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Enhancing Diabetes Care by Treating Insomnia

Enhancing Diabetes Care: Implementing Cognitive Behavioral Therapy for Insomnia to Improve Sleep and Cardiometabolic Outcomes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a 6-week program of cognitive behavioral therapy for insomnia can improve sleep and diabetes control. This therapy helps people change thoughts and habits that affect sleep. The study is for patients age 40 or older at a participating clinic who have type 2 diabetes that is not well controlled and trouble sleeping.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are age 40 or older.
  • Get primary care at a participating clinic.
  • Have type 2 diabetes.
  • Have a most recent A1c result above 7% from the past year. A1c measures average blood sugar.
  • Score 15 or higher on the Insomnia Severity Index, a survey about trouble sleeping.
  • Can speak English.

Who can't join

  • Have diagnosed or self-reported sleep apnea, a condition that causes breathing to stop and start during sleep.
  • Are pregnant or plan to become pregnant during the study.
  • Have a mental or physical health condition that would keep you from completing study tasks.
  • Are taking part in another diabetes clinical trial.
  • Live in the same household as another study participant.
  • Must work night shifts.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study sites (1)

LA