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

NCT ID: NCT01425255

Last Updated: 2016-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Parents of children with Type 1 diabetes

before and several weeks after initiating using RT-CGM of their children.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tel Aviv Medical Center

OTHER

Sponsor Role collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role collaborator

Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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zohar landau

Head of Pediatric Endocrinology Service

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zohar Landau, MD

Role: PRINCIPAL_INVESTIGATOR

Wolfson Medical Center

Locations

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E. Wolfson Medical Center

Holon, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0077-11-WOMC

Identifier Type: -

Identifier Source: org_study_id

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