Enhancing Diabetes Care by Treating Insomnia
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Cognitive Behavioral Therapy for Insomnia
Behavioral6 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
Usual care for diabetes management
Other interventionUsual clinical care for management of diabetes (may include pharmacological and non-pharmacological approaches as determined by provider and patient)
Usual care for treatment of insomnia
Other interventionUsual clinical care for treatment of insomnia (may include pharmacological and non-pharmacological approaches as determined by provider and patient)
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Cognitive Behavioral Therapy for InsomniaExperimental treatment 3 interventions
Group B: Usual CareActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Between-group difference in change in HbA1c from baseline to 3 months
Difference between intervention and usual care groups in change in hemoglobin A1c (HbA1c) from baseline to 3 months
Time frame
3 monthsSecondary outcomes
1
Between-group difference in change in insomnia symptoms from baseline to 3 months
Difference between intervention and usual care groups in change in Insomnia Severity Index (ISI) score from baseline to 3 months. The ISI is a 7-item questionnaire with scale score ranging from 0 to 28, with higher scores indicating more insomnia symptoms.
Time frame
3 months2
Between-group difference in change in fasting glucose from baseline to 3 months
Difference between intervention and usual care groups in change in fasting glucose from baseline to 3 months
Time frame
3 months3
Between-group difference in change in concentration of insulin from baseline to 3 months
Difference between intervention and usual care groups in change in concentration of insulin from baseline to 3 months
Time frame
3 months4
Between-group difference in change in sleep efficiency from baseline to 3 months
Difference between intervention and usual care groups in change in sleep efficiency from baseline to 3 months. Sleep efficiency will be calculated from wearable device data as the percent of time in bed spent asleep.
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov