Discovery Diabetes: A Pilot Randomized Controlled Trial
Phase: NA
Conditions: Type 1 Diabetes
Sponsor: Vanderbilt University Medical Center

Document: 
Study Protocol 
 
 
Official Study Title: 
Discovery Diabetes: A Pilot Randomized Controlled Trial 
 
 
NCT07116434 
 
 
Document Date:  
July 15, 2025 

Version Date: July 15th, 2025 
Discovery Diabetes:  
A Pilot Randomized Controlled Trial 
 
 
Principal Investigator: 
Shelagh A. Mulvaney, PhD 
Associate Professor 
School of Nursing, Vanderbilt University 
425 Godchaux Hall 
21st Avenue South 
Nashville, TN 37241 
Phone: 615-322-1198 
Email: shelagh.mulvaney@vanderbilt.edu  
 
Co-Investigators: 
Karishma Datye, MD, MSCI 
Assistant Professor of Pediatrics, Pediatric Endocrinology 
Vanderbilt University Medical Center 
 
Cindy Lybarger, MSN, APRN, FNP-BC 
Senior Associate in Pediatrics 
Vanderbilt Eskind Pediatric Diabetes Clinic 
 
 
Study Contact: 
Abigail Doyle, MSHI 
Program Manager  
Abigail.m.doyle@vanderbilt.edu 
615-343-6075 
 
 
 
 
 
 
 

Version Date: July 15th, 2025 
Table of Contents 
1.0 Background 
2.0 Rationale and Specific Aims 
3.0 Inclusion/Exclusion Criteria 
4.0 Enrollment/Randomization 
5.0 Study Procedures 
6.0 Reporting of Adverse Events or Unanticipated Problems involving Risk to Participants or 
Others 
7.0 Study Withdrawal/Discontinuation 
8.0 Statistical Considerations 
9.0 Privacy/Confidentiality Issues 
10.0 
Follow-up and Record Retention 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.0 Background 
Adolescents and young adults (AYAs) with type 1 diabetes (T1D) face unique psychosocial 
barriers that hinder effective diabetes self-management (DSM), resulting in poor glycemic 
outcomes. Psychological burdens such as stress, burnout, stigma, and lack of social support 
contribute to inadequate DSM. These barriers contribute to poor glycemic outcomes, with 
only 17% of adolescents meeting the recommended HbA1c target of 7.0%. Current diabetes 
care practices often do not address these psychosocial challenges, resulting in a gap 
between clinical goals and actual outcomes. This study seeks to evaluate an intervention 
that integrates 1) clinical informatics-based data collection, 2) clinician-provided support, 
and 3) personalized mobile health communications to address these barriers. 
 
2.0 Rationale and Specific Aims 
The Discovery Program is a novel intervention designed to address these psychosocial 
barriers by integrating a hybrid model of care that combines completion of a patient 
reported measure in the patient portal (My Health at Vanderbilt, MHAV), in-clinic 
collaborative psychosocial goal setting with a nurse practitioner (NP), and between-visit 
personalized mobile health communications (digital stories and SMS messages). By 
leveraging clinical, in-person routine care clinic visits, and mobile resources, the 
intervention aims to improve DSM behaviors, alleviate psychosocial burdens, and ultimately 
enhance glycemic control in adolescents with T1D. The intervention will be evaluated within 
the context of routine care at the Eskind Pediatric Diabetes Clinic, a leading regional center 
for adolescent diabetes care at Vanderbilt University Medical Center. 
 
2.1 Specific Aim 1: Assess the efficacy of the Discovery Program on primary and 
secondary outcomes in adolescents with T1D. Specifically, we will measure changes 
in glycemic control, barriers to diabetes adherence, problem-solving skills, diabetes 
distress, and diabetes self-management efficacy. 
 
2.1.1 Primary Outcome Measures: Change in glycemic control (measured by 
HbA1c): Glycemic control will be assessed through changes in HbA1c 
levels assessed through routine care visits at baseline, 3 months, 6 
months, and 9 months. We will also explore CGM time in range (TIR) as a 
secondary glycemic outcome, as approximately 70% of participants use 
CGM devices at baseline, 3 months, 6 months, and 9 months. 
 
2.1.2 Secondary Outcome Measures: Change in diabetes distress (PAID-T); 
Change in barriers to adherence (BDA); Change in problem-solving skills 
(SPSI-R); Change in diabetes self-management efficacy (SCI). 
 
2.2 Specific Aim 2: Evaluate the success of the intervention implementation and 
adolescent, parent and clinician satisfaction with the intervention and related 

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processes using self-report and interview methods at 3 and 6 months. 
 
3.0 Inclusion/Exclusion Criteria 
3.1 Inclusion Criteria 
3.1.1 Adolescents (13-17 years) and young adults (aged 18-21 years), 
3.1.2 Diagnosed with T1D for at least one year, 
3.1.3 Access to a smartphone, 
3.1.4 A My Health at Vanderbilt (MHAV) patient portal account, 
3.1.5 Ability to read, speak, and understand English 
3.1.6 An appointment with an NP in the Eskind Clinic within 7 months of initial 
contact 
 
3.2 Exclusion Criteria 
3.2.1 Diagnosis of type 2 diabetes 
3.2.2 Any physical, cognitive, sensory or emotional condition precluding 
participation in the intervention (seeing/using a phone, hearing digital 
stories, answering questions). 
 
4.0 Enrollment/Randomization 
4.1 Study Recruitment Methods 
All possible recruitment strategies have been developed in coordination with and 
the approval of the VU-VUSN liaison service 
(https://starbrite.app.vumc.org/research/development/vumcliaison) and the 
Vanderbilt Coordinating Center (VCC). See the recruitment methods Table 1 below. 
 
Per VUMC policy, the only mechanism by which VUSN research staff will directly 
contact potential participants is after obtaining a completed written online REDCap 
form indicating that a parent/young adult wishes to be contacted. All other methods 
of recruitment that result in the online form completion are required to be carried 
out by a VUMC employee, either a clinician key study personnel on the project, the 
VCC or VUMC personnel, or distribution of flyers in the community by the local 
chapter of Breakthrough T1D (formerly JDRF). 
 
Flow diagrams that illustrate the entire process from recruitment to the conclusion 
of participation are included in the appendix. These diagrams provide a clear visual 
representation of each step involved in the Discovery Diabetes RCT, ensuring 
transparency and ease of understanding. 
 
Table 1. Recruitment Methods and Responsible Parties 

Version Date: July 15th, 2025 
 
VCC or 
VUMC 
Staﬀ 
Eskind 
Clinic 
KSP 
VICTR 
EHR 
Recruitm
ent Staﬀ 
Break-
through 
T1D staﬀ 
VUSN 
Research 
Staﬀ 
Send mailed leters home to parents and 
young adults with a QR code  
X 
 
 
 
 
Send emails to parents/young adults to 
the Vanderbilt research distribuƟon list 
with QR code 
 
 
 
 
X 
Call parents and young adults at home 
X 
 
 
 
 
Send MHAV messages to parents of 
minors with VUSN phone number and 
link to the online form 
X 
X 
 
 
 
Send MHAV messages to adult paƟents 
including a VUSN phone number and link 
to the online form 
 
 
X 
 
 
Distribute QR code to online form via 
ﬂyers and handouts in clinic 
 
X 
 
 
X 
Distribute interest cards for parents or 
young adults to complete in the Eskind 
Clinic (saved in lock box) 
 
X 
 
 
X 
Respond to Completed Online Requests 
 
 
 
 
X 
Flyers distributed by Breakthrough T1D 
staﬀ at events and meeƟngs 
 
 
 
X 
X 
 
4.1.1 Letters Home to Parents and Young Adults 
Two separate letters will be used: one addressed to parents/guardians of 
eligible potential participants aged 13-17 and one to potential young 
adult participants aged 18-21. Letters will be mailed by the VCC staff 
hired by the research team. These letters will introduce the study, explain 
its purpose, and provide contact information for the study team for those 
interested in learning more. The letters clarify that recipients are under 
no obligation to respond or participate. Letters will contain a simple URL 
and QR code for parents and young adults to complete an online interest 
form. They will have the option to complete the online interest form or 
wait until a researcher contacts them. Copies of the letters are included 
in this application. 
 

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4.1.2 Vanderbilt Research Notification Distribution List 
The email distribution list allows researchers to email IRB-approved 
participant recruitment announcements to the Vanderbilt community. 
Members of the distribution list have the option to 
subscribe/unsubscribe with each email. For recruitment via email, there 
will be a link directing the potential participants to the interest form in 
REDCap. After receiving the completed online form, researchers will 
contact the parent or young adult. They will have the option to complete 
online interest form, contact the research team via phone or email or 
wait until a researcher contacts them. A copy of the email message for 
the Research Notification Distribution List is included in this application. 
 
4.1.3 Reporting Workbench 
Recruiting Workbench Reports are available/viewable in eStar by VUMC 
KSP. These reports are developed using real-time data and can be 
customized to meet study-specific inclusion/exclusion criteria that are 
computable in the EHR. The reports often include additional variables to 
facilitate study team outreach, such as Research OK to Contact status, 
MHAV account status, contact information, next upcoming appointment 
in a specific clinic. While the report displays certain variables/data, it 
provides easy access to a patient's record for additional screening and 
confirmation of eligibility. Research team members with appropriate 
eStar access can view/run the reports as frequently as needed. We plan 
to use the results from our custom Recruiting Workbench report to 
facilitate outreach in the following way: 1) To have VUMC KSP send Direct 
To Patient Messages, as detailed below in recruiting strategy 4.3.1, and 2) 
To have the VICTR EHR Recruitment Support team send My Health at 
Vanderbilt (MHAV) recruitment requests, as detailed below in recruiting 
strategy 4.3.2. Recruitment outreach will be restricted to those patients 
marked as ‘OK to Contact’. 
 
4.1.4 MHAV Messages to Parents/Guardians of Minors 
Only Key Study Personnel (KSP) who are VUMC employees will have 
access to send these messages directly to the parent/guardian accounts 
based on potentially eligible participants identified through the reporting 
workbench report. Clinician KSP and VCC/VUMC staff will use MHAV to 
send messages to the parents or guardians of potential minor 
participants (ages 13-17). The message will contain general study 
information, contact details, and instructions for parents to reach out 
directly to the study coordinator by phone or email for additional details 
or eligibility screening. The study team-managed MHAV Direct to Patient 

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Message is included in this application. 
 
The appearance of the message in MHAV will display as "to Proxy" and 
will specify it is “for [patient name]” to make clear that the 
communication is intended for the parent/guardian on behalf of the 
minor participant. 
 
Although the minor cannot directly access the message via their MHAV 
account, the message is linked to their medical record. Therefore, the 
message may be viewable if the patient or their representative were to 
request the medical record in the future. This information will be 
included in the recruitment plan to ensure transparency. By following this 
structured workflow, we aim to maintain compliance, protect participant 
privacy, and reduce the risk of accidental non-compliance in our study 
recruitment process. 
 
Direct to Patient Messaging Workflow: To ensure compliance and 
prevent messaging the minor patient directly, KSP will follow a specific 
workflow: 
 
4.1.4.1 Eskind KSP and VCC/VUMC staff will confirm that only the 
parent/guardian (proxy) account is selected as the recipient. The 
patient’s account will be deselected to avoid direct 
communication with the minor. 
 
4.1.4.2 The MHAV message will be configured with the "do not allow 
replies" option. Parents or guardians interested in the study will 
be directed in the message to contact the study coordinator 
directly via phone or email, as specified in the message content. 
 
4.1.5 Centrally-managed MHAV Recruitment Requests 
The VICTR EHR Recruitment Support Team will send recruitment requests 
via My Health at Vanderbilt (MHAV) to eligible young adults (ages 18-21) 
who are marked as "OK to Contact" in eStar. MHAV, VUMC’s patient 
portal, enables patients or their proxies to manage healthcare activities 
and can be used to send recruitment messages to potentially eligible 
participants. The MHAV recruitment request message is included in this 
application. 
 
For this study, the MHAV recruitment request message includes a direct 
link to the online interest form survey on REDCap. Patients will be 

Version Date: July 15th, 2025 
encouraged to click on this direct link and complete the IRB-approved 
online interest form directly, rather than clicking on ‘I’m interested’.   
 
If the patient clicks ‘I'm Interested’ instead of completing the online 
interest form, the designated KSP (with eStar access) will receive an In 
Basket message in eStar indicating the patient is interested. The In Basket 
messages in eStar will be monitored by VUMC KSP and/or the VU-VUMC 
Liaison team. In the event a patient clicks ‘I’m Interested’, they will 
receive a second message from VUMC KSP and/or the VU-VUMC Liaison 
team directing them to complete the online interest form. A copy of this 
message is included in this application.  
 
From this point onward, VUMC KSP will manually update a patient’s 
enrollment status accordingly. The study team will contact interested 
patients who sign the consent form by telephone or email to confirm 
their eligibility. Eligibility will be further confirmed through the screening 
process described below in section 4.2. If eligible, the study team will 
schedule an in-person or virtual baseline visit. If a patient does not meet 
eligibility criteria, they will be notified immediately upon completion of 
the screening process. This ineligibility notification will include contact 
information for the study coordinator should they have any questions or 
concerns.  
 
4.1.6 Flyers in Designated Spaces 
Flyers containing a QR code linked to the online interest form will be 
distributed by Eskind Clinic KSP and VUSN Research Staff. These flyers will 
be strategically placed in Eskind clinic practice manager-approved spaces, 
such as waiting rooms, and common areas. The QR code will direct 
individuals to an online form where they can express their interest in 
participating in the study. The flyers will include brief information about 
the study, its purpose, and instructions on how to use the QR code to 
access the interest form. 
 
4.1.7 Flyers Distributed by Breakthrough T1D Staff 
Breakthrough T1D is a leading organization dedicated to improving the 
lives of those affected by type 1 diabetes through advocacy, research, 
and community support. The local Middle-Tennessee chapter, based in 
Nashville, will distribute flyers containing a QR code linked to the online 
interest form in various community locations. These locations may 
include local diabetes support groups, local newsletters, and other local 
venues frequented by potential participants. The flyers will provide brief 

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information about the study, its purpose, and instructions on how to use 
the QR code to access the interest form.  
 
4.1.8 Interest Cards in Eskind Clinics 
Parents and young adults will be able to complete interest cards available 
to them in the Eskind Clinic, distributed to potential participants by study 
KSP. If completed, VUSN research staff will contact the parent or young 
adult followed by the adolescent (only if the parent consents). Consent 
will be obtained followed by screening questions for eligibility. The 
screening process is further described below in section 4.2. 
 
4.1.9 Response to Completed Online Interest Forms 
VUSN Research Staff will monitor and respond to completed online 
interest forms submitted by potential participants. Upon receiving a 
completed form, the research staff will reach out to the parent or young 
adult to provide further details about the study, address any questions, 
and guide them through the next steps. This may include completing the 
e-consent for screening data collection or scheduling a follow-up contact. 
The research staff will ensure timely and personalized communication to 
maintain participant engagement and facilitate the enrollment process. 
 
4.2 Screening  
After a parent/guardian or young adult has expressed interest in the study, via one 
of the methods described above, the next step will involve a screening process to 
confirm eligibility and collect key information. The study team will conduct the 
screening process using the screening script provided in this application or by 
accessing relevant information in the consented participant’s medical record via the 
Vanderbilt Health Connect. 
 
Vanderbilt Health Connect is a comprehensive platform designed to streamline and 
enhance patient care at VUMC. Vanderbilt Health Connect provides secure access to 
personal health records, including lab results, medical history, and treatment plans. 
By signing the consent, the parent/guardian or young adult participant will give 
permission to the study team to access relevant information from their medical 
record through Vanderbilt Health Connect for screening purposes. This information 
can only be obtained by VUSN study team personnel once the patient’s research 
enrollment status has been updated accordingly in Epic by VUMC personnel with 
appropriate access to eStar. 
 
4.2.1 Consent and Assent 
Before initiating the screening process, consent will be obtained from the 

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parent/guardian or young adult (18-21 years old). The consent form will 
be sent electronically via REDCap, and the participant will be required to 
sign it before any screening questions are asked. For minor participants 
under the age of 18, only the parents may grant permission for their 
child’s participation in research. After permission has been obtained from 
the parents via the signed consent form, assent is to be sought from the 
child. Assent may alternatively be collected during the baseline visit, if 
scheduled. No minor participant will be contacted prior to obtaining 
written/signed consent from the parent/guardian. 
 
4.2.2 Screening Eligibility Confirmation 
Using the screening script and/or screening relevant EHR data via the 
Vanderbilt Health Connect (described above), research staff will confirm 
the following eligibility criteria: 
4.2.2.1 Age: Confirm that the potential participant is between 13 and 21 
years old.  
4.2.2.2 Diagnosis: Confirm that the participant has been diagnosed with 
type 1 diabetes for at least one year. Collect diagnosis date (if 
known). 
4.2.2.3 Smartphone Access: Confirm that the participant has access to a 
smartphone.  
4.2.2.4 MHAV Patient Portal: Confirm willingness to download and install 
the My Health at Vanderbilt (MHAV) patient portal app if not 
already in use.  
4.2.2.5 Language: Confirm that the participant can read, speak, and 
understand English. 
4.2.2.6 Clinic Appointment: Confirm that the participant has an 
appointment with a nurse practitioner at the Eskind Clinic within 
the next 7 months. 
4.2.2.7 HbA1c Score: Confirm that the most recent HbA1c score is 
between 8.0% and 12.0%. 
4.2.2.8 Type 2 Diabetes (exclusion criteria): Confirm that the participant 
does not have a diagnosis of type 2 diabetes or any other type of 
diabetes other than type 1. 
4.2.2.9 Other conditions (exclusion criteria): Confirm that the participant 
does not have any physical, cognitive, sensory, or emotional 
conditions that would prevent them from participating in the 
intervention. 
 

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4.2.3 Additional Information Collection 
In addition to confirming eligibility, the following key information will be 
collected during the screening process: 
4.2.3.1 Name of the nurse practitioner the patient sees in routine care 
4.2.3.2 Insurance status (provider; public/private/none) 
 
4.2.4 Eligibility 
Based on the screening results:  
4.2.4.1 If eligible: The participant will be informed that they meet all the 
criteria for the study, and the next steps will be discussed.  
4.2.4.2 If not eligible: The participant will be thanked for their time and 
interest, and informed that they do not meet the eligibility criteria 
for the study. Contact information will be provided for any further 
questions or information. 
 
4.3 Randomization 
This study will employ a 2:1 randomization ratio, assigning participants to either the 
intervention (Discovery Program, n=100) or control (usual care, n=50) group. The 
intervention group will receive the 3-month intervention followed by a 6-month 
follow-up. The usual care group participants will continue with standard diabetes 
care practices without the psychosocial intervention and will be administered the 
same research study measures as the intervention group on the same schedule. 
Randomization will occur during the baseline session after participants have been 
confirmed eligible for the study, consented/assented, and completed baseline 
assessments. Randomization will be managed through the REDCap randomization 
module, which will automatically assign participants to one of the two groups 
according to a pre-specified 2:1 ratio. To ensure comparability between groups, 
randomization will be stratified by the following key variables: 1) HbA1c Levels: 
Moderate (8-10%) and High (10.1-12%), and 2) Health Insurance Status: Private, 
public, or none. The REDCap module will manage this stratified randomization 
scheme, which helps maintain balanced group sizes within each stratum, thereby 
minimizing potential biases related to these characteristics. This approach will 
ensure allocation concealment and reduce the likelihood of unbalanced groups. 
 
5.0 Study Procedures 
 
5.1 Baseline Questionnaires 
The measures described below in Section 5.2 and provided in the appendix will be 
administered after consent/assent and before random assignment. In addition to 
the baseline administration of measures, clinical and research data will be collected 
from both the intervention and usual care group participants at 3, and 6 months. 

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EHR and routine clinical data will also be obtained at 9 months. All self-report 
instruments used in this study have demonstrated adequate internal consistency 
(Cronbach’s alpha ≥ 0.70). All measures are included in the appendix. 
 
5.2 Study Measures 
In addition to the baseline administration of measures described below, clinical and 
research data will be collected from both the intervention and usual care group 
participants at 3, and 6 months. EHR and routine clinical data described below in this 
section will also be obtained in collaboration with VCLIC and/or the VUMC DataCore. 
 
Table 2. Study Measures and Schedule of Administration 
 
Study Measure 
Source 
Baseline 
(REDCap) 
Month 1 
Month 
3* 
(REDCap) 
Month 6 
Pre-NP 
Visit 
(MHAV) 
Post-
Visit 
(REDCap) 
Pre-NP 
Visit 
(MHAV) 
Post-Visit 
(REDCap) 
Diabetes Distress 
(PAID-T) 
ParƟcipant 
 
X 
 
 
X 
 
X 
Barriers to Diabetes 
Adherence (BDA) 
ParƟcipant 
 
X 
 
X 
X 
 
Problem-Solving Skills 
(SPSI-R: SF) 
ParƟcipant 
X 
 
 
X 
 
X 
Self-Care Inventory 
(SCI-R) 
ParƟcipant 
X 
 
 
X 
 
X 
CommunicaƟon 
Assessment Tool (CAT) 
ParƟcipant 
 
 
X 
 
 
X 
Clinician Fidelity 
Check-In 
Nurse 
PracƟƟoner 
 
 
X 
 
 
 
Economic and LogisƟc 
Burdens of Diabetes 
Care 
Parent/Guardian 
and Young Adult 
ParƟcipants 
(18+) 
X 
 
 
 
 
 
CollaboraƟve Parent 
Involvement (CPI) 
ParƟcipant 
X 
 
 
X 
 
X 
Exit Interview* 
ParƟcipant 
(IntervenƟon 
Group only) 
 
 
 
X 
 
 
* Exit Interviews will be conducted with a subset of intervenƟon group parƟcipants only during the month 3 visit 
with the study team described in the procedures below. All other measures will be administered via REDCap for 
both groups.  
 

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5.2.1 Glycemic Outcomes: including point-of-care HbA1c values, are obtained 
during routine clinic visits and recorded in the EHR. No additional testing 
will be requested or completed in relation to this research. Reports 
including data from diabetes devices such as CGM, insulin pumps, and 
blood glucose monitors, will also be obtained from the EHR for the year 
prior to the study, during the intervention period, and for 9 months after 
the intervention is complete. 
 
5.2.2 Demographic and Clinical Information: will be obtained from the EHR 
and parent/young adult reports at baseline. Clinical data, including 
missed appointments, HbA1c history, and diabetes device reports will be 
obtained after consent/assent. All clinical data that will be obtained 
either through self-report or the EHR for this research is listed in the 
appendix. 
 
5.2.3 Economic and Logistic Burdens of Diabetes Care: At baseline, parents 
and young adults will complete assessments related to the economic and 
logistical burdens of diabetes care, including socioeconomic status 
(household income, parent education, and insurance type/status), access 
to reliable transportation, distance from the clinic, and the difficulty of 
leaving work for diabetes care. 
 
5.2.4 Barriers to Diabetes Adherence: The Barriers to Diabetes Adherence 
(BDA) questionnaire is administered in routine care before each NP visit 
through the My Health at Vanderbilt (MHAV) patient portal via patient 
devices at home or utilizing Clinic Epic Welcome tablets. All participants 
will complete the BDA for this study through this routine care 
administration. The Barriers to Diabetes Adherence (BDA) is a 21-item 
self-report measure assessing psychosocial barriers to diabetes self-
management (DSM) in adolescents with T1D. The BDA includes five 
subscales: stress/burnout, stigma, social support, parental autonomy 
support, and time pressures. This measure has shown concurrent validity 
with HbA1c. All patients over 13 are administered the BDA in routine care 
within My Health at Vanderbilt patient portal before visits with their NP. 
Currently no patients see the results of the BDA. During the trial, 
intervention participants will be directed to their results feedback and to 
complete goal setting after completing the BDA. Usual care groups will 
continue as typical, with no results of their BDA. All data collected 
through MHAV patient portal will be pulled into the REDCap project 
nightly through a CDIS process built by the VICTR DataCore for this 

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research. 
 
5.2.5 Self-Management: The Self-Care Inventory-Revised (SCI-R) is a 15-item 
questionnaire completed by participants assessing diabetes-related self-
care behaviors for individuals with type 1 diabetes (Weinger et al 2005). 
Items cover the primary components of a diabetes treatment regimen 
such as monitoring and recording glucose levels, administering and 
adjusting insulin, regulating meals and exercise, and keeping medical 
appointments. Respondents indicate how often they do each behavior 
using a 5-point Likert scale (1 = “never do it”; 5 = “always do this as 
recommended, without fail”, with a “not applicable” option only for 
certain questions). Scores on the SCI-R are converted to a 0- to 100-point 
scale (higher scores = more optimal T1D management behaviors) 
 
5.2.6 Diabetes Distress: The Problem Areas in Diabetes – Teen version (PAID-T) 
is a 14-item self-report questionnaire that assesses diabetes-specific 
distress in adolescents. Unlike the BDA, which focuses on the frequency 
of barriers, the PAID-T examines the level of distress caused by those 
barriers. Respondents indicate how often they do each behavior using a 
5-point Likert scale (1 = “not a problem”; 5 = “a large problem”). 
 
5.2.7 Social Problem Solving: The Social Problem-Solving Inventory – Revised, 
Short Form (SPSI-R: SF) is a 25-item self-report questionnaire that 
assesses an individual’s social problem-solving skills in five key domains: 
positive problem solving, negative problem solving, rational problem 
solving, impulsivity, and avoidance. Each item is rated on a 5-point scale 
regarding how true that statement is for the participant. 
 
5.2.8 Parent Involvement: The Collaborative Parent Involvement (CPI) 
questionnaire consists of 12 items assessing perceptions of parent 
involvement in DSM and problem-solving activities. This measure will be 
administered to adolescents at baseline and follow-up timepoints to 
assess the role of parental support in diabetes management. 
 
5.2.9 Communication: The Communication Assessment Tool (CAT) is a 14-item 
self-report questionnaire that measures adolescent satisfaction with 
health-related communication and is completed by the adolescent. This 
measure will be administered at baseline and follow-up timepoints to 
assess changes in satisfaction with communication across the 
intervention period. 
 

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5.2.10 Clinician Fidelity Check-In: The Discovery Diabetes Clinician Check-In, 
administered via REDCap after the first routine clinic visit, evaluates 
clinician interactions with research participants. The form includes 
questions on positive engagement, reviewing results, discussing 
challenges and solutions, setting SMART goals, and providing feedback. It 
also captures guidance levels, goal changes, additional actions, 
encountered challenges, and insights for program improvement. 
 
5.2.11 Goal Setting: The Goal Setting Questionnaire is administered ONLY to the 
intervention group participants through the MHAV patient portal. As 
described in this protocol, this questionnaire displays in MHAV after 
intervention participants complete their BDA. The questionnaire includes 
13 questions focused on setting a goal in relation to their BDA results and 
other relevant factors, such as why a barrier may be occurring. The items 
on the BDA and this goal setting questionnaire are used to personalized 
communications using SMS. 
 
5.2.12 Intervention Experiences and Feedback Interview: At month 3, 
intervention participants will meet with study staff. At the end of that 
meeting, a subgroup will participate in an ‘experience and feedback’ 
interview. The 20-minute semi-structured interview will initiate a 
discussion about experiences in participating in the program, any 
problems understanding or accessing the program, the role of the 
clinician in helping them, and any feedback to improve the program 
moving forward. 
 
5.2.13 Additional EHR Data to be Extracted for Participants: Data to be 
extracted by the study team from the participant’s EHR includes 
insurance status and diagnosis details, and most recent BDA score at time 
of recruitment, and BDA, PHQ-9, HbA1c tests, device data (pump, CGM, 
BG meter), and appointment records from 6 months prior to recruitment 
through 9 months of the study. A table of this data is included in the 
appendix.  
 
5.3 Intervention  
5.3.1 Intervention Orientation Session 
Within 1 month prior to their NP clinic visit 1, consented participants 
randomly assigned to the intervention group will have an orientation 
session. This orientation will be conducted either in-person or virtual 
modality via Zoom depending on the availability of the participants. Up to 
5 participants may take part in an orientation session.  

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Participants will receive an appropriate packet of information 
(intervention or usual care) about the program via mail, email or in 
person depending on the modality of the orientation session. 
Intervention participants will watch a 3-minute animated video about 
psychosocial problem-solving and view one of the digital stories from the 
program as an example of the intervention. The video, designed with 
input from adolescents, introduces strategies to address common 
diabetes management challenges, such as stigma around insulin bolus 
administration at school. They will also receive a walk-through of the 
intervention components (Journey Map in Appendix), including the 
problem-solving and text message components and a Discovery Users 
Guide handout. All onboarding materials are included in the appendix.  
 
Parents, adolescents and young adults will be asked to log into their 
MHAV account during the orientation session. They will also be sent a 
test text message to establish the functionality of their mobile phone and 
interaction with the program via SMS.  Intervention participants will be 
given a Discovery Program logo water bottle after orientation. 
 
5.3.2 Pre-Visit MHAV Patient Portal 
Once an intervention participant has completed their pre-visit BDA 
through the MHAV portal, they will be able to view their BDA results via a 
graph (see screenshot in Appendix) and will be taken to the goal setting 
questionnaire (appendix). The BDA and goal setting responses will be 
used to tailor the mobile content of the intervention. After viewing their 
results, they are guided through a series of goal-setting questions that 
help them identify specific, actionable self-management goals. This 
process will include problem identification, brainstorming solutions, and 
identifying potential barriers and facilitators to success. 
 
5.3.3 Clinic Visit 1 with NP 
During the clinic visit, the NP will review the intervention group 
participant’s BDA results and guide them through a collaborative goal-
setting session. The NP will either pull the participant’s BDA results and 
share their screen with the participant or the participant will open their 
own MHAV app to share their results with the NP. The NP will discuss the 
specific barriers identified, review or develop a timeline for addressing 
them, and identify safe, realistic changes. Device data available in the 
medical record, such as continuous glucose monitoring, will be used to 
help inform the goal. The NP will help the participant locate the 

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appropriate handouts, called "Cheat Sheets" tailored to the psychosocial 
burden they identified during the goal-setting session. These 1-page 
documents, available in print and through MHAV, provide easy-to-
understand information about the barrier, myths surrounding it, and 
actionable strategies for reducing its impact. The handouts are included 
in the appendix. 
 
5.3.4 Mobile Support 
All digital content is sent directly to participants via SMS and participants 
do not interact with each other in this program. 
 
5.3.4.1 SMS System Description: The SMS system used in this study is 
designed to ensure secure and efficient communication with 
participants while maintaining compliance with HIPAA and 
institutional data security standards. All messages are encrypted 
using 256-bit HTTPS encryption to protect the privacy of 
transmitted data. The system integrates with Twilio, a cloud-
based communication service, to facilitate reliable message 
delivery, two-way communication, and status tracking. Twilio 
processes all data in transit and does not store participant-
identifying information.  
 
The backend system is built using Ruby on Rails and is hosted on 
VUMC's secure IT infrastructure, managed by the Department of 
Biostatistics. Only the Subject ID and participant phone number 
are stored in the database, with all other data being transitory. 
Digital stories are hosted on Vimeo, and responses to story 
questions are reviewed by project staff before being shared 
anonymously with other participants. The system supports two-
way messaging, allowing participants to interact with the study 
team, and offers an opt-out option for participants to discontinue 
SMS communications at any time. 
 
5.3.4.2 Digital Stories: Once per week for 12 weeks intervention group 
participants will receive a link via SMS to digital stories created by 
AYAs with T1D. These stories, approximately 3-5 minutes, address 
common challenges in diabetes management, such as overcoming 
stigma or burnout. The stories provide relatable, real-life 
examples of problem-solving strategies as told by youth with T1D. 
After viewing each story, participants will complete a series of 
questions to facilitate learning from the story. These "food for 

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thought" questions prompt them to relate the story to their own 
experience, evaluate the outcome, and brainstorm ways to 
overcome similar challenges. Participants will also view peer 
responses to the questions to foster social learning. Examples of 
the digital stories are included in the appendix. 
 
5.3.4.3 SMS: In addition to the digital stories, participants will receive 
four SMS messages per week (a total of 5 SMS messages per 
week). One message will contain a link to a digital story selected 
based on the participant diabetes barrier and self-management 
goal. The other messages reinforce the problem-solving behaviors 
viewed in the stories, guide the participant through problem 
solving steps for addressing their specific psychosocial burden, 
and link the intervention to intrinsic motivation through processes 
to encourage autonomy, relatedness, and competence. 
 
5.3.5 Month 3 Session with Study Staff 
Before this session with the study team, using REDCap participants will 
complete a BDA and complete self-reflection questions called “How did it 
Go?” regarding their perceptions of their problem solving. During the 
session, participants will review graphical feedback of their BDA results. 
Participants will receive a certificate summarizing their achievement at 
this time (see appendix). A subset of 20 adolescents from the 
intervention group will be invited to participate in exit interviews 
conducted by the study team at the 3-month time point. A non-
probability sub-sample of participants that reflects the full range of age 
and male/female will be selected. These interviews, lasting 15-20 
minutes, will document participants' experiences with the Discovery 
Program, focusing on: 1) Engagement with the mobile communications, 
2) Perceived benefits or challenges of the intervention, and 3) 
Suggestions for improving the intervention and its clinical 
implementation. This visit will be conducted either in-person or virtual 
modality via Zoom depending on the availability of the participants. 
 
5.3.6 Month 6 Clinic Visit 2 with NP 
5.3.6.1 Pre-Visit: In routine care activities, all participants will proceed 
through completing the BDA before their routine care visit with 
their NP. The intervention group will proceed through BDA 
feedback, and follow-up goal setting questions.  
 

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5.3.6.2 During Visit: Their NP will discuss their BDA results and their 
experience in the program and provide additional guidance on 
sustaining the changes made. All participants will complete the 6-
month study measures (same as baseline/3-month measures) in 
REDCap at this time point. 
 
5.4 Usual Care Group 
Participants in the Usual Care Group will continue receiving standard care as 
provided by the Eskind Pediatric Diabetes Clinic, without the intervention. The usual 
care group will complete the same study measures in REDCap at baseline, 3 months, 
and 6 months. 
 
5.5 Parents/Guardians of Minor Participants 
Parent/guardians of participants ages 13-17 will complete demographic and clinical 
measures at baseline and parent involvement questionnaire at baseline and 3 
months as specified in the measures section. 
 
5.6 Compensation 
All adolescent and young adult participants (regardless of group allocation) will be 
paid $25 for each set of questionnaires completed for a possible total of $75 for 
questionnaires. In addition, adolescent and young adult intervention group 
participants who are invited and complete an interview after month 3 will be 
provided an additional $25. Compensation will be in the form of e-gift cards sent 
directly to participants. 
 
6.0 Reporting of Adverse Events of Unanticipated Problems involving Risk to Participants or 
Others 
All adverse events (AEs) or unanticipated problems (UPs) involving risk to participants or 
others will be reported promptly in accordance with institutional and regulatory 
requirements. If an AE or UP indicates that participants may be at increased risk of harm, 
affected participants will be notified as soon as possible. If necessary, modifications to the 
study procedures will be implemented to reduce the risk of future events, and participants 
will be informed of these changes. The principal investigator (PI) will be responsible for 
assessing, documenting, and reporting AEs and UPs. For any AE or UP, the PI will ensure 
appropriate follow-up actions are taken to protect participants' safety. All AEs and UPs will 
be documented in detail in the study records, including the nature of the event, the 
assessment of its relation to the study, and any actions taken to mitigate further risk. A 
summary of AEs and UPs will be included in progress reports submitted to the IRB as 
required. 
 
6.1 Potential Risks to Participants and Mitigation Strategies 

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6.1.1 Consent and Assent 
This research includes adolescents ages 13-17 and young adults ages 18-
21. Parents of adolescents will always provide consent before the 
adolescent is introduced to the study and assent is obtained. After 
reviewing the study goals, protocol, and compensation, potential 
participants will be provided with detailed written information about the 
study through an electronic consent or assent form in REDCap. During the 
baseline study session participants, and their legal guardians if applicable, 
will have ample time to review the consent form, ask questions of study 
staff, and consider participation before providing consent or assent. 
 
6.1.2 Emotional Distress 
While the study involves minimal emotional or physical risks, participants 
may experience additional insights about problems when completing self-
reflection activities or psychosocial assessments related to diabetes self-
management. Should a participant express to the study staff that they 
are experiencing emotional discomfort or distress, they will be given the 
option to pause or discontinue participation at any time. If warranted, 
the PI (a clinical psychologist) may contact the parent/participant to 
discuss any possible distress and provide appropriate resources for 
further assistance. In cases of severe distress or concern for a 
participant’s safety, the study team will notify the participant’s parent or 
guardian and provide resources, such as referrals to mental health 
services. 
 
6.1.3 Breach of Confidentiality 
There is a potential risk of loss of confidentiality due to the collection of 
personal data and responses related to diabetes management and 
psychosocial burdens. All participants will be fully informed about how 
their data will be used and protected. Privacy will be maintained through 
the use of secure, HIPAA-compliant platforms (REDCap for data collection 
and Epic for medical records). All data, including study measures and 
clinical data, will be stored in a secure, password-protected digital 
environment. Participants will be informed that their identities will 
remain confidential throughout the study, and any shared data will be 
de-identified in reports or publications. If data are shared with other 
researchers, a data use agreement will be in place to ensure that 
confidentiality is maintained. 
 
6.1.4 Time Commitment 
Participants will be asked to engage in study activities over a 6-month 

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period, including baseline, 3-month, and 6-month assessments. These 
assessments will be completed online on their own device. While the 
time commitment involves routine diabetes management appointments, 
the commitment also includes study-specific measures and participants 
may experience inconvenience or time constraints. Feedback on the time 
burden will be collected through interviews, and participants will be 
encouraged to communicate any concerns to the study team throughout 
the study. 
 
6.1.5 Technology Use 
Participants will use technology platforms such as My Health at 
Vanderbilt (MHAV) to complete pre-visit activities and receive SMS 
notifications as part of the intervention group. The use of these platforms 
presents minimal risk, including potential technological difficulties or 
discomfort with mobile engagement. Participants will be provided with 
technical support if needed and will receive clear instructions on using 
these platforms to ensure smooth participation. 
 
6.1.6 Physical Risks 
This study does not involve any physical interventions or procedures 
beyond routine clinical diabetes care. There are no physical risks 
associated with completing study measures or viewing mobile content. 
As this study involves regular clinic appointments, the physical risks do 
not exceed those participants would encounter in standard diabetes care. 
 
6.1.7 Summary of Risks 
The risks associated with this study are minimal and primarily involve 
potential emotional discomfort during psychosocial assessments and 
potential confidentiality breach related to the unintended disclosure of 
personal health data. All measures will be taken to minimize these risks, 
and support will be provided to participants as needed to ensure their 
safety and well-being throughout the study. 
 
7.0 Study Withdrawal/Discontinuation 
Participants may voluntarily withdraw from the study at any time without any 
consequences or impact on their medical care. Participation in the study is entirely optional, 
and all efforts will be made to ensure that participants are aware of their right to 
discontinue at any point without penalty. 
 
7.1 Reasons for Withdrawal by the Study Team 
The research team may withdraw a participant from the study under the following 

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circumstances: 1) Failure to attend 2 consecutive scheduled study visits or complete 
2 consecutive assessments within the specified timeframe, or 2) An adverse event or 
emergence of medical or psychological conditions that increase the participant’s risk 
or make participation inadvisable, based on the discretion of the principal 
investigator (PI). 
 
7.2 Procedures for Withdrawal  
If a participant chooses to withdraw, or is withdrawn by the research team, the 
following steps will be taken: 
7.2.1 Data Collection: Any data collected up to the point of withdrawal will be 
retained unless the participant specifically requests that their data be 
removed from the study. No further data will be collected after 
withdrawal. Participants are informed in consent/assent documents that 
participation or withdrawal will not impact their healthcare. The reason 
for withdrawal (if provided) and the date of withdrawal will be 
documented in the study records. If the participant is withdrawn by the 
research team, the rationale for this decision will also be documented. 
 
7.3 Discontinuation of the Study 
In the event that the entire study is discontinued due to unforeseen circumstances, 
all participants will be informed as soon as possible. The reasons for study 
discontinuation will be provided, and any necessary follow-up care or resources will 
be offered. Participants will be allowed to keep any incentives or compensation 
earned up to the point of discontinuation. 
 
8.0 Statistical Considerations 
This pilot randomized controlled trial will include 150 participants (100 intervention; 50 
control) assigned using a 2:1 randomization ratio. Randomization will be stratified by 
baseline HbA1c category (moderate: 8–10%, high: 10.1–12%) and insurance status (private, 
public, none) using the REDCap randomization module to ensure balance across key 
prognostic factors.  
 
The primary outcome is change in HbA1c over time (baseline, 3 months, 6 months, and 9 
months) between the intervention and usual care groups. Secondary outcomes include 
changes in diabetes distress (PAID-T), self-management barriers (BDA), problem-solving 
(SPSI-R), and DSM efficacy (SCI-R). 
 
As a pilot study, the primary objective is to assess feasibility and preliminary efficacy to 
inform a larger trial. Therefore, while the study is powered to detect a moderate effect size 
(Cohen’s d = 0.5) in the primary outcome with 80% power and α = 0.05, inferential statistics 
will be interpreted with caution, and emphasis will also be placed on estimating effect sizes 

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and confidence intervals.  
 
Process and implementation outcomes (e.g., intervention fidelity, satisfaction, engagement 
with digital content) will be analyzed descriptively and thematically in the case of qualitative 
feedback (e.g., exit interviews). 
 
9.0 Privacy/Confidentiality Issues 
All data collection, storage, and sharing processes will adhere to institutional, legal, and 
regulatory standards, ensuring the confidentiality of participants' personal information 
throughout the study. 
 
9.1 Data Collection and Storage 
All study data, including demographic information, surveys, clinical data, and any 
psychosocial assessments, will be collected and stored in secure, HIPAA-compliant 
systems, including REDCap for surveys and Vanderbilt’s Epic system for clinical data. 
 
Personally Identifiable Information (PII) and Protected Health Information (PHI) will 
be collected only when necessary and will be de-identified wherever possible. Each 
participant will be assigned a unique study ID, which will be used to label all 
collected data and ensure confidentiality.  
 
Access to identifiable data will be limited to authorized study personnel who have 
completed training in data security, HIPAA regulations, and the responsible conduct 
of research 
 
9.2 Sharing of Study Data 
Participants’ clinical data and responses to psychosocial measures (e.g., BDA, PAID-T, 
SCI) will be collected for research purposes only and will be aggregated for 
dissemination. Interviews will be coded with a study ID and the matched participant 
data will be stored in a separate document within REDCap. De-identified data may 
be used for research publications or presentations. 
 
9.3 Data Access and Use 
Study data will be accessible only to the principal investigator (PI) and authorized 
study personnel. Data will not be shared with external parties unless consent is 
obtained from the participant.  
 
Collected data will be used solely for the purposes outlined in the consent forms, 
including research analysis, publication, and presentations.  
 
De-identified clinical and psychosocial data may be used for publications or 

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presentations, and no identifying information will be included in any external 
reporting. 
 
9.4 Breach of Confidentiality 
In the unlikely event of a data breach or unauthorized access to participant data, the 
research team will immediately inform the affected participant(s) and report the 
breach to Vanderbilt’s Institutional Review Board (IRB) and the appropriate 
authorities, following institutional and regulatory guidelines. Affected participants 
will be notified of any risks posed by the breach, and corrective measures will be 
taken to prevent future breaches. 
 
10.0 
Follow-up and Record Retention 
All de-identified research data will be retained indefinitely for research purposes, including 
future secondary analysis. Personal identifiers, including responses from surveys and other 
sensitive information, will be securely stored for up to six years following the completion of 
the study, after which they will be securely destroyed. Any data that are no longer needed 
or have reached the end of their retention period will be securely deleted or destroyed to 
ensure no unauthorized access. 
 
10.1 
Record Retention: All study records, including data collected during the 
intervention, post-intervention surveys, and any follow-up assessments, will be 
retained in compliance with institutional and regulatory requirements.  
 
10.2 
Data Retention Period: All research data, including consent forms, de-identified 
survey responses, clinical data, and interview transcripts, will be retained for at least 
six years after the completion of the study. This retention period ensures that the 
data are available for analysis, reporting, and potential publication. 
 
10.3 
Confidentiality and Secure Storage: All electronic records, including survey data, 
clinical information, and interview transcripts (if applicable) will be stored in HIPAA-
compliant platforms such as REDCap and Vanderbilt’s secure Box system. Access to 
the data will be restricted to authorized personnel and protected by password 
encryption. De-identified data used for analysis and reporting will be securely 
stored, and all identifying information will be kept separate from the research data. 
 
10.4 
Disposal of Data: At the end of the retention period, all data containing personal 
identifiers will be securely deleted or destroyed to protect participant 
confidentiality. This includes the deletion of survey responses, clinical records, and 
any personal information stored in electronic systems. De-identified data may be 
retained indefinitely for research purposes, including future secondary analysis. 
 

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10.5 
Participant Requests for Data Removal: Participants have the right to request 
the removal of their data from the study at any point before or during the data 
retention period. If a participant withdraws from the study and requests their data 
be removed, the research team will ensure that all associated data are deleted, 
provided that it has not already been de-identified and included in published 
analyses. Participants will be informed of this option during the consent process. 
 
10.6 
Compliance with Regulatory Requirements: The research team will comply with 
all applicable regulatory requirements regarding the retention, security, and disposal 
of research data. Any changes to the record retention policy or additional retention 
requirements by the study sponsor or IRB will be promptly implemented and 
communicated to the relevant parties.