Cognitive behavioral therapy for insomnia in adults with type 1 diabetes
CBTi for the Treatment of Insomnia in Type 1 Diabetes
This trial will test whether virtual cognitive behavioral therapy for insomnia (CBT-I) helps adults with type 1 diabetes sleep better and improves blood sugar control and quality of life.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Illinois at Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT07091318 on ClinicalTrials.gov |
What this trial studies
Researchers will compare adults with type 1 diabetes who receive eight virtual CBT-I sessions with those who receive a healthy-living education intervention. CBT-I participants meet with a therapist via Zoom weekly for four weeks and then every other week for four more sessions, while the comparison group receives weekly health education emails and brief coach calls. Outcomes include insomnia symptoms, continuous glucose monitor measures of blood sugar control, and quality of life metrics such as mood and fatigue. Participants must be 18–65, have had type 1 diabetes for at least a year, use a continuous glucose monitor, and be able to attend three in-person visits at the study site.
Who should consider this trial
Good fit: Adults aged 18–65 with at least one year of type 1 diabetes who use a continuous glucose monitor, report poor sleep, can participate in English-language virtual therapy, and can attend three clinic visits are ideal candidates.
Not a fit: People who are pregnant or breastfeeding, work rotating or night shifts, are high risk for obstructive sleep apnea, take sleep medications, have moderately severe to severe depression or major medical comorbidities, or cannot participate in English virtual therapy are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, CBT-I could improve sleep and potentially lead to better blood sugar control and improved mood and energy for adults with type 1 diabetes.
How similar studies have performed: CBT-I is a well-established treatment for insomnia and some smaller studies suggest sleep improvement can modestly affect glucose control, but its specific impact in type 1 diabetes is not yet well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chicago, Illinois
- University of Illinois Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Jennifer Duffecy, PhD
- Email: jduffecy@uic.edu
- Phone: 312-413-1225
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.