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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: Clinical Trial NA study, sponsored by Tulane University.
NCT07062406 is a NA study that has not yet begun recruiting, run by Tulane University. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Difference between intervention and usual care groups in change in hemoglobin A1c (HbA1c) from baseline to 3 months
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 |
What is known before NCT07062406 opens enrollment
NCT07062406 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Cognitive Behavioral Therapy for Insomnia is the first listed.
NCT07062406 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07062406's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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