVID-19 Epidemic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 11
- 主要终点
- HbA1c
研究概览
简要总结
Prospective, non-interventional, multicentric study
详细描述
The rapid spread of the COVID-19 pandemic and the isolation at home implemented in France, creates unprecedented challenges for diabetic patients.
Patients with diabetes have been considered to be at higher risk of infection by the virus, with a greater risk of mortality; this has been a great source of anxiety for them.
It is well known that stress has an impact on plasma glucose levels. The French situation where a general confinement has been decreed over the whole territory (which is not the case for all countries) and for a period of two months, makes it possible to study the impact of this unique situation on stress, sedentary lifestyle, changes in diet and decrease in physical activity. There are no similar experiences described in the literature.
The investigators hypothesize there will be an increase of HbA1c in the coming months.
The main objective is to assess changes in glycemic control in diabetic patients after the confinement period.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 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
- •Adult patient (≥ 18 years old)
- •Diabetic patient (type 1 or type 2) regardless of their diabetes treatment who experienced complete confinement in their own home, in France.
- •Patients who had a measured HbA1 or an estimated HbA1c with a glucose sensor Freestyle libre with a known result, between November 1, 2019 and February 29,
- •Patients agreeing to have their HbA1c measured between May 15 and July 31,
- •Having been informed of the study and not objecting to participating in it
排除标准
- •Adults over the age of legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty.
结局指标
主要结局
HbA1c
时间窗: Baseline
The change in HbA1c over the first confinement period as compared to the value in early 2020.
次要结局
- Stress(Baseline)