CBTi for the Treatment of Insomnia in Type 1 Diabetes

NCT07091318 | Recruiting Early Phase 1

• 1 other identifier: 2024-0987
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn if treating insomnia with a therapy intervention in people with type 1 diabetes will help to better control sugar levels, sleep, and quality of life. The questions this study aims to answer include: Will this intervention help the insomnia symptoms? Will obtaining better sleep aid in the control of diabetes through measures like sugar levels? Will the intervention help with quality of life factors like mood and fatigue? Researchers will compare participants receiving the therapy intervention for sleep with those in the "healthy living" intervention to see if the outcomes are different based on the treatment. Participants in the therapy intervention group will:

• meet virtually with a therapist for 8 sessions via Zoom. Once a week for the first 4 weeks and then every other week for the last 4 sessions. Participants in the healthy living group will:
• receive weekly health education emails
• receive brief weekly calls from a coach to answer any questions Participants, regardless of intervention, over the 12 week study period will:
• monitor their sleep for 2 weeks through a sleep-monitoring watch
• share their continuous glucose monitoring data throughout the study
• answer questionnaires prior to the intervention, halfway through the intervention and then after the intervention
• attend 3 in person office visits

Conditions

Diabetes Mellitus Type 1; Insomnia

Keywords

insomnia; diabetes; sleep; adults; type 1 diabetes; stress; A1c

Outcome Measures

Primary Outcomes (1)

• Acceptability

  Will be measured via the Acceptability of Intervention Measure (AIM) at the end of the interventions. AIM is measured through 4 questions on a scale of 1-5 resulting in scores from 4 to 20 points. The higher the score the higher the acceptability.

  From enrollment to the end of the intervention (12 weeks)

Secondary Outcomes (5)

• Glycemic Variability

  Week 0 (Baseline), 6 weeks (midpoint0 and 12 weeks (end of treatment)

• Pittsburgh Sleep Quality Index (PSQI)

  Week 0 (baseline), Week 6 (midpoint) and Week 12 (end of treatment)

• Glycemic Control

  Week 0 (baseline) and Week 12 (end of treatment)

• Sleep duration

  Week 0 (baseline) and Week 12 (end of treatment)

• Patient-Reported Outcomes Measurement Information System (PROMIS) for Sleep Disturbance

  Week 0 (baseline), Week 6 (midpoint) and Week 12 (end of treatment)

Study Arms (2)

Cognitive Behavioral Therapy Intervention for Insomnia

EXPERIMENTAL

Virtual CBTi sessions will be tailored to be address the specific challenges that come with type 1 diabetes.

Behavioral: Sleep quality improvement therapy

Healthy Living

ACTIVE COMPARATOR

Psychoeducation about general health and sleep alongside brief calls from a coach will be provided.

Behavioral: Healthy Living

Interventions

Sleep quality improvement therapy BEHAVIORAL

8 virtual CBTi sessions will be provided through a therapist weekly for the first four weeks and every other week for the last eight weeks of the study.

Cognitive Behavioral Therapy Intervention for Insomnia

Healthy Living BEHAVIORAL

Health education emails and brief coaching calls will be provided weekly. The phone coaches will not provide counseling or goal setting but can clarify what participants had questions on like terms and concepts.

Healthy Living

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18 to 65 years old
• Have been diagnosed with Type 1 Diabetes for at least a year
• Use a continuous glucose monitor
• Have poor sleep quality
• Able to attend 3 office visits

You may not qualify if:

• Currently or planning pregnancy or breast feeding
• Employed with a rotating or night shift
• Are at a high risk for obstructive sleep apnea
• Non-English speaking (unable to participate in therapy or questionnaire).
• Take medications for sleep
• moderately severe to severe depression
• Have a significant medical history that includes conditions like heart failure, cirrhosis, COPD, diseases requiring oxygen, active treatment for cancer or psychiatric problems, history of stroke with neurological deficits, cognitive impairment, kidney failure that requires dialysis, illicit drug use, use of ADHD stimulant medications.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Sleep Initiation and Maintenance Disorders; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Jennifer Duffecy, PhD

CONTACT

312-413-1225; jduffecy@uic.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to either the treatment group or the control group.

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: July 29, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 22, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)