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
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).