Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 1
Intervention Behavioral: Sleep Promotion
Enrollment 40
Recruitment Details  
Pre-assignment Details 1 participant consented, completed baseline data, then withdrew
Arm/Group Title Sleep Promotion Usual Care
Hide Arm/Group 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.

Sleep Promotion: Behavioral intervention to improve sleep quality and duration.

Usual Care
Period Title: Overall Study
Started 20 19
Baseline Teen Survey Data Completed 20 18 [1]
Baseline Parent Survey Completed 20 18 [1]
Actigraph Data Complete 14 17 [1]
A1C Data Baseline 20 18 [1]
Session 1 Completed 17 0
Session 2 Completed 16 0
Session 3 Completed 16 0
3 Month Teen Survey Completed 17 18
3 Month Parent Survey Completed 17 18
A1C 3 Month 15 17
Completed 17 18
Not Completed 3 1
Reason Not Completed
Withdrawal by Subject             3             0
Physician Decision             0             1
[1]
One participant withdrawn and data excluded due to becoming ineligible due to a new diagnosis
Arm/Group Title Sleep Promotion Usual Care Total
Hide Arm/Group 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.

Sleep Promotion: Behavioral intervention to improve sleep quality and duration.

Usual Care Total of all reporting groups
Overall Number of Baseline Participants 20 18 38
Hide Baseline Analysis Population Description
1 family enrolled and was randomized to usual care. Teen was diagnosed with a condition that caused them to be excluded, so they were removed from baseline analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 18 participants 38 participants
14.85  (1.27) 15.72  (1.32) 15.26  (1.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 18 participants 38 participants
Female
10
  50.0%
8
  44.4%
18
  47.4%
Male
10
  50.0%
10
  55.6%
20
  52.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 18 participants 38 participants
White, Non-Hispanic
15
  75.0%
14
  77.8%
29
  76.3%
Non-White
4
  20.0%
2
  11.1%
6
  15.8%
Hispanic
1
   5.0%
2
  11.1%
3
   7.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 18 participants 38 participants
20 18 38
Annual Income  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 18 participants 38 participants
<$39,999
7
  35.0%
2
  11.1%
9
  23.7%
$40,000-$79,999
7
  35.0%
5
  27.8%
12
  31.6%
>$80,000
5
  25.0%
10
  55.6%
15
  39.5%
Missing
1
   5.0%
1
   5.6%
2
   5.3%
Treatment Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 18 participants 38 participants
Insulin Pump
12
  60.0%
11
  61.1%
23
  60.5%
Injection
8
  40.0%
7
  38.9%
15
  39.5%
1.Primary Outcome
Title Sleep Quality: Baseline
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sleep Promotion Usual Care
Hide Arm/Group 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.

Sleep Promotion: Behavioral intervention to improve sleep quality and duration.

Usual Care
Overall Number of Participants Analyzed 20 18
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.3  (1.7) 4.5  (1.5)
2.Primary Outcome
Title Sleep Quality 3 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
includes only participants with baseline and 3 month data
Arm/Group Title Sleep Promotion Usual Care
Hide Arm/Group 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.

Sleep Promotion: Behavioral intervention to improve sleep quality and duration.

Usual Care
Overall Number of Participants Analyzed 17 18
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.9  (1.5) 4.8  (1.6)
3.Primary Outcome
Title Glycemic Control (HbA1c) Baseline
Hide Description HbA1C is a measure of average blood glucose levels. It is measured quarterly at regular clinic visits.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sleep Promotion Usual Care
Hide Arm/Group 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.

Sleep Promotion: Behavioral intervention to improve sleep quality and duration.

Usual Care
Overall Number of Participants Analyzed 20 18
Mean (Standard Deviation)
Unit of Measure: percentage of glycosylated Hgb
9.4  (2.2) 9.1  (1.5)
4.Primary Outcome
Title Glycemic Control (HbA1c) 3 or 6 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants missed the 3 month appointment, so the final result is a combination of 3 month and 6 month values
Arm/Group Title Sleep Promotion Usual Care
Hide Arm/Group 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.

Sleep Promotion: Behavioral intervention to improve sleep quality and duration.

Usual Care
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: percentage of glycosylated Hemoglobin
9.2  (2.0) 9.2  (1.2)
5.Primary Outcome
Title Sleep Duration: Baseline
Hide Description Sleep duration will be measured with actigraphy (total sleep time)
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
only participants with usable actigraph data
Arm/Group Title Sleep Promotion Usual Care
Hide Arm/Group 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.

Sleep Promotion: Behavioral intervention to improve sleep quality and duration.

Usual Care
Overall Number of Participants Analyzed 14 17
Mean (Standard Deviation)
Unit of Measure: hours
6.85  (0.82) 6.69  (1.00)
6.Primary Outcome
Title Sleep Duration: 3 Months
Hide Description Sleep duration will be measured with actigraphy (total sleep time)
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
only participants with usable actigraph data
Arm/Group Title Sleep Promotion Usual Care
Hide Arm/Group 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.

Sleep Promotion: Behavioral intervention to improve sleep quality and duration.

Usual Care
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: hours
7.02  (0.78) 6.37  (0.92)
7.Secondary Outcome
Title Quality of Life (PedsQL)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
only participants with both baseline and 3 month data
Arm/Group Title Sleep Promotion Usual Care
Hide Arm/Group 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.

Sleep Promotion: Behavioral intervention to improve sleep quality and duration.

Usual Care
Overall Number of Participants Analyzed 17 18
Mean (Standard Deviation)
Unit of Measure: score on a scale
baseline 70.3  (8.0) 74.5  (8.6)
3 months 72.5  (10.3) 75.4  (9.9)
8.Secondary Outcome
Title Adherence (Self Care Inventory) Parent
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sleep Promotion Usual Care
Hide Arm/Group 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.

Sleep Promotion: Behavioral intervention to improve sleep quality and duration.

Usual Care
Overall Number of Participants Analyzed 17 18
Mean (Standard Deviation)
Unit of Measure: score on a scale
baseline 3.7  (.66) 3.8  (.69)
3 months 3.8  (.84) 3.7  (.73)
9.Secondary Outcome
Title Adherence (Self Care Inventory) Teen
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sleep Promotion Usual Care
Hide Arm/Group 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.

Sleep Promotion: Behavioral intervention to improve sleep quality and duration.

Usual Care
Overall Number of Participants Analyzed 17 18
Mean (Standard Deviation)
Unit of Measure: score on a scale
baseline 3.9  (.76) 3.7  (.79)
3 months 3.8  (.46) 3.9  (.59)
Time Frame baseline to 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sleep Promotion Usual Care
Hide Arm/Group 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.

Sleep Promotion: Behavioral intervention to improve sleep quality and duration.

Usual Care
All-Cause Mortality
Sleep Promotion Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%) 
Hide Serious Adverse Events
Sleep Promotion Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sleep Promotion Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sarah S Jaser
Organization: Vanderbilt University Medical Center
Phone: 6153436775
EMail: sarah.jaser@vumc.org
Layout table for additonal information
Responsible Party: Sarah Jaser, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02786953    
Other Study ID Numbers: 151271
First Submitted: May 18, 2016
First Posted: June 1, 2016
Results First Submitted: September 16, 2019
Results First Posted: October 18, 2019
Last Update Posted: January 18, 2020