Behavioral intervention to improve sleep for adolescents with type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.