search
Back to results

Sleep Promotion to Improve Diabetes Management in Adolescents With T1D

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep Promotion
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Sleep, Adherence, Diabetes Management, Adolescent

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sleep Promotion

Usual Care

Arm Description

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.

Usual Care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
May 18, 2016
Last Updated
January 6, 2020
Sponsor
Vanderbilt University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02786953
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 19, 2017 (Actual)
Primary Completion Date
October 23, 2018 (Actual)
Study Completion Date
February 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Sleep, Adherence, Diabetes Management, Adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep Promotion
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual Care
Intervention Type
Behavioral
Intervention Name(s)
Sleep Promotion
Intervention Description
Behavioral intervention to improve sleep quality and duration.
Primary Outcome Measure Information:
Title
Sleep Quality: Baseline
Description
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.
Time Frame
baseline
Title
Sleep Quality 3 Months
Description
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.
Time Frame
3 months
Title
Glycemic Control (HbA1c) Baseline
Description
HbA1C is a measure of average blood glucose levels. It is measured quarterly at regular clinic visits.
Time Frame
Baseline
Title
Glycemic Control (HbA1c) 3 or 6 Months
Description
HbA1C is a measure of average blood glucose levels. It is measured quarterly at regular clinic visits.
Time Frame
3 months or 6 months
Title
Sleep Duration: Baseline
Description
Sleep duration will be measured with actigraphy (total sleep time)
Time Frame
baseline
Title
Sleep Duration: 3 Months
Description
Sleep duration will be measured with actigraphy (total sleep time)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Quality of Life (PedsQL)
Description
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.
Time Frame
Baseline and 3 months
Title
Adherence (Self Care Inventory) Parent
Description
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.
Time Frame
Baseline and 3 months
Title
Adherence (Self Care Inventory) Teen
Description
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.
Time Frame
Baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah S Jaser, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Sleep Promotion to Improve Diabetes Management in Adolescents With T1D

We'll reach out to this number within 24 hrs