Health Behavior Intervention for Adults With Type 1 Diabetes

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 knowl

Первичные конечные точки

• Multidimensional sleep health composite score [Срок оценки: Baseline, 3, 6 and 9 months post-intervention]
• Glycated hemoglobin (HbA1C) [Срок оценки: Baseline, 3, 6 and 9 months post-intervention]

Вторичные конечные точки (4)

• Glucose variability [Срок оценки: Baseline, 3, 6 and 9 months post-intervention]
• Time in range (70-140 mg/dL) [Срок оценки: Baseline, 3, 6 and 9 months post-intervention]
• General distress symptoms [Срок оценки: Baseline, 3, 6 and 9 months post-intervention]
• Diabetes distress symptoms [Срок оценки: Baseline, 3, 6 and 9 months post-intervention]

Критерии участия

Критерии включения

• Aged 18 to 40 years
• Type 1 Diabetes at least 1 year
• One or more sleep health dimension out of range

Критерии исключения

• Non-English speaking
• A1C < 7% or >80% time in glucose range

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Emory University — Atlanta

Идентификаторы

NCT: NCT05823142 · 2025P011836 · R01DK136604 · STUDY20230448

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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