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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

November 20, 2009
October 4, 2012
November 2009
April 2012   (final data collection date for primary outcome measure)
HbA1c in % [ Time Frame: Day 0 or Day 3 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01017965 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Impact of Objective Sleep Duration on Blood Glucose Control in Type 1 Diabetes Adult Patients
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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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

Non-Probability Sample

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

Type 1 Diabetes
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
Not Provided
Borel AL, Pépin 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
79
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01017965
0917, 2009-A00816-51
No
University Hospital, Grenoble
University Hospital, Grenoble
Not Provided
Principal Investigator: Pierre-Yves Benhamou, PhD University Hospital, Grenoble
University Hospital, Grenoble
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP