Self-Management in Young Adults With Type 1 Diabetes 2023

Study Overview
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Brief Summary
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Type 1 diabetes (T1D) affects approximately 2 million Americans, and only 2 in 8 young adults ages 18-30 years achieve glycemic targets (glycated hemoglobin A1C <7.0%). Achieving glycemic targets is associated with reduced risk of micro-and macrovascular complications. Sleep deprivation leads to impaired glucose tolerance and insulin sensitivity in adults without chronic conditions and with T1D. Promoting sleep in laboratory and natural environments contributes to improvements in insulin sensitivity, glucose levels, and distress symptoms in young adults without chronic conditions and more time in range in adolescents with T1D. Multiple dimensions of sleep health (alertness, timing, efficiency, and sleep duration) are associated with better achievement of glycemic targets in adults with T1D. Therefore, sleep health dimensions are appropriate therapeutic targets to improve glucoregulation and other diabetes self-management outcomes in this population. Our primary objective is to evaluate the immediate and short-term effects of a 12-week CB-sleep intervention compared to enhanced usual care (time balanced attention control) on actigraphy- and self-report derived sleep health dimensions and diabetes self-management outcomes (glycemia and distress symptoms) over 9-months (Stage II of the NIH Model for Behavior Change, ORBIT phase III). CB-sleep is guided by principles and practices from motivational interviewing and the Transtheoretical Model of Behavior Change with interactive stage-matched sessions.

Detailed Description
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Overview: The investigators will conduct a powered randomized controlled trial (RCT) and recruit a contemporary cohort of 248 young adults with T1D and randomly assign them to one of two conditions: CB-sleep or a time-balanced attention control (enhanced usual care) condition. The study will evaluate the immediate and short-term effects of CB-sleep compared to enhanced usual care on actigraphy and self-report derived sleep health dimensions (aim 1), glycemia and other diabetes self-management outcomes (aim 2), and whether sleep health mediates associations between the CB-sleep and enhanced usual care conditions (aim 3). All participants will complete a battery of validated questionnaires and objective measures of sleep and glycemia captured at baseline to post-intervention (3 months) and at a 6- and 9-month follow-up. Study Design: A two-arm, RCT will be used to evaluate the efficacy of CB-sleep compared to a time-balanced attention control condition (enhanced usual care). Data collection will include T0 baseline measures (questionnaires and 14-days of sleep/glucose monitoring), T1 will include the allocation to the experimental or control condition, T2 will include immediate post baseline measures at 3-months, T3 will include repeating measures at 6-months, and T4 will include repeating measures at 9-months.

Official Title
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Self-Management in Young Adults With Type 1 Diabetes 2023 (R01DK136604)

Conditions
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Type1diabetes

Intervention / Treatment
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* Behavioral: CB Sleep


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are between the ages of 18-31 years; have been diagnosed with T1D for at least 1 year (diagnosis confirmed with ICD 10 code + ≥ 2 of the following: <10 years age at dx, positive autoantibodies [GAD65, IA2, ICA, ZnT8], <30 kg/m2 BMI at dx, diabetes ketoacidosis any time, C-peptide < 0.8 ng/mL + associated glucose >80 mg/dL, family history of 1st degree relative); are not currently participating in intervention studies; read/speak English, have ≥ 1 poor sleep health dimensions (satisfaction: PROMIS > 56; alertness: ESS > 7.5; timing/regularity: >1 hour variability in bed or waketimes; efficiency: <85%; or duration: < 7 hours). treated sleep apnea and willingness to continue treatment for intervention (>80% adherence), not achieving glycemic targets (defined as A1C ≥ 7%, or CGM derived glucose management indicator ≥ 7% or ≤ 80% time in glucose range). Exclusion Criteria: those with major chronic complex medical conditions (heart failure, GFR < 45 using creatinine, frequent visits for chronic management); severe psychiatric illness (e.g., bipolar, schizophrenia); current pregnancy; recent or planned night shift work or trans-meridian travel; Unable to complete protocol (e.g., bereavement, currently homeless) and known history of untreated sleep apnea (obstructive or central).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 31 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Behavioral: Sleep Self-Management
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CB-sleep<br>Initial instruction for the CB-sleep intervention will occur 60-minute telehealth session. The initial action planning session with a sleep report and booster sessions will be interactive and stage matched. The intervention will include an interactive PowerPoint with the participant's clinician sleep report with personalized feedback. They will be encouraged to systematically extend their time in bed by 1 hour and maintain the extension on both weekends and weekdays. Weekly titration will occur according to the following parameters: if sleep efficiency is ≥ 85%, time in bed is increased by 15 minutes per week until a total of a 1 hour increase in time in bed is achieved, if sleep efficiency is <85%, time in bed remains the same. There will be weekly follow-ups (email, phone, text, video chat) and telehealth 4-week booster sessions. Sleep reports generated by the baseline actigraphy report will be shared with participants with brief action planning and goal setting. | Behavioral: CB Sleep<br>* The CB-sleep intervention is a cognitive behavioral intervention guided by principles and practices from motivational interviewing and the psychology of behavior change, primarily drawing on self-efficacy and action planning theory. The goals of CB-sleep are for participants to achieve adequate sleep duration (7-9 hours per night), adequate sleep efficiency (≥ 85%), and regular sleep timing (<60-minute differences in bed and wake times). The intervention components include improving sleep knowledge (hygiene), developing a nightly routine, addressing competing activities, modifying environmental conditions, lifestyle (avoiding caffeine and vigorous exercise before bed), technology (limiting or avoiding screens for at least one hour before bed), basic stress-management (progressive muscle relaxation and guided imagery), and self- monitoring.<br>|
| No Intervention: Attention Control Enhanced Usual Care arm<br>After baseline, the RA assigned to this condition will schedule a 60-minute telehealth appointment to provide instruction for enhanced usual care at the initial consultation visit via contact at T1 (60-minute telehealth session in a private location). The time-balanced follow-up sessions will remain neutral and focused on health perceptions, current plan of care, and relationship building as opposed to the CB-sleep condition's focus on sleep promotion and extension. The RA assigned to the control condition will ask participants to (a) describe how they are doing and (b) ask how confident they are in achieving the goals they have set for themselves. These calls will help to build a relationship with participants to promote study retention. The investigators recognize that participants may obtain self-initiated diabetes self-management in this group, which will vary and will use a Diabetes Self-Management Tracking Form to monitor weekly information acquisition. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic target-chronic | Glycated hemoglobin (A1C) | From (T0) baseline thorough (T4) 9 months post intervention | 
| Sleep Health: Satisfaction | PROMIS Sleep Disturbance SF v1.0 (Cronbach's α = 0.90), a raw score of 10 converts to a T-score of 35.9 with a standard error (SE) of 3.3. Thus, the 95% confidence interval around the observed score ranges from 29.4 to 42.4 (T-score + (1.96*SE) or 35.9 + (1.96*3.3). Higher scores indicate more sleep disturbances | From (T0) baseline thorough (T4) 9 months post intervention | 
| Sleep Health: Alertness | Epworth Sleepiness Scale (Cronbach's α = 0.88, ICC 0.74 to 0.80), 0 to 10 = normal range of sleepiness in healthy adults. 11 to 14 = mild sleepiness. 15 to 17 = moderate sleepiness. 18 to 24 = severe sleepiness. | From (T0) baseline thorough (T4) 9 months post intervention | 
| Sleep Health: *Regularity | Non-dominant wrist-worn actigraphy to be worn 24/7 (ActiGraph GT9x-Link) | From (T0) baseline thorough (T4) 9 months post intervention | 
| Sleep Health: Timing*, Efficiency* and Duration, *Regularity | daily sleep diary items | From (T0) baseline thorough (T4) 9 months post intervention | 
| Sleep Health: Efficiency* and Duration, | Pittsburgh sleep quality index, The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. | From (T0) baseline thorough (T4) 9 months post intervention | 
| Sleep Health: Timing* | Morningness-Eveningness Questionnaire (Cronbach's α =0.87, ICC 0.90), Scores can range from 16-86. Scores of 41 and below indicate evening types. Scores of 59 and above indicate morning types. Scores between 42-58 indicate intermediate types. | From (T0) baseline thorough (T4) 9 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose variability/time in range | Continuous glucose monitor (CGM) or glucose meter | From (T0) baseline thorough (T4) 9 months post intervention | 
| General distress symptoms | PROMIS v1.0 Emotional Distress (Cronbach's α = 0.95, ICC 0.69 to 0.88), With a standardized normative T-score of 50 and a standard deviation of 10, T-scores <55 would translate as normal; 55-60 as mild; 60-70 as moderate, and ≥70 as severe distress | From (T0) baseline thorough (T4) 9 months post intervention | 
| Diabetes distress symptoms | Diabetes Distress Scale (Cronbach's α = 0.88 to 0.93, ICC 0.44 to 0.64), Average score of < 2.0 = reflects little or no distress Average score between 2.0 and 2.9 = reflects moderate distress, Average score > 3.0 = reflects high distress, A total or subscale score > 2.0 (moderate distress) is considered clinically significant. | From (T0) baseline thorough (T4) 9 months post intervention |