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Trial Outcomes & Findings for Sleep Promotion to Improve Diabetes Management in Adolescents With T1D (NCT NCT02786953)

NCT ID: NCT02786953

Last Updated: 2020-01-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

baseline

Results posted on

2020-01-18

Participant Flow

1 participant consented, completed baseline data, then withdrew

Participant milestones

Participant milestones
Measure
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. Sleep Promotion: Behavioral intervention to improve sleep quality and duration.
Usual Care
Usual Care
Overall Study
STARTED
20
19
Overall Study
Baseline Teen Survey Data Completed
20
18
Overall Study
Baseline Parent Survey Completed
20
18
Overall Study
Actigraph Data Complete
14
17
Overall Study
A1C Data Baseline
20
18
Overall Study
Session 1 Completed
17
0
Overall Study
Session 2 Completed
16
0
Overall Study
Session 3 Completed
16
0
Overall Study
3 Month Teen Survey Completed
17
18
Overall Study
3 Month Parent Survey Completed
17
18
Overall Study
A1C 3 Month
15
17
Overall Study
COMPLETED
17
18
Overall Study
NOT COMPLETED
3
1

Reasons for withdrawal

Reasons for withdrawal
Measure
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. Sleep Promotion: Behavioral intervention to improve sleep quality and duration.
Usual Care
Usual Care
Overall Study
Withdrawal by Subject
3
0
Overall Study
Physician Decision
0
1

Baseline Characteristics

Sleep Promotion to Improve Diabetes Management in Adolescents With T1D

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sleep Promotion
n=20 Participants
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
n=18 Participants
Usual Care
Total
n=38 Participants
Total of all reporting groups
Age, Continuous
14.85 years
STANDARD_DEVIATION 1.27 • n=5 Participants
15.72 years
STANDARD_DEVIATION 1.32 • n=7 Participants
15.26 years
STANDARD_DEVIATION 1.35 • n=5 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
8 Participants
n=7 Participants
18 Participants
n=5 Participants
Sex: Female, Male
Male
10 Participants
n=5 Participants
10 Participants
n=7 Participants
20 Participants
n=5 Participants
Race/Ethnicity, Customized
White, Non-Hispanic
15 Participants
n=5 Participants
14 Participants
n=7 Participants
29 Participants
n=5 Participants
Race/Ethnicity, Customized
Non-White
4 Participants
n=5 Participants
2 Participants
n=7 Participants
6 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
Region of Enrollment
United States
20 participants
n=5 Participants
18 participants
n=7 Participants
38 participants
n=5 Participants
Annual Income
<$39,999
7 Participants
n=5 Participants
2 Participants
n=7 Participants
9 Participants
n=5 Participants
Annual Income
$40,000-$79,999
7 Participants
n=5 Participants
5 Participants
n=7 Participants
12 Participants
n=5 Participants
Annual Income
>$80,000
5 Participants
n=5 Participants
10 Participants
n=7 Participants
15 Participants
n=5 Participants
Annual Income
Missing
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Treatment Type
Insulin Pump
12 Participants
n=5 Participants
11 Participants
n=7 Participants
23 Participants
n=5 Participants
Treatment Type
Injection
8 Participants
n=5 Participants
7 Participants
n=7 Participants
15 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Sleep Promotion
n=20 Participants
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
n=18 Participants
Usual Care
Sleep Quality: Baseline
4.3 score on a scale
Standard Deviation 1.7
4.5 score on a scale
Standard Deviation 1.5

PRIMARY outcome

Timeframe: 3 months

Population: includes only participants with baseline and 3 month data

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.

Outcome measures

Outcome measures
Measure
Sleep Promotion
n=17 Participants
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
n=18 Participants
Usual Care
Sleep Quality 3 Months
3.9 score on a scale
Standard Deviation 1.5
4.8 score on a scale
Standard Deviation 1.6

PRIMARY outcome

Timeframe: Baseline

HbA1C is a measure of average blood glucose levels. It is measured quarterly at regular clinic visits.

Outcome measures

Outcome measures
Measure
Sleep Promotion
n=20 Participants
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
n=18 Participants
Usual Care
Glycemic Control (HbA1c) Baseline
9.4 percentage of glycosylated Hgb
Standard Deviation 2.2
9.1 percentage of glycosylated Hgb
Standard Deviation 1.5

PRIMARY outcome

Timeframe: 3 months or 6 months

Population: Some participants missed the 3 month appointment, so the final result is a combination of 3 month and 6 month values

HbA1C is a measure of average blood glucose levels. It is measured quarterly at regular clinic visits.

Outcome measures

Outcome measures
Measure
Sleep Promotion
n=17 Participants
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
n=17 Participants
Usual Care
Glycemic Control (HbA1c) 3 or 6 Months
9.2 percentage of glycosylated Hemoglobin
Standard Deviation 2.0
9.2 percentage of glycosylated Hemoglobin
Standard Deviation 1.2

PRIMARY outcome

Timeframe: baseline

Population: only participants with usable actigraph data

Sleep duration will be measured with actigraphy (total sleep time)

Outcome measures

Outcome measures
Measure
Sleep Promotion
n=14 Participants
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
n=17 Participants
Usual Care
Sleep Duration: Baseline
6.85 hours
Standard Deviation 0.82
6.69 hours
Standard Deviation 1.00

PRIMARY outcome

Timeframe: 3 months

Population: only participants with usable actigraph data

Sleep duration will be measured with actigraphy (total sleep time)

Outcome measures

Outcome measures
Measure
Sleep Promotion
n=13 Participants
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
n=12 Participants
Usual Care
Sleep Duration: 3 Months
7.02 hours
Standard Deviation 0.78
6.37 hours
Standard Deviation 0.92

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: only participants with both baseline and 3 month data

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.

Outcome measures

Outcome measures
Measure
Sleep Promotion
n=17 Participants
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
n=18 Participants
Usual Care
Quality of Life (PedsQL)
baseline
70.3 score on a scale
Standard Deviation 8.0
74.5 score on a scale
Standard Deviation 8.6
Quality of Life (PedsQL)
3 months
72.5 score on a scale
Standard Deviation 10.3
75.4 score on a scale
Standard Deviation 9.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Sleep Promotion
n=17 Participants
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
n=18 Participants
Usual Care
Adherence (Self Care Inventory) Parent
baseline
3.7 score on a scale
Standard Deviation .66
3.8 score on a scale
Standard Deviation .69
Adherence (Self Care Inventory) Parent
3 months
3.8 score on a scale
Standard Deviation .84
3.7 score on a scale
Standard Deviation .73

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Sleep Promotion
n=17 Participants
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
n=18 Participants
Usual Care
Adherence (Self Care Inventory) Teen
baseline
3.9 score on a scale
Standard Deviation .76
3.7 score on a scale
Standard Deviation .79
Adherence (Self Care Inventory) Teen
3 months
3.8 score on a scale
Standard Deviation .46
3.9 score on a scale
Standard Deviation .59

Adverse Events

Sleep Promotion

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Usual Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sarah S Jaser

Vanderbilt University Medical Center

Phone: 6153436775

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place