Health Behavior Intervention for Adults With Type 1 Diabetes

NCT05823142 | Recruiting DMC

• 3 other identifiers: 2025P011836R01DK136604STUDY20230448
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Multidimensional sleep health composite score

  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.

  Baseline, 3, 6 and 9 months post-intervention

• Glycated hemoglobin (HbA1C)

  Changes in glycemia will be measured by glycated hemoglobin (HbA1C) at baseline, 3, 6 and 9 months.

  Baseline, 3, 6 and 9 months post-intervention

Secondary Outcomes (4)

• Glucose variability

  Baseline, 3, 6 and 9 months post-intervention

• Time in range (70-140 mg/dL)

  Baseline, 3, 6 and 9 months post-intervention

• General distress symptoms

  Baseline, 3, 6 and 9 months post-intervention

• Diabetes distress symptoms

  Baseline, 3, 6 and 9 months post-intervention

Study Arms (2)

CB-sleep

EXPERIMENTAL

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.

Behavioral: CB Sleep

Attention Control Enhanced Usual Care arm

NO INTERVENTION

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 BEHAVIORAL

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.

CB-sleep

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 to 40 years
• Type 1 Diabetes at least 1 year
• One or more sleep health dimension out of range

You may not qualify if:

• Non-English speaking
• A1C \< 7% or \>80% time in glucose range

Sponsors & Collaborators

• Emory University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Study Officials

• Stephanie Griggs, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Griggs, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Both conditions will receive time-balanced sessions with the study team. Participants will not be told whether in the experimental condition or the condition delivering usual care until after the completion of the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Behavioral: Sleep Self-Management

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 21, 2023
• Study Start: December 20, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)