RecruitingEarly Phase 1NCT07091318

CBTi for the Treatment of Insomnia in Type 1 Diabetes


Sponsor

University of Illinois at Chicago

Enrollment

15 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests cognitive behavioral therapy for insomnia (CBTi) — a structured, evidence-based talk therapy for sleep problems — in adults with Type 1 diabetes who have poor sleep quality. Poor sleep in diabetes can worsen blood sugar control, so this study aims to address both issues together. **You may be eligible if...** - You are 18–65 years old - You have had Type 1 diabetes for at least a year - You use a continuous glucose monitor - You have poor sleep quality - You can attend 3 in-person office visits **You may NOT be eligible if...** - You are pregnant, planning to become pregnant, or breastfeeding - You work night shifts or rotating shifts - You are at high risk for obstructive sleep apnea - You do not speak English (the program is not yet available in other languages) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALSleep 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.

BEHAVIORALHealthy 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.


Locations(1)

University of Illinois Chicago

Chicago, Illinois, United States

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NCT07091318