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NCT Number: NCT07091318

CBTi for the Treatment of Insomnia in Type 1 Diabetes

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

Recruiting

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Key information

Conditions

Diabetes Mellitus Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Insomnia Mental Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location status: Recruiting

Location contact

Jennifer Duffecy, PhD

CONTACT

[email protected]

312-413-1225

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Acceptability

    Time frame: From enrollment to the end of the intervention (12 weeks)

    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.

Secondary outcomes

  1. Glycemic Variability

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

    Assessed as time in, above or below range as collected by the continuous glucose monitor.

  2. Pittsburgh Sleep Quality Index (PSQI)

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

    The PSQI is a questionnaire that assesses sleep quality and disturbances within the last month. It consists of 18 questions that either have scaled questions with four options or asks the participant for input regarding factors like bed time, time to fall asleep, hours of sleep etc. Each participant answer, both on the scale and on input, is assigned a score between 0 and 3. Thus, the score range goes from 0 to 54, with a higher score indicating worse sleep quality.

  3. Glycemic Control

    Time frame: Week 0 (baseline) and Week 12 (end of treatment)

    Assessed through A1C

  4. Sleep duration

    Time frame: Week 0 (baseline) and Week 12 (end of treatment)

    Measured by actigraphy watch

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

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

    The PROMIS questionnaire assesses self-reported sleep quality through the lens of depth and restoration. It contains 8 questions regarding the last 7 days and is scored on a scale of 1 to 5 for each question. The scores range from 8 to 40. A higher score indicates worse sleep quality.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Duffecy, PhD

CONTACT

[email protected]

312-413-1225

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 29, 2025
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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