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Trial record 39 of 2791 for:    Type 1 Diabetes

The Impact of Continuous Glucose Monitoring Use on Sleep in Parents of Children With Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01425255
Recruitment Status : Withdrawn (Enrollment finished and a paper was published.)
First Posted : August 29, 2011
Last Update Posted : June 21, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this prospective exploratory study is to compare sleep quality and sleep-wake patterns in parents of children with type 1 diabetes (T1D) before and several weeks after initiating using real-time continuous glucose monitoring (RT-CGM) of their children.

Condition or disease
Type 1 Diabetes

Detailed Description:
Few weeks before scheduled initiation of RT-CGM use of a child with T1D, the 'dominant parent' (the main caregiver during the nighttime in the family) will obtain an informed consent. This will be done during a routine visit in the diabetes clinic. The participants will complete a sleep quality questionnaire (PSQI) and instructions on care of the actigraph and how to keep complete the daily sleep diary will be given. The participants will be instructed to wear the actigraph for 7 consequences nights. Four to eight weeks after initiation of RT-CGM use, the 'dominant parent' will be asked to wear the actigraph for 7 consequences nights and to complete the sleep quality questionnaire and the daily sleep diary.

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Prospective Exploratory Study Evaluating Sleep Quality and Sleep-Wake Patterns in Parents of Children With Type 1 Diabetes Before and Several Weeks After Initiating Using RT-CGM of Their Children.
Study Start Date : August 2011
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Groups and Cohorts

Parents of children with Type 1 diabetes
before and several weeks after initiating using RT-CGM of their children.

Outcome Measures

Primary Outcome Measures :
  1. sleep quality [ Time Frame: 1 year ]


    Sleep Diary:During the weeks participants will wear the actigraph, they will be asked to rate their previous nights' sleep using a very short questionnaire.

    Pittsburgh Sleep Quality Index (PSQI):

Secondary Outcome Measures :
  1. Glycemic control [ Time Frame: one year ]
    1. HbA1c level
    2. Mean blood glucose level:
    3. Number of severe hypoglycemic episodes and diabetic ketoacidoacidosis episodes

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Juvenile Diabetes Clinics

Inclusion Criteria:

  • Parents of children up to 16 years old with type 1 diabetes

Exclusion Criteria:

  • Either the child or parent had obstructive sleep apnea, narcolepsy, or restless legs syndrome.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01425255

E. Wolfson Medical Center
Holon, Israel, 58100
Sponsors and Collaborators
Wolfson Medical Center
Tel Aviv Medical Center
Sheba Medical Center
Principal Investigator: Zohar Landau, MD Wolfson Medical Center
More Information

Responsible Party: zohar landau, Head of Pediatric Endocrinology Service, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01425255     History of Changes
Other Study ID Numbers: 0077-11-WOMC
First Posted: August 29, 2011    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: August 2011

Keywords provided by zohar landau, Wolfson Medical Center:
Type 1 diabetes
Sleep quality

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