Sleep Promotion to Improve Diabetes Management in Adolescents With T1D

Sleep Coach: Sleep Promotion to Improve Diabetes Management in Adolescents With T1D

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Behavioral: Sleep Promotion

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
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality: 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.	baseline
Sleep Quality 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 months
Glycemic Control (HbA1c) Baseline	HbA1C is a measure of average blood glucose levels. It is measured quarterly at regular clinic visits.	Baseline
Glycemic Control (HbA1c) 3 or 6 Months	HbA1C is a measure of average blood glucose levels. It is measured quarterly at regular clinic visits.	3 months or 6 months
Sleep Duration: Baseline	Sleep duration will be measured with actigraphy (total sleep time)	baseline
Sleep Duration: 3 Months	Sleep duration will be measured with actigraphy (total sleep time)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life (PedsQL)	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.	Baseline and 3 months
Adherence (Self Care Inventory) Parent	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.	Baseline and 3 months
Adherence (Self Care Inventory) Teen	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.	Baseline and 3 months

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2017
• Primary Completion (Actual): October 23, 2018
• Study Completion (Actual): February 5, 2019

Study Registration Dates

• First Submitted: May 18, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (Estimate): June 1, 2016

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Adolescent; Adherence; Diabetes Management; Sleep
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 151271

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No