Type1diabetesNCT07522866
Thrive With Type 1 Diabetes 2026
A study testing TranS-C Intervention Arm in people with Type1diabetes, run by Emory University at 2 sites in United States.
Trial summary
This study aims to learn whether a cognitive behavioral intervention can improve lifestyle and glucose targets for adults with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 31 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type1diabetes
- What is being tested?
- TranS-C Intervention Arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2026to Apr 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 31 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 31 to 75 years
- Type 1 Diabetes for at least 1 year
- One or more sleep health dimensions are out of range
Who cannot join
- Non-English speaking
- Recent night shift work or transmeridian travel
- Life-limiting illness
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Emory University, Nell Hodgson Woodruff School of Nursing
Atlanta, Georgia, 30322
- Recruiting
Emory University
Atlanta, Georgia, 30329
About this study
Official title: Intervention to Thrive With Type 1 Diabetes 2026
This study aims to learn whether a cognitive behavioral intervention can improve lifestyle and glucose targets for adults with type 1 diabetes.
Read the detailed description
Type 1 diabetes (T1D), a common yet understudied chronic condition in young adulthood, is a life-shortening disorder leading to beta-cell destruction and absolute insulin deficiency. Suboptimal glucose diabetes self-management is associated with a higher risk for premature vascular complications, both macrovascular (e.g., coronary artery disease, peripheral arterial disease, and stroke) and microvascular (retinopathy, nephropathy, neuropathy) through accelerated vascular aging. Yet a majority of adults with T1D do not achieve recommended glycemic targets (A1C <7%) or blood pressure targets.
- Conditions
- Type1diabetes
- Being tested
- TranS-C Intervention Arm, Attention Control Enhanced Usual Care (EUC) Arm
- Keywords
- Glycemia, A1C, Sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TranS-C Intervention ArmBehavioural
This 12-week cognitive behavioral intervention uses motivational interviewing and behavior change principles, focusing on self-efficacy and action planning. Participants target 7-9 hours of sleep per night, ≥85% sleep efficiency, and <60 minutes' variability in bed and wake times.
Components include sleep education and hygiene, nightly routines, the management of competing activities, sleep environment optimization, lifestyle modifications (e.g., avoiding caffeine and vigorous exercise before bedtime), screen time reduction, basic stress management (e.g., progressive muscle relaxation), and self-monitoring. Following a baseline visit, a research assistant conducts a 60-minute telehealth session via HIPAA-compliant Zoom/Teams, with booster sessions at weeks 4, 8, and 12. Sleep time is adjusted weekly based on sleep efficiency criteria.
Attention Control Enhanced Usual Care (EUC) ArmBehavioural
Also called Enhanced Usual Care (EUC)
This time- and attention-balanced 12-week condition will focus on enhancing usual care. After the initial baseline visit, the RA for this group will schedule a 60-minute telehealth appointment for the enhanced usual care. Follow-up sessions (weeks 4 and 8) will focus on health perceptions, care plans, and relationship-building rather than sleep promotion. The RA will encourage participants to share their progress and confidence in their self-set goals to foster engagement and retention. Participants may engage in self-initiated diabetes management, which will be tracked using a Diabetes Self-Management Tracking Form.
| Study group | Role | What they receive |
|---|---|---|
| Transdiagnostic Intervention for Sleep and Circadian (TranS-C) Dysfunction Intervention Arm | Experimental | Participants will work with a health coach to aim for 7-9 hours of sleep per night, at least 85% sleep efficiency, and less than 60 minutes' variation in bed and wake times. Receives: Behavioral: TranS-C Intervention Arm |
| Enhanced Usual Care (EUC) Arm | Active comparator | Participants will work with a health coach focused on enhanced usual care. Receives: Behavioral: Attention Control Enhanced Usual Care (EUC) Arm |
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 assesses six domains: regularity, satisfaction, alertness, timing, efficiency, and duration. Sleep regularity, timing, efficiency, and duration will be measured using a non-dominant wrist-worn research-grade actigraph (Ametris CentrePoint Insight Watch) worn 24/7 during the monitoring period. Sleep satisfaction will be assessed using the global score of the 19-item Pittsburgh Sleep Quality Index (PSQI; range 0-21; scores <5 coded as 1, indicating good sleep). Alertness will be assessed using the Epworth Sleepiness Scale (ESS; range 0-24; scores <8 coded as 1, indicating good daytime alertness). Each component will be scored according to predefined criteria and summed to create a composite score ranging from 0 to 6, with higher scores indicating better overall sleep health over the 1-week monitoring period at each time point. The composite score (unitless) will be assessed at baseline and post-intervention.
Measured: Baseline and post-intervention (14 weeks from baseline)
Glycated hemoglobin (HbA1C)
HbA1C will be measured by the FDA-approved A1C Now Self-Check. HbA1C reflects the average blood glucose level over the preceding approximately 2-3 months and will be reported as a percentage (%). Changes in glycemia will be assessed by comparing HbA1C values measured at baseline and post intervention. Units = percent (%).
Measured: Baseline and post-intervention (14 weeks from baseline)
Secondary outcomes (2)
Glucose variability
Glucose variability (GV) will be collected using data from the participant's own continuous glucose monitor (CGM) over the 1-week monitoring period at each time point. CGMs provide real-time glucose readings every 5 minutes, offering up to 288 measurements in 24 hours, with high accuracy (test-retest 0.77-0.95). Changes in glucose variability will be assessed by the coefficient of variation (CV) (cv = σ/μ) from baseline to post intervention. Based on the published literature, the 2017 international consensus statement on the use of CGM suggested that 'stable glucose levels are defined as a CV <36% and unstable glucose levels are defined as CV ≥36%. Units = percent (%).
Measured: Baseline and post-intervention (14 weeks from baseline)
Time in range
Time in Range (%TIR) is the percentage of time that a person spends with their blood glucose levels in a target range (70-180 mg/dL). This will be measured by the CGM. Units = percent (%).
Measured: Baseline and post-intervention (14 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study startSep 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Griggs, Emory University
- Investigators
- Stephanie Griggs, PhD, RN, FAAN, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522866
- Sponsor's protocol ID
- 2026P000152
- Status last verified
- Aug 2026
- First submitted
- 4 Apr 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers will share Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Thrive With Type 1 Diabetes 2026
- ClinicalTrials.gov ID
- NCT07522866
- Acronym / sponsor ID
- 2026P000152
- Conditions
- Type1diabetes
- Keywords
- Glycemia, A1C, Sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 13 Apr 2026 (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.
This study aims to learn whether a cognitive behavioral intervention can improve lifestyle and glucose targets for adults with type 1 diabetes.
Detailed description
Type 1 diabetes (T1D), a common yet understudied chronic condition in young adulthood, is a life-shortening disorder leading to beta-cell destruction and absolute insulin deficiency. Suboptimal glucose diabetes self-management is associated with a higher risk for premature vascular complications, both macrovascular (e.g., coronary artery disease, peripheral arterial disease, and stroke) and microvascular (retinopathy, nephropathy, neuropathy) through accelerated vascular aging. Yet a majority of adults with T1D do not achieve recommended glycemic targets (A1C <7%) or blood pressure targets.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transdiagnostic Intervention for Sleep and Circadian (TranS-C) Dysfunction Intervention Arm | Experimental | Behavioral: TranS-C Intervention ArmParticipants will work with a health coach to aim for 7-9 hours of sleep per night, at least 85% sleep efficiency, and less than 60 minutes' variation in bed and wake times. |
| Enhanced Usual Care (EUC) Arm | Active comparator | Behavioral: Attention Control Enhanced Usual Care (EUC) ArmParticipants will work with a health coach focused on enhanced usual care. |
Who may qualify
- Ages
- 31 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 31 to 75 years
- Type 1 Diabetes for at least 1 year
- One or more sleep health dimensions are out of range
Key exclusion criteria (3 listed)
- Non-English speaking
- Recent night shift work or transmeridian travel
- Life-limiting illness
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 |
|---|---|---|
| TranS-C Intervention ArmThis 12-week cognitive behavioral intervention uses motivational interviewing and behavior change principles, focusing on self-efficacy and action planning. Participants target 7-9 hours of sleep per night, ≥85% sleep efficiency, and <60 minutes' variability in bed and wake times. Components include sleep education and hygiene, nightly routines, the management of competing activities, sleep environment optimization, lifestyle modifications (e.g., avoiding caffeine and vigorous exercise before bedtime), screen time reduction, basic stress management (e.g., progressive muscle relaxation), and self-monitoring. Following a baseline visit, a research assistant conducts a 60-minute telehealth session via HIPAA-compliant Zoom/Teams, with booster sessions at weeks 4, 8, and 12. Sleep time is adjusted weekly based on sleep efficiency criteria. | Behavioural | Transdiagnostic Intervention for Sleep and Circadian (TranS-C) Dysfunction Intervention Arm |
| Attention Control Enhanced Usual Care (EUC) ArmAlso: Enhanced Usual Care (EUC)This time- and attention-balanced 12-week condition will focus on enhancing usual care. After the initial baseline visit, the RA for this group will schedule a 60-minute telehealth appointment for the enhanced usual care. Follow-up sessions (weeks 4 and 8) will focus on health perceptions, care plans, and relationship-building rather than sleep promotion. The RA will encourage participants to share their progress and confidence in their self-set goals to foster engagement and retention. Participants may engage in self-initiated diabetes management, which will be tracked using a Diabetes Self-Management Tracking Form. | Behavioural | Enhanced Usual Care (EUC) Arm |
Primary outcome
Multidimensional sleep health composite score
Time frame: Baseline and post-intervention (14 weeks from baseline)
The multidimensional sleep health composite score assesses six domains: regularity, satisfaction, alertness, timing, efficiency, and duration. Sleep regularity, timing, efficiency, and duration will be measured using a non-dominant wrist-worn research-grade actigraph (Ametris CentrePoint Insight Watch) worn 24/7 during the monitoring period. Sleep satisfaction will be assessed using the global score of the 19-item Pittsburgh Sleep Quality Index (PSQI; range 0-21; scores <5 coded as 1, indicating good sleep). Alertness will be assessed using the Epworth Sleepiness Scale (ESS; range 0-24; scores <8 coded as 1, indicating good daytime alertness). Each component will be scored according to predefined criteria and summed to create a composite score ranging from 0 to 6, with higher scores indicating better overall sleep health over the 1-week monitoring period at each time point. The composite score (unitless) will be assessed at baseline and post-intervention.
Glycated hemoglobin (HbA1C)
Time frame: Baseline and post-intervention (14 weeks from baseline)
HbA1C will be measured by the FDA-approved A1C Now Self-Check. HbA1C reflects the average blood glucose level over the preceding approximately 2-3 months and will be reported as a percentage (%). Changes in glycemia will be assessed by comparing HbA1C values measured at baseline and post intervention. Units = percent (%).
2 secondary outcomes
Glucose variability
Time frame: Baseline and post-intervention (14 weeks from baseline)
Time in range
Time frame: Baseline and post-intervention (14 weeks from baseline)
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 6 Aug 2026.
- Individual participant dataSharing planned: Yes. Researchers will share Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Stephanie Griggs, PhD, RN, FAAN principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TranS-C Intervention Arm in people with Type1diabetes, run by Emory University at 2 sites 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 3 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 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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, RN, FAAN (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 and post-intervention (14 weeks from baseline)). 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 6 Aug 2026.