Impact of Objective Sleep Duration on Blood Glucose Control in Type 1 Diabetes Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- HbA1c in %
研究概览
简要总结
The objective of this study is to assess the impact of objective sleep duration on blood glucose control in type 1 diabetes adult patients.
This study will also evaluate the impact of objective sleep duration on blood pressure over a 24-hour period and the impact of objective sleep duration on quality of life.
Last, it will investigate the influence of objective physical activity duration on blood glucose control, blood pressure and quality of life.
详细描述
The objective of this study is to assess the impact of objective sleep duration on blood glucose control in type 1 diabetes adult patients.
This study will also evaluate the impact of objective sleep duration on blood pressure over a 24-hour period and the impact of objective sleep duration on quality of life.
Last, it will investigate the influence of objective physical activity duration on blood glucose control, blood pressure and quality of life.
This study will enrol ambulatory patients only. On day 0, patients receive an actimeter and an ambulatory blood pressure monitoring device. The actimeter measures activity and sleep duration. The patient keeps the actimeter for 3 consecutive days and the blood pressure monitoring device for 24 hours. A blood sample is also collected.
Patients will be divided into 2 groups, based on objective sleep duration: 'short-sleepers' and 'long-sleepers'. The threshold will be the median of the total population. HbA1c will be compared between the 2 groups with a Student test or a Mann-Whitney test, depending on the normality of distribution.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patient affiliated to Social Security
- •Written consent to participate to the study
- •Ambulatory medical follow-up
- •Patient with type 1 diabetes, defined by the criteria of the American Diabetes Association in 1997, stable (no ketoacidosis episode or hypoglycaemia with loss of consciousness requiring the intervention of a third person, during the previous month)
排除标准
- •Underage patient, major patient under guardianship or protected by the Law
- •Pregnant, parturient or breastfeeding woman
- •Person with no freedom (prisoner), person hospitalized without consent and not protected by the Law
- •Non-stabilized diabetes with at least one ketoacidosis episode or hypoglycaemia with loss of consciousness requiring the intervention of a third person, during the previous month.
- •Bedridden person or person with mobility impairment.
- •Patient already hospitalized at enrolment time
- •Patient whose physical or psychological health could interfere with obtention of informed consent and compliance to the protocol (especially answers to the questionnaires)
- •Terminally-ill patient
结局指标
主要结局
HbA1c in %
时间窗: Day 0 or Day 3
次要结局
- Objective sleep duration in minutes(Day 0 to Day 3)
- Blood pressure in cm Hg(Day 0, 24 hours)
- Quality of life assessed through questionnaire(Day 0 to Day 3)