RecruitingNot ApplicableNCT07062406

Enhancing Diabetes Care by Treating Insomnia

Enhancing Diabetes Care: Implementing Cognitive Behavioral Therapy for Insomnia to Improve Sleep and Cardiometabolic Outcomes


Sponsor

Tulane University

Enrollment

30 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Insomnia is highly prevalent in individuals with type 2 diabetes (T2D) and is associated with poor glycemic control. Louisiana has one of the highest diabetes prevalence rates in the U.S., with significant disparities by race, income, and rural residence. Despite growing recognition of sleep's role in diabetes management, sleep disturbances remain largely unaddressed in diabetes care. Cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment for chronic insomnia, yet it is underutilized in primary care clinics such as federally qualified health centers (FQHCs) that serve high-risk populations. The long-term goal of this research is to improve cardiometabolic health and reduce diabetes disparities by integrating sleep interventions into diabetes care. This pilot study aims to: (1) evaluate the impact of CBT-I on sleep and diabetes-related outcomes, and (2) assess the acceptability, feasibility, and fidelity of implementing a 6-week CBT-I program in an FQHC setting. The investigators will conduct a randomized controlled trial (RCT) with 30 FQHC patients (aged 40+) with uncontrolled T2D (HbA1c \>7%) and comorbid insomnia (Insomnia Severity Index (ISI) score ≥15). Participants will be randomly assigned to either the CBT-I intervention or usual care. Sleep (ISI scores, actigraphy) and cardiometabolic (HbA1c, fasting glucose, insulin) outcomes will be assessed at baseline and three months post-randomization. Implementation success will be evaluated using fidelity, feasibility, and acceptability measures. Findings will provide preliminary evidence for integrating CBT-I into primary care, informing larger trials to improve diabetes outcomes and reduce disparities in Louisiana.


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Cognitive Behavioral Therapy for Insomnia, Usual care for diabetes management, and others for people with diabetes type 2 and insomnia. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALCognitive Behavioral Therapy for Insomnia

6 weekly sessions delivered by a Sleep Coaching Team comprised of a federally qualified health center behavioral health provider and a health coach, focusing on stimulus control, sleep restriction, and cognitive therapy

OTHERUsual care for diabetes management

Usual clinical care for management of diabetes (may include pharmacological and non-pharmacological approaches as determined by provider and patient)

OTHERUsual care for treatment of insomnia

Usual clinical care for treatment of insomnia (may include pharmacological and non-pharmacological approaches as determined by provider and patient)


Locations(1)

Southeast Community Health Systems

Zachary, Louisiana, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07062406


Related Trials