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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Insufficient Sleep Mental Disorders Metabolic Diseases Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Deprivation Sleep Wake Disorders

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado, Barbara Davis Center

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Number of nocturnal awakenings per week

Time frame: One week per participant

We will identify the number of nocturnal awakenings per week for comparison of those with insufficient sleep identified by actigraphy watch to those with sufficient sleep.
Assessment of facilitators and barriers to good sleep quality and duration

Time frame: One week per participant

Qualitative interviews will be conducted and analyzed for themes to identify causes of sleep disruptions and any potential barriers or facilitators to improving sleep health.

Secondary outcomes

Identification of common causes of sleep disruptors in adolescents with type 1 diabetes

Time frame: One week per participant

Sleep diaries will be used to determine common causes of sleep disruptors in adolescents with type 1 diabetes.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

Juvenile Diabetes Research Foundation
The Leona M. and Harry B. Helmsley Charitable Trust

Registry information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: May 11, 2022
Registry last updated: Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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