Sleep Coach for Adolescents With Type 1 Diabetes

Sleep Promoting Intervention to Improve Diabetes Outcomes and Executive Function in Adolescents With T1D

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: Sleep Coach; Behavioral: Diabetes Education

Detailed Description

This randomized controlled trial will assess whether a behavioral coaching intervention to improve sleep duration and quality in adolescents with type 1 diabetes will improve glucose control and executive function. We will recruit a sample of 150 adolescents with type 1 diabetes (T1D) and their caregivers at a single medical center. We plan to recruit equal numbers of boys and girls and over-enroll youth from minoritized racial and ethnic groups. After obtaining informed consent/assent and baseline data, we will randomize adolescents to the Sleep Coach condition (n=75) or the Enhanced Usual Care condition (n=75). Randomization will be computerized, and adolescents will be stratified by diabetes device use (insulin pumps, continuous glucose monitors) and age (11-14 years vs. 15-17 years). Adolescents and caregivers will complete survey measures again at 3 months, 6 months, and 12 months during regularly scheduled clinic visits. Adolescents will complete the NIH Toolbox measures of executive function at each study visit. Adolescents will be asked to wear a FitBit watch to assess sleep and complete sleep diaries at baseline and 3 months.

Participants randomized to the Sleep Coach group will be sent a binder with intervention materials for the 4 sessions. They will schedule individual phone calls with a trained member of the research team at a convenient time. The first call is expected to last 20-30 minutes, and the other calls are expected to last 10-15 minutes. Caregivers will receive an overview of the sleep intervention content, and they will be asked to support adolescents' attempts to change sleep habits.

Adolescents randomized to Enhanced Usual Care will receive diabetes education materials developed by our team for adolescents with T1D (based on publicly available materials on diabetes.org). Printed materials will be sent via mail and content will be shared via smart phone messages on the same schedule as participants randomized to the Sleep Coach intervention.

A representative group of 50 of the 150 adolescents in the study will be invited to participate in an additional study visit prior to the intervention to obtain magnetic resonance imaging (MRI) of the brain. Adolescents who agree to complete MRI of the brain will be asked to complete a follow-up visit approximately 6 months after the baseline visit, following the same protocol, and they will complete the daily sleep diary questions and share sleep data for another week.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Milner, MPH; Phone Number: 615-875-7970; Email: lauren.l.milner@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: Lauren Milner, MPH; Email: lauren.l.milner@vumc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 11-17 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

Exclusion Criteria:

• 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)

Inclusion criteria for caregivers:

• Currently living with the child (at least 50% of the time)
• Speak and read English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep-Promoting Intervention; Individualized sleep-promoting program for adolescents with type 1 diabetes	Behavioral: Sleep Coach; Sleep-promoting intervention consisting of 4 phone sessions to improve sleep duration and consistency.
Active Comparator: Enhanced Usual Care; Educational Materials	Behavioral: Diabetes Education; Participants will receive a a binder with educational information about diabetes and educational messages from the study team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Executive Function BRIEF2	Behavior Rating Inventory of Executive Function 2nd Edition: 63-item measure, completed by parents to assess adolescent executive function in their daily life. Higher Global Executive Composite score indicates better executive function.	12 months
NIH Toolbox Dimensional Card Sort Test	Dimensional Change Card Sort Test takes 4 minutes for adolescents to complete on an iPad, assesses inhibition, a component of executive function	12 months
NIH Toolbox List Sorting Working Memory Test	List Sorting Working Memory takes 8-10 minutes for adolescents to complete on an iPad, assesses working memory, a component of executive function	12 months
Diabetes Management - Adolescent Report	Self-Care Inventory-Short Form: 9-item measure, assesses key components of adolescent diabetes management. Higher mean scores indicate better diabetes self-care.	12 months
Diabetes Management - Parent Report	Self-Care Inventory-Short Form: 9-item measure, assesses key components of adolescent diabetes management. Higher mean scores indicate better diabetes self-care.	12 months
Sleep Quality	Pittsburgh Sleep Quality Index (PSQI): 21-item measure completed by adolescents, assesses sleep quality. Higher scores indicate poorer sleep quality.	12 months
Hemoglobin A1C	An indicator of average blood glucose levels. HbA1c is collected as part of usual care and will be extracted from adolescents' medical records	12 months
Time in Range	Blood glucose levels, measured with continuous glucose monitors, that are within the target range (70-180 mg/dL) over 14 days. Time in Range is reported as a percentage and higher levels indicate better glycemic control.	12 months
Magnetic Resonance Imaging (MRI) of Brain: Glymphatic Flow	Fluid motion along perivascular spaces is assessed from MRI of the brian	6 months
Fractional Anisotropy from MRI of the Brain	Fractional anisotropy is calculated from diffusion tensor imaging MRI. Higher FA is associated with better white matter integrity in the brain	6 months

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Sarah Jaser, PhD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 230074

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