Type 1 Diabetes Clinical Trial
Official title:
Impact of Objective Sleep Duration on Blood Glucose Control in Type 1 Diabetes Adult Patients
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.
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.
A model of multiple linear regression will be created. HbA1c will be entered as dependant
variable and objective sleep duration as independent variable
Patients will be divided into 2 groups, based on objective activity duration: 'low-activity'
and 'high-activity'. The threshold will be the median of the total population. HbA1c, blood
pressure, quality of life, biological results and general characteristics will be compared
between the 2 groups with a Student test or a Mann-Whitney test, depending on the normality
of distribution. Qualitative variables will be studied with a chi-square test.
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Observational Model: Case-Only, Time Perspective: Prospective
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