Diabetes Mellitus, Type 1
Conditions
Keywords
Sleep, Adherence, Diabetes Management, Adolescent
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.
Interventions
BEHAVIORALSleep Promotion
Behavioral intervention to improve sleep quality and duration.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Duration: 3 Months | 3 months | Sleep duration will be measured with actigraphy (total sleep time) |
| Glycemic Control (HbA1c) Baseline | 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 | 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 | baseline | Sleep duration will be measured with actigraphy (total sleep time) |
| Sleep Quality: Baseline | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence (Self Care Inventory) Parent | 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 | 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. |
| Quality of Life (PedsQL) | 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. |
Countries
United States
Participant flow
Pre-assignment details
1 participant consented, completed baseline data, then withdrew
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Usual Care Usual Care | 18 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Total | Sleep Promotion | Usual Care |
|---|---|---|---|
| Age, Continuous | 15.26 years STANDARD_DEVIATION 1.35 | 14.85 years STANDARD_DEVIATION 1.27 | 15.72 years STANDARD_DEVIATION 1.32 |
| Annual Income <$39,999 | 9 Participants | 7 Participants | 2 Participants |
| Annual Income $40,000-$79,999 | 12 Participants | 7 Participants | 5 Participants |
| Annual Income >$80,000 | 15 Participants | 5 Participants | 10 Participants |
| Annual Income Missing | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Non-White | 6 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized White, Non-Hispanic | 29 Participants | 15 Participants | 14 Participants |
| Region of Enrollment United States | 38 participants | 20 participants | 18 participants |
| Sex: Female, Male Female | 18 Participants | 10 Participants | 8 Participants |
| Sex: Female, Male Male | 20 Participants | 10 Participants | 10 Participants |
| Treatment Type Injection | 15 Participants | 8 Participants | 7 Participants |
| Treatment Type Insulin Pump | 23 Participants | 12 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 0 / 20 | 0 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 |
Outcome results
Primary
Glycemic Control (HbA1c) 3 or 6 Months
HbA1C is a measure of average blood glucose levels. It is measured quarterly at regular clinic visits.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Promotion | Glycemic Control (HbA1c) 3 or 6 Months | 9.2 percentage of glycosylated Hemoglobin | Standard Deviation 2 |
| Usual Care | Glycemic Control (HbA1c) 3 or 6 Months | 9.2 percentage of glycosylated Hemoglobin | Standard Deviation 1.2 |
Primary
Glycemic Control (HbA1c) Baseline
HbA1C is a measure of average blood glucose levels. It is measured quarterly at regular clinic visits.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Promotion | Glycemic Control (HbA1c) Baseline | 9.4 percentage of glycosylated Hgb | Standard Deviation 2.2 |
| Usual Care | Glycemic Control (HbA1c) Baseline | 9.1 percentage of glycosylated Hgb | Standard Deviation 1.5 |
Primary
Sleep Duration: 3 Months
Sleep duration will be measured with actigraphy (total sleep time)
Time frame: 3 months
Population: only participants with usable actigraph data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Promotion | Sleep Duration: 3 Months | 7.02 hours | Standard Deviation 0.78 |
| Usual Care | Sleep Duration: 3 Months | 6.37 hours | Standard Deviation 0.92 |
Primary
Sleep Duration: Baseline
Sleep duration will be measured with actigraphy (total sleep time)
Time frame: baseline
Population: only participants with usable actigraph data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Promotion | Sleep Duration: Baseline | 6.85 hours | Standard Deviation 0.82 |
| Usual Care | Sleep Duration: Baseline | 6.69 hours | Standard Deviation 1 |
Primary
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.
Time frame: 3 months
Population: includes only participants with baseline and 3 month data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Promotion | Sleep Quality 3 Months | 3.9 score on a scale | Standard Deviation 1.5 |
| Usual Care | Sleep Quality 3 Months | 4.8 score on a scale | Standard Deviation 1.6 |
Primary
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.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Promotion | Sleep Quality: Baseline | 4.3 score on a scale | Standard Deviation 1.7 |
| Usual Care | Sleep Quality: Baseline | 4.5 score on a scale | Standard Deviation 1.5 |
Secondary
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.
Time frame: Baseline and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sleep Promotion | Adherence (Self Care Inventory) Parent | baseline | 3.7 score on a scale | Standard Deviation 0.66 |
| Sleep Promotion | Adherence (Self Care Inventory) Parent | 3 months | 3.8 score on a scale | Standard Deviation 0.84 |
| Usual Care | Adherence (Self Care Inventory) Parent | baseline | 3.8 score on a scale | Standard Deviation 0.69 |
| Usual Care | Adherence (Self Care Inventory) Parent | 3 months | 3.7 score on a scale | Standard Deviation 0.73 |
Secondary
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.
Time frame: Baseline and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sleep Promotion | Adherence (Self Care Inventory) Teen | baseline | 3.9 score on a scale | Standard Deviation 0.76 |
| Sleep Promotion | Adherence (Self Care Inventory) Teen | 3 months | 3.8 score on a scale | Standard Deviation 0.46 |
| Usual Care | Adherence (Self Care Inventory) Teen | baseline | 3.7 score on a scale | Standard Deviation 0.79 |
| Usual Care | Adherence (Self Care Inventory) Teen | 3 months | 3.9 score on a scale | Standard Deviation 0.59 |
Secondary
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.
Time frame: Baseline and 3 months
Population: only participants with both baseline and 3 month data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sleep Promotion | Quality of Life (PedsQL) | baseline | 70.3 score on a scale | Standard Deviation 8 |
| Sleep Promotion | Quality of Life (PedsQL) | 3 months | 72.5 score on a scale | Standard Deviation 10.3 |
| Usual Care | Quality of Life (PedsQL) | baseline | 74.5 score on a scale | Standard Deviation 8.6 |
| Usual Care | Quality of Life (PedsQL) | 3 months | 75.4 score on a scale | Standard Deviation 9.9 |