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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes
- Sponsor
- Wolfson Medical Center
- Locations
- 1
- Primary Endpoint
- sleep quality
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
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.
Investigators
zohar landau
Head of Pediatric Endocrinology Service
Wolfson Medical Center
Eligibility 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.
Outcomes
Primary Outcomes
sleep quality
Time Frame: 1 year
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 Outcomes
- Glycemic control(one year)