Sleep, Glycemia, and Self-Management in Young Adults With Type 1 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Non-dominant Wrist-worn Actigraph to be Worn 24/7 (Spectrum Plus)
Study Overview
Brief Summary
Type 1 Diabetes (T1D) affects 1.6 million Americans, and only 14% of young adults age 18-25 years achieve glycemic targets (glycosylated hemoglobin A1C <7.0%). Achieving glycemic targets is associated with reduced risk for both micro-and macrovascular complications, better neurocognitive function, and better diabetes quality of life. In lab studies, sleep deprivation led to impaired glucose tolerance and insulin sensitivity in adults without chronic condition and in one study of adults with T1D. Extending sleep in natural environments contributes to improved insulin sensitivity and glucose levels, neurocognition, and psychological symptoms in young adults without chronic conditions. Modifiable dimensions of sleep health (appropriate sleep duration, stability, and timing) are associated with better glycemic control in adults with T1D. Therefore, improving sleep duration, stability, and timing may be potential therapeutic targets to improve glucoregulation and clinical outcomes (diabetes self-management, neurocognitive function, and symptoms) in this high-risk population.
The overall objective is to test and compare the effects of a cognitive-behavioral sleep self-management intervention (sleep extension and consistency in sleep timing) compared to an attention control condition (habitual sleep duration + diabetes self-management education) on improving sleep duration, stability, and timing, and glycemia (glycemic control and glucose variability) in short-sleeping young adults with T1D in a pilot randomized controlled trial.
Detailed Description
This is a two-arm randomized controlled trial, with participants assigned to either the Sleep Self-Management arm or the attention control arm (Diabetes Self-Management Education). The Sleep Self-Management condition involves an initial 50-minute face-to-face consultation with brief 5-10 minute weekly follow-ups in a format TBD by aim 1 (e.g., call, text, video conference) with 3-week booster sessions in person. The Sleep Self-Management intervention activities are provided in addition to "usual care."
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Masking Description
Both conditions will receive time-balanced sessions with the study team. Participants will not be told whether in the experimental condition or the condition delivering usual care until after the completion of the study.
Eligibility Criteria
- Ages
- 18 Years to 26 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1) Age range: from 18 to 26 years
- •2) Diagnosed with T1D for at least 6 months
- •3) No other major health problems (e.g., chronic medical condition or major psychiatric illness
- •4) Not currently participating in any intervention studies
- •5) Read/speak English
- •6) Have a most recent A1C or eA1C value ≥ 7%.
Exclusion Criteria
- •1) Previous OSA diagnosis/high-risk sleep apnea
- •2) Current pregnancy
- •3) Night shift workers
- •4) Habitually sleep > 7 hours on work or school days.
Arms & Interventions
Sleep Self-Management
The Sleep Self-Management Intervention involves an initial 50-minute face-to-face interactive session in a private location. Participants are asked to extend time in bed by 1 hour and consistently maintain the extension on both weekends and weekdays. Bedtimes and waketimes will be assessed to ascertain which time is most modifiable for the participant's lifestyle and routine. There will be weekly follow-ups and in-person 3-week booster sessions. Sleep reports generated by the actigraphy will be shared with participants with brief action planning and goal setting to address progress towards goal achievement. A need to revise plans for future weeks will be the booster sessions' major goal.
Intervention: Sleep Self-Management (Behavioral)
Diabetes Self-Management Education
The Attention Control arm will receive Diabetes Self-Management Education at the initial consultation visit via in-person contact at T1. There will be weekly follow-ups and in-person 3-week sessions. A Diabetes Self-Management Tracking Form will be used to monitor the weekly acquisition of information and plans for the 6-week intervention and at the 3-month and 6-month data points.
Outcomes
Primary Outcomes
Non-dominant Wrist-worn Actigraph to be Worn 24/7 (Spectrum Plus)
Time Frame: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.
Average sleep duration as assessed as the average minutes per night participants spent asleep over the 7-14 days preceding each time point (Change in sleep duration (longer sleep duration indicates improvement).
Time in Range 70-180 mg/dL
Time Frame: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.
Change in time in range 70-180mg/dL over the monitoring period (7-14 days). Continuous Glucose Monitor (CGM) data downloaded directly from each participant's existing or provided blinded Dexcom G6 \[trademark\]
Secondary Outcomes
- Paper-based Trail Making Test Parts A and B (Executive Function)(From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.)
- Diabetes Distress Scale (17-item)(From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.)
- Diabetes Symptom Checklist Revised (34-item)(From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.)
- Diabetes Self-Management Questionnaire (27-item)(From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.)
- Paper-based Trail Making Test Parts A and B (Executive Function)(From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.)
- Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression Short Form(From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.)
- Diabetes Distress Scale (17-item)(From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.)
- Diabetes Symptom Checklist Revised (34-item)(From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.)