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NCT07062406 · ClinicalTrials.gov registry record · NA
Enhancing Diabetes Care by Treating Insomnia
A NA study, sponsored by Tulane University.
- Not yet
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT07062406 is a NA study that has not yet begun recruiting, run by Tulane University. The registered enrollment target is 30 participants.
The verdict
NCT07062406, a NA study, has not yet begun recruiting, sponsored by Tulane University.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy for Insomnia
- OTHER Usual care for diabetes management
- OTHER Usual care for treatment of insomnia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2027-02-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07062406
The ClinicalTrials.gov registry entry for NCT07062406 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tulane University, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Cognitive Behavioral Therapy for Insomnia is the first listed.
NCT07062406 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07062406 about?
NCT07062406 is a clinical study titled "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 ...
What is the current status of trial NCT07062406?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2026-06-01. Estimated completion is 2027-02-28.
What interventions are being tested in trial NCT07062406?
The interventions under investigation include: Cognitive Behavioral Therapy for Insomnia (BEHAVIORAL), Usual care for diabetes management (OTHER), Usual care for treatment of insomnia (OTHER).
Who is sponsoring clinical trial NCT07062406?
This trial is sponsored by Tulane University, which has 73 total clinical trials registered on ClinicalTrials.gov.
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