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

NCT05370339 | Completed

• 1 other identifier: 21-4311
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes; Insufficient Sleep

Outcome Measures

Primary Outcomes (2)

• Number of nocturnal awakenings per week

  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.

  One week per participant

• Assessment of facilitators and barriers to good sleep quality and duration

  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.

  One week per participant

Secondary Outcomes (1)

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

  One week per participant

Study Arms (1)

Adolescents

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

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents with type 1 diabetes

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Juvenile Diabetes Research Foundation: collaborator
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (1)

University of Colorado, Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Sleep Deprivation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 11, 2022
• Study Start: June 15, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)