CBTi for the Treatment of Insomnia in Type 1 Diabetes

NCT ID: NCT07091318

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive Behavioral Therapy Intervention for Insomnia

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

Group Type: EXPERIMENTAL

Sleep quality improvement therapy

Intervention Type: 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.

Healthy Living

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

Group Type: ACTIVE_COMPARATOR

Healthy Living

Intervention Type: 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.

Interventions

Sleep quality improvement therapy

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.

Intervention Type: BEHAVIORAL

Healthy Living

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Illinois Chicago

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jennifer Duffecy, PhD

Role: CONTACT

jduffecy@uic.edu

312-413-1225

Facility Contacts

Jennifer Duffecy, PhD

Role: primary

jduffecy@uic.edu

312-413-1225

Other Identifiers

2024-0987

Identifier Type: -

Identifier Source: org_study_id