Improving diabetes care by treating insomnia with CBT-I
Official title: Enhancing Diabetes Care: Implementing Cognitive Behavioral Therapy for Insomnia to Improve Sleep and Cardiometabolic Outcomes
Run by Tulane University · NCT07062406 · Data updated 2026-11-12
A pilot test to see if a 6-week CBT-I program added to usual diabetes care helps sleep and diabetes control for adults with type 2 diabetes and insomnia in an FQHC setting.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Tulane University Academic / other |
| Locations | 1 site (Zachary, Louisiana) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | September 2, 2026 |
| Trial ID | NCT07062406 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 40+ with type 2 diabetes, insomnia (ISI ≥15), and HbA1c >7% within the past year, receiving care at participating clinics, and able to speak English.
✕Probably not a fit
Patients with sleep apnea, pregnancy, certain medical or psychiatric conditions, or those already in another diabetes trial may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study tests whether a six-week cognitive behavioral therapy for insomnia (CBT-I) program can improve sleep quality and diabetes-related outcomes in adults with type 2 diabetes who have insomnia. Participants receive CBT-I alongside usual diabetes care and insomnia treatment, compared to usual care alone. The study focuses on feasibility, acceptability, and fidelity of implementing CBT-I in a federally qualified health center serving a high-risk population in Louisiana. Outcomes include sleep measures and glycemic control, with emphasis on real-world clinical integration. Enrollment targets adults 40 years and older who are English-speaking and meet specific insomnia and diabetes criteria.
Why it matters
Potential benefit: If successful, the program could improve sleep and glycemic control and guide integration of sleep interventions into primary diabetes care.
How similar studies have gone: There is prior evidence that CBT-I can improve sleep; this study tests implementation in a real primary-care setting with a high-risk population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * aged 40 or older * receive primary care from participating clinic * diagnosis of type 2 diabetes * most recent hemoglobin A1c (HbA1c) \>7% within the past year * Insomnia Severity Index (ISI) score ≥15 * able to speak English Exclusion Criteria: * diagnosed or self-reported sleep apnea * pregnant or planning to become pregnant during the study period * having a psychiatric or medical condition that would interfere with the ability to complete study procedures * participating in another diabetes clinical trial * living in same household as another participant * required to work night shifts
Where it's running
-
Southeast Community Health Systems
Zachary, Louisiana, United States Recruiting
Study contacts
- Study coordinator: Erin Peacock, PhD, MPH
- Email: epeacoc@tulane.edu
- Phone: 504-988-1075
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.