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Purpose

This study aims to learn whether a cognitive behavioral intervention can improve lifestyle and glucose targets for adults with type 1 diabetes.

Condition

Eligibility

Eligible Ages
Between 31 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Aged 31 to 75 years - Type 1 Diabetes for at least 1 year - One or more sleep health dimensions are out of range

Exclusion Criteria

  • Non-English speaking - Recent night shift work or transmeridian travel - Life-limiting illness

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Transdiagnostic Intervention for Sleep and Circadian (TranS-C) Dysfunction Intervention Arm 		Participants will work with a health coach to aim for 7-9 hours of sleep per night, at least 85% sleep efficiency, and less than 60 minutes' variation in bed and wake times.
  • 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.
Active Comparator
Enhanced Usual Care (EUC) Arm 		Participants will work with a health coach focused on enhanced usual care.
  • 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.
    Other names:
    • Enhanced Usual Care (EUC)

Recruiting Locations

Emory University, Nell Hodgson Woodruff School of Nursing
Atlanta, Georgia 30322

Emory University
Atlanta, Georgia 30329

More Details

Status
Recruiting
Sponsor
Emory University

Study Contact

Stephanie Griggs, PhD, RN, FAAN
404-544-9915
stephanie.griggs2@emory.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.