Clinical trial NCT01017965: Impact of Objective Sleep Duration on Blood Glucose Control in Type 1 Diabetes Adult Patients
Official title: Impact of Objective Sleep Duration on Blood Glucose Control in Type 1 Diabetes Adult Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2009-11-23
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll type 1 diabetes patients who come for a consultation in Grenoble University Hospital.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: HbA1c in %
timeFrame: Day 0 or Day 3
Secondary outcomes:
measure: Objective sleep duration in minutes
timeFrame: Day 0 to Day 3
measure: Blood pressure in cm Hg
timeFrame: Day 0, 24 hours
measure: Quality of life assessed through questionnaire
timeFrame: Day 0 to Day 3
Other outcomes:
Locations:
city: Grenoble Cedex 9
country: France
facility: Service de Diabétologie du Pr Halimi, CHU
Study officials:
affiliation: University Hospital, Grenoble
name: Pierre-Yves Benhamou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.