Enhancing Diabetes Care by Treating Insomnia

Starting soon · Not applicable

Conditions studied: Diabetes Type 2, Insomnia

In brief

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.

Key facts

Study ID: NCT07062406
Run by: Tulane University
People needed: 30
Starts: 2026-06-01
Expected to finish: 2027-02-28
Last updated by the study team: 2026-04-22

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

Southeast Community Health Systems — Zachary, Louisiana, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.