Enhancing Diabetes Care by Treating Insomnia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorTulane University

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Cognitive Behavioral Therapy for Insomnia
  • Usual care for diabetes management
  • Usual care for treatment of insomnia

Treatment groups

30 Participants
are divided into 2 treatment groups

Locations

1
Southeast Community Health Systems70791, ZacharyLouisiana, United States

Sponsors and collaborators

Tulane University

Lead sponsor