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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Promotion | Experimental | 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 | No Intervention | Usual Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Promotion | Behavioral | Behavioral intervention to improve sleep quality and duration. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah S Jaser, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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1 participant consented, completed baseline data, then withdrew
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Usual Care | Usual Care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | baseline |
|
baseline to 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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pilot study with small sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah S Jaser | Vanderbilt University Medical Center | 6153436775 | sarah.jaser@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 20, 2017 | Sep 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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 |
| Usual Care |
Usual Care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Annual Income | Count of Participants | Participants |
|
| Treatment Type | Count of Participants | Participants |
|
Usual Care |
|
|
| 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. | includes only participants with baseline and 3 month data | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Primary | Glycemic Control (HbA1c) Baseline | HbA1C is a measure of average blood glucose levels. It is measured quarterly at regular clinic visits. | Posted | Mean | Standard Deviation | percentage of glycosylated Hgb | Baseline |
|
|
|
| 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. | Some participants missed the 3 month appointment, so the final result is a combination of 3 month and 6 month values | Posted | Mean | Standard Deviation | percentage of glycosylated Hemoglobin | 3 months or 6 months |
|
|
|
| Primary | Sleep Duration: Baseline | Sleep duration will be measured with actigraphy (total sleep time) | only participants with usable actigraph data | Posted | Mean | Standard Deviation | hours | baseline |
|
|
|
| Primary | Sleep Duration: 3 Months | Sleep duration will be measured with actigraphy (total sleep time) | only participants with usable actigraph data | Posted | Mean | Standard Deviation | hours | 3 months |
|
|
|
| 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. | only participants with both baseline and 3 month data | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Usual Care | Usual Care | 0 | 19 | 0 | 19 | 0 | 19 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |