Self-Management in Young Adults With Type 1 Diabetes 2023

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ClinicalTrials.gov Identifier: NCT05823142
Recruitment Status : Not yet recruiting
First Posted : April 21, 2023
Last Update Posted : April 21, 2023
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Stephanie Griggs, Case Western Reserve University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Type1diabetes Behavioral: CB Sleep Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Behavioral: Sleep Self-Management
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.
Primary Purpose: Supportive Care
Official Title: Self-Management in Young Adults With Type 1 Diabetes 2023 (R01DK136604)
Estimated Study Start Date : August 1, 2023
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : July 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: CB-sleep
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
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.

No Intervention: Attention Control Enhanced Usual Care arm
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.



Primary Outcome Measures :
  1. Glycemic target-chronic [ Time Frame: From (T0) baseline thorough (T4) 9 months post intervention ]
    Glycated hemoglobin (A1C)

  2. Sleep Health: Satisfaction [ Time Frame: From (T0) baseline thorough (T4) 9 months post intervention ]
    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 (see scoring table for the 4a v1.0 short form in the Appendix). 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

  3. Sleep Health: Alertness [ Time Frame: From (T0) baseline thorough (T4) 9 months post intervention ]
    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.

  4. Sleep Health: *Regularity [ Time Frame: From (T0) baseline thorough (T4) 9 months post intervention ]
    Non-dominant wrist-worn actigraphy to be worn 24/7 (ActiGraph GT9x-Link)

  5. Sleep Health: Timing*, Efficiency* and Duration, *Regularity [ Time Frame: From (T0) baseline thorough (T4) 9 months post intervention ]
    daily sleep diary items

  6. Sleep Health: Efficiency* and Duration, [ Time Frame: From (T0) baseline thorough (T4) 9 months post intervention ]
    Pittsburgh sleep quality index, The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

  7. Sleep Health: Timing* [ Time Frame: From (T0) baseline thorough (T4) 9 months post intervention ]
    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."


Secondary Outcome Measures :
  1. Glucose variability/time in range [ Time Frame: From (T0) baseline thorough (T4) 9 months post intervention ]
    Continuous glucose monitor (CGM) or glucose meter

  2. General distress symptoms [ Time Frame: From (T0) baseline thorough (T4) 9 months post intervention ]
    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

  3. Diabetes distress symptoms [ Time Frame: From (T0) baseline thorough (T4) 9 months post intervention ]
    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.



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Ages Eligible for Study:   18 Years to 31 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. are between the ages of 18-31 years;
  2. 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);
  3. are not currently participating in intervention studies;
  4. read/speak English,
  5. 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).
  6. treated sleep apnea and willingness to continue treatment for intervention (>80% adherence),
  7. not achieving glycemic targets (defined as A1C ≥ 7%, or CGM derived glucose management indicator ≥ 7% or ≤ 80% time in glucose range).

Exclusion Criteria:

  1. those with major chronic complex medical conditions (heart failure, GFR < 45 using creatinine, frequent visits for chronic management);
  2. severe psychiatric illness (e.g., bipolar, schizophrenia);
  3. current pregnancy;
  4. recent or planned night shift work or trans-meridian travel;
  5. Unable to complete protocol (e.g., bereavement, currently homeless) and
  6. known history of untreated sleep apnea (obstructive or central).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05823142


Contacts
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Contact: Stephanie Griggs, PhD 216-368-5518 stephanie.griggs@case.edu
Contact: Mary Leuchtag, MSSA 216-368-4417 mary.leuchtag@case.edu

Locations
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United States, Ohio
University Hospitals of Cleveland Medical Center
Cleveland, Ohio, United States, 44106-4904
Sponsors and Collaborators
Case Western Reserve University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Stephanie Griggs, PhD Case Western Reserve University
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Responsible Party: Stephanie Griggs, Assistant Professor, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT05823142    
Other Study ID Numbers: STUDY20230448
First Posted: April 21, 2023    Key Record Dates
Last Update Posted: April 21, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases