Enhancing Diabetes Care by Treating Insomnia

NCT07062406 | Not Yet Recruiting

• 1 other identifier: 2025-138
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Type 2; Insomnia

Outcome Measures

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

  3 months

Secondary Outcomes (12)

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

  3 months

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

  3 months

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

  3 months

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

  3 months

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

  3 months

Study Arms (2)

Cognitive Behavioral Therapy for Insomnia

EXPERIMENTAL

Behavioral: Cognitive Behavioral Therapy for Insomnia; Other: Usual care for diabetes management; Other: Usual care for treatment of insomnia

Usual Care

ACTIVE COMPARATOR

Other: Usual care for diabetes management; Other: Usual care for treatment of insomnia

Interventions

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)

Cognitive Behavioral Therapy for Insomnia; Usual Care

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)

Cognitive Behavioral Therapy for Insomnia; Usual Care

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

Cognitive Behavioral Therapy for Insomnia

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tulane University: lead

Study Sites (1)

Southeast Community Health Systems

Zachary, Louisiana, 70791, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Erin Peacock, PhD, MPH

CONTACT

504-988-1075; epeacoc@tulane.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 14, 2025
• Study Start: June 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)