Diabetes Mellitus, Type 1NCT02786953
Sleep Promotion to Improve Diabetes Management in Adolescents With T1D
A study testing Sleep Promotion in people with Diabetes Mellitus, Type 1, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Sleep Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2017to 5 Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with type 1 diabetes for at least 12 months
- Speak and read English
- Report Insufficient sleep (< 8 hours/night most school nights)
Who cannot join
- Other major health problems or sleep disorders (other than insomnia)
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Sleep Coach: Sleep Promotion to Improve Diabetes Management in Adolescents With T1D
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Sleep Promotion
- Keywords
- Sleep, Adherence, Diabetes Management, Adolescent
- 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.
Sleep PromotionBehavioural
Behavioral intervention to improve sleep quality and duration.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sleep Promotion |
| Usual Care | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Glycemic Control (HbA1c) Baseline
HbA1C is a measure of average blood glucose levels. It is measured quarterly at regular clinic visits.
Measured: 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.
Measured: 3 months or 6 months
Sleep Duration: Baseline
Sleep duration will be measured with actigraphy (total sleep time)
Measured: baseline
Sleep Duration: 3 Months
Sleep duration will be measured with actigraphy (total sleep time)
Measured: 3 months
Secondary outcomes (3)
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.
Measured: Baseline and 3 months
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.
Measured: 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.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study start19 Oct 2017
- Primary completion23 Oct 2018
- Study completion5 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Jaser, Vanderbilt University Medical Center
- Investigators
- Sarah S Jaser, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786953
- Sponsor's protocol ID
- 151271
- Status last verified
- Jan 2020
- First submitted
- 18 May 2016
- Last updated
- 18 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Coach: Sleep Promotion to Improve Diabetes Management in Adolescents With T1D
- ClinicalTrials.gov ID
- NCT02786953
- Acronym / sponsor ID
- 151271
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Sleep, Adherence, Diabetes Management, Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 23 Oct 2018 (actual)
- Study completion
- 5 Feb 2019 (actual)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Posted 18 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Promotion | Experimental | Behavioral: Sleep PromotionBehavioral 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 |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosed with type 1 diabetes for at least 12 months
- Speak and read English
- Report Insufficient sleep (< 8 hours/night most school nights)
Key exclusion criteria (1 listed)
- Other major health problems or sleep disorders (other than insomnia)
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 |
|---|---|---|
| Sleep PromotionBehavioral intervention to improve sleep quality and duration. | Behavioural | Sleep Promotion |
Primary outcome
Sleep Quality: Baseline
Time frame: 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
Time frame: 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.
Glycemic Control (HbA1c) Baseline
Time frame: 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
Time frame: 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
Time frame: baseline
Sleep duration will be measured with actigraphy (total sleep time)
Sleep Duration: 3 Months
Time frame: 3 months
Sleep duration will be measured with actigraphy (total sleep time)
3 secondary outcomes
Quality of Life (PedsQL)
Time frame: Baseline and 3 months
Adherence (Self Care Inventory) Parent
Time frame: Baseline and 3 months
Adherence (Self Care Inventory) Teen
Time frame: Baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sarah S Jaser, PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Promotion in people with Diabetes Mellitus, Type 1, run by Vanderbilt University Medical Center 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 3 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 18 Jan 2020. 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?
Yes. Results are posted in the registry (first posted 18 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sleep Quality: Baseline (time frame: baseline). The study lists 6 primary outcomes in all. 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 18 Jan 2020.