Sleep Coach for Adolescents With Type 1 Diabetes
- Conditions
- Type 1 Diabetes
- Interventions
- Behavioral: Diabetes EducationBehavioral: Sleep Coach
- Registration Number
- NCT06516614
- Lead Sponsor
- Vanderbilt University Medical Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enhanced Usual Care Diabetes Education Educational Materials Sleep-Promoting Intervention Sleep Coach Individualized sleep-promoting program for adolescents with type 1 diabetes
- Primary Outcome Measures
Name Time Method Sleep Duration 3 months Total Sleep Time (average minutes per night) measured with Fitbit over 7 nights
Sleep Variability 3 months Individual difference in sleep duration (minutes) measured with Fitbit over 7 nights
- Secondary Outcome Measures
Name Time Method Diabetes Management - Adolescent Report 12 months Self-Care Inventory-Short Form: 9-item measure, assesses key components of adolescent diabetes management. Higher mean scores indicate better diabetes self-care.
Sleep Quality 12 months Pittsburgh Sleep Quality Index (PSQI): 21-item measure completed by adolescents, assesses sleep quality. Higher scores indicate poorer sleep quality.
NIH Toolbox List Sorting Working Memory Test 12 months List Sorting Working Memory takes 8-10 minutes for adolescents to complete on an iPad, assesses working memory, a component of executive function
Diabetes Management - Parent Report 12 months Self-Care Inventory-Short Form: 9-item measure, assesses key components of adolescent diabetes management. Higher mean scores indicate better diabetes self-care.
Magnetic Resonance Imaging (MRI) of Brain: Glymphatic Flow 6 months Fluid motion along perivascular spaces is assessed from MRI of the brian
Fractional Anisotropy from MRI of the Brain 6 months Fractional anisotropy is calculated from diffusion tensor imaging MRI. Higher FA is associated with better white matter integrity in the brain
Executive Function BRIEF2 12 months 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.
Hemoglobin A1C 12 months An indicator of average blood glucose levels. HbA1c is collected as part of usual care and will be extracted from adolescents' medical records
NIH Toolbox Dimensional Card Sort Test 12 months Dimensional Change Card Sort Test takes 4 minutes for adolescents to complete on an iPad, assesses inhibition, a component of executive function
Time in Range 12 months 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.
Trial Locations
- Locations (1)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States