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Health Behavior Intervention for Adults With Type 1 Diabetes
NCT05823142 · Emory University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
Overview: The investigators will conduct a powered randomized controlled trial (RCT) and recruit a contemporary cohort of 248 young adults with T1D and randomly assign them to one of two conditions: CB-sleep or a time-balanced attention control (enhanced usual care) condition. The study will evaluate the immediate and short-term effects of CB-sleep compared to enhanced usual care on actigraphy and self-report derived sleep health dimensions (aim 1), glycemia and other diabetes self-management outcomes (aim 2), and whether sleep health mediates associations between the CB-sleep and enhanced usual care conditions (aim 3). All participants will complete a battery of validated questionnaires and objective measures of sleep and glycemia captured at baseline to post-intervention (3 months) and at a 6- and 9-month follow-up.
Study Design:
A two-arm, RCT will be used to evaluate the efficacy of CB-sleep compared to a time-balanced attention control condition (enhanced usual care). Data collection will include T0 baseline measures (questionnaires and 14-days of sleep/glucose monitoring), T1 will include the allocation to the experimental or control condition, T2 will include immediate post baseline measures at 3-months, T3 will include repeating measures at 6-months, and T4 will include repeating measures at 9-months.
Eligibility criteria
Inclusion Criteria:
* Aged 18 to 40 years
* Type 1 Diabetes at least 1 year
* One or more sleep health dimension out of range
Exclusion Criteria:
* Non-English speaking
* A1C \< 7% or \>80% time in glucose range
Study design
Enrollment target: 300 participants
Allocation: randomized
Masking: single
Age groups: adult
Timeline
Starts: 2023-12-20
Estimated completion: 2028-12
Last updated: 2025-12-19
Interventions
Behavioral: CB Sleep
Primary outcomes
- • Multidimensional sleep health composite score (Baseline, 3, 6 and 9 months post-intervention)
- • Glycated hemoglobin (HbA1C) (Baseline, 3, 6 and 9 months post-intervention)
Sponsor
Emory University · other
With: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
Contacts & investigators
ContactStephanie Griggs, PhD · contact · Stephanie.griggs2@emory.edu · 404-544-9915
InvestigatorStephanie Griggs, PhD · principal_investigator, Emory University
All locations (1)
Emory UniversityRecruiting
Atlanta, Georgia, United States