Sleep Coach for Adolescents With Type 1 Diabetes

NCT06516614 | Recruiting DMC

• 1 other identifier: 230074
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this work is to conduct a randomized trial evaluating the effects of a behavioral intervention to increase sleep duration and quality for adolescents with type 1 diabetes (T1D). The impact of the sleep-promoting intervention on executive function and glycemic outcomes will be assessed. We will also explore multiple components of the recently identified central nervous system glymphatic system and evaluate how these components change and impact brain integrity and function with improved sleep.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• Sleep Duration

  Total Sleep Time (average minutes per night) measured with Fitbit over 7 nights

  3 months

• Sleep Variability

  Individual difference in sleep duration (minutes) measured with Fitbit over 7 nights

  3 months

Secondary Outcomes (10)

• Executive Function BRIEF2

  12 months

• NIH Toolbox Dimensional Card Sort Test

  12 months

• NIH Toolbox List Sorting Working Memory Test

  12 months

• Diabetes Management - Adolescent Report

  12 months

• Diabetes Management - Parent Report

  12 months

Study Arms (2)

Sleep-Promoting Intervention

EXPERIMENTAL

Individualized sleep-promoting program for adolescents with type 1 diabetes

Behavioral: Sleep Coach

Enhanced Usual Care

ACTIVE COMPARATOR

Educational Materials

Behavioral: Diabetes Education

Interventions

Sleep Coach BEHAVIORAL

Sleep-promoting intervention consisting of 4 phone sessions to improve sleep duration and consistency.

Sleep-Promoting Intervention

Diabetes Education BEHAVIORAL

Participants will receive a a binder with educational information about diabetes and educational messages from the study team.

Enhanced Usual Care

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years of age at the time of enrollment
• Diagnosed with type 1 diabetes for ≥ 12 months
• Report insufficient sleep (\< 8 hrs./night for 13-17 year-olds, \<9 hrs./night for 11-12 year-olds) but have no other sleep disorders or sleep apnea
• Are not meeting the target for HbA1c (\<7%)
• Able to read /speak English

You may not qualify if:

• Participant has other serious health conditions that interfere with diabetes management
• Optional MRI portion of the study - anything that would prevent an adolescent from receiving a high-quality MRI of the brain (metal implants or inability to hold still for an MRI which may take up to 60 minutes)
• Currently living with the child (at least 50% of the time)
• Speak and read English

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sarah Jaser, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Milner, MPH

CONTACT

615-875-7970; lauren.l.milner@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 24, 2024
• Study Start: September 18, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

US (1)