CBTi for the Treatment of Insomnia in Type 1 Diabetes (NCT07091318) | Clinical Trial Compass
RecruitingEarly Phase 1
CBTi for the Treatment of Insomnia in Type 1 Diabetes
United States15 participantsStarted 2025-12-01
Plain-language 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
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acceptability
Timeframe: From enrollment to the end of the intervention (12 weeks)