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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes; Insufficient Sleep

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado, Barbara Davis Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adolescents with type 1 diabetes

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Adolescents; Adolescents with type 1 diabetes between the ages of 11 and 17 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of common causes of sleep disruptors in adolescents with type 1 diabetes	Sleep diaries will be used to determine common causes of sleep disruptors in adolescents with type 1 diabetes.	One week per participant

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Sleep Deprivation
• Other Study ID Numbers: 21-4311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No