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NCT Number: NCT07522866

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.

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Key information

Conditions

Type1diabetes

Age range

31 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 31 to 75 years
  • Type 1 Diabetes for at least 1 year
  • One or more sleep health dimensions are out of range

Exclusion criteria

  • Non-English speaking
  • Recent night shift work or transmeridian travel
  • Life-limiting illness

Treatment and study plan

TranS-C Intervention Arm

Behavioral

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) Arm

Behavioral

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.

Other names: Enhanced Usual Care (EUC)

Primary outcomes

  1. 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.

  2. 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 (%).

Secondary outcomes

  1. Glucose variability

    Time frame: Baseline and post-intervention (14 weeks from baseline)

    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 (%).

  2. Time in range

    Time frame: Baseline and post-intervention (14 weeks from baseline)

    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 (%).

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie Griggs, PhD, RN, FAAN

CONTACT

[email protected]

404-544-9915

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Intervention to Thrive With Type 1 Diabetes 2026

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 13, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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