Diabetes Journey: An Intervention to Improve Adherence Barriers for Adolescents With Type 1 Diabetes
Phase: NA
Conditions: Type 1 Diabetes, Adherence, Patient
Sponsor: Children's Hospital Medical Center, Cincinnati

Version 11 (June 8, 2023) p. 1 
 
 
Diabetes Journey: An Adolescent Adherence Barriers Intervention 
Study Protocol 
 
Clinicaltrials.gov NCT04404556 
 
Unique Protocol ID: 2020-0162 
 
Document Date: Version 11 - June 8, 2023 
 
 

Version 11 (June 8, 2023) p. 2 
 
CINCINNATI CHILDREN’S HOSPITAL MEDICAL CENTER 
 
STUDY PROTOCOL 
 
Study Title: Diabetes Journey: An Intervention to Improve Adherence Barriers for 
Adolescents with Type 1 Diabetes 
 
Principal Investigators:  Avani C. Modi, Ph.D. (CCHMC) and Kimberly A. Driscoll, Ph.D. 
(University of Florida) 
 
1. ABSTRACT 
Type 1 diabetes (T1D) treatment adherence is complex and involves glucose monitoring, 
counting carbohydrates, and intensive insulin delivery via injections or insulin pump in response 
to food intake, exercise, and illness to achieve near-normal blood glucose levels. Evidence 
demonstrates that adhering to T1D treatment is challenging, especially during adolescence. 
Non-adherence leads to suboptimal glycemic levels that severely compromise health and 
quality of life. Suboptimal adherence to T1D treatment regimen is common in >50% of 
adolescents and directly related to suboptimal glycemic control, increased risk of 
hospitalizations for diabetic ketoacidosis, and decreased health-related quality of life (HRQOL). 
The maximum benefits of current diabetes technology are limited by the knowledge, skills, 
adherence barriers, and non-adherence behaviors.10-14 Ultimately, adolescents have to 
overcome these barriers in order to benefit from technological advances. Thus, there is a clear 
need for behaviorally focused interventions to identify and reduce adherence barriers. The 
overall objective of this study is to identify adolescents with elevated adherence barriers and 
provide novel tailored mHealth intervention (Diabetes Journey) targeting these barriers. The 
pilot randomized controlled clinical trial will examine feasibility, acceptability and preliminary 
efficacy of Diabetes Journey versus enhanced standard of care (control group) in approximately 
190 adolescents with type 1 diabetes. Primary and secondary outcomes include adherence 
barriers, adherence, health-related quality of life and A1C. Satisfaction and acceptability will 
also be examined. Mediators and moderators will include executive functioning, diabetes 
distress, family conflict, depressive symptoms, fear of hypoglycemia and sleep.  
 
2. PURPOSE OF STUDY 
The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a 
mHealth intervention addressing adherence barriers in adolescents with T1D, and to identify 
moderators that predict intervention responsiveness, as well as mediators of adherence barriers 
and adherence responsiveness.  
 
3. BACKGROUND  
Urgent Need to Improve T1D Adherence and Glycemic Control in Adolescents. Long-term 
T1D complications are related to both glycemic control and T1D duration. There is an urgent 
need to improve glycemic control for adolescents, given that 17% of youth ages 13-17 years 
with T1D have A1C values >9.5%,2 which is much greater than A1C of <7.5% recommended by 
the American Diabetes Association.6 Further, T1D is a lifelong chronic condition and 
establishing optimal adherence behaviors in adolescence can set the stage for positive 
outcomes in adulthood. Suboptimal adherence to the T1D treatment regimen is directly related 
to suboptimal glycemic control,7,8 increased risk of hospitalizations for diabetic ketoacidosis,9 and 
decreased health-related quality of life (HRQOL). Alarmingly, the average A1C of 9% in 13-17 
year-olds is similar to the average A1C of 9.5% of youth from the Diabetes Control and 
Complications Trial more than 30 years ago,1 suggesting that advances in diabetes technology 
such as blood glucose monitors, continuous glucose monitors, and insulin pumps, have not led 
to reductions in A1C and T1D complications. The maximum benefits of current diabetes 
technology are limited by the knowledge, skills, barriers, and non-adherence behaviors of the 
user of these technologies, especially insulin pumps.10-14 Ultimately, adolescents have to use 
the technology for it to be beneficial and clearly there is a need for behaviorally-focused 
interventions to identify barriers and improve adherence behaviors. 

Version 11 (June 8, 2023) p. 3 
 
 
Adolescence is often accompanied by desire for autonomy, feelings of invincibility, and 
decreased parental monitoring.36 Adolescence is the only period of human development in 
which the primary causes of morbidity and mortality are behavioral (e.g., reckless driving) rather 
than disease-based.37 Adolescents are motivated by novel experiences and predisposed to 
impulsive and risky behaviors due to an immature inhibitory control system (i.e., executive 
dysfunction).38 This makes adolescents more likely to engage in behaviors that have immediate 
rewards (e.g., omitting blood glucose checks and insulin boluses when out with friends15) and 
less likely to be concerned about the negative consequences of their decisions for the future 
(e.g., blindness, amputation, cardiovascular disease).18, 21 T1D non-adherence during 
adolescence is often attributed to family conflict,16-19 and psychological conditions (e.g., 
depression).20-23 These areas have frequently been targeted by existing interventions, with some 
success. In addition, stress (e.g., negative life events,24 familial,25 T1D burnout) and executive 
dysfunction (e.g., problem-solving, organizing/planning, working memory)3 are known to 
negatively influence adherence behaviors. Unfortunately, these barriers have never been 
targeted in adherence interventions and represent an important opportunity to improve T1D 
outcomes. Fortunately, adherence barriers have been addressed in other chronic conditions 
with both statistically and clinically meaningful improvements (see C1d and C1e) underscoring 
the need for effective intervention in T1D. If the aims of this R01 are achieved, adherence to the 
T1D treatment regimen and A1C will improve. 
 
Patient Reported Outcomes (PROs) are Recommended as a Part of Comprehensive T1D 
Care. Although A1C is recognized as the gold standard outcome in T1D, there is widespread 
recognition of its limitations26 and the need for assessment of meaningful PROs to complement 
existing clinical metrics. Integrating PROs into T1D clinical care is key to: 1) designing 
interventions that are tailored to the needs of adolescents with T1D; and 2) enhancing 
collaboration between families and health care teams by expanding providers’ focus beyond 
A1C to better address the broader impact of T1D.27 However, obstacles (e.g., lack of personnel 
to administer and intervene when necessary, lack of referral resources) exist to systematic 
integration of PROs into routine clinical practice, which impedes the ability to provide tailored 
interventions to patients during routine clinical care. The integration of T1D-specific PROs into 
T1D clinical care, such as the Barriers to Diabetes Adherence scale and the PedsQL-Diabetes 
Module, is recommended.27 
 
The Barriers to Diabetes Adherence scale comprises two subscales, including the 
Stress/Burnout and Time Pressure/Planning (executive dysfunction) subscales, that are 
associated with suboptimal adherence (r=0.21, p<0.05) and glycemic levels (r=0.38, p<0.01).3 
The magnitude of these relationships is similar in other validated measures of executive 
functioning, including the Diabetes Executive Functioning Scale, with correlations in the 
medium effect range (0.27-0.66).28-31 Targeting executive dysfunction is essential because 
some children with T1D demonstrate significant deficits in learning and memory,32 which can 
lead to adherence barriers , including stress33 and poor planning skills,34 and eventual non-
adherence. In addition, severe hypoglycemia has been implicated in executive dysfunction in 
children.35-38 Executive dysfunction is also associated with poor HRQOL (rs= -0.24 to -0.32, 
ps<0.05).4 Specifically, deficits in the ability to problem-solve, initiate tasks, transition between 
activities, and hold information in one’s memory negatively impacts HRQOL in adolescents with 
T1D.4 Combined, these data suggest that stress/burnout and executive dysfunction may be 
critical PROs for clinic-based intervention that have not yet been addressed in pediatric T1D 
adherence interventions. Thus, if the aims of this R01 are achieved, we will systematically 
integrate an extremely important PRO that negatively impacts adherence and A1C – adherence 
barriers. 
 
We are proposing a novel intervention, Diabetes Journey, which will focus on improving 
adherence barriers, specifically Stress/Burnout and Time Pressure/Planning. We hypothesize 
the intervention will also improve our secondary outcomes (i.e., adherence, glycemic levels, and 
HRQOL). We will explore whether depressive symptoms and family conflict moderate 

Version 11 (June 8, 2023) p. 4 
 
intervention effectiveness. In addition, we will explore potential mediators (e.g., adolescent 
distress, executive functioning) of the relationship between barriers and adherence. Notably, the 
primary goal of the current proposal is to assess, intervene on, and improve adherence barriers, 
an important PRO that has been neglected in prior research yet shown to strongly influence 
health outcomes and HRQOL. 
 
Critical Targets for Intervention Include Adherence Barriers via Mobile Health and 
Telemedicine. Although T1D interventions including multisystemic therapy,39,40 problem-
solving,41 coping skills,42 and behavioral systems therapy43,44 yield small, but clinically 
meaningful effects on glycemic levels (0.44% reductions5), these effects are insufficient to 
prevent long-term T1D complications. Moreover, these small effects are likely due to lack of 
intervention integration into T1D clinical care and a mismatch between intervention targets and 
the difficulties that plague 1/3 of adolescents with T1D on a daily basis (e.g., stress, executive 
dysfunction).3 Thus, we propose to measure and target adherence barriers for the current 
proposal. 
 
 
Telemedicine and mHealth (mobile health) interventions have the potential to significantly 
improve T1D care and health outcomes in adolescents, yet there is a fundamental gap in the 
extant literature investigating the impact on pediatric T1D outcomes. mHealth tools are well-
matched to the information consumption patterns of adolescents as approximately 90% have 
cell phones (73% smartphones), 90% of those with cell phones use text messaging,45 and 91% 
access the internet on their mobile device (with a notable increase in use for minority youth).45 
Using telemedicine to deliver interventions with adolescents in routine T1D clinical care will 
increase access to adherence interventions, provide flexibility, and decrease burden (e.g., travel 
time, missed school). Moreover, it is well-known that there is a 17-year time lag for translating 
research into clinical practice.46 By simultaneously testing the efficacy of our intervention and 
implementing our research into clinical practice,47 “we can more rapidly translate our evidenced-
based findings into clinical practice, and more effectively disseminate novel and impactful 
information to researchers and decision makers.” 
 
Overall Impact 
If successful, the results of this study would have a large impact on pediatric T1D outcomes.  
Telemedicine and mHealth (mobile health) interventions have the potential to significantly 
improve T1D care and health outcomes in adolescents. Knowledge gained in this study has the 
potential to improve the treatment of pediatric T1D by reducing adherence barriers, enhancing 
adherence and T1D management skills that, consequently, would improve health outcomes 
(i.e., A1C) and quality of life in this population. Data elicited through the study will also allow us 
to modify the intervention to improve the generalizability and potential efficacy of the 
intervention for future trials.   
 
4. STUDY DESIGN 
We will conduct a pilot randomized clinical trial of adolescents with T1D and their caregivers 
(n=190) to evaluate the feasibility, acceptability and preliminary efficacy of an adherence 
barriers mHealth intervention for adolescents with T1D.  
 
5. DURATION 
Participants will be in the study for 6 months. The pilot randomized clinical trial will last 
approximately 48 months overall.  
 
6. SELECTION & RECRUITMENT OF PARTICIPANTS 
Study Participants 
Study participants will include n=190 adolescents, ages 12-17, with T1D and their caregivers 
from Cincinnati Children’s Hospital Medical Center (CCHMC), the University of Florida (UF) and 
the University of Colorado Barbara Davis Center for Diabetes (BDC). Adolescents and 
caregivers will be recruited during routine diabetes clinic visits and will meet the following 
inclusion/exclusion criteria: 

Version 11 (June 8, 2023) p. 5 
 
 
Inclusion Criteria 
• 
T1D diagnosis >1 year 
• 
Adolescents with T1D ages 12-17 
• 
Elevations on the Barriers to Diabetes Adherence questionnaire (scores of ≥ 2 of 5 for 
the Stress/Burnout and/or Time Pressure/Planning subscales) based on their previous 
clinic visit scores 
• 
Ability to read/speak English (all measures are in English) 
 
Exclusion Criteria 
• 
Diagnosis of significant developmental disorders (e.g., autism spectrum disorder, 
moderate/severe developmental or intellectual disability) 
• 
Comorbid medical diagnoses (e.g., cystic fibrosis) with the exception of endocrine 
disorders (e.g., Celiac disease, thyroid) 
 
Recruitment Procedures  
Potential participants meeting eligibility criteria will be identified by a trained research assistant 
in collaboration with the members of the Diabetes teams at each site. Specifically, patients will 
be pre-screened based on their scheduled appointments for inclusion/exclusion criteria. 
Elevations on the BDA is one of our inclusion criteria for study entry. At CCHMC and the 
University of Florida, BDA elevations will most often be identified by reviewing responses from 
the patient’s clinic visit or through a screening process. For eligible participants who do not have 
a completed Barriers to Diabetes Adherence (BDA) measure, study coordinators may 
administer a screening BDA to determine further study eligibility, but only after informed 
consent/assent is obtained. If the participant does not have any elevations on the BDA, they will 
be deemed a screen-fail and will not participate in the Diabetes Journey intervention. If the 
participant completes the BDA at a later clinic visit and has elevations on the BDA that make 
them eligible for study participation, and study staff determine they still meet all other inclusion 
criteria, the participant may be re-consented for study participation at that time. 
 
The University of Colorado Barbara Davis Center does not administer the BDA clinically. Thus, 
adolescents from the University of Colorado Barbara Davis Center who are eligible for Diabetes 
Journey will be identified through an ongoing study at the University of Colorado Barbara Davis 
Center (PI: Dr. Holly O’Donnell) in which participants in that study complete a variety of 
psychosocial questionnaires including the BDA; this approach is approved by the University of 
Colorado Multiple IRB. If participants are elevated on Stress and Burnout and/or Time Pressure 
and Planning, a trained research assistant will approach families about participating in Diabetes 
Journey.  
 
At all sites, if potential participants are eligible, a trained research assistant will approach 
families with adolescents with T1D either during a routine diabetes follow-up clinic visit or via 
other recruitment methods (i.e., phone calls, recruitment letters). A thorough overview of the 
study will be provided, including study procedures, benefits, and risks. All questions will be 
addressed, and informed consent/assent will be obtained if the family agrees to participate.  
 
Following written informed consent from the caregiver/legal guardian and adolescent assent, 
copies of informed consent/assent forms will be provided to participants at recruitment. 
Subsequently, handouts about diabetes device download will be provided and baseline 
assessment questionnaires will be completed via REDCap or by paper/pencil surveys. 
Recruitment materials, including flyers, scripts, etc. can be found in Appendices A, B, and H.  
 
7. PROCESS OF OBTAINING CONSENT AND ASSENT 
As noted above, once participants are identified as study eligible, they will be approached 
during or following their diabetes clinic visit and provided a description of the study (e.g., study 
procedures, benefits, risks) by a trained research coordinator. Due to restrictions in the wake of 
COVID-19, eligible participants may be mailed recruitment letters and/or called to assess 

Version 11 (June 8, 2023) p. 6 
 
interest in the study. After addressing all questions from potential participants, informed 
consent/assent will be obtained by trained research staff. Consent/assent forms will be signed 
electronically using REDCap, a secure web-based interface supported by the CCHMC Division 
of Biomedical Informatics in compliance with HIPAA designed to protect PHI in the electronic 
transfer and storage of the consent/assent forms. Should technical issues arise with the 
REDCap interface, paper copies of consent forms may also be used. For all consent/assent 
visits, all pertinent aspects of consent/assent will be covered including study purpose, 
risks/benefits, confidentiality, and right to withdraw. Patients will be informed that their care at 
CCHMC or other collaborating study sites will not be affected by whether they choose to 
participate in the study. A copy of the assent/consent form will be provided to all participants. 
 
For eligible participants who do not have a completed Barriers to Diabetes Adherence (BDA) 
measure upon recruitment, study coordinators may administer a screening BDA to determine 
further study eligibility, but only after informed consent/assent is obtained. If the participant does 
not have any elevations on the BDA, they will be deemed a screen-fail and will not participate in 
the Diabetes Journey intervention. If the participant completes the BDA at a later clinic visit and 
has elevations on the BDA that make them eligible for study participation, and study staff 
determine they still meet all other inclusion criteria, the participant may be re-consented for 
study participation at that time. 
 
Participants recruited in-person will either complete the informed consent document via e-
consent on a tablet/computer or via a paper/pencil form. For participants who decide to 
participate after the clinic visit, we will use telephonic electronic consent. Specifically, a member 
of the study team will provide a link to access the consent/assent form in REDCap via email or 
text message. A paper copy of the form may also be mailed if necessary. During the 
consent/assent call, research staff will ensure all questions are answered. In compliance with 
CCHMC SOP Number 41-1.6, study staff will sign and date accordingly, on the signature page 
of each form corresponding to the date the forms were received, not necessarily reviewed with 
the family. The method used to obtain participant consent/assent will also be written on the 
Informed Consent Process Note. 
 
8. STUDY PROCEDURES  
After participants provide informed consent/assent as noted above, baseline questionnaires will 
be completed via REDCap or by paper/pencil (see Table 1). All questionnaires will be hosted on 
REDCap, a secure web-based interface or stored in a secure cabinet. Some questionnaires are 
completed as a part of standard clinical care and thus may not be repeated, if unnecessary. 
Participants must provide an email address for the online questionnaires. If they do not have 
one, we will help them create one or we will text the link to their cellular phones. If participating 
caregivers and adolescents prefer to complete paper/pencil questionnaires, we will provide 
them.  
 
During the visit or recruitment call, participants will be asked to share all blood glucose monitors, 
continuous glucose monitors, and/or insulin pumps data for the study via Tidepool (e.g., free 
software for diabetes devices downloads used clinically) when possible. If data is not shared 
during the clinic visit or while on the call with study staff, families will be given instructions about 
how to download diabetes device data to Tidepool remotely following their recruitment date. We 
will also offer a videoconference appointment to assist with the upload. Families will be provided 
with a username and password to access their Tidepool account.  Research staff may contact 
participants via phone after their clinical visit if technical support is needed to complete remote 
download of diabetes device data from patients’ blood glucose monitors, continuous glucose 
monitors, or pumps. If participants have difficulty with Tidepool, other software used as a part of 
routine clinical care (e.g., Glooko, Carelink, TConnect) may be used to download diabetes 
devices. Additionally, Tidepool experts at other sites may be consulted for further 
troubleshooting with Tidepool. All downloaded data will be de-identified, given a unique ID 

Version 11 (June 8, 2023) p. 7 
 
number, and password protected to ensure 
privacy. A medical chart review will also be 
conducted to gather information about 
hemoglobin A1C, data downloaded from 
devices, medications, comorbidities, 
hospitalizations, and time since diagnosis.  
 
It is the goal for all participant families to  
complete their baseline visit prior to being 
randomized to intervention. This will include 
completion of questionnaires and download 
data from their T1D device. However, 
participating families may be randomized if the 
primary outcome measure (BDA) and a 
baseline A1C within 4 weeks of enrollment is 
available, at a minimum. Participants will have 
an opportunity to complete baseline 
questionnaires until the initiation of the first 
intervention session. Device downloads will not 
be required for randomization as these data 
can be retrieved from the medical record. 
 
After completion of the required questionnaires 
and A1C at a minimum will be randomized to 
either: Diabetes Journey or Enhanced 
Standard of Care (Figure 1).  Stratified block 
randomization with two strata and blocks of 
size 2 or 4 chosen randomly within each 
stratum will be used and stratification will be based on baseline A1C (i.e., >9% or <9%), site 
(i.e., CCHMC, the University of Colorado Barbara Davis Center or the University of Florida), and 
Barriers to Diabetes Adherence elevation type within the treatment arm (i.e., elevated on one or 
both of the subscales). The A1C criterion was selected because the average A1C in 13-17 year 
olds with T1D in the US is 9%, which will result in comparable sample sizes above and below 
9%. In addition, although the American Diabetes Association recommends an A1C <7%, very 
few adolescents achieve this. Site was chosen as a stratification variable to ensure balance for 
any site-related differences. This randomization strategy will minimize imbalance of the number 
of participants across groups. The randomization list will be held by an individual independent of 
the study to reduce any potential biases. Participants will be notified of their randomization 
group within 3 business days of completion of baseline data and be provided with appropriate 
materials (e.g., log-in information or website information and links). Total treatment time is up to 
12 weeks, which coincides with routine quarterly T1D clinic appointments. This also enables 
sufficient time for cancelled and/or rescheduled sessions that are likely to occur given 
adolescents’ busy schedules.  
 
Control Group (Enhanced Standard of Care) 
Participants randomized to Enhanced Standard of Care will receive general education via the 
T1DToolkit website, as well as 4 Zoom sessions (e.g., Zoom for Healthcare; See Appendix C) 
with certified diabetes educators (CDEs) from either CCHMC or UF across 12-weeks. Notably, if 
technical difficulties arise, telephone sessions will be conducted and audio recorded. Content to 
address adherence barriers were modified and or newly developed for the Enhanced Standard 
of Care group via the T1DToolkit website. Depending on the participant’s elevated score(s) on 
the Barriers to Diabetes Adherence scale, patients will receive information specifically 
addressing elevated scales of the BDA. Treatment fidelity will be assessed via audio recordings 
and completion of checklists, which will be reviewed weekly by Dr. Kichler with the CDEs who 
deliver this intervention.  
 
          RCT    D               
Diabetes Clinic  isit: Eligibility
I                                              D        
A                                                      
                                                            
                              
Baseline
 C        A       PRO                            
M       C     R       P    M     D         
R
         
D               
       D  M       
            
                       
                      
           
I                      
                         
 DA                      
                      
                       
                      
E        S        
   C   
                    
               
                 
I                      
                         
 DA                      
                              
                            
               
D        C      
E                        
        
A  H     A      I           
          
Post  reatment  
 PRO                   M       C     R       
P    M     D         
D        
C       
P    T     
         
 ollow up  
 PRO                   M       C     R       P    M     
D         
D        
C       
  P  
         

Version 11 (June 8, 2023) p. 8 
 
Modules 
T1Dtoolkit.com links 
Stress and Burnout 
Burnout  
https://t1dtoolkit.org/for-teens-young-adults/burnout-2/ 
Sharing responsibility  
https://t1dtoolkit.org/for-teens-young-adults/sharing-responsibility/ 
Strategies to Manage Pain 
https://t1dtoolkit.org/uncategorized/strategies-to-manage-pain/ 
Building a Support Network  
https://t1dtoolkit.org/uncategorized/building-a-support-network/ 
Time Pressure and Planning 
Setting Reminders 
https://t1dtoolkit.org/for-teens-young-adults/setting-reminders/ 
Prioritizing and Planning  
https://t1dtoolkit.org/for-teens-young-adults/14472/ 
Organization of Your Environment 
https://t1dtoolkit.org/for-teens-young-adults/organizing-your-
environment/ 
Eating on Your Own  
https://t1dtoolkit.org/for-teens-young-adults/eating-on-your-own/ 
 
Treatment (Diabetes Journey) 
All Diabetes Journey participants will first receive the mandatory Introduction and Problem-
Solving Modules. Participants with elevations on only one subscale will then receive 4 additional 
modules based on their individual subscale elevations (5 modules total). If the participant is 
elevated on both Barriers to Diabetes Adherence subscales, they will receive all 8 modules. 
This will yield completion of 5 or 8 total modules and 5 or 8 HIPAA compliant video-sessions 
(e.g., Zoom for Healthcare; See Appendix C) with a therapist from CCHMC or UF. No therapists 
will be utilized from the University of Colorado Barbara Davis Center.  
 
The primary foundational skill that will be taught is problem-solving, the first core module. As a 
part of Problem-Solving Module, an engaging and visually appealing video reviewing problem-
solving skills will be viewed. The following approach to teach problem-solving skills will be used: 
1) Define the problem (e.g., feeling stressed and cannot sleep resulting in high blood glucoses); 
2) Teach the adolescent to generate several solutions (e.g., deep breathing before bed, 
listening to relaxing music, talking to a caregiver); 3) Evaluate the pros and cons of each 
potential solution; 4) Select one solution for implementation; and 5) Review detailed solution 
with specifics regarding who, when, where, and how the solution will be attempted. The 
therapist plays a critical role in helping apply problem-solving skills in daily life. Notably, if 
technical difficulties arise, telephone sessions will be conducted and audio recorded. If 
adolescents lack access to mobile devices, an iPad will be provided to the participant.  
 
The images below illustrate the 
draft layout of Diabetes 
Journey and the modules that 
will be used. Treatment fidelity 
will be assessed via audio 
recordings of the sessions and 
completion of checklists, which 
will be reviewed weekly by the 
supervising licensed 
psychologist at each site or 
designee. Treatment sessions 
may be delivered by 
interventionists at CCHMC or 
the University of Florida. 
 
 
Session 
Content 
Diabetes Journey Modules 
1 
Introduction and 
Problem Solving 
Ticket Booth and Pirates 
of Problem-Solving 
 
Stress and Burnout 
 
Stress 
Stressolator 
 
Diabetes Burnout 
Burnout Bumper Cars 
 
Emotional Control 
The Mood Swing 
 
Time Pressure and Planning 
 
Planning 
Planning Parachutes 
 
Working Memory 
Memory Monorail 
 
Inhibition 
The Inhibitor Roller Coaster 
5 or 8 
Wrap-Up 
Closing Time 

Version 11 (June 8, 2023) p. 9 
 
 
 
Following the 12 week active intervention phase, participants will complete  
one follow-up visit as shown in Figure 1. 
 
8.1 Data collection procedures and measures 
Participants will complete a demographic questionnaire that provides general information about 
the child’s age, history of T1D, and family information. Both adolescents and caregivers will 
complete questionnaires. All participants will have the same baseline, post-treatment (3-months 
from baseline) and follow-up study visits (6 months from baseline), which includes 
questionnaires, diabetes device downloads, and health outcomes through medical chart 
reviews. In light of COVID-19, the COVID-19 Exposure and Family Impact Survey (CEFIS) will 
be administered to adolescents and caregivers to determine the impact of COVID-19 on their 
functioning (see Appendices J and K). The medical chart review will include key patient medical 
characteristics (e.g., insulin regimen type, A1C, PROs collected during routine clinical care)  
 
Sources of data for the current study will include: 1) adherence data downloaded from blood 
glucose meters, continuous glucose monitors, insulin pumps, and hybrid closed loop systems; 
2) REDCap web-based questionnaires completed by adolescents and caregivers assessing 
demographics, barriers to T1D adherence, health-related quality of life, depressive symptoms, 
T1D distress, executive functioning, family conflict, and feasibility/acceptability of the Diabetes 
Journey intervention; and 3) mail, electronic-mail, and telephone contact with participants to 
coordinate study visits and maintain study retention (See Appendices D, F, and E for relevant 
materials). T1D devices will be downloaded to industry standard HIPAA compliant software and 
cloud-based programs, which is diabetes standard of care.  
 
 
 
 
 
 
 

Version 11 (June 8, 2023) p. 10 
 
 
8.2 Sample Size Considerations and Power Analysis:  
Sample size for this study is based on our preliminary work with this intervention in epilepsy 
(i.e., Epilepsy Journey), which found moderate to large effect sizes from baseline to 6-month 
follow-up, ranging from d = 0.55 to d = 0.93 for the Global Executive Composite Score, the 
composite measure of the Behavior Rating Inventory of Executive Function, which represented 
our barriers outcome of interest. Additionally, preliminary data on our primary outcomes 
collected at CCHMC from 2016-2017 (i.e., Stress/Burnout and Time Pressure/Planning 
subscales) show that our patients improve slightly over one year with Enhanced Standard of 
Care, corresponding to an effect size of d = 0.19. A Monte Carlo simulation in Mplus with n = 
5000 replications was conducted assuming: 1) proper handling of missing data; 2) 25% attrition; 
3) standardization of all analysis variables; 4) at least 30% of the error variance in our primary 
outcome (R2 = 0.30) being explained by baseline barriers scores and covariates; 5) we will 
observe the smallest effect size from our preliminary work in the treatment group (i.e., d = 0.55); 
and 6) we will observe a small improvement in our control group (d = 0.19). Recent interim 
analyses and meetings with our NIH program officer have yielded a change in our study 
design from a fully powered RCT to detect subgroup differences to a pilot RCT focused 
on feasibility, acceptability, satisfaction and preliminary efficacy differences between the 
control and treatment groups. These new analyses indicate the need for a total sample 
size of n=190 (n=95 in the control group and n=95 in the treatment group).   
 
9. POTENTIAL BENEFITS 
No immediate or direct benefits to patients participating in this study are expected. However, it 
is our hope that participants will have reduced adherence barriers and learn better disease 
management skills. The information obtained from this study can ultimately be used to increase 
Construct Measured 
Respondent 
Stages and Time points 
 
C= Caregiver; 
Y=Youth 
M= Med Chart 
Review 
D= Doctor/ Clinician 
Screening 
(may 
apply) 
Baseline 
Post Treatment 
(3-month post-
txt) 
Follow-up 1 (6-
months post-txt) 
ORDER OF MEASURES (As applicable) 
Background Questionnaires  
C 
 
X 
 
 
Diabetes-Related Executive 
Functioning Scale (DREFS) 
Y/C 
 
X 
X 
X 
Diabetes Family Conflict Scale 
(DFCS) 
Y/C 
 
X 
X 
X 
Barriers to Diabetes Adherence: 
Stress/Burnout and Time 
Pressure/Planning subscales 
(BDA) 
Y 
X 
X 
X 
X 
Type 1 Diabetes and Life 
(T1DAL) 
Y 
 
X 
X 
X 
Problem Area in Diabetes- Teen 
Version  
(PAID-T) 
Y 
 
X 
X 
X 
Patient Health Questionnaire-8 
(PHQ-8) 
Y 
 
X 
X 
X 
University of Virginia- Low 
Blood Sugar Survey 
Y 
 
X 
X 
X 
ASWS 
Y 
 
X 
X 
X 
Pittsburg (PSQI) 
Y 
 
X 
X 
X 
COVID-19 Exposure and Family 
Impact Surveys (CEFIS) 
Y/C 
 
X 
X 
X 
Satisfaction and Acceptability 
Questionnaire 
Y/C 
 
 
X 
X 
Device Downloads 
Y 
 
X 
X 
X 
Fingerstick Blood Sample 
D 
 
X 
X 
X 
Medical Record/Patient Record  
D 
 
X 
X 
X 

Version 11 (June 8, 2023) p. 11 
 
knowledge in the scientific community about how to improve adherence barriers in youth with 
T1D. 
 
10. POTENTIAL RISKS, DISCOMFORTS, INCONVENIENCES, & PRECAUTIONS 
There are minimal potential risks/discomforts/inconveniences to participants in this study, no 
greater than those encountered in routine behavioral assessment and clinical care. There are 
no medical risks. All the questionnaires have been used in research, including our own, without 
any reported negative effects; however, it is possible that a small group may feel uncomfortable 
responding to questions. Participants may decline answering questions that cause them to feel 
uncomfortable and will be reminded of this prior to each study visit. Participants may also 
withdraw from the study at any time and will be informed of this right during the consent/assent 
process. 
 
If a participant is distressed by any study procedures, the site PI or designee will be contacted 
immediately to assess the situation. The study PI or their designee will provide appropriate 
referrals and/or intervention. Safety procedures for suicidal ideation and reports of 
abuse/neglect are delineated in our safety monitoring committee plan (See Appendix E). In both 
cases and similar to above, the study PI or their designee at each site will be contacted 
immediately and he/she will assess the risk profile of the caregiver and/or adolescent participant 
with subsequent recommendations based on the level of risk. Further, the PHQ-8 assesses 
participants for depressive symptomology. Though the suicidal ideation item has been removed 
from this version (e.g. PHQ-8 not PHQ-9) for the purposes of the current study, a significant 
elevation on the PHQ-8 suggests the participant is experiencing significant depressive 
symptomology. The PHQ is given during routine diabetes clinic visits and data from the 
measure will be entered into REDCap when available. The diabetes clinical team addresses 
elevations on the PHQ during routine clinical care and thus if elevations are addressed during 
clinic, no further action will be taken by our research team. However, if the PHQ is only 
administered via the research protocol and there is an elevation on the PHQ, the following 
actions will be taken. REDCap is now programmed to send an alert if anyone scores >10 
(considered moderate risk) on the PHQ. The alert will be sent to the site PI, supervising 
psychologist and coordinators. Results will also be communicated to the primary caregiver or 
adult participant within 3 business days of the elevation and appropriate referrals to outpatient 
mental health services will be provided, as necessary. In the instance a family is unable to be 
contacted within 3 business days despite several attempts, a letter (see Appendix P) will be sent 
to the address on file detailing this information. Additional details on these procedures are 
provided in Appendix E.  
 
There is also the risk of possible loss of privacy of data or loss of confidentiality. These risks are 
inherent in all research studies, and a statement to this effect will be included in the informed 
consent/assent documents. Every effort will be made to ensure that all participant information 
will be kept confidential. A majority of this study is going to be conducted via Zoom sessions. 
Participants will access or receive information from several different sources including REDCap, 
Tidepool, Diabetes Journey site, T1Dtoolkit site, and Zoom for Healthcare. De-identified ID 
numbers will be used when possible for the sites. For example, enrolled participants will be 
assigned a secure login ID and password by the study staff to access measures via REDCap 
and/or to upload diabetes devices through Tidepool or other platforms. Each site will only be 
able to see their own site’s participants in REDCap, with the exception of the lead site 
(CCHMC). Additionally, The University of Florida PI and her study team will manage the study 
for the University of Colorado Barbara Davis Center. They are all non-paid employees of the 
University of Colorado Barbara Davis Center and are authorized to have access to the 
University of Colorado Barbara Davis Center data. The University of Florida and University of 
Colorado Barbara Davis Center teams will meet weekly to review the study protocol, monitor 
recruitment and discuss other study related issues that may arise. Participants will be asked not 
to share their ID or password with anyone else. Use of Protected Health Information (PHI) on 
online measures will be minimized and participants will not be asked to enter their last name, 
date of birth, or medical record number on the online measures. When the study is complete, 

Version 11 (June 8, 2023) p. 12 
 
the content of the site will be taken down. Setup is consistent with HIPAA guidelines and was 
designed to support projects that contain PHI and are subsequently subject to compliance with 
federal and state regulations regarding data of this type. Similarly, the Wordpress and 
T1Dtoolkit sites for the DJ modules will be linked to their study ID and there will be no identifying 
information listed in this site. Similarly, although Zoom for Healthcare is HIPAA compliant, 
participants will be required to login to the secured Zoom server for sessions and will be 
provided with the Zoom link to their email accounts. This information and protection of the 
participant’s identity will be clarified in the informed consent and assent forms. We will provide 
each participant with a unique anonymous Tidepool username and password (See Appendix I). 
Finally, because interventionists can be from CCHMC or the University of Florida, participant 
information to conduct intervention sessions will be shared with the interventionist and 
appropriate supervisor in order to contact them.  
 
To communicate study related information across sites, our team will be using Trello, a task 
management system that is frequently used by research teams. No identifying information will 
be entered into the Trello system; however, we will be tracking participants through the study 
procedures using their study ID.  
 
Notably, the only place the study ID will be linked to the name and demographics is the 
participant database, which is password protected, individually, at each site by the research 
team. No other individuals outside of the IRB-approved research team from both sites will have 
access to this participant database.  
 
11. RISK/BENEFIT ANALYSIS 
There is minimal risk associated with study participation. If participants feel distressed as a 
result of their participation, they will be encouraged to discontinue. The PI and site PIs or their 
designee will be available to participants during study participation to assess for discomfort, 
safety, and risk, as needed. The minimal risks of this study do not outweigh the potential indirect 
benefits that may be gained through increasing knowledge about best practices for improving 
adherence barriers to treatment in adolescents with T1D.  
 
12. DATA SAFETY AND MONITORING 
This is a multisite observational study and is considered minimal risk. Safety monitoring will 
occur at the level of the multiple PIs due to the minimal risk nature of the study. See Appendix E 
for details of the NIDDK approved data safety and monitoring plan.  
 
13. PRIVACY AND CONFIDENTIALITY 
All study personnel have been trained in data safety and monitoring, privacy and confidentiality, 
minimizing risks related to loss of privacy and confidentiality. We will closely monitor 
performance of our research personnel to ensure the strictest standards. Additional information 
related to privacy and confidentiality is noted above in section 10. 
 
13.1 Data De-Identification: All data will be de-identified with the use of unique assigned study 
identifier codes. No other identifying data such as address, phone numbers, social security 
number, or zip code will be entered on electronic measures. Electronic data files (including 
downloads of data from REDCap measures) will only identify participants via study identifier 
codes and will be password protected. Electronic data files will be maintained on CCHMC hard 
drives.  
 
Because this research study involves payment for participation, we are required by Internal 
Revenue Service (IRS) rules to collect and use participant’s social security number (SSN) or 
taxpayer identification number (TIN) in order to track the amount of money that we pay them. 
Unless they have given specific permission for another use of their SSN or TIN related to this 
research study, we will only use their SSN or TIN to keep track of how much money we pay 
them and their SSN or TIN will not be used as part of this research study. 
 

Version 11 (June 8, 2023) p. 13 
 
13.2 Data Storage and Management 
Informed consent/assent documents and all electronically collected data will be maintained in 
REDCap, a secure web-based platform, and in a password protected electronic database on 
CCHMC hard drives. Device data downloaded from Tidepool (a HIPAA compliant website used 
routine for clinical care) will be kept in password protected electronic databases at CCHMC. 
CCHMC is the Primary Site and will manage all the final deidentified data. Paper informed 
consent/assent documents will be maintained in locked storage cabinets, if they are needed, 
and will be kept separate from participant data.  
 
Trello (www.trello.com), a web-based project management tool, will be used to coordinate 
study-related tasks across sites. No identifiable patient information will be saved in this platform. 
Medical chart data will be collected by trained study staff at each site under the supervision of 
the PI or site PI. These risk protection methods have been effectively used by the PI and her 
collaborators for numerous studies. 
 
Individual data will not be available to anyone not directly associated with the study. All study 
personnel have been trained in data safety and monitoring, privacy and confidentiality, 
minimizing risks related to loss of privacy and confidentiality. We will closely monitor 
performance of our research personnel to ensure the strictest standards. Study-related 
information will not be released without written permission of the participant. 
 
14. COST OF PARTICIPATION 
There are no costs for participation in this research study. Participants will be responsible for the 
usual costs of medical care. 
 
15. PAYMENT FOR PARTICIPATION 
Caregivers will be compensated for participation in the study in the form of a reloadable debit 
card (ClinCard). They will receive a handout that will explain how to use this card. A graduate 
incentive schedule will be as follows: 
 
 
 
 
 
 
 
 
 
 
 
Adolescents 
Caregivers 
 
Questionnaires 
Device 
Download 
Questionnaires 
Phase 2 (n=256) 
 
 
 
Baseline 
$10 
$10 
$10 
Post-treatment 
$15 
$10 
$10 
Follow-up  
$20 
$10 
$10 
TOTAL  
Up to $75 
Up to $30 

Version 11 (June 8, 2023) p. 14 
 
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