NCT07062406

Enhancing Diabetes Care by Treating Insomnia

Not yet recruiting NA Last updated 17 February 2026

What this trial tests

NA trial testing Cognitive Behavioral Therapy for Insomnia in Diabetes Type 2 in 30 participants. Not yet recruiting.

Timeline

1 April 2026

Primary endpoint
31 January 2027

31 January 2027

Quick facts

Lead sponsor	Tulane University
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	30
Start date	1 April 2026
Primary completion	31 January 2027
Estimated completion	31 January 2027
Sites	1 location across United States

Drugs / interventions tested

• Cognitive Behavioral Therapy for Insomnia
• Usual care for diabetes management
• Usual care for treatment of insomnia

Conditions studied

• Diabetes Type 2 — all drugs for Diabetes Type 2 →
• Insomnia — all drugs for Insomnia →

Sponsor

Tulane University

Who can join

40 and older, any sex, with Diabetes Type 2 or Insomnia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.