Diabetes Type 2, Insomnia
Conditions
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 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
BEHAVIORALCognitive Behavioral Therapy for Insomnia
6 weekly sessions delivered by a Sleep Coaching Team comprised of a federally qualified health center behavioral health provider and a health coach, focusing on stimulus control, sleep restriction, and cognitive therapy
OTHERUsual care for diabetes management
Usual clinical care for management of diabetes (may include pharmacological and non-pharmacological approaches as determined by provider and patient)
OTHERUsual care for treatment of insomnia
Usual clinical care for treatment of insomnia (may include pharmacological and non-pharmacological approaches as determined by provider and patient)
Sponsors
Tulane University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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. |
| Between-group difference in change in insomnia symptoms from baseline to 6 weeks | 6 weeks | Difference between intervention and usual care groups in change in Insomnia Severity Index (ISI) score from baseline to 6 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 sleep efficiency from baseline to 6 weeks | 6 weeks | Difference between intervention and usual care groups in change in sleep efficiency from baseline to 6 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 6 weeks | 6 weeks | Difference between intervention and usual care groups in change in wake after sleep onset (WASO) from baseline to 6 weeks. 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 6 weeks | 6 weeks | Difference between intervention and usual care groups in proportion with Insomnia Severity Index (ISI) score \<15 at 6 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 glucose time-in-range from baseline to 6 weeks | 6 weeks | Difference between intervention and usual care groups in change in glucose time-in-range from baseline to 6 months. Time-in-range will be calculated from continuous glucose monitoring data as the percent of time spent in the range \>= 70 mg/dL and \<=180 mg/dL. |
| Between-group difference in change in glucose time-in-range from baseline to 3 months | 3 months | Difference between intervention and usual care groups in change in glucose time-in-range from baseline to 3 months. Time-in-range will be calculated from continuous glucose monitoring data as the percent of time spent in the range \>= 70 mg/dL and \<=180 mg/dL. |
Countries
United States
Contacts
CONTACTErin Peacock, PhD, MPH
Outcome results
None listed