Sleep Promotion to Improve Diabetes Management in Adolescents With T1D

• 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: Vanderbilt University Medical Center
• Information provided by (Responsible Party): Sarah Jaser, Vanderbilt University Medical Center

Tracking Information

• First Submitted Date: May 18, 2016
• First Posted Date: June 1, 2016
• Results First Submitted Date: September 16, 2019
• Results First Posted Date: October 18, 2019
• Last Update Posted Date: January 18, 2020
• Actual Study Start Date: October 19, 2017
• Actual Primary Completion Date: October 23, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 6, 2020)

• 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.
• 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.
• Glycemic Control (HbA1c) Baseline [ Time Frame: Baseline ]
  HbA1C is a measure of average blood glucose levels. It is measured quarterly at regular clinic visits.
• 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.
• Sleep Duration: Baseline [ Time Frame: baseline ]
  Sleep duration will be measured with actigraphy (total sleep time)
• Sleep Duration: 3 Months [ Time Frame: 3 months ]
  Sleep duration will be measured with actigraphy (total sleep time)

Original Primary Outcome Measures (submitted: May 25, 2016)

• Sleep Quality measured with actigraphy and the Pittsburgh Sleep Quality Index [ Time Frame: 3 months ]
  Sleep quality will be measured with actigraphy data (efficiency) and the Pittsburgh Sleep Quality Index total score. A composite variable will be created from these two measures to indicate sleep quality.
• Glycemic Control (HbA1c) [ Time Frame: 6 months ]
  HbA1C data will be collected 3 months and 6 months after study enrollment. HbA1c is a measure of average blood glucose levels, and it is obtained quarterly in patients with type 1 diabetes during outpatient clinic visits as part of regular care. HbA1c < 7.5% is recommended for adolescents with type 1 diabetes by the American Diabetes Association.
• Sleep Duration measured with actigraphy [ Time Frame: 3 months ]
  Sleep duration will be measured with actigraphy (total sleep time)

Current Secondary Outcome Measures (submitted: October 17, 2019)

• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: May 25, 2016)

• Quality of Life (PedsQL) [ Time Frame: 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.
• Adherence (Self Care Inventory) [ Time Frame: 3 months ]
  The parent and self-report 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sleep Promotion to Improve Diabetes Management in Adolescents With T1D
• Official Title: Sleep Coach: Sleep Promotion to Improve Diabetes Management in Adolescents With T1D
• 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.
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
• Condition: Diabetes Mellitus, Type 1

Intervention

Behavioral: Sleep Promotion

Behavioral intervention to improve sleep quality and duration.

Study Arms

• 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.
  Intervention: Behavioral: Sleep Promotion
• No Intervention: Usual Care
  Usual Care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 25, 2016): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 5, 2019
• Actual Primary Completion Date: October 23, 2018 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 13 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02786953
• Other Study ID Numbers: 151271
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Sarah Jaser, Vanderbilt University Medical Center
• Study Sponsor: Vanderbilt University Medical Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sarah S Jaser, PhD; Vanderbilt University Medical Center

• PRS Account: Vanderbilt University Medical Center
• Verification Date: January 2020