Enhancing Diabetes Care by Treating Insomnia

Not Applicable

Not yet recruiting

• Conditions: Diabetes Type 2; Insomnia

• Registration Number: NCT07062406
• Lead Sponsor: Tulane University

Brief 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 an 8-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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-07-02
• Study First Posted: 2025-07-14
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-24
• Study Start: 2025-09-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Between-group difference in change in HbA1c from baseline to 3 months	3 months	Difference between intervention and usual care groups in change in hemoglobin A1c (HbA1c) from baseline to 3 months

Secondary Outcome Measures

Name	Time	Method
Between-group difference in proportion without clinical insomnia symptoms at 8 weeks	8 weeks	Difference between intervention and usual care groups in proportion with Insomnia Severity Index (ISI) score \<15 at 8 weeks. The ISI is a 7-item questionnaire with scale score ranging from 0 to 28, with higher scores indicating more insomnia symptoms. An ISI score \>= 15 indicates symptoms consistent with clinical insomnia.
Between-group difference in change in sleep efficiency from baseline to 8 weeks	8 weeks	Difference between intervention and usual care groups in change in sleep efficiency from baseline to 8 weeks. Sleep efficiency will be calculated from wearable device data as the percent of time in bed spent asleep.
Between-group difference in change in wake after sleep onset (WASO) from baseline to 8 weeks	8 weeks	Difference between intervention and usual care groups in change in wake after sleep onset (WASO) from baseline to 8 weeks. WASO will be calculated from wearable device data as the number of minutes spent awake after first sleep onset.
Between-group difference in change in insomnia symptoms from baseline to 3 months	3 months	Difference between intervention and usual care groups in change in Insomnia Severity Index (ISI) score from baseline to 3 months. The ISI is a 7-item questionnaire with scale score ranging from 0 to 28, with higher scores indicating more insomnia symptoms.
Between-group difference in change in concentration of insulin from baseline to 3 months	3 months	Difference between intervention and usual care groups in change in concentration of insulin from baseline to 3 months
Between-group difference in change in fasting glucose from baseline to 3 months	3 months	Difference between intervention and usual care groups in change in fasting glucose from baseline to 3 months
Between-group difference in change in sleep efficiency from baseline to 3 months	3 months	Difference between intervention and usual care groups in change in sleep efficiency from baseline to 3 months. Sleep efficiency will be calculated from wearable device data as the percent of time in bed spent asleep.
Between-group difference in change in insomnia symptoms from baseline to 8 weeks	8 weeks	Difference between intervention and usual care groups in change in Insomnia Severity Index (ISI) score from baseline to 8 weeks. The ISI is a 7-item questionnaire with scale score ranging from 0 to 28, with higher scores indicating more insomnia symptoms.
Between-group difference in change in wake after sleep onset (WASO) from baseline to 3 months	3 months	Difference between intervention and usual care groups in change in wake after sleep onset (WASO) from baseline to 3 months. WASO will be calculated from wearable device data as the number of minutes spent awake after first sleep onset.
Between-group difference in proportion without clinical insomnia symptoms at 3 months	3 months	Difference between intervention and usual care groups in proportion with Insomnia Severity Index (ISI) score \<15 at 3 months. The ISI is a 7-item questionnaire with scale score ranging from 0 to 28, with higher scores indicating more insomnia symptoms. An ISI score \>= 15 indicates symptoms consistent with clinical insomnia.

Trial Locations

Locations (1)

Southeast Community Health Systems; 🇺🇸 Zachary, Louisiana, United States