Diabetes Mellitus, Type 1SleepT1DNCT02908555
Sleep, Coping and Executive Functioning in Youth With Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1, run by Yale University at 1 site in United States.
Trial summary
The purpose of this exploratory study is to evaluate the characteristics of sleep, perceptions of barriers and facilitators to adequate sleep, and the associations among sleep characteristics, executive functioning, coping, adherence, 24-hour glucose levels, and adjustment in adolescents with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 15 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: 40 youth with type 1 diabetes, age 10-16 years, diagnosed for at least 6 months
Who may be able to join
- diagnosed for at least 6 months
Who cannot join
- able to comply with protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Nursing
West Haven, Connecticut, 06516-0972
About this study
Official title: Sleep, Coping, and Executive Functioning in Youth With Type 1 Diabetes
The purpose of this exploratory study is to evaluate the characteristics of sleep, perceptions of barriers and facilitators to adequate sleep, and the associations among sleep characteristics, executive functioning, coping, adherence, 24-hour glucose levels, and adjustment in adolescents with type 1 diabetes. A mixed methods approach that includes a quantitative component, consisting of actigraphy and sleep diaries, questionnaires, tests of executive function and continuous glucose monitoring (CGM) as well as a narrative qualitative component will be used. Results from this pilot study will be used to provide the effect sizes needed for a larger-scale descriptive study and to establish the need for a possible sleep-promoting intervention for adolescents with type 1 diabetes. This project is consistent with ongoing research focused on developing preventive, behavioral interventions for youth with type 1 diabetes and their families to improve physiological (i.e., glycemic control) and psychological (i.e., quality of life) outcomes. Sleep promotion may become an important component of these interventions. Thus, the following specific aims will be addressed:
- Describe the objective and subjective characteristics of sleep (duration, continuity, bed time/rise times); sleep quality and sleep habits among adolescents with type 1 diabetes.
- Explore the relationship between characteristics of self-reported sleep (i.e., habits, duration, daytime sleepiness) and executive function, coping, adherence, and adjustment (i.e., depressive symptoms, quality of life) in adolescents with type 1 diabetes.
- Explore the relationship of glucose excursions on sleep characteristics and executive functioning.
- Conduct a qualitative study using narrative analysis with adolescents to identify perceived barriers, facilitators, and consequences associated with insufficient sleep in adolescents with type 1 diabetes.
Read the detailed description
A mixed methods approach will be used to characterize sleep and explore the associations between sleep disturbances and executive function, coping, glycemic control, adherence, and adjustment in adolescents with type 1 diabetes. To understand these relationships, the investigators will collect quantitative data, including self-report and parent-report questionnaires and a test of cognitive functioning after consent and screening. Clinical data related to diabetes will be collected from the medical chart and CGM, and overnight sleep data will be collected during the subsequent week. The investigators will also collect qualitative data, using semi-structured interviews.
Aim 1. Describe the objective and subjective characteristics of sleep (duration, continuity, bed time/rise times); sleep quality and sleep habits among adolescents with type 1 diabetes.
After completing the initial recruitment procedures and questionnaires, adolescents will wear the Respironics Minimitter Actiwatch AW64, a wrist-worn accelerometer, continuously for 1 week, removing them only for bathing, and depress the event marker at "lights out" and "lights on" times to demarcate time in bed. Sleep diaries will be completed daily in the mornings and evenings to track daytime sleep-related behaviors (e.g., caffeine use, exercise) and nocturnal sleep characteristics (e.g., bedtime, wakings). The research assistants will call adolescents the day after enrollment to address any problems and elicit understanding. At the end of the week, they will call adolescents as a reminder to complete the data collection and return the watch and diary in a prepaid mailer.
Data Analysis. Actigraph data will be scored with Actiware v. 5 software. Diary forms have been prepared in scannable format to reduce the need for research staff entering data manually. Forms will be examined for improperly filled items and missing data, scanned and committed to an MS Access database. Descriptive statistics will be used to summarize each of the primary sleep variables (diary and actigraph) (% wake after sleep onset, time in bed, sleep efficiency, sleep latency, duration) over the 1-week interval. Descriptive statistics will also be used to characterize the total and component scores of the Children's Sleep Questionnaire.
The expected outcome of this aim is a more detailed characterization of sleep patterns in adolescents with T1D to identify the key variables to be measured in a large scale study.
Aim 2. Explore the relationship between characteristics of self-reported sleep (i.e., habits, duration, daytime sleepiness) and executive function, coping, adherence, and adjustment (i.e., depressive symptoms, quality of life, anxiety) in adolescents with type 1 diabetes. Questionnaires and test of executive function will be completed by adolescents and their parent/guardian after screening and consent.
Measures: The proposed measures have been used in our ongoing studies with adolescents with T1D, and they have established reliability and validity. The questionnaires will take about 20-30 minutes to complete, and the test of executive function will take 5 minutes. Following the established protocol, a trained RA will demonstrate the Trail Making Test using the sample sheet. The adolescent will be timed on the full test (drawing lines to connect 25 circles, alternating letters and numbers).
Data Analysis: To explore the relationship between sleep and executive function, coping, adherence, and adjustment, the investigators will use bivariate correlations. To evaluate the extent to which insufficient sleep is associated with executive function, coping, adherence, and adjustment in this population the investigators will use conduct independent groups t-tests to obtain estimates of the differences on key variables between adolescents who get insufficient vs. sufficient sleep (< 7 hours/night vs. > 7 hours/night). The investigators will also calculate the effect size from these data to establish the basis for a power analysis for a possible future larger study. Finally, using a linear regression model, the effect of sleep duration on key variables will be examined after controlling for potential confounders; gender, race/ethnicity, and income have been shown to impact sleep habits. Further, the investigators will explore the extent to which there is an effect of gender on the outcome variables or their interactions.
The expected outcome of this aim is estimates of effect sizes needed to conduct power analyses for a full-scale study of the associations between sleep and cognitive function, coping, adherence, and adjustment.
Aim 3. Explore the relationship of glucose excursions on sleep characteristics and executive function. Using CGM data from the iPro CGM system, glucose excursions and time with hypoglycemia or hyperglycemia will be identified. Youth who are already using CGM will not have to wear a second monitor, but will provide downloaded data from their CGM at the return visit.
Data analyses: Bivariate correlations to examine relationships among sleep and executive function, coping, adherence, and adjustment and glycemic excursions will be conducted. To evaluate the extent to which insufficient sleep is associated with executive function, coping, adherence, and adjustment in this population independent groups t-tests will be used to obtain estimates of the differences on key variables between adolescents with nighttime hypo- or hyperglycemia. The effect size will be calculated from these data to establish the basis for a power analysis for a possible future larger study. Finally, using a linear regression model, the effect of sleep duration on key variables will be examined after controlling for potential confounders; gender, race/ethnicity, and income have been shown to impact sleep habits. Further, the extent to which there is an effect of gender on the outcome variables or their interactions will be determined.
The expected outcome of this aim is estimates of the effect sizes needed to conduct power analyses for a full-scale study of the associations among glucose excursions, sleep characteristics, and cognitive function, coping, adherence, and adjustment.
Aim 4. Conduct qualitative study using narrative inquiry with all adolescents in our population to identify perceived factors associated with insufficient sleep in adolescents with type 1 diabetes.
In the past several decades, adolescents have shifted to later sleep times, while wake times have remained the same, resulting in insufficient sleep. Barriers to sleep in adolescents include extracurricular activities, work, academics, and social interaction. More recently, electronic media use and video-game playing have been linked to shorter sleep duration. Predictors of disturbed sleep in adolescents and young adults (college students) include emotional and academic stress. Many of these are modifiable behaviors that could be addressed in future interventions. For adolescents with T1D, sleeping late on the weekends has additional risks of hypoglycemic episodes. What is not known are the barriers and facilitators to sleep specific to this population. Interviews will be conducted with adolescents to learn through their stories what are important factors associated with insufficient sleep in this population.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- No intervention
- Keywords
- type 1 diabetes, adolescents, sleep
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is a descriptive study with no intervention
| Study group | Role | What they receive |
|---|---|---|
| no intervention | Descriptive study without groups Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Hemoglobin A1C
Measured: baseline
Secondary outcomes (1)
Executive functioning
Trail Making Test Part B
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startJan 2016
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaret Grey, DrPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908555
- Sponsor's protocol ID
- 1507016174
- Acronym
- SleepT1D
- Status last verified
- Jun 2018
- First submitted
- 8 Sep 2016
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified data will be shared once analyses are final.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep, Coping, and Executive Functioning in Youth With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02908555
- Acronym / sponsor ID
- SleepT1D / 1507016174
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- type 1 diabetes, adolescents, sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this exploratory study is to evaluate the characteristics of sleep, perceptions of barriers and facilitators to adequate sleep, and the associations among sleep characteristics, executive functioning, coping, adherence, 24-hour glucose levels, and adjustment in adolescents with type 1 diabetes. A mixed methods approach that includes a quantitative component, consisting of actigraphy and sleep diaries, questionnaires, tests of executive function and continuous glucose monitoring (CGM) as well as a narrative qualitative component will be used. Results from this pilot study will be used to provide the effect sizes needed for a larger-scale descriptive study and to establish the need for a possible sleep-promoting intervention for adolescents with type 1 diabetes. This project is consistent with ongoing research focused on developing preventive, behavioral interventions for youth with type 1 diabetes and their families to improve physiological (i.e., glycemic control) and psychological (i.e., quality of life) outcomes. Sleep promotion may become an important component of these interventions. Thus, the following specific aims will be addressed:
- Describe the objective and subjective characteristics of sleep (duration, continuity, bed time/rise times); sleep quality and sleep habits among adolescents with type 1 diabetes.
- Explore the relationship between characteristics of self-reported sleep (i.e., habits, duration, daytime sleepiness) and executive function, coping, adherence, and adjustment (i.e., depressive symptoms, quality of life) in adolescents with type 1 diabetes.
- Explore the relationship of glucose excursions on sleep characteristics and executive functioning.
- Conduct a qualitative study using narrative analysis with adolescents to identify perceived barriers, facilitators, and consequences associated with insufficient sleep in adolescents with type 1 diabetes.
Detailed description
A mixed methods approach will be used to characterize sleep and explore the associations between sleep disturbances and executive function, coping, glycemic control, adherence, and adjustment in adolescents with type 1 diabetes. To understand these relationships, the investigators will collect quantitative data, including self-report and parent-report questionnaires and a test of cognitive functioning after consent and screening. Clinical data related to diabetes will be collected from the medical chart and CGM, and overnight sleep data will be collected during the subsequent week. The investigators will also collect qualitative data, using semi-structured interviews.
Aim 1. Describe the objective and subjective characteristics of sleep (duration, continuity, bed time/rise times); sleep quality and sleep habits among adolescents with type 1 diabetes.
After completing the initial recruitment procedures and questionnaires, adolescents will wear the Respironics Minimitter Actiwatch AW64, a wrist-worn accelerometer, continuously for 1 week, removing them only for bathing, and depress the event marker at "lights out" and "lights on" times to demarcate time in bed. Sleep diaries will be completed daily in the mornings and evenings to track daytime sleep-related behaviors (e.g., caffeine use, exercise) and nocturnal sleep characteristics (e.g., bedtime, wakings). The research assistants will call adolescents the day after enrollment to address any problems and elicit understanding. At the end of the week, they will call adolescents as a reminder to complete the data collection and return the watch and diary in a prepaid mailer.
Data Analysis. Actigraph data will be scored with Actiware v. 5 software. Diary forms have been prepared in scannable format to reduce the need for research staff entering data manually. Forms will be examined for improperly filled items and missing data, scanned and committed to an MS Access database. Descriptive statistics will be used to summarize each of the primary sleep variables (diary and actigraph) (% wake after sleep onset, time in bed, sleep efficiency, sleep latency, duration) over the 1-week interval. Descriptive statistics will also be used to characterize the total and component scores of the Children's Sleep Questionnaire.
The expected outcome of this aim is a more detailed characterization of sleep patterns in adolescents with T1D to identify the key variables to be measured in a large scale study.
Aim 2. Explore the relationship between characteristics of self-reported sleep (i.e., habits, duration, daytime sleepiness) and executive function, coping, adherence, and adjustment (i.e., depressive symptoms, quality of life, anxiety) in adolescents with type 1 diabetes. Questionnaires and test of executive function will be completed by adolescents and their parent/guardian after screening and consent.
Measures: The proposed measures have been used in our ongoing studies with adolescents with T1D, and they have established reliability and validity. The questionnaires will take about 20-30 minutes to complete, and the test of executive function will take 5 minutes. Following the established protocol, a trained RA will demonstrate the Trail Making Test using the sample sheet. The adolescent will be timed on the full test (drawing lines to connect 25 circles, alternating letters and numbers).
Data Analysis: To explore the relationship between sleep and executive function, coping, adherence, and adjustment, the investigators will use bivariate correlations. To evaluate the extent to which insufficient sleep is associated with executive function, coping, adherence, and adjustment in this population the investigators will use conduct independent groups t-tests to obtain estimates of the differences on key variables between adolescents who get insufficient vs. sufficient sleep (< 7 hours/night vs. > 7 hours/night). The investigators will also calculate the effect size from these data to establish the basis for a power analysis for a possible future larger study. Finally, using a linear regression model, the effect of sleep duration on key variables will be examined after controlling for potential confounders; gender, race/ethnicity, and income have been shown to impact sleep habits. Further, the investigators will explore the extent to which there is an effect of gender on the outcome variables or their interactions.
The expected outcome of this aim is estimates of effect sizes needed to conduct power analyses for a full-scale study of the associations between sleep and cognitive function, coping, adherence, and adjustment.
Aim 3. Explore the relationship of glucose excursions on sleep characteristics and executive function. Using CGM data from the iPro CGM system, glucose excursions and time with hypoglycemia or hyperglycemia will be identified. Youth who are already using CGM will not have to wear a second monitor, but will provide downloaded data from their CGM at the return visit.
Data analyses: Bivariate correlations to examine relationships among sleep and executive function, coping, adherence, and adjustment and glycemic excursions will be conducted. To evaluate the extent to which insufficient sleep is associated with executive function, coping, adherence, and adjustment in this population independent groups t-tests will be used to obtain estimates of the differences on key variables between adolescents with nighttime hypo- or hyperglycemia. The effect size will be calculated from these data to establish the basis for a power analysis for a possible future larger study. Finally, using a linear regression model, the effect of sleep duration on key variables will be examined after controlling for potential confounders; gender, race/ethnicity, and income have been shown to impact sleep habits. Further, the extent to which there is an effect of gender on the outcome variables or their interactions will be determined.
The expected outcome of this aim is estimates of the effect sizes needed to conduct power analyses for a full-scale study of the associations among glucose excursions, sleep characteristics, and cognitive function, coping, adherence, and adjustment.
Aim 4. Conduct qualitative study using narrative inquiry with all adolescents in our population to identify perceived factors associated with insufficient sleep in adolescents with type 1 diabetes.
In the past several decades, adolescents have shifted to later sleep times, while wake times have remained the same, resulting in insufficient sleep. Barriers to sleep in adolescents include extracurricular activities, work, academics, and social interaction. More recently, electronic media use and video-game playing have been linked to shorter sleep duration. Predictors of disturbed sleep in adolescents and young adults (college students) include emotional and academic stress. Many of these are modifiable behaviors that could be addressed in future interventions. For adolescents with T1D, sleeping late on the weekends has additional risks of hypoglycemic episodes. What is not known are the barriers and facilitators to sleep specific to this population. Interviews will be conducted with adolescents to learn through their stories what are important factors associated with insufficient sleep in this population.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no intervention | – | Other: No interventionDescriptive study without groups |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 40 youth with type 1 diabetes, age 10-16 years, diagnosed for at least 6 months
Key inclusion criteria (1 listed)
- diagnosed for at least 6 months
Key exclusion criteria (1 listed)
- able to comply with protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is a descriptive study with no intervention | Other | no intervention |
Primary outcome
Glycemic control
Time frame: baseline
Hemoglobin A1C
1 secondary outcome
Executive functioning
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Individual participant dataSharing planned: Yes. De-identified data will be shared once analyses are final.
Related trials for Diabetes Mellitus, Type 1
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
RecruitingPhase 3
A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus
Obesity or Overweight
Not yet recruitingPhase 1/2
Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
Sarcoma, Osteoid Sarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Grey, DrPH principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.