Sleep Coach: Sleep Promotion to Improve Diabetes Management in Adolescents With T1D
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Sponsor: Vanderbilt University Medical Center

Sleep Promotion to Improve Diabetes Management in Adolescents 
With T1D
NCT02786953 
August 20, 2017

NIDDK 
Sleep Promotion to Improve Diabetes 
Management in Adolescents with T1D 
Pilot Study 
Sarah Jaser, PhD, Department of Pediatric Endocrinology, VUMC 
Sarah S. Jaser, PhD, Associate Professor 
Department of Pediatrics 
Vanderbilt University 

NIDDK 
 
 
 
 
Table of Contents: 
 
Study Schema 
1.0 
Background 
2.0 
Rationale and Specific Aims 
3.0 
Animal Studies and Previous Human Studies 
4.0 
Inclusion/Exclusion Criteria 
5.0 
Enrollment/Randomization 
6.0 
Study Procedures 
7.0 
Risks of Investigational Agents/Devices (side effects) 
8.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk 
to Participants or Others 
9.0 
Study Withdrawal/Discontinuation 
10.0 Statistical Considerations 
11.0 Privacy/Confidentiality Issues 
12.0 Follow-up and Record Retention 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.0 
Background 
 
Type 1 diabetes (T1D) is one of the most common chronic health conditions in youth, 
with over 18,000 new cases diagnosed each year, and the prevalence is increasing. The 
recommended treatment regimen is complex and demanding, including frequent blood 
glucose monitoring, insulin administration (via injections or pump), careful tracking of diet 
and activity levels, and frequent insulin adjustments. Adherence to this regimen is linked 
with better glycemic control and reduces the risk for acute and long-term medical 
complications. However, this intensive level of self-care is difficult to maintain and can 
negatively impact quality of life in adolescents. Problems with adherence are reported by 
the majority of adolescents with T1D (up to 93%), and poor diabetes-specific quality of 
life has been shown to contribute to suboptimal glycemic control. Despite recent 
advances in technology (e.g., insulin pumps, continuous glucose monitoring), many 
adolescents continue to have suboptimal glycemic control; a recent national study found 
that only 17% of adolescents were meeting the American Diabetes Associations' 
recommended targets. Thus, novel interventions are needed to improve glycemic 
control, adherence, and quality of life in adolescents with T1D.  
 
Sleep disturbances have recently gained attention as a potential risk factor for 
individuals with diabetes, but the associations between sleep and diabetes outcomes are 
complex and bidirectional - poor sleep contributes to problems with glycemic control, and 
diabetes-related distress and poor glycemic control are likely to cause sleep disruptions. 
In laboratory studies with adults with T1D, reduced sleep duration and sleep 
disturbances have been shown to increase evening cortisol and growth hormone levels 
(hormones counter-regulatory to insulin) and increased insulin resistance. Results from a 
national survey indicate that nearly 70% of adolescents in the general population obtain 
insufficient sleep (defined as <8 hours/night), and similar rates have been reported in 
adolescents with T1D. Nevertheless, sleep characteristics, such as total sleep time, 
sleep/wake times, or sleep quality, are not routinely addressed in standards of 
care for youth with T1D, and the role of sleep in self-management and adherence is not 
fully understood. 
 
Adolescents with T1D are at high risk for poor adherence and suboptimal glycemic 
control. Sleep disturbances, such as poor quality and insufficient sleep, are a potentially 
modifiable risk factor for poor diabetes outcomes in adolescents with T1D. We propose 
to pilot test a sleep-promoting intervention tailored for this population. By improving 
sleep quality and/or increasing duration of sleep, we may improve outcomes in 
adolescents with T1D through both an indirect, behavioral pathway (i.e., adherence) and 
a direct, physiological pathway (i.e., glycemic control). The proposed research is 
innovative in its plan to target sleep promotion in adolescents with T1D as a way to 
improve diabetes management, glycemic control, and quality of life.  
 
2.0 
Rationale and Specific Aims 
 
Working from a biopsychosocial and contextual model of sleep, which highlights the 
need to consider the social environment and psychosocial factors, we propose to 
intervene on the modifiable aspects of sleep disturbance in adolescents. We have 

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conducted interviews with adolescents and their caregivers to identify barriers, 
facilitators, and consequences of insufficient sleep for adolescents with T1D. The results 
of these interviews have informed the development of an intervention protocol that is 
tailored to the needs of this population. We propose to pilot test a behavioral sleep 
intervention for adolescents with type 1 diabetes. This low-cost, innovative intervention is 
designed to induce greater sleep duration and higher quality of sleep in adolescents 
(age 13-17) through tailored exercises in sleep hygiene education, cognitive 
restructuring, and relaxation. 
 
The specific aim of this project is: 
To evaluate the feasibility and preliminary efficacy of this novel intervention with a pilot 
randomized trial of adolescents with T1D. The primary outcomes will be sleep quality 
and glycemic control, and secondary outcomes include adherence and quality of life.  
Hypothesis: Adolescents who receive the sleep-promoting intervention will 
demonstrate improved sleep quality and glycemic control, as well as fewer 
problems with adherence and quality of life, as compared to those who receive 
usual care. 
 
3.0 
Animal Studies and Previous Human Studies 
 
Dr. Jaser and colleagues conducted qualitative interviews with 25 adolescents with type 1 
diabetes and their caregivers, which identified several barriers and facilitators to 
achieving sufficient sleep (PMCID: PMC6460925). Results from this study informed the 
intervention tested in the pilot study. 
 
4.0 
Inclusion/Exclusion Criteria 
 
List the criteria:  
• 
adolescent age 13-17  
• 
adolescent has been diagnosed with type 1 diabetes for at least 12 months 
• 
adolescent reports insufficient sleep (<8 hours/night most school nights) 
• 
adolescent does not have a diagnosed sleep disorder or other health problem 
that would interfere with sleep 
• 
adolescent and parent able to speak and read English 
 
5.0 
Enrollment/Randomization 
 
Participants will be enrolled at the Children’s Diabetes Program at Vanderbilt (Vanderbilt 
University Medical Center, 
, Nashville, TN 3
). A trained 
research analyst (RA) will approach families (teen and parent) in the diabetes clinic. The 
teen and their parents will be described, in-depth, details regarding the format and 
procedures of the study and address any questions or concerns the participants may 
have in a private space. After consenting/assenting and completing all baseline 
questionnaire data, teens will be given instructions to wear an actigraph watch and 
complete a sleep diary for 7 nights. 
 
When the sleep watch and diary are returned in the pre-paid envelope, the teen will be 
randomly assigned to the intervention condition (Sleep Coach) or usual care. 
Randomization will be stratified by the adolescents' treatment type (insulin pump vs. 

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injections) to remove the possibility of confounding by differences related to insulin 
regimen. Randomization will be determined by a computerized program created by the 
biostatistician on the project (Chris Slaughter). 
 
6.0 
Study Procedures 
 
At baseline and 3 months, teens and parents will complete surveys consisting of 
measures are widely validated and have been used successfully by our research team in 
previous studies. Questionnaire data collection is timed to correspond with regularly 
scheduled clinic visits. The measures take about 30 minutes to complete.  
 
In addition, teens will receive 7 days of automated text messages to collect data on 
sleep habits 6 weeks after randomization. Each day, they will receive a series of 4 text 
messages, asking them to confirm the date, report the time they fell asleep the night 
before, the time they woke up that morning, and rate the quality of their sleep. 
All data will be collected using REDCap. 
 
Clinical data (HbA1c values, blood glucose data) will be extracted from participants’ 
medical charts. 
 
 
Teen Measures: 
Self-Care Inventory (SCI-C): assesses key elements of the treatment regimen for T1D: 
diet, exercise, blood glucose monitoring, insulin administration, and attending medical 
appointments. The wording applies to various insulin regimens (i.e., pump and 
injections). It has been shown to have good reliability and validity. The mean score will 
be used in data analyses.  
 
Pediatric Quality of Life (PedsQL) diabetes-specific measure. The 28 items will be 
summed to create a total diabetes-related quality of life score. Scaled scores range from 
0-100, and higher scores reflect better quality of life. 
 
Patient Health Questionnaire (PHQ-9) will be used as a measure of current depressive 
symptoms. The PHQ consists of 9 items, and higher scores indicate higher current 
levels of depression, with a score of 11 or higher suggesting clinical levels of depression, 
with sensitivity of 89.5% and specificity of 77.5% for detecting major depression.  
 
The Child Hypoglycemia Fear Survey (C-HFS) is a measure of worries and behaviors 
that stem from fear related to hypoglycemia. The C-HFS consists of 33 items and has 
been shown to have good reliability and validity in this population. 
 
The Daytime and Nighttime Activity Modules consists of six questions regarding daytime 
and nighttime activities that can impact sleep. 
 
Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD): an eight item 
measure of how likely an adolescent is to doze in various situations. This scale has been 
shown to have good reliability and validity in children and adolescents. 
 
Morningness-Eveningness Questionnaire: a widely used, ten item questionnaire that 
assesses perceived alertness across times of day to determine circadian rhythms. 

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Pittsburgh Sleep Quality Index (PSQI): a widely used, 19-item questionnaire assessing 
sleep habits and disturbances. It has been shown to have good validity and reliability. 
 
Problem Areas in Diabetes: Teen Version (PAID-T): assesses feelings of day-to-day 
burdens and hassle related to diabetes. It is comprised of 26 items and has been 
demonstrated to have good reliability and validity in teens. 
 
Adolescents will wear the Phillips Actiwatch Spectrum Plus, a wrist-worn accelerometer, 
continuously for 7 days, and will be asked to press the event marker at "lights out" and 
"lights on" times to demarcate time in bed. Actigraph data will be scored with Phillips 
Spectrum Plus software. Descriptive statistics will be used to summarize each of the 
primary sleep variables (% wake after sleep onset, time in bed, sleep efficiency, sleep 
latency, duration) over the 7 day week interval, and these will be entered in the REDCap 
database. 
 
Parent Measures:  
Self-Care Inventory - Parent (SCI-P): assesses key elements of adherence to the 
treatment regimen for T1D: diet, exercise, blood glucose monitoring, insulin 
administration, and attending medical appointments. The wording applies to 
various insulin regimens (i.e., pump and injections). It has been shown to have good 
reliability and validity. 
 
The Parent Hypoglycemia Fear Survey (P-HFS): a measure of parent worries and 
behaviors that stem from fear surround their child experiencing hypoglycemia. The P-
HFS consists of 33 items, and has been shown to have good reliability and validity in this 
population. 
 
Problem Areas in Diabetes: Parent Revised Version (PAID-PR): assesses feelings of 
day-to-day burden and hassle associated with their child's diabetes. It is comprised of 18 
items and has been demonstrated to have good reliability and validity. 
 
Nighttime Behaviors Module: a six item questionnaire covering habits surrounding 
parent's nocturnal caregiving.  
 
WHO-5 Well-Being Index (WHO-5): a brief, five item questionnaire that measures 
subjective quality of life, with higher scores indicating better quality of life. It has been 
shown to exhibit good psychometric properties. 
 
Satisfaction Survey – completed by teens and parents at 3 month follow-up 
 
Interventions 
 
Participants randomized to the Sleep Coach condition (n=20) will receive a binder of 
study materials. These materials will include educational information on healthy sleep 
habits and how to implement strategies to improve sleep. Over the course of the study, 
teens will  participate in three phone sessions with a trained Master's level interventionist 
(who will be supervised by a licensed clinical psychologist). During these sessions, the 
interventionist will go over informational materials with the teen and walk them through 
exercises designed to help the teen prepare for and practice health sleep habits. The 

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phone calls will take place at a time that the teen has indicated are convenient to them. 
The first phone call will last approximately 30 minutes. The second call will last 
approximately 10-15 minutes and take place about one week after the initial phone 
session. The third call will last approximately 10-15 minutes and will take place about 
three weeks after the second call. Parents will not participate in phone calls but will be 
provided with materials designed to help them support their teen in implementing healthy 
sleep habits. 
 
Teens assigned to the Usual Care group (n=20) will have access to regular diabetes 
care. 
 
7.0 
Risks 
 
Data collection requires participants (teens and parents) to spend approximately 30 
minutes at each collection (baseline, 3 months) completing surveys. Teens will also 
spend a few minutes completing sleep diaries for 7 nights at baseline and 3 months. 
 
Teens in the sleep coach condition will engage in 3 intervention phone calls that will last 
10-30 minutes This is not anticipated to be an undue burden for the participants. 
 
The potential benefit of this study is to gain knowledge on how to improve sleep in 
adolescents with Type 1 Diabetes. The results from this study will inform providers and 
caregivers on how to most effectively motivate adolescents to improve their sleep habits, 
which may have positive effects on glycemic control and diabetes management. In sum, 
there are more compelling benefits than risks.  
 
Several steps will be taken to protect the subjects against risk. First, participants will be 
informed that they are free to skip any questions that they feel uncomfortable answering 
and that they are free to withdraw from the study at any time without penalty. There are 
no potential legal or social risks to participants consenting to participate in this 
investigation. 
 
Additionally, if teen participants indicate self-harm on the 9th item of the PHQ-9 
questionnaire or score 11 or higher, RAs will administered the Self-Harm Assessment 
and will notify the PI and the social worker. The PI and/or the Social Worker will 
determine the steps that need to be taken to ensure safety of the participant. RAs will 
not be asked to determine the clinical significance of the harm. RAs will speak with 
parents describing the results of the assessments and provide the family with a list of 
resources. 
 
All children will receive clinical care throughout the course of the study. All diabetes 
treatment decisions will be made by the diabetes treatment team. All patients have 
access to the treatment team 24 hours/day and 7 days per week. Participants will be 
informed that they may discontinue the study at any time or skip any questions they do 
not feel comfortable answering. There are no potential legal or social risks to 
participants consenting to participate in this investigation. Parents will be told to follow 
the diabetes clinic providers' guidance on any questions related to diabetes 
management. 
 
 

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The PI will ensure that the trial is conducted according to the approved protocol and will 
be responsible for carrying out the data safety monitoring plan, which includes: 
- Review of study components for data completeness and accuracy as well as protocol 
compliance 
- Evaluate adverse events (AEs, described below) for severity, relationship to the 
research and actions to be taken 
- Promptly report all severe AEs and unanticipated problems to the data and safety 
officer, IRB, and NIH 
 
KSP will complete human subjects training prior to any contact with participants and 
maintain annual training. KSP will also complete Good Clinical Practice training for social 
and behavioral research annually. 
 
Data Safety and Monitoring 
 
Randi Streisand, PhD, CDE will serve as the Safety Officer for the project. Dr. Streisand 
is a clinical health psychologist and certified diabetes educator working in a clinical 
research setting with roles in research, clinical service, and training. 
She a Professor of Psychology & Behavioral Health and Pediatrics, and she serves as 
the Director for Psychology Research across Children's National Health System, as well 
as the Diabetes Team's Director for Psychosocial Research and Service. Her current 
work is funded by the NIH and focuses on managing type 1 diabetes in young children, 
and she has served as PI or Co-I for several interventions focused on stress reduction 
and/or adherence in families of children with chronic illness. 
 
Safety reports will be sent bi-annually (every six months) to the Safety Officer and 
annually to NIDDK and the Vanderbilt University IRB. The PI will prepare data for interim 
analyses, which will be conducted every 6 months by the biostatistician. The Safety 
Officer will review the safety reports in an aggregate fashion, blinded to treatment 
groups. 
 
Safety Reports will provide a study summary and identify any problems or issues and 
will include details on the status of the study and/or preliminary findings. In addition, any 
deviations from protocol will be noted. Each safety report will include the following: 
A table indicating the expected vs. actual enrollment per month, including number of 
patients approached, ineligible, and refused. 
A table of overall subject status, as well as detail on each participant's progress through 
the study. This table will include information on the number of active participants, the 
number of participants who have completed the study, participants who drop out 
(including reasons) of the study and those who are unable to be reached (lost to follow 
up).  
An enrollment report, indicating the racial ethnic characteristics of the study sample 
A table indicating the demographic and key baseline characteristics (including A1C, 
depression, and adherence) by group. 
A table listing all adverse events, actions taken, and outcomes. 
 
8.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk 
to Participants or Others 
 

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Any adverse events occurring during the course of this trial will be collected, 
documented and reported by the PI (Dr. Sarah Jaser), to the Safety Officer (Randi 
Streisand, PhD, CDE), along with reporting to the NIDDK and institutional review boards 
as required. Although not anticipated, if any event is identified that may have caused 
any type of harm to a participant, study accrual will be immediately halted until the 
study team and DSMB can review the event and determine if any study procedures need 
to be revised. Study accrual will only resume after review of study protocol has been 
completed and any recommended revisions made as suggested by the DSMB. 
 
9.0 
Study Withdrawal/Discontinuation 
 
Study participants may contact the study team if they wish to withdraw. 
 
10.0 Statistical Considerations 
 
Power Analysis: Based on effect sizes from cognitive-behavioral interventions to treat 
insomnia showing medium to large effect sizes for total sleep time after 3 months (d = 
.71), we would need a sample of 52 to have sufficient power to detect a treatment 
difference in sleep time. With a sample of 40, we will have power of .71 to detect a 
significant treatment difference. The small sample size of this pilot study does not 
provide the power to test the efficacy of the intervention. The focus of this study is to see 
initial evidence for an effect on the direct target – improvement in adolescents’ sleep 
duration and quality – as well as feasibility of the trial. By collecting A1C data for 6 
months, we will be able to determine if there is an impact on glycemic control. 
 
Preliminary Analyses: Preliminary Analyses: We will conduct unadjusted tests of the 
association of demographic covariates including gender, race/ethnicity income, fear of 
hypoglycemia, and circadian preference with sleep habits. While we anticipate our 
randomized design will mitigate confounding, adjusting for covariates associated with the 
sleep outcomes will improve the precision of our estimate of the treatment effect. 
Actigraph data will be scored with Phillips Spectrum Plus software with guidance from 
Vanderbilt’s Sleep Core. Objective actigraph data will be supplemented with sleep 
diaries to determine bedtime and wake time. Descriptive statistics will be used to 
summarize each of the primary sleep variables: sleep efficiency, sleep latency, and total 
sleep time (duration) over the 7-day interval.  
 
Longitudinal models will be conducted using baseline and follow-up data to determine 
the preliminary effect of the intervention on the primary outcomes (sleep quality and 
glycemic control), as well as the secondary outcomes of adherence and quality of life. 
The longitudinal responses will be analyzed using generalized least squares to account 
for correlation arising from taking repeated observations on the same subject over time.  
We anticipate that two measurements made more closely in time will be more highly 
correlated than measurements made distant in time, and we anticipate some longitudinal 
measures could have negative correlations (e.g. poor sleep on one night leading to 
better sleep on the next night).  To those ends, we will use an unstructured correlation 
for the primary analysis. The choice of unstructured will be compared to other correlation 
structures using AIC.  Mean time-response profiles over time will be flexibly modeled 
using restricted cubic splines.  Analyses will provide estimates of effect sizes, within-
subject variances, and between-subject variances to be used in power analyses for a full 
scale trial.  

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Feasibility and Acceptability: To determine the feasibility of the intervention, we will 
examine recruitment and retention data. Our benchmark for retention is > 85%. In 
addition, fidelity checks will be conducted by audiotaping 20% of the telephone sessions, 
which will be coded for content by an independent rater. We propose a feasibility 
benchmark of >90% fidelity. Logistic regression will be used to determine if baseline 
covariates can be used to predict retention or fidelity 
 
To evaluate acceptability of the intervention, we will examine participation (attendance), 
adherence (completion of homework), and satisfaction ratings. We propose a feasibility 
benchmark of > 80% attendance. We will also conduct exit interviews with adolescents, 
including those who did not complete the study, to find out what they liked and did not 
like about the intervention. Interviews will be transcribed and analyzed with a content 
analysis approach to identify themes across participants. By integrating input from 
participants, we plan to maximize engagement with and increase feasibility in a large-
scale trial.  
 
11.0 Privacy/Confidentiality Issues 
 
Confidential participant data will be safeguarded by multiple password protection 
requirements, data encryption, and locked secure storage of paper documents. 
 
Only Key Study Personnel (KSP) will have access to research information, and all KSP 
will complete training in Good Clinical Practice. 
 
Participants will be identified with an ID number; names will not be included on any data 
outside of RedCAP. Only research staff who have completed IRB training and have been 
added as KSP have access to the study RedCAP. All identifying information will be 
destroyed at the earliest possible time following completion of the study. All data will be 
analyzed by groups, with no potential for individual patients to be identified. Any 
publications arising from the study will not contain personal information. 
Digital files will be erased after completion of the study. 
 
12.0 Follow-up and Record Retention 
 
Duration of the study is anticipated to be 2 years. All data will be analyzed by groups, 
with no potential for individual patients to be identified. Any publications arising from 
the study will not contain personal information.  
 
Research records will be maintained for at least three (3) years from the date the 
research is closed with the IRB. All Health Insurance Portability and Accountability Act 
(HIPAA) related documentation will be maintained for at least six (6) years from the 
date of the last use or disclosure of the Protected Health Information (PHI).