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Enhancing Diabetes Care by Treating Insomnia

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Feb 28, 2027 → Jun 30, 2027
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Record History

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  1. Notable Recruitment opened
    • Start date changed from estimate of Jun 1, 2026 to Sep 1, 2026
    • Primary and study completion pushed from Feb 28, 2027 to Jun 30, 2027
    • Site details revised
    v8
  2. Notable Start date: Apr 1, 2026 to Jun 1, 2026
    • Primary and study completion dates: Jan 31, 2027 to Feb 28, 2027
    v7
  3. Minor Secondary endpoints: 10 to 12
    • Eligibility criteria expanded, about 5 words
    v6
  4. Notable Start date: Mar 1, 2026 to Apr 1, 2026
    • Primary and study completion dates: Dec 31, 2026 to Jan 31, 2027
    v5
  5. Notable Primary and study completion dates: Jun 30, 2026 to Dec 31, 2026
    • Start date: Nov 1, 2025 to Mar 1, 2026
    v4
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  1. Notable Start date: Sep 1, 2025 to Nov 1, 2025v3
  2. Minor Secondary endpoints revised (10)v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT07062406
Lead Sponsor Tulane University
Conditions
(from sponsor)
Diabetes Type 2, Insomnia
Related terms Diabetes Mellitus, Type 2, Sleep Initiation and Maintenance Disorders
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov