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.
Lead Sponsor: Wolfson Medical Center
|Source||Wolfson Medical Center|
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.
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.
|Start Date||August 2011|
|Completion Date||August 2012|
|Primary Completion Date||August 2012|
Sampling Method: Non-Probability Sample
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.
- Parents of children up to 16 years old with type 1 diabetes
- Either the child or parent had obstructive sleep apnea, narcolepsy, or restless legs syndrome.
Minimum Age: 20 Years
Maximum Age: 70 Years
Healthy Volunteers: Accepts Healthy Volunteers
Type: Principal Investigator
Investigator Affiliation: Wolfson Medical Center
Investigator Full Name: zohar landau
Investigator Title: Head of Pediatric Endocrinology Service
|Has Expanded Access||No|
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