Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2024-09-18
2028-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sleep-Promoting Intervention
Individualized sleep-promoting program for adolescents with type 1 diabetes
Sleep Coach
Sleep-promoting intervention consisting of 4 phone sessions to improve sleep duration and consistency.
Enhanced Usual Care
Educational Materials
Diabetes Education
Participants will receive a a binder with educational information about diabetes and educational messages from the study team.
Interventions
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Sleep Coach
Sleep-promoting intervention consisting of 4 phone sessions to improve sleep duration and consistency.
Diabetes Education
Participants will receive a a binder with educational information about diabetes and educational messages from the study team.
Eligibility Criteria
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Inclusion Criteria
* 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
* Currently living with the child (at least 50% of the time)
* Speak and read English
Exclusion Criteria
* 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)
11 Years
17 Years
ALL
No
Sponsors
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Vanderbilt University Medical Center
OTHER
Responsible Party
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Sarah Jaser
Professor of Pediatrics
Principal Investigators
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Sarah Jaser, PhD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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230074
Identifier Type: -
Identifier Source: org_study_id
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