Enhancing Diabetes Care by Treating Insomnia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Behavioral Therapy for Insomnia, Usual care for diabetes management, Usual care for treatment of insomnia.
- Who it may be relevant to
- Registry conditions: Diabetes Type 2, Insomnia. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Enhancing Diabetes Care: Implementing Cognitive Behavioral Therapy for Insomnia to Improve Sleep and Cardiometabolic Outcomes
Overview
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.
Interventions
- Behavioral Cognitive Behavioral Therapy for Insomnia
6 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 - Other Usual care for diabetes management
Usual clinical care for management of diabetes (may include pharmacological and non-pharmacological approaches as determined by provider and patient) - Other Usual care for treatment of insomnia
Usual clinical care for treatment of insomnia (may include pharmacological and non-pharmacological approaches as determined by provider and patient)
Primary outcome measures
- Between-group difference in change in HbA1c from baseline to 3 months [Time frame: 3 months]
Secondary outcome measures (12)
- Between-group difference in change in insomnia symptoms from baseline to 3 months [Time frame: 3 months]
- Between-group difference in change in fasting glucose from baseline to 3 months [Time frame: 3 months]
- Between-group difference in change in concentration of insulin from baseline to 3 months [Time frame: 3 months]
- Between-group difference in change in sleep efficiency from baseline to 3 months [Time frame: 3 months]
- Between-group difference in change in wake after sleep onset (WASO) from baseline to 3 months [Time frame: 3 months]
- Between-group difference in proportion without clinical insomnia symptoms at 3 months [Time frame: 3 months]
- Between-group difference in change in insomnia symptoms from baseline to 6 weeks [Time frame: 6 weeks]
- Between-group difference in change in sleep efficiency from baseline to 6 weeks [Time frame: 6 weeks]
- Between-group difference in change in wake after sleep onset (WASO) from baseline to 6 weeks [Time frame: 6 weeks]
- Between-group difference in proportion without clinical insomnia symptoms at 6 weeks [Time frame: 6 weeks]
- Between-group difference in change in glucose time-in-range from baseline to 3 months [Time frame: 3 months]
- Between-group difference in change in glucose time-in-range from baseline to 6 weeks [Time frame: 6 weeks]
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Southeast Community Health Systems — Zachary
Identifiers
NCT: NCT07062406 · 2025-138