Observational Study of Glycemic Control and Self-management of Young People (Aged 13 to 25 Years ) With Type 1 Diabetes During COVID-19 Lockdown.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Changes in percentage of time spent in range 70-180 mg/dL after lockdown compared to before lockdown
研究概览
简要总结
Lockdown resulting from the COVID-19 pandemic was an unpreceded model of the impact of lifestyle on chronic diseases, especially for adolescents and young adults with type 1 diabetes (T1D) whose lifestyle is known to strongly impact disease management. The investigators aimed to assess changes in self-monitoring and glycemic control in this population before, during, and after the two-month French lockdown. Te investigators hypothesized an improvement in glucose control and glucose sensor usage.
The protocol will include all patients with T1D from 13 to 25 years old using a flash glucose monitoring related to the LibreView cloud platform.
The primary outcome, evolution of percentage of glucose time in range 70-180 mg/dL (TIR), and secondary outcomes (glucose management indicator GMI, time spent below range TBR, and sensor usage) will be analyzed with a linear mixed-effects regression model.
详细描述
Continuous glucose monitoring (CGM) data will be collected from the cloud-based platform, LibreView.
Data will be collected for patients from Sud-Francilien hospital (Corbeil-Essonnes, France) and Kremlin-Bicêtre hospital (Kremlin-Bicêtre, France). Data related to glucose control and sensor usage will be collected from the Libreview platform. Data related to patients' characteristics, treatment and telemedicine visits (number of contacts with health professionals) will be collected from the medical record and confirmed with telephone-administered questionnaire.
The lockdown imposed by the French government occurred from March 17 to May 10, 2020. Therefore, outcomes will be assessed 4 times: the month before lockdown, during the first month, the second month of lockdown, and one month after lockdown ended.
Potential confounding factors will be studied: age, gender, type of insulin delivery (multiple daily injections, MDI; insulin pump), contacts with health professionals (physician or nurse).
Descriptive statistics will include means with standard deviations, numbers of patients and percentages.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •Age between 13 and 25 years
- •use of a flash glucose monitoring related to the LibreView cloud platform
- •patients follow-up by the diabetes department of Hopital Sud Francilien or the diabetes department of Hôpital Bicêtre.
- •patient informed of the study and not having objected to it.
排除标准
- •patients out of France during lockdown
- •other type of diabetes
- •Duration of diabetes of less than one year
- •patient aged under 13 years or above 26 years old
结局指标
主要结局
Changes in percentage of time spent in range 70-180 mg/dL after lockdown compared to before lockdown
时间窗: Measure repeated 2 times : month before lockdown (28 days), after lockdown
Percentage of time spent in glucose range from 70 to 180 mg/dL over a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Changes in percentage of time spent in range 70-180 mg/dL during second month of lockdown compared to before lockdown
时间窗: Measure repeated 2 times : month before lockdown (28 days), second month of lockdown (28 days)
Percentage of time spent in glucose range from 70 to 180 mg/dL over a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Changes in percentage of time spent in range 70-180 mg/dL during first month of lockdown compared to before lockdown
时间窗: Measure repeated 2 times : month before lockdown (28 days), first month of lockdown (28 days)
Percentage of time spent in glucose range from 70 to 180 mg/dL over a month (28 days) according to continuous glucose monitoring data collected on Libreview.
次要结局
- Evolution of glucose sensor use compared to before lockdown.(Measures repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).)
- Evolution of glucose management indicator (GMI) compared to before lockdown.(Measures repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).)
- Evolution of glucose time spent below range 54 - 70 mg/dL(Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).)
- Evolution of glucose time spent below range 180-250 mg/dL(Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).)
- Evolution of glucose time spent below range <54 mg/dL(Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).)
- Evolution of glucose time spent below range > 250 mg/dL(Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).)
- Evolution of average glucose in mg/dL compared to before lockdown.(Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).)
- Evolution of hypoglycaemia frequency compared to before lockdown.(Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).)