Enhancing Diabetes Care by Treating Insomnia
Recruiting · NCT07062406 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
1 location listed across 1 US state.
- Southeast Community Health Systems - Zachary, Louisiana, United States