The Impact of Continuous Glucose Monitoring Use on Sleep in Parents of Children With Type 1 Diabetes Mellitus
Recruitment status was Recruiting
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.
Type 1 Diabetes
|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.|
- sleep quality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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):
- Glycemic control [ Time Frame: one year ] [ Designated as safety issue: No ]
- HbA1c level
- Mean blood glucose level:
- Number of severe hypoglycemic episodes and diabetic ketoacidoacidosis episodes
|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)|
Parents of children with Type 1 diabetes
before and several weeks after initiating using 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425255
|Contact: Zohar Landau, MDfirstname.lastname@example.org|
|Contact: Mariana Rachmiel, MDemail@example.com|
|E. Wolfson Medical Center||Recruiting|
|Holon, Israel, 58100|
|Contact: Zohar Landau, MD 972-3-5028420 firstname.lastname@example.org|
|Contact: Marianna Rachmiel, MD 972-57-7346636 email@example.com|
|Sub-Investigator: Shirli Abiri, MD|
|Principal Investigator:||Zohar Landau, MD||Wolfson Medical Center|