Type 1 Diabetes
Conditions
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.
Interventions
BEHAVIORALSleep Coach
Sleep-promoting intervention consisting of 4 phone sessions to improve sleep duration and consistency.
BEHAVIORALDiabetes Education
Participants will receive a a binder with educational information about diabetes and educational messages from the study team.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 - 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. |
| 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. |
| Sleep Quality | 12 months | Pittsburgh Sleep Quality Index (PSQI): 21-item measure completed by adolescents, assesses sleep quality. Higher scores indicate poorer sleep quality. |
| 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. |
| 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. |
| 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 |
| 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 |
Countries
United States
Contacts
Primary ContactLauren Milner, MPH
Outcome results
None listed