Type1diabetesNCT05823142
Health Behavior Intervention for Adults With Type 1 Diabetes
A study testing CB Sleep in people with Type1diabetes, run by Emory University at 1 site in United States.
Trial summary
Type 1 diabetes (T1D) affects approximately 2 million Americans, and only 2 in 8 young adults ages 18-31 years achieve glycemic targets (glycated hemoglobin A1C <7.0%). Achieving glycemic targets is associated with reduced risk of micro-and macrovascular complications. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- CB Sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2023to Dec 2028
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18 to 40 years
- Type 1 Diabetes at least 1 year
- One or more sleep health dimension out of range
Who cannot join
- Non-English speaking
- A1C < 7% or >80% time in glucose range
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
Emory University
Atlanta, Georgia, 30322
Stephanie Griggs, PhD, 4045449915, Stephanie.griggs2@emory.edu
About this study
Type 1 diabetes (T1D) affects approximately 2 million Americans, and only 2 in 8 young adults ages 18-31 years achieve glycemic targets (glycated hemoglobin A1C <7.0%). Achieving glycemic targets is associated with reduced risk of micro-and macrovascular complications. Sleep deprivation leads to impaired glucose tolerance and insulin sensitivity in adults without chronic conditions and with T1D. Promoting sleep in laboratory and natural environments contributes to improvements in insulin sensitivity, glucose levels, and distress symptoms in young adults without chronic conditions and more time in range in adolescents with T1D. Multiple dimensions of sleep health (alertness, timing, efficiency, and sleep duration) are associated with better achievement of glycemic targets in adults with T1D. Therefore, sleep health dimensions are appropriate therapeutic targets to improve glucoregulation and other diabetes self-management outcomes in this population.
Our primary objective is to evaluate the immediate and short-term effects of a 12-week CB-sleep intervention compared to enhanced usual care (time balanced attention control) on actigraphy- and self-report derived sleep health dimensions and diabetes self-management outcomes (glycemia and distress symptoms) over 9-months (Stage II of the NIH Model for Behavior Change, ORBIT phase III). CB-sleep is guided by principles and practices from motivational interviewing and the Transtheoretical Model of Behavior Change with interactive stage-matched sessions.
Read the detailed description
Overview: The investigators will conduct a powered randomized controlled trial (RCT) and recruit a contemporary cohort of 248 young adults with T1D and randomly assign them to one of two conditions: CB-sleep or a time-balanced attention control (enhanced usual care) condition. The study will evaluate the immediate and short-term effects of CB-sleep compared to enhanced usual care on actigraphy and self-report derived sleep health dimensions (aim 1), glycemia and other diabetes self-management outcomes (aim 2), and whether sleep health mediates associations between the CB-sleep and enhanced usual care conditions (aim 3). All participants will complete a battery of validated questionnaires and objective measures of sleep and glycemia captured at baseline to post-intervention (3 months) and at a 6- and 9-month follow-up.
Study Design:
A two-arm, RCT will be used to evaluate the efficacy of CB-sleep compared to a time-balanced attention control condition (enhanced usual care). Data collection will include T0 baseline measures (questionnaires and 14-days of sleep/glucose monitoring), T1 will include the allocation to the experimental or control condition, T2 will include immediate post baseline measures at 3-months, T3 will include repeating measures at 6-months, and T4 will include repeating measures at 9-months.
- Conditions
- Type1diabetes
- Being tested
- CB Sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CB SleepBehavioural
The CB-sleep intervention is a cognitive behavioral intervention guided by principles and practices from motivational interviewing and the psychology of behavior change, primarily drawing on self-efficacy and action planning theory. The goals of CB-sleep are for participants to achieve adequate sleep duration (7-9 hours per night), adequate sleep efficiency (≥ 85%), and regular sleep timing (<60-minute differences in bed and wake times). The intervention components include improving sleep knowledge (hygiene), developing a nightly routine, addressing competing activities, modifying environmental conditions, lifestyle (avoiding caffeine and vigorous exercise before bed), technology (limiting or avoiding screens for at least one hour before bed), basic stress-management (progressive muscle relaxation and guided imagery), and self- monitoring.
| Study group | Role | What they receive |
|---|---|---|
| CB-sleep | Experimental | Initial instruction for the CB-sleep intervention will occur 60-minute telehealth session. The initial action planning session with a sleep report and booster sessions will be interactive and stage matched. The intervention will include an interactive PowerPoint with the participant's clinician sleep report with personalized feedback. They will be encouraged to systematically extend their time in bed by 1 hour and maintain the extension on both weekends and weekdays. Weekly titration will occur according to the following parameters: if sleep efficiency is ≥ 85%, time in bed is increased by 15 minutes per week until a total of a 1 hour increase in time in bed is achieved, if sleep efficiency is <85%, time in bed remains the same. There will be weekly follow-ups (email, phone, text, video chat) and telehealth 4-week booster sessions. Sleep reports generated by the baseline actigraphy report will be shared with participants with brief action planning and goal setting. Receives: Behavioral: CB Sleep |
| Attention Control Enhanced Usual Care arm | No intervention | After baseline, the RA assigned to this condition will schedule a 60-minute telehealth appointment to provide instruction for enhanced usual care at the initial consultation visit via contact at T1 (60-minute telehealth session in a private location). The time-balanced follow-up sessions will remain neutral and focused on health perceptions, current plan of care, and relationship building as opposed to the CB-sleep condition's focus on sleep promotion and extension. The RA assigned to the control condition will ask participants to (a) describe how they are doing and (b) ask how confident they are in achieving the goals they have set for themselves. These calls will help to build a relationship with participants to promote study retention. The investigators recognize that participants may obtain self-initiated diabetes self-management in this group, which will vary and will use a Diabetes Self-Management Tracking Form to monitor weekly information acquisition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensional sleep health composite score
The multidimensional sleep health composite score will measure sleep regularity, satisfaction, alertness, timing, efficiency, and duration of sleep. The total possible score range is 0-6 with higher scores indicating higher or better sleep health.
Measured: Baseline, 3, 6 and 9 months post-intervention
Glycated hemoglobin (HbA1C)
Changes in glycemia will be measured by glycated hemoglobin (HbA1C) at baseline, 3, 6 and 9 months.
Measured: Baseline, 3, 6 and 9 months post-intervention
Secondary outcomes (4)
Glucose variability
% coefficient of variation will be measured by Continuous glucose monitor (CGM) or glucose meter
Measured: Baseline, 3, 6 and 9 months post-intervention
Time in range (70-140 mg/dL)
Time in rage for glycemic control (70-140 mg/dL) will be measured by Continuous glucose monitor (CGM) or glucose meter
Measured: Baseline, 3, 6 and 9 months post-intervention
General distress symptoms
PROMIS v1.0 Emotional Distress (Cronbach's α = 0.95, ICC 0.69 to 0.88), With a standardized normative T-score of 50 and a standard deviation of 10, T-scores <55 would translate as normal; 55-60 as mild; 60-70 as moderate, and ≥70 as severe distress
Measured: Baseline, 3, 6 and 9 months post-intervention
Diabetes distress symptoms
Diabetes Distress Scale (Cronbach's α = 0.88 to 0.93, ICC 0.44 to 0.64), Average score of < 2.0 = reflects little or no distress Average score between 2.0 and 2.9 = reflects moderate distress, Average score > 3.0 = reflects high distress, A total or subscale score > 2.0 (moderate distress) is considered clinically significant.
Measured: Baseline, 3, 6 and 9 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start20 Dec 2023
- Primary completionJul 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Behavioral: Sleep Self-Management
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Stephanie Griggs, Emory University
- Investigators
- Stephanie Griggs, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823142
- Sponsor's protocol ID
- 2025P011836
- Other IDs
- R01DK136604, STUDY20230448
- Status last verified
- Dec 2025
- First submitted
- 4 Apr 2023
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Behavior Intervention for Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05823142
- Acronym / sponsor ID
- 2025P011836
- Conditions
- Type1diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 21 Apr 2023 (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.
Type 1 diabetes (T1D) affects approximately 2 million Americans, and only 2 in 8 young adults ages 18-31 years achieve glycemic targets (glycated hemoglobin A1C <7.0%). Achieving glycemic targets is associated with reduced risk of micro-and macrovascular complications. Sleep deprivation leads to impaired glucose tolerance and insulin sensitivity in adults without chronic conditions and with T1D. Promoting sleep in laboratory and natural environments contributes to improvements in insulin sensitivity, glucose levels, and distress symptoms in young adults without chronic conditions and more time in range in adolescents with T1D. Multiple dimensions of sleep health (alertness, timing, efficiency, and sleep duration) are associated with better achievement of glycemic targets in adults with T1D. Therefore, sleep health dimensions are appropriate therapeutic targets to improve glucoregulation and other diabetes self-management outcomes in this population.
Our primary objective is to evaluate the immediate and short-term effects of a 12-week CB-sleep intervention compared to enhanced usual care (time balanced attention control) on actigraphy- and self-report derived sleep health dimensions and diabetes self-management outcomes (glycemia and distress symptoms) over 9-months (Stage II of the NIH Model for Behavior Change, ORBIT phase III). CB-sleep is guided by principles and practices from motivational interviewing and the Transtheoretical Model of Behavior Change with interactive stage-matched sessions.
Detailed description
Overview: The investigators will conduct a powered randomized controlled trial (RCT) and recruit a contemporary cohort of 248 young adults with T1D and randomly assign them to one of two conditions: CB-sleep or a time-balanced attention control (enhanced usual care) condition. The study will evaluate the immediate and short-term effects of CB-sleep compared to enhanced usual care on actigraphy and self-report derived sleep health dimensions (aim 1), glycemia and other diabetes self-management outcomes (aim 2), and whether sleep health mediates associations between the CB-sleep and enhanced usual care conditions (aim 3). All participants will complete a battery of validated questionnaires and objective measures of sleep and glycemia captured at baseline to post-intervention (3 months) and at a 6- and 9-month follow-up.
Study Design:
A two-arm, RCT will be used to evaluate the efficacy of CB-sleep compared to a time-balanced attention control condition (enhanced usual care). Data collection will include T0 baseline measures (questionnaires and 14-days of sleep/glucose monitoring), T1 will include the allocation to the experimental or control condition, T2 will include immediate post baseline measures at 3-months, T3 will include repeating measures at 6-months, and T4 will include repeating measures at 9-months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Behavioral: Sleep Self-Management
| Arm | Type | Receives |
|---|---|---|
| CB-sleep | Experimental | Behavioral: CB SleepInitial instruction for the CB-sleep intervention will occur 60-minute telehealth session. The initial action planning session with a sleep report and booster sessions will be interactive and stage matched. The intervention will include an interactive PowerPoint with the participant's clinician sleep report with personalized feedback. They will be encouraged to systematically extend their time in bed by 1 hour and maintain the extension on both weekends and weekdays. Weekly titration will occur according to the following parameters: if sleep efficiency is ≥ 85%, time in bed is increased by 15 minutes per week until a total of a 1 hour increase in time in bed is achieved, if sleep efficiency is <85%, time in bed remains the same. There will be weekly follow-ups (email, phone, text, video chat) and telehealth 4-week booster sessions. Sleep reports generated by the baseline actigraphy report will be shared with participants with brief action planning and goal setting. |
| Attention Control Enhanced Usual Care arm | No intervention | –After baseline, the RA assigned to this condition will schedule a 60-minute telehealth appointment to provide instruction for enhanced usual care at the initial consultation visit via contact at T1 (60-minute telehealth session in a private location). The time-balanced follow-up sessions will remain neutral and focused on health perceptions, current plan of care, and relationship building as opposed to the CB-sleep condition's focus on sleep promotion and extension. The RA assigned to the control condition will ask participants to (a) describe how they are doing and (b) ask how confident they are in achieving the goals they have set for themselves. These calls will help to build a relationship with participants to promote study retention. The investigators recognize that participants may obtain self-initiated diabetes self-management in this group, which will vary and will use a Diabetes Self-Management Tracking Form to monitor weekly information acquisition. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18 to 40 years
- Type 1 Diabetes at least 1 year
- One or more sleep health dimension out of range
Key exclusion criteria (2 listed)
- Non-English speaking
- A1C < 7% or >80% time in glucose range
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 |
|---|---|---|
| CB SleepThe CB-sleep intervention is a cognitive behavioral intervention guided by principles and practices from motivational interviewing and the psychology of behavior change, primarily drawing on self-efficacy and action planning theory. The goals of CB-sleep are for participants to achieve adequate sleep duration (7-9 hours per night), adequate sleep efficiency (≥ 85%), and regular sleep timing (<60-minute differences in bed and wake times). The intervention components include improving sleep knowledge (hygiene), developing a nightly routine, addressing competing activities, modifying environmental conditions, lifestyle (avoiding caffeine and vigorous exercise before bed), technology (limiting or avoiding screens for at least one hour before bed), basic stress-management (progressive muscle relaxation and guided imagery), and self- monitoring. | Behavioural | CB-sleep |
Primary outcome
Multidimensional sleep health composite score
Time frame: Baseline, 3, 6 and 9 months post-intervention
The multidimensional sleep health composite score will measure sleep regularity, satisfaction, alertness, timing, efficiency, and duration of sleep. The total possible score range is 0-6 with higher scores indicating higher or better sleep health.
Glycated hemoglobin (HbA1C)
Time frame: Baseline, 3, 6 and 9 months post-intervention
Changes in glycemia will be measured by glycated hemoglobin (HbA1C) at baseline, 3, 6 and 9 months.
4 secondary outcomes
Glucose variability
Time frame: Baseline, 3, 6 and 9 months post-intervention
Time in range (70-140 mg/dL)
Time frame: Baseline, 3, 6 and 9 months post-intervention
General distress symptoms
Time frame: Baseline, 3, 6 and 9 months post-intervention
Diabetes distress symptoms
Time frame: Baseline, 3, 6 and 9 months post-intervention
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 19 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Type1diabetes
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
Active, not recruitingPhase 2
Probiotics in Newly Diagnosed T1D
Type 1 Diabetes, Type1diabetes
RecruitingObservational study
Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children
Type1diabetes
Active, not recruitingPhase 2
Reducing Innate Inflammation in New Onset Type 1 Diabetes
Type 1 Diabetes, type1diabetes
Recruiting
Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D)
Non-Nutritive Sweetener, Type 1 Diabetes
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.
Stephanie Griggs, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CB Sleep in people with Type1diabetes, run by Emory 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 3 inclusion and 2 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 19 Dec 2025. 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 Stephanie Griggs, PhD (404-544-9915, Stephanie.griggs2@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidimensional sleep health composite score (time frame: Baseline, 3, 6 and 9 months post-intervention). The study lists 2 primary outcomes in all. 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 19 Dec 2025.