Enhancing Diabetes Care by Treating Insomnia
Launched by TULANE UNIVERSITY · Jul 2, 2025
Trial Information
Current as of July 24, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether treating insomnia (trouble sleeping) can help people with type 2 diabetes manage their condition better. Since many people with diabetes also have difficulty sleeping, and poor sleep can make blood sugar harder to control, the researchers want to see if a special therapy called cognitive behavioral therapy for insomnia (CBT-I) can improve both sleep and diabetes health. This therapy is a proven way to help with chronic insomnia but hasn’t been widely used in clinics that serve high-risk communities, like federally qualified health centers in Louisiana, where diabetes rates are high.
The study is looking for adults aged 40 or older who have type 2 diabetes with blood sugar levels above the recommended range and who also have significant insomnia symptoms. Participants will be randomly assigned to either receive the 8-week CBT-I program or continue with their usual diabetes care. The researchers will check sleep quality and diabetes-related health measures at the start and after three months. The goal is to see if this sleep treatment is practical and helpful in real-world healthcare settings and if it can eventually help reduce health differences seen in Louisiana. If you qualify and join, you can expect to participate in the sleep therapy sessions and have your health monitored throughout the study.
Gender
ALL
Eligibility 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
About Tulane University
Tulane University, a prestigious institution located in New Orleans, Louisiana, is dedicated to advancing medical research and improving public health through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, Tulane leverages its extensive resources and expertise in various fields, including tropical medicine, infectious diseases, and population health. The university's commitment to ethical research practices and patient-centered approaches ensures that clinical trials conducted under its auspices not only contribute to scientific knowledge but also prioritize the well-being of participants. As a leader in clinical research, Tulane University aims to translate findings into tangible health solutions that benefit local communities and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Zachary, Louisiana, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported