Type1diabetes
Conditions
Keywords
Glycemia, A1C, Sleep
Brief summary
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.
Interventions
BEHAVIORALTranS-C Intervention Arm
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.
BEHAVIORALAttention Control Enhanced Usual Care (EUC) Arm
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.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
31 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Multidimensional sleep health composite score | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Glucose variability | 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 (%). |
| Time in range | 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 (%). |
Countries
United States
Contacts
CONTACTStephanie Griggs, PhD, RN, FAAN
PRINCIPAL_INVESTIGATORStephanie Griggs, PhD, RN, FAAN
Emory University
Outcome results
None listed