A Sleep Intervention in Type 1 Diabetes
Condition: Short Sleep Phenotype; Type1diabetes
MeSH terms: Sleep Wake Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Insufficient sleep and sleep irregularity (variability in sleep duration) are increasingly
      recognized as important contributors to glucose control and diabetes distress in type 1
      diabetes (T1D). Up to 40% of adults with T1D had a sleep duration less than 6-6.5 hours per
      night. Diabetes distress is reported (40% prevalence) in individuals with T1D and is
      associated with poor glucose control. Despite findings that sleep disturbances are common in
      T1D, the current understanding of the effects of strategies to improve sleep on diabetes
      distress, and glucose control is limited. The purpose of this pilot study is to evaluate the
      effects of a sleep intervention on sleep duration, diabetes distress and glucose control in
      individuals with T1D and habitual short sleep. A randomized controlled trial in 20 adults
      aged 18 to 65 years with T1D is proposed. Eligible participants will be randomly assigned to
      a sleep intervention group or a control group. Differences between the two groups on the
      outcomes of sleep duration, diabetes distress and glucose control will be evaluated. Findings
      from this proposed pilot study will serve as the foundation for a larger clinical trial to
      improve sleep, reduce diabetes distress, and improve glucose control.
    

Detailed description: 
      Insufficient sleep and sleep irregularity (variability in sleep duration) are increasingly
      recognized as important contributors to glycemic control and diabetes distress in type 1
      diabetes (T1D). Up to 40% of adults with T1D had a sleep duration < 6-6.5 hours per night,
      either by self-report or objectively assessed actigraphy. Diabetes distress is reported (40%
      prevalence) in individuals with T1D and is associated with poor glycemic control. Despite
      findings that sleep disturbances are common in T1D, the current understanding of the effects
      of sleep optimization on sleep, diabetes distress, and glycemic control is limited. The
      purpose of this pilot and feasibility trial is to evaluate the effects of a T1D-specific
      sleep optimization intervention (Sleep-Opt-In) on the outcomes of sleep, diabetes distress
      and glycemic control in individuals with T1D and habitual short sleep. The specific aims are
      to determine if Sleep-Opt-In will: 1) be feasible and acceptable to the target population; 2)
      result in improved sleep duration and regularity; 3) result in improved glycemic control; and
      4) lower diabetes distress. To achieve these aims, a randomized controlled trial in 20 adults
      aged 18 to 65 years with T1D is proposed. Participants will be screened for habitual sleep
      duration < 6.5 hours per night. Eligible subjects will be randomized to the T1D-Sleep-Opt-In
      group or attention control group. A one-week run-in period is planned, with baseline measures
      of sleep (duration and regularity), glycemia (A1C, fructosamine, glycemic variability), and
      diabetes distress (Diabetes Distress Scale). The T1D-Sleep-Opt-In will entail a novel
      technology-assisted behavioral sleep extension intervention developed to leverage rapidly
      increasing public interest in sleep tracking by consumers (+500% in 3 years). This technology
      employs four elements: a wearable sleep tracker, didactic content, an interactive smartphone
      application, and brief telephone counseling. The intervention will be T1D-specific by
      addressing T1D-related sleep issues such as nocturnal hypoglycemia. The attention control
      group will participate in a healthy living information program. At completion (Week 8) and
      post-program (Weeks 12 and 24), baseline measures will be repeated to determine differences
      between the two groups and sustainability of the intervention. Findings from this proposed
      pilot study will serve as the foundation for a larger clinical trial to improve sleep, reduce
      diabetes distress, and improve glycemic control.
    

Intervention name(s): Sleep Opt-In; Healthy Living
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling; 8-week intervention that includes weekly telephone counseling on healthy living.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sleep optimization intervention will be compared to a healthy living attention control
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 1 diabetes; glycemic control; sleep; diabetes distress