Sleep Promotion to Improve Diabetes Management in Adolescents With T1D
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Adolescents with type 1 diabetes (T1D) are at increased risk for problems with adherence and
      suboptimal glycemic control, and novel approaches are needed to improve outcomes in this
      high-risk population. The majority of adolescents obtain insufficient sleep (defined as <8
      hours/night), and sleep disturbance has been significantly associated with poorer adherence
      and predicted greater problems with quality of life and worse glycemic control. Yet, no
      interventions have addressed sleep in youth with T1D. Working from a biopsychosocial and
      contextual model of sleep, the investigators propose to tailor a sleep-promoting intervention
      to meet the needs of adolescents with T1D by conducting interviews with to identify the
      barriers and facilitators to adequate sleep specific to this population. The sleep-promoting
      intervention will be developed and tested, building on successful sleep interventions in
      other populations, including components such as limiting caffeine, establishing a media
      curfew, and positive bedtime routines, while addressing the needs unique to adolescents with
      T1D, such as fear of hypoglycemia. The study will be conducted by a multidisciplinary team,
      consisting of Sarah Jaser, PhD, a pediatric psychologist, and two co-investigators, Beth
      Malow, MD, MS, a neurologist with specialty in sleep medicine, and Jill Simmons, MD, a
      pediatric endocrinologist. Sleep is a potentially modifiable risk factor that may have both a
      physiological and behavioral impact on diabetes outcomes. Given the strong associations
      between sleep and diabetes outcomes in the preliminary data, and recent evidence from sleep
      restriction studies indicating the impact of insufficient sleep on insulin sensitivity,
      behavior, and mood, there is reason to believe that a sleep-promoting intervention has the
      potential to improve outcomes in adolescents with T1D indirectly by improving adherence and
      directly through its effect on metabolic function. Therefore, the proposed study offers a
      novel approach to improve adherence, quality of life, and glycemic control in adolescents
      with T1D.
    

Detailed description: 
      Working from a biopsychosocial and contextual model of sleep, this study will pilot test a
      sleep-promoting intervention tailored to meet the needs of adolescents with T1D, building on
      successful sleep interventions in other populations, including components such as limiting
      caffeine, establishing a media curfew, and positive bedtime routines, while addressing the
      needs unique to adolescents with T1D, such as fear of hypoglycemia. The study will be
      conducted by a multidisciplinary team, consisting of Sarah Jaser, PhD, a pediatric
      psychologist, and two co-investigators, Beth Malow, MD, MS, a neurologist with specialty in
      sleep medicine, and Jill Simmons, MD, a pediatric endocrinologist. Sleep is a potentially
      modifiable risk factor that may have both a physiological and behavioral impact on diabetes
      outcomes. Given the strong associations between sleep and diabetes outcomes in the
      preliminary data, and recent evidence from sleep restriction studies indicating the impact of
      insufficient sleep on insulin sensitivity, behavior, and mood, there is reason to believe
      that a sleep-promoting intervention has the potential to improve outcomes in adolescents with
      T1D indirectly by improving adherence and directly through its effect on metabolic function.
      Therefore, the proposed study offers a novel approach to improve adherence, quality of life,
      and glycemic control in adolescents with T1D.
    

Intervention name(s): Sleep Promotion
Intervention type(s): Behavioral
Intervention description(s): Behavioral intervention to improve sleep quality and duration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Sleep; Adherence; Diabetes Management; Adolescent