Recruiting
Early Phase 1

Therapy Intervention vs. Healthy Living

Sponsor:

University of Illinois at Chicago

Code:

NCT07091318

Conditions

Diabetes Mellitus Type 1

Insomnia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Sleep quality improvement therapy

Healthy Living

Study Details

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 ID

NCT07091318

Start date

Dec 1, 2025

Status verified date

Jul, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cognitive Behavioral Therapy Intervention for Insomnia

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

active comparator: Healthy Living

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

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.

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.

Primary outcome measure

  • Acceptability [ Time Frame: From enrollment to the end of the intervention (12 weeks) ]

Central Contacts and Locations

Central contacts

Jennifer Duffecy, PhD

312-413-1225jduffecy@uic.edu

Locations

University of Illinois Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Jennifer Duffecy, PhD

312-413-1225jduffecy@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jan 22, 2026

Last verified

Jul, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-01-22.