Trials / Not Yet Recruiting
Not Yet RecruitingNCT07522866
Thrive With Type 1 Diabetes 2026
Intervention to Thrive With Type 1 Diabetes 2026
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Emory University · Academic / Other
- Sex
- All
- Age
- 31 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
This study aims to learn whether a cognitive behavioral intervention can improve lifestyle and glucose targets for adults with type 1 diabetes.
Detailed description
Type 1 diabetes (T1D), a common yet understudied chronic condition in young adulthood, is a life-shortening disorder leading to beta-cell destruction and absolute insulin deficiency. Suboptimal glucose diabetes self-management is associated with a higher risk for premature vascular complications, both macrovascular (e.g., coronary artery disease, peripheral arterial disease, and stroke) and microvascular (retinopathy, nephropathy, neuropathy) through accelerated vascular aging. Yet a majority of adults with T1D do not achieve recommended glycemic targets (A1C \<7%) or blood pressure targets.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | TranS-C Intervention Arm | This 12-week cognitive behavioral intervention uses motivational interviewing and behavior change principles, focusing on self-efficacy and action planning. Participants target 7-9 hours of sleep per night, ≥85% sleep efficiency, and \<60 minutes' variability in bed and wake times. Components include sleep education and hygiene, nightly routines, the management of competing activities, sleep environment optimization, lifestyle modifications (e.g., avoiding caffeine and vigorous exercise before bedtime), screen time reduction, basic stress management (e.g., progressive muscle relaxation), and self-monitoring. Following a baseline visit, a research assistant conducts a 60-minute telehealth session via HIPAA-compliant Zoom/Teams, with booster sessions at weeks 4, 8, and 12. Sleep time is adjusted weekly based on sleep efficiency criteria. |
| BEHAVIORAL | Attention Control Enhanced Usual Care (EUC) Arm | This time- and attention-balanced 12-week condition will focus on enhancing usual care. After the initial baseline visit, the RA for this group will schedule a 60-minute telehealth appointment for the enhanced usual care. Follow-up sessions (weeks 4 and 8) will focus on health perceptions, care plans, and relationship-building rather than sleep promotion. The RA will encourage participants to share their progress and confidence in their self-set goals to foster engagement and retention. Participants may engage in self-initiated diabetes management, which will be tracked using a Diabetes Self-Management Tracking Form. |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2028-04-01
- Completion
- 2028-04-01
- First posted
- 2026-04-13
- Last updated
- 2026-04-13
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT07522866. Inclusion in this directory is not an endorsement.