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.

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01425255

Enrollment

Registered

2011-08-29

Start date

2011-08-31

Completion date

2012-08-31

Last updated

2016-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes, Sleep quality, Parents

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.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Glycemic control	one year	1. HbA1c level 2. Mean blood glucose level: 3. Number of severe hypoglycemic episodes and diabetic ketoacidoacidosis episodes

Countries

Israel

Outcome results