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

Withdrawn

• Conditions: Type 1 Diabetes

• Registration Number: NCT01425255
• Lead Sponsor: 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.

Study Timeline

• Status Verified: 2011-08
• Study Start: 2011-08
• Study First Submitted: 2011-08-26
• Study First Submitted QC: 2011-08-26
• Study First Posted: 2011-08-29
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2016-06-18
• Last Update Posted: 2016-06-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sleep quality	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 Outcome Measures

Name	Time	Method
Glycemic control	one year	1. HbA1c level; 2. Mean blood glucose level: 3. Number of severe hypoglycemic episodes and diabetic ketoacidoacidosis episodes

Trial Locations

Locations (1)

E. Wolfson Medical Center; 🇮🇱 Holon, Israel