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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-A00816-51 | Registry Identifier | ID CRB |
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intermediary analysis was performed and significant results were found for the main objective
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actimeter + blood pressure monitoring | Device | Patients will receive an actimeter that they will wear for 3 days and an ambulatory blood pressure monitoring device that they will keep for 24 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c in % | Day 0 or Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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This study will enroll type 1 diabetes patients who come for a consultation in Grenoble University Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Pierre-Yves Benhamou, PhD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Diabétologie du Pr Halimi, CHU | Grenoble | 38043 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23715755 | Derived | Borel AL, Pepin JL, Nasse L, Baguet JP, Netter S, Benhamou PY. Short sleep duration measured by wrist actimetry is associated with deteriorated glycemic control in type 1 diabetes. Diabetes Care. 2013 Oct;36(10):2902-8. doi: 10.2337/dc12-2038. Epub 2013 May 28. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015924 | Blood Pressure Monitors |
| ID | Term |
|---|---|
| D019722 | Sphygmomanometers |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
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A sample of serum will be retained in order to compare indicators of inflammation with sleep duration and diabetes complications
| Day 0 to Day 3 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |