Self-Management in Young Adults With Type 1 Diabetes 2023

Type1diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05823142
• Other study ID #: STUDY20230448
• Secondary ID: R01DK136604
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2023
• Est. completion date: July 31, 2028

Study information

• Verified date: May 2024
• Source: Case Western Reserve University
• Contact: Stephanie Griggs, PhD
• Phone: 216-368-5518
• Email: stephanie.griggs[@]case.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Type 1 diabetes (T1D) affects approximately 2 million Americans, and only 2 in 8 young adults ages 18-31 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: July 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 31 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	University Hospitals of Cleveland Medical Center	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Case Western Reserve University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic target-chronic	Glycated hemoglobin (A1C)	From (T0) baseline thorough (T4) 9 months post intervention
Primary	Sleep Health: Satisfaction	PROMIS Sleep Disturbance SF v1.0 (Cronbach's a = 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
Primary	Sleep Health: Alertness	Epworth Sleepiness Scale (Cronbach's a = 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
Primary	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
Primary	Sleep Health: Timing*, Efficiency* and Duration, *Regularity	daily sleep diary items	From (T0) baseline thorough (T4) 9 months post intervention
Primary	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
Primary	Sleep Health: Timing*	Morningness-Eveningness Questionnaire (Cronbach's a =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	Glucose variability/time in range	Continuous glucose monitor (CGM) or glucose meter	From (T0) baseline thorough (T4) 9 months post intervention
Secondary	General distress symptoms	PROMIS v1.0 Emotional Distress (Cronbach's a = 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
Secondary	Diabetes distress symptoms	Diabetes Distress Scale (Cronbach's a = 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