Clinical trial NCT05823142: Self-Management in Young Adults With Type 1 Diabetes 2023
Official title: Self-Management in Young Adults With Type 1 Diabetes 2023 (R01DK136604)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type1diabetes
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Institutes of Health (NIH)
First posted: 2023-04-21
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 31
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Behavioral: Sleep Self-Management
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility 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).

Primary outcomes:
measure: Glycemic target-chronic
timeFrame: From (T0) baseline thorough (T4) 9 months post intervention
measure: Sleep Health: Satisfaction
timeFrame: From (T0) baseline thorough (T4) 9 months post intervention
measure: Sleep Health: Alertness
timeFrame: From (T0) baseline thorough (T4) 9 months post intervention
measure: Sleep Health: *Regularity
timeFrame: From (T0) baseline thorough (T4) 9 months post intervention
measure: Sleep Health: Timing*, Efficiency* and Duration, *Regularity
timeFrame: From (T0) baseline thorough (T4) 9 months post intervention
measure: Sleep Health: Efficiency* and Duration,
timeFrame: From (T0) baseline thorough (T4) 9 months post intervention
measure: Sleep Health: Timing*
timeFrame: From (T0) baseline thorough (T4) 9 months post intervention
Secondary outcomes:
measure: Glucose variability/time in range
timeFrame: From (T0) baseline thorough (T4) 9 months post intervention
measure: General distress symptoms
timeFrame: From (T0) baseline thorough (T4) 9 months post intervention
measure: Diabetes distress symptoms
timeFrame: From (T0) baseline thorough (T4) 9 months post intervention
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals of Cleveland Medical Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Stephanie Griggs, PhD
role: PRINCIPAL_INVESTIGATOR
References: