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Sleep Promotion to Improve Diabetes Management in Adolescents With T1D

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02786953
Recruitment Status : Completed
First Posted : June 1, 2016
Results First Posted : October 18, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Sarah Jaser, Vanderbilt University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Behavioral: Sleep Promotion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Sleep Coach: Sleep Promotion to Improve Diabetes Management in Adolescents With T1D
Actual Study Start Date : October 19, 2017
Actual Primary Completion Date : October 23, 2018
Actual Study Completion Date : February 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Sleep Promotion
Behavioral sleep-promoting intervention, including components such as limiting caffeine, establishing a media curfew, and positive bedtime routines, as well as needs unique to adolescents with T1D, such as fear of hypoglycemia.
Behavioral: Sleep Promotion
Behavioral intervention to improve sleep quality and duration.

No Intervention: Usual Care
Usual Care



Primary Outcome Measures :
  1. Sleep Quality: Baseline [ Time Frame: baseline ]
    Sleep quality will be measured with the Pittsburgh Sleep Quality Index total score. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.

  2. Sleep Quality 3 Months [ Time Frame: 3 months ]
    Sleep quality will be measured with the Pittsburgh Sleep Quality Index total score. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.

  3. Glycemic Control (HbA1c) Baseline [ Time Frame: Baseline ]
    HbA1C is a measure of average blood glucose levels. It is measured quarterly at regular clinic visits.

  4. Glycemic Control (HbA1c) 3 or 6 Months [ Time Frame: 3 months or 6 months ]
    HbA1C is a measure of average blood glucose levels. It is measured quarterly at regular clinic visits.

  5. Sleep Duration: Baseline [ Time Frame: baseline ]
    Sleep duration will be measured with actigraphy (total sleep time)

  6. Sleep Duration: 3 Months [ Time Frame: 3 months ]
    Sleep duration will be measured with actigraphy (total sleep time)


Secondary Outcome Measures :
  1. Quality of Life (PedsQL) [ Time Frame: Baseline and 3 months ]
    The PedsQL, Type 1 Diabetes module, a self-report measure of quality of life will be used. Scaled scores range from 0-100, and higher scores indicate better quality of life.

  2. Adherence (Self Care Inventory) Parent [ Time Frame: Baseline and 3 months ]
    The parent versions of the Self Care Inventory will be used to measure adherence to the diabetes treatment regimen. Mean scores are calculated, ranging from 1-5, with higher scores indicating better adherence.

  3. Adherence (Self Care Inventory) Teen [ Time Frame: Baseline and 3 months ]
    The teen versions of the Self Care Inventory will be used to measure adherence to the diabetes treatment regimen. Mean scores are calculated, ranging from 1-5, with higher scores indicating better adherence.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with type 1 diabetes for at least 12 months
  • Speak and read English
  • Report Insufficient sleep (< 8 hours/night most school nights)

Exclusion Criteria:

  • Other major health problems or sleep disorders (other than insomnia)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786953


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Sarah S Jaser, PhD Vanderbilt University Medical Center
  Study Documents (Full-Text)

Documents provided by Sarah Jaser, Vanderbilt University Medical Center:
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Responsible Party: Sarah Jaser, Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02786953    
Other Study ID Numbers: 151271
First Posted: June 1, 2016    Key Record Dates
Results First Posted: October 18, 2019
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sarah Jaser, Vanderbilt University Medical Center:
Sleep
Adherence
Diabetes Management
Adolescent
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases