NCT05823142 · Emory University
Health Behavior Intervention for Adults With Type 1 Diabetes
What this study is about
Type 1 diabetes (T1D) affects approximately 2 million Americans, and only 2 in 8 young adults ages 18-31 years achieve glycemic targets (glycated hemoglobin A1C \<7.0%). Achieving glycemic targets is associated with reduced risk of micro-and macrovascular complications. Sleep deprivation leads to impaired glucose tolerance and insulin sensitivity in adults without chronic conditions and with T1D.
View original scientific description
Type 1 diabetes (T1D) affects approximately 2 million Americans, and only 2 in 8 young adults ages 18-31 years achieve glycemic targets (glycated hemoglobin A1C \<7.0%). Achieving glycemic targets is associated with reduced risk of micro-and macrovascular complications. Sleep deprivation leads to impaired glucose tolerance and insulin sensitivity in adults without chronic conditions and with T1D. Promoting sleep in laboratory and natural environments contributes to improvements in insulin sensitivity, glucose levels, and distress symptoms in young adults without chronic conditions and more time in range in adolescents with T1D. Multiple dimensions of sleep health (alertness, timing, efficiency, and sleep duration) are associated with better achievement of glycemic targets in adults with T1D. Therefore, sleep health dimensions are appropriate therapeutic targets to improve glucoregulation and other diabetes self-management outcomes in this population. Our primary objective is to evaluate the immediate and short-term effects of a 12-week CB-sleep intervention compared to enhanced usual care (time balanced attention control) on actigraphy- and self-report derived sleep health dimensions and diabetes self-management outcomes (glycemia and distress symptoms) over 9-months (Stage II of the NIH Model for Behavior Change, ORBIT phase III). CB-sleep is guided by principles and practices from motivational interviewing and the Transtheoretical Model of Behavior Change with interactive stage-matched sessions.
Interventions
BEHAVIORAL
CB Sleep
The CB-sleep intervention is a cognitive behavioral intervention guided by principles and practices from motivational interviewing and the psychology of behavior change, primarily drawing on self-efficacy and action planning theory. The goals of CB-sleep are for participants to achieve adequate sleep duration (7-9 hours per night), adequate sleep efficiency (≥ 85%), and regular sleep timing (\<60-minute differences in bed and wake times). The intervention components include improving sleep knowledge (hygiene), developing a nightly routine, addressing competing activities, modifying environmental conditions, lifestyle (avoiding caffeine and vigorous exercise before bed), technology (limiting or avoiding screens for at least one hour before bed), basic stress-management (progressive muscle relaxation and guided imagery), and self- monitoring.
Primary outcome measures
Multidimensional sleep health composite score
Time frame: Baseline, 3, 6 and 9 months post-intervention
The multidimensional sleep health composite score will measure sleep regularity, satisfaction, alertness, timing, efficiency, and duration of sleep. The total possible score range is 0-6 with higher scores indicating higher or better sleep health.
Glycated hemoglobin (HbA1C)
Time frame: Baseline, 3, 6 and 9 months post-intervention
Changes in glycemia will be measured by glycated hemoglobin (HbA1C) at baseline, 3, 6 and 9 months.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Atlanta, Georgia
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 19, 2025 · Source of record for eligibility and locations