Behavioral intervention to improve sleep for adolescents with type 1 diabetes
Sleep Promoting Intervention to Improve Diabetes Outcomes and Executive Function in Adolescents With T1D
This study is testing whether a coaching program can help teenagers with type 1 diabetes sleep better and see if that improves their blood sugar control and thinking skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 11 Years to 17 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06516614 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to evaluate the effects of a behavioral coaching intervention designed to enhance sleep duration and quality in adolescents diagnosed with type 1 diabetes. The study will involve 150 participants who will be randomly assigned to either the Sleep Coach intervention or Enhanced Usual Care. The intervention includes four sessions with a trained coach, focusing on improving sleep habits, and will assess the impact on glucose control and executive function over a year. Participants will also wear FitBit devices to monitor sleep patterns and complete surveys at multiple time points.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 11-17 years with type 1 diabetes who report insufficient sleep and have not achieved target HbA1c levels.
Not a fit: Patients with other serious health conditions affecting diabetes management or those with sleep disorders like sleep apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved sleep quality, better glucose control, and enhanced cognitive function in adolescents with type 1 diabetes.
How similar studies have performed: While the specific approach of this study is novel, previous studies have indicated that improving sleep can have positive effects on diabetes management and cognitive function.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Sarah Jaser, PhD — Vanderbilt University Medical Center
- Study coordinator: Lauren Milner, MPH
- Email: lauren.l.milner@vumc.org
- Phone: 615-875-7970
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.