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

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.

Sponsors

Lead Sponsor: Wolfson Medical Center

Collaborator: Tel Aviv Medical Center
Sheba Medical Center

Source Wolfson Medical Center
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.

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.

Overall Status Withdrawn
Start Date August 2011
Completion Date August 2012
Primary Completion Date August 2012
Study Type Observational
Primary Outcome
Measure Time Frame
sleep quality 1 year
Secondary Outcome
Measure Time Frame
Glycemic control one year
Condition
Eligibility

Sampling Method: Non-Probability Sample

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.

Gender: All

Minimum Age: 20 Years

Maximum Age: 70 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Zohar Landau, MD Principal Investigator Wolfson Medical Center
Location
Facility: E. Wolfson Medical Center
Location Countries

Israel

Verification Date

August 2011

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Wolfson Medical Center

Investigator Full Name: zohar landau

Investigator Title: Head of Pediatric Endocrinology Service

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Parents of children with Type 1 diabetes

Description: before and several weeks after initiating using RT-CGM of their children.

Study Design Info

Observational Model: Case-Crossover

Time Perspective: Prospective

Source: ClinicalTrials.gov