Impact of Objective Sleep Duration on Blood Glucose Control in Type 1 Diabetes Adult Patients

Type 1 Diabetes Clinical Trial

— DIAPASOM2  

Official title:

Impact of Objective Sleep Duration on Blood Glucose Control in Type 1 Diabetes Adult Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01017965
• Other study ID #: 0917
• Secondary ID: 2009-A00816-51
• Status: Terminated
• Phase: N/A
• First received: November 20, 2009
• Last updated: October 4, 2012
• Start date: November 2009
• Est. completion date: April 2012

Study information

• Verified date: October 2012
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 79
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Actimeter + blood pressure monitoring
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.

Locations

Country	Name	City	State
France	Service de Diabétologie du Pr Halimi, CHU	Grenoble Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c in %		Day 0 or Day 3	No
Secondary	Objective sleep duration in minutes		Day 0 to Day 3	No
Secondary	Blood pressure in cm Hg		Day 0, 24 hours	No
Secondary	Quality of life assessed through questionnaire		Day 0 to Day 3	No