Impact of Objective Sleep Duration on Blood Glucose Control in Type 1 Diabetes Adult Patients (DIAPASOM2)

This study has been terminated.
(intermediary analysis was performed and significant results were found for the main objective)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01017965
First received: November 20, 2009
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Device: Actimeter + blood pressure monitoring

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of Objective Sleep Duration on Blood Glucose Control in Type 1 Diabetes Adult Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • HbA1c in % [ Time Frame: Day 0 or Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective sleep duration in minutes [ Time Frame: Day 0 to Day 3 ] [ Designated as safety issue: No ]
  • Blood pressure in cm Hg [ Time Frame: Day 0, 24 hours ] [ Designated as safety issue: No ]
  • Quality of life assessed through questionnaire [ Time Frame: Day 0 to Day 3 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

A sample of serum will be retained in order to compare indicators of inflammation with sleep duration and diabetes complications


Enrollment: 79
Study Start Date: November 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Names:
    • Actiwatch-16, Mini-Mitter Inc, Bend,Oregon
    • SPACELABS 90207
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This study will enroll type 1 diabetes patients who come for a consultation in Grenoble University Hospital.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01017965

Locations
France
Service de Diabétologie du Pr Halimi, CHU
Grenoble Cedex 9, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Pierre-Yves Benhamou, PhD University Hospital, Grenoble
  More Information

No publications provided by University Hospital, Grenoble

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01017965     History of Changes
Other Study ID Numbers: 0917, 2009-A00816-51
Study First Received: November 20, 2009
Last Updated: October 4, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
Type 1 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014