Diabetes Type 2NCT07062406
Enhancing Diabetes Care by Treating Insomnia
A study testing Cognitive Behavioral Therapy for Insomnia in people with Diabetes Type 2 and Insomnia, run by Tulane University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Type 2, Insomnia
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Southeast Community Health Systems
Zachary, Louisiana, 70791
Erin Peacock, PhD, MPH, 504-988-1075, epeacoc@tulane.edu
About this study
Official title: Enhancing Diabetes Care: Implementing Cognitive Behavioral Therapy for Insomnia to Improve Sleep and Cardiometabolic Outcomes
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.
- Conditions
- Diabetes Type 2, Insomnia
- Being tested
- Cognitive Behavioral Therapy for Insomnia, Usual care for diabetes management, Usual care for treatment of insomnia
- Medical subject headings
- Diabetes Mellitus, Type 2, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
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
Usual care for diabetes managementOther
Usual clinical care for management of diabetes (may include pharmacological and non-pharmacological approaches as determined by provider and patient)
Usual care for treatment of insomniaOther
Usual clinical care for treatment of insomnia (may include pharmacological and non-pharmacological approaches as determined by provider and patient)
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia; Other: Usual care for diabetes management; Other: Usual care for treatment of insomnia |
| Usual Care | Active comparator | Not described Receives: Other: Usual care for diabetes management; Other: Usual care for treatment of insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group difference in change in HbA1c from baseline to 3 months
Difference between intervention and usual care groups in change in hemoglobin A1c (HbA1c) from baseline to 3 months
Measured: 3 months
Secondary outcomes (12)
Between-group difference in change in insomnia symptoms from baseline to 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.
Measured: 3 months
Between-group difference in change in fasting glucose from baseline to 3 months
Difference between intervention and usual care groups in change in fasting glucose from baseline to 3 months
Measured: 3 months
Between-group difference in change in concentration of insulin from baseline to 3 months
Difference between intervention and usual care groups in change in concentration of insulin from baseline to 3 months
Measured: 3 months
Between-group difference in change in sleep efficiency from baseline to 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.
Measured: 3 months
Between-group difference in change in wake after sleep onset (WASO) from baseline to 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.
Measured: 3 months
Between-group difference in proportion without clinical insomnia symptoms at 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.
Measured: 3 months
Between-group difference in change in insomnia symptoms from baseline to 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.
Measured: 6 weeks
Between-group difference in change in sleep efficiency from baseline to 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.
Measured: 6 weeks
Between-group difference in change in wake after sleep onset (WASO) from baseline to 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.
Measured: 6 weeks
Between-group difference in proportion without clinical insomnia symptoms at 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.
Measured: 6 weeks
Between-group difference in change in glucose time-in-range from baseline to 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.
Measured: 3 months
Between-group difference in change in glucose time-in-range from baseline to 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Sep 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062406
- Sponsor's protocol ID
- 2025-138
- Status last verified
- Sep 2026
- First submitted
- 2 Jul 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Diabetes Care: Implementing Cognitive Behavioral Therapy for Insomnia to Improve Sleep and Cardiometabolic Outcomes
- ClinicalTrials.gov ID
- NCT07062406
- Acronym / sponsor ID
- 2025-138
- Conditions
- Diabetes Type 2, Insomnia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia, Other: Usual care for diabetes management, Other: Usual care for treatment of insomnia |
| Usual Care | Active comparator | Other: Usual care for diabetes management, Other: Usual care for treatment of insomnia |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia6 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 | Behavioural | Cognitive Behavioral Therapy for Insomnia |
| Usual care for diabetes managementUsual clinical care for management of diabetes (may include pharmacological and non-pharmacological approaches as determined by provider and patient) | Other | Cognitive Behavioral Therapy for Insomnia, Usual Care |
| Usual care for treatment of insomniaUsual clinical care for treatment of insomnia (may include pharmacological and non-pharmacological approaches as determined by provider and patient) | Other | Cognitive Behavioral Therapy for Insomnia, Usual Care |
Primary outcome
Between-group difference in change in HbA1c from baseline to 3 months
Time frame: 3 months
Difference between intervention and usual care groups in change in hemoglobin A1c (HbA1c) from baseline to 3 months
12 secondary outcomes
Between-group difference in change in insomnia symptoms from baseline to 3 months
Time frame: 3 months
Between-group difference in change in fasting glucose from baseline to 3 months
Time frame: 3 months
Between-group difference in change in concentration of insulin from baseline to 3 months
Time frame: 3 months
Between-group difference in change in sleep efficiency from baseline to 3 months
Time frame: 3 months
Between-group difference in change in wake after sleep onset (WASO) from baseline to 3 months
Time frame: 3 months
Between-group difference in proportion without clinical insomnia symptoms at 3 months
Time frame: 3 months
Between-group difference in change in insomnia symptoms from baseline to 6 weeks
Time frame: 6 weeks
Between-group difference in change in sleep efficiency from baseline to 6 weeks
Time frame: 6 weeks
Between-group difference in change in wake after sleep onset (WASO) from baseline to 6 weeks
Time frame: 6 weeks
Between-group difference in proportion without clinical insomnia symptoms at 6 weeks
Time frame: 6 weeks
Between-group difference in change in glucose time-in-range from baseline to 3 months
Time frame: 3 months
Between-group difference in change in glucose time-in-range from baseline to 6 weeks
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia in people with Diabetes Type 2 and Insomnia, run by Tulane University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Peacock, PhD, MPH (504-988-1075, epeacoc@tulane.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-group difference in change in HbA1c from baseline to 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.