Assessment of Sleep and Sleep Disruptors in Adolescents With Type 1 Diabetes

NCT ID: NCT05370339

Last Updated: 2023-09-21

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

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-15

Study Completion Date

2023-08-30

Brief Summary

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The goal of this study is to identify causes of insufficient sleep and sleep disruptors in adolescents with type 1 diabetes. For this study, adolescents will wear an actigraphy watch and complete sleep diaries for seven days. On completion of the seven days, they will complete several questionnaires regarding sleep, fear of hypoglycemia, and anxiety and depression. A subset of participants will additionally complete a qualitative interview session to obtain a deeper understanding of sleep disruptors and barriers and facilitators to improving sleep health.

Detailed Description

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Conditions

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Type 1 Diabetes Insufficient Sleep

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adolescents

Adolescents with type 1 diabetes between the ages of 11 and 17 years.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with T1D at least 3 months
* Receive clinical care at the Barbara Davis Center

Exclusion Criteria

* Have an active underlying sleep disorder, such as narcolepsy, insomnia, or untreated sleep apnea
* Participation in an interventional research protocol
* Unable to complete study procedures
Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Juvenile Diabetes Research Foundation

OTHER

Sponsor Role collaborator

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Colorado, Barbara Davis Center

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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21-4311

Identifier Type: -

Identifier Source: org_study_id

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