CBTi for the Treatment of Insomnia in Type 1 Diabetes

Recruiting now · Early Phase 1

Conditions studied: Diabetes Mellitus Type 1, Insomnia

In brief

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

Key facts

Study ID

NCT07091318

Run by

University of Illinois at Chicago

People needed

15

Starts

2025-12-01

Expected to finish

2027-06-30

Last updated by the study team

2026-01-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Illinois Chicago — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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