Recruiting

Observational Study

Sponsor:

Emory University

Code:

NCT05823142

Conditions

Type1diabetes

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

CB Sleep

Study Details

Brief summary:

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.

Conditions

Type1diabetes

Study ID

NCT05823142

Start date

Dec 20, 2023

Status verified date

Dec, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

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

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: CB-sleep

Initial instruction for the CB-sleep intervention will occur 60-minute telehealth session. The initial action planning session with a sleep report and booster sessions will be interactive and stage matched. The intervention will include an interactive PowerPoint with the participant's clinician sleep report with personalized feedback. They will be encouraged to systematically extend their time in bed by 1 hour and maintain the extension on both weekends and weekdays. Weekly titration will occur according to the following parameters: if sleep efficiency is ≥ 85%, time in bed is increased by 15 minutes per week until a total of a 1 hour increase in time in bed is achieved, if sleep efficiency is <85%, time in bed remains the same. There will be weekly follow-ups (email, phone, text, video chat) and telehealth 4-week booster sessions. Sleep reports generated by the baseline actigraphy report will be shared with participants with brief action planning and goal setting.

no intervention: Attention Control Enhanced Usual Care arm

After baseline, the RA assigned to this condition will schedule a 60-minute telehealth appointment to provide instruction for enhanced usual care at the initial consultation visit via contact at T1 (60-minute telehealth session in a private location). The time-balanced follow-up sessions will remain neutral and focused on health perceptions, current plan of care, and relationship building as opposed to the CB-sleep condition's focus on sleep promotion and extension. The RA assigned to the control condition will ask participants to (a) describe how they are doing and (b) ask how confident they are in achieving the goals they have set for themselves. These calls will help to build a relationship with participants to promote study retention. The investigators recognize that participants may obtain self-initiated diabetes self-management in this group, which will vary and will use a Diabetes Self-Management Tracking Form to monitor weekly information acquisition.

Interventions

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 measure

  • Multidimensional sleep health composite score [ Time Frame: Baseline, 3, 6 and 9 months post-intervention ]
  • Glycated hemoglobin (HbA1C) [ Time Frame: Baseline, 3, 6 and 9 months post-intervention ]

Central Contacts and Locations

Central contacts

Stephanie Griggs, PhD

404-544-9915Stephanie.griggs2@emory.edu

Locations

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Stephanie Griggs, PhD

4045449915Stephanie.griggs2@emory.edu

More Information

Sponsor

Emory University

Last update posted

Dec 19, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-12-19.