No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Tulane University · Other
Who this trial is looking for
This trial is looking for people aged 40 and older who have type 2 diabetes and insomnia. If you join, you might receive a 6-week therapy program to help with your sleep, and we'll track how it affects your diabetes health.
Are You a Good Fit for This Trial?
You may be able to join if
I am 40 years old or older
I receive primary care from the clinic involved in the study
I have been diagnosed with type 2 diabetes
My most recent hemoglobin A1c (HbA1c) level is over 7% within the past year
I have an Insomnia Severity Index score of 15 or higher
I can speak English
You may not be able to join if
I have been diagnosed with sleep apnea
I am pregnant or planning to become pregnant during the study
I have a psychiatric or medical condition that interferes with study procedures
I am participating in another diabetes clinical trial
I live with someone else who is participating in this trial
I work night shifts
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 be…
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.
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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 …
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
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