Assessing the Impact of the COVID-19 Lockdown on Metabolic Control and Access to Health Care in Patients With Diabetes: a Monocentric Cross-sectional Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Compare glycated hemoglobin levels of patients with diabetes from the University Hospital of Nancy between the period preceding and following the lockdown related to the COVID-19 pandemic.
研究概览
简要总结
The outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the COVID-19 (Coronavirus Disease-2019) in December 2019 has led to an unprecedented international health situation. Exceptional measures have been taken by public authorities worldwide in order to slow the spread of the virus and prevent healthcare systems from becoming overloaded. In France, a national lockdown has been established during approximately 2 months to increase social distancing and restrict population movements. Hospital routine care appointments have been cancelled, in order to reallocate medical resources towards COVID-19 units and limit contacts between patients within hospitals or waiting rooms. While the virus itself, the disease and potential treatments are currently extensively studied, little data are available on the effect of these public health decisions on the management of a chronic condition such as diabetes.
The French regional CONFI-DIAB study aims at assessing the collateral impact of routine care cancellation during the national lockdown due to COVID-19 in patients with a chronic condition such as diabetes. Special attention will be given to metabolic control and access to health care.
This cross-sectional study should provide information on the consequences of a global lockdown and the associated routine care cancellation on the management of diabetes, and inform future decision making in the event of a new pandemic.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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 patients
- •Patient with diabetes known for at least 6 months before inclusion
- •Patient followed by a specialist physician from the University Hospital of Nancy for routine care within the 6 months prior to the lockdown.
- •Patient who was assessed for prioritization of care following the end of the lockdown by the department of endocrinology, diabetology and nutrition
排除标准
- •Subjects opposed to the use of their data
- •Minors, adults under guardianship, protected persons
结局指标
主要结局
Compare glycated hemoglobin levels of patients with diabetes from the University Hospital of Nancy between the period preceding and following the lockdown related to the COVID-19 pandemic.
时间窗: 6 months period prior to lockdown - 6 weeks period following the end of the lockdown
HbA1c levels before and after the lockdown period. A 3 months period is required between the 2 values.
次要结局
- Describe the clinical and biological characteristics of patients with diabetes followed in routine care at the University Hospital of Nancy(6 weeks period following the end of the lockdown)
- Describe the proportion of patients who forgot and/or discontinued one or several medication(s) during the lockdown.(6 weeks period following the end of the lockdown)
- Describe the proportion of patients who (1) was tested for SARS-CoV-2 by PCR, (2) developped COVID-19 confirmed by PCR and (3) was hospitalized due to the severity of COVID-19.(6 weeks period following the end of the lockdown)
- Describe the change from baseline of biological and clinical parameters of patients with diabetes followed in routine care at the University Hospital of Nancy between the period preceding and following the lockdown.(6 months period prior to lockdown - 6 weeks period following the end of the lockdown)
- Describe the proportion of patients who presented with one or more significant clinical event during the lockdown.(6 weeks period following the end of the lockdown)
- Describe healthcare consumption of patients with diabetes during the lockdown.(6 weeks period following the end of the lockdown)
- Describe the proportion of patients who changed their lifestyle's habits during the lockdown.(6 weeks period following the end of the lockdown)