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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Wolfson Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Tel Aviv Medical Center
Sheba Medical Center
Information provided by (Responsible Party):
zohar landau, Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01425255
First received: August 26, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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
Type 1 Diabetes

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • sleep quality [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Actigraphy:

    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:
  • Glycemic control [ Time Frame: one year ] [ Designated as safety issue: No ]
    1. HbA1c level
    2. Mean blood glucose level:
    3. Number of severe hypoglycemic episodes and diabetic ketoacidoacidosis episodes


Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Parents of children with Type 1 diabetes
before and several weeks after initiating using RT-CGM of their children.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Juvenile Diabetes Clinics

Criteria

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
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: NCT01425255

Contacts
Contact: Zohar Landau, MD 972-3-5028420 landau.zohar@gmail.com
Contact: Mariana Rachmiel, MD 972-57-7346636 rmarianna@gmail.com

Locations
Israel
E. Wolfson Medical Center Recruiting
Holon, Israel, 58100
Contact: Zohar Landau, MD    972-3-5028420    landau.zohar@gmail.com   
Contact: Marianna Rachmiel, MD    972-57-7346636    rmarianna@gmail.com   
Sub-Investigator: Shirli Abiri, MD         
Sponsors and Collaborators
Wolfson Medical Center
Tel Aviv Medical Center
Sheba Medical Center
Investigators
Principal Investigator: Zohar Landau, MD Wolfson Medical Center
  More Information

No publications provided

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
Study First Received: August 26, 2011
Last Updated: August 26, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Wolfson Medical Center:
Type 1 diabetes
Sleep quality
Parents

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

ClinicalTrials.gov processed this record on August 21, 2014