Sleep Coach for Adolescents With Type 1 Diabetes

Last updated: September 19, 2024
Sponsor: Vanderbilt University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus Types I And Ii

Diabetes Prevention

Diabetes And Hypertension

Treatment

Sleep Coach

Diabetes Education

Clinical Study ID

NCT06516614
230074
  • Ages 11-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 on an average of 3 out of 5 school nights)but have no other sleep disorders or sleep apnea

  • Are not meeting the target for HbA1c (<7%)

  • Able to read /speak English

Exclusion

Exclusion Criteria:

  • Participant has other serious health conditions that interfere with diabetesmanagement

  • Optional MRI portion of the study - anything that would prevent an adolescent fromreceiving a high-quality MRI of the brain (metal implants or inability to hold stillfor 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 Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Sleep Coach
Phase:
Study Start date:
September 18, 2024
Estimated Completion Date:
September 30, 2028

Study 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.

Connect with a study center

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37212
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.