Clinical Trials Directory

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

TypeNameDescription
BEHAVIORALTranS-C Intervention ArmThis 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.
BEHAVIORALAttention Control Enhanced Usual Care (EUC) ArmThis 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.