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NCT Number: NCT07062406

Enhancing Diabetes Care by Treating Insomnia

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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Key information

Conditions

Diabetes Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Insomnia Mental Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southeast Community Health Systems

Zachary, Louisiana, 70791, United States

Location contact

Erin Peacock, PhD, MPH

CONTACT

[email protected]

504-988-1075

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia

Behavioral

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

Usual care for diabetes management

Other

Usual 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

Usual clinical care for treatment of insomnia (may include pharmacological and non-pharmacological approaches as determined by provider and patient)

Primary outcomes

  1. Between-group difference in change in HbA1c from baseline to 3 months

    Time frame: 3 months

    Difference between intervention and usual care groups in change in hemoglobin A1c (HbA1c) from baseline to 3 months

Secondary outcomes

  1. Between-group difference in change in insomnia symptoms from baseline to 3 months

    Time frame: 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.

  2. Between-group difference in change in fasting glucose from baseline to 3 months

    Time frame: 3 months

    Difference between intervention and usual care groups in change in fasting glucose from baseline to 3 months

  3. Between-group difference in change in concentration of insulin from baseline to 3 months

    Time frame: 3 months

    Difference between intervention and usual care groups in change in concentration of insulin from baseline to 3 months

  4. Between-group difference in change in sleep efficiency from baseline to 3 months

    Time frame: 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.

  5. Between-group difference in change in wake after sleep onset (WASO) from baseline to 3 months

    Time frame: 3 months

    Difference between intervention and usual care groups in change in wake after sleep onset (WASO) from baseline to 3 months. WASO will be calculated from wearable device data as the number of minutes spent awake after first sleep onset.

  6. Between-group difference in proportion without clinical insomnia symptoms at 3 months

    Time frame: 3 months

    Difference between intervention and usual care groups in proportion with Insomnia Severity Index (ISI) score <15 at 3 months. The ISI is a 7-item questionnaire with scale score ranging from 0 to 28, with higher scores indicating more insomnia symptoms. An ISI score >= 15 indicates symptoms consistent with clinical insomnia.

  7. Between-group difference in change in insomnia symptoms from baseline to 6 weeks

    Time frame: 6 weeks

    Difference between intervention and usual care groups in change in Insomnia Severity Index (ISI) score from baseline to 6 weeks. The ISI is a 7-item questionnaire with scale score ranging from 0 to 28, with higher scores indicating more insomnia symptoms.

  8. Between-group difference in change in sleep efficiency from baseline to 6 weeks

    Time frame: 6 weeks

    Difference between intervention and usual care groups in change in sleep efficiency from baseline to 6 weeks. Sleep efficiency will be calculated from wearable device data as the percent of time in bed spent asleep.

  9. Between-group difference in change in wake after sleep onset (WASO) from baseline to 6 weeks

    Time frame: 6 weeks

    Difference between intervention and usual care groups in change in wake after sleep onset (WASO) from baseline to 6 weeks. WASO will be calculated from wearable device data as the number of minutes spent awake after first sleep onset.

  10. Between-group difference in proportion without clinical insomnia symptoms at 6 weeks

    Time frame: 6 weeks

    Difference between intervention and usual care groups in proportion with Insomnia Severity Index (ISI) score <15 at 6 weeks. The ISI is a 7-item questionnaire with scale score ranging from 0 to 28, with higher scores indicating more insomnia symptoms. An ISI score >= 15 indicates symptoms consistent with clinical insomnia.

  11. Between-group difference in change in glucose time-in-range from baseline to 3 months

    Time frame: 3 months

    Difference between intervention and usual care groups in change in glucose time-in-range from baseline to 3 months. Time-in-range will be calculated from continuous glucose monitoring data as the percent of time spent in the range >= 70 mg/dL and <=180 mg/dL.

  12. Between-group difference in change in glucose time-in-range from baseline to 6 weeks

    Time frame: 6 weeks

    Difference between intervention and usual care groups in change in glucose time-in-range from baseline to 6 months. Time-in-range will be calculated from continuous glucose monitoring data as the percent of time spent in the range >= 70 mg/dL and <=180 mg/dL.

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Peacock, PhD, MPH

CONTACT

[email protected]

504-988-1075

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Registry information

Official study title

Enhancing Diabetes Care: Implementing Cognitive Behavioral Therapy for Insomnia to Improve Sleep and Cardiometabolic Outcomes

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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