NCT01017965

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

October 5, 2012

Status Verified

October 1, 2012

Enrollment Period

2.4 years

First QC Date

November 20, 2009

Last Update Submit

October 4, 2012

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes

Outcome Measures

Primary Outcomes (1)

  • HbA1c in %

    Day 0 or Day 3

Secondary Outcomes (3)

  • 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

    Day 0 to Day 3

Interventions

Actimeter + blood pressure monitoringDEVICE

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.

Also known as: Actiwatch-16, Mini-Mitter Inc, Bend,Oregon, SPACELABS 90207

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Diabétologie du Pr Halimi, CHU

Grenoble, 38043, France

Location

Related Publications (1)

  • 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.

    PMID: 23715755DERIVED

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Blood Pressure Monitors

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

SphygmomanometersDiagnostic EquipmentEquipment and Supplies

Study Officials

  • Pierre-Yves Benhamou, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2009

First Posted

November 23, 2009

Study Start

November 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

October 5, 2012

Record last verified: 2012-10

Locations

FR(1)