Increasing Health Equity Through In-The-Moment Reading Assistance for Adults With Diabetes Served at Community Health Centers
Phase: NA
Conditions: Diabetes Mellitus, Type 2, Health Knowledge, Attitudes, Practice, Literacy
Sponsor: GogyUp Inc

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RCT OF ASSISTIVE-READING TECHNOLOGY 
FOR POST-VISIT TYPE 2 DIABETES PATIENT 
EDUCATION 
Protocol Number: 1 
National Clinical Trial (NCT) Identified Number:  NCT05337306 
Principal Investigators: Ned Zimmerman-Bence, Dr. Nathan Shippee 
Sponsor:  GogyUp Inc 
Grant Title: Increasing Health Equity Through In-The-Moment Reading Assistance for 
Adults with Diabetes Served at Community Health Centers 
Grant Number*: 1R43NR020340 
Funded by: National Institute of Nursing Research 
Version Number:  1.2 
2022 – 12-26 
 
 
 

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1 
STATEMENT OF COMPLIANCE __________________________________________ 7 
1 
INVESTIGATOR’S SIGNATURE __________________________________________ 8 
2 
PROTOCOL SUMMARY _________________________________________________ 9 
2.1 
Synopsis ___________________________________________________________________ 9 
2.2 
Schema ___________________________________________________________________ 11 
2.3 
Schedule of Activities ________________________________________________________ 12 
3 
INTRODUCTION _______________________________________________________ 13 
3.1 
Study Rationale ____________________________________________________________ 13 
3.2 
Background ________________________________________________________________ 13 
3.3 
Risk/Benefit Assessment _____________________________________________________ 15 
3.3.1 
Known Potential Risks _____________________________________________________________ 15 
3.3.2 
Known Potential Benefits __________________________________________________________ 15 
3.3.3 
Assessment of Potential Risks and Benefits ____________________________________________ 16 
4 
OBJECTIVES AND ENDPOINTS _________________________________________ 17 
5 
STUDY DESIGN________________________________________________________ 18 
5.1 
Overall Design _____________________________________________________________ 18 
5.1.1 
Phase of study/trial: _______________________________________________________________ 18 
5.1.2 
Study intervention: _______________________________________________________________ 18 
5.1.3 
Type/design of trial: _______________________________________________________________ 18 
5.2 
Scientific Rationale for Study Design ___________________________________________ 19 
5.3 
Justification for Intervention __________________________________________________ 20 
5.4 
End-of-Study Definition ______________________________________________________ 20 
6 
STUDY POPULATION __________________________________________________ 21 
6.1 
Inclusion Criteria ___________________________________________________________ 21 
6.2 
Exclusion Criteria ___________________________________________________________ 21 

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6.3 
Lifestyle Considerations ______________________________________________________ 21 
6.4 
Screen Failures _____________________________________________________________ 21 
6.5 
Strategies for Recruitment and Retention _______________________________________ 21 
7 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) _______ 22 
7.1 
Study Intervention(s) or Experimental Manipulation(s) Administration _______________ 22 
7.1.1 
Study Intervention or Experimental Manipulation Description _____________________________ 22 
7.1.2 
Administration and/or Dosing _______________________________________________________ 23 
7.2 
Fidelity ___________________________________________________________________ 23 
7.2.1 
Interventionist Training and Tracking _________________________________________________ 23 
7.3 
Measures to Minimize Bias: Randomization and Blinding __________________________ 24 
7.4 
Study Intervention/Experimental Manipulation Adherence _________________________ 24 
7.5 
Concomitant Therapy _______________________________________________________ 25 
7.5.1 
Rescue Therapy __________________________________________________________________ 25 
8 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION 
AND PARTICIPANT DISCONTINUATION/WITHDRAWAL ______________________ 25 
8.1 
Discontinuation of Study Intervention/Experimental Manipulation __________________ 25 
8.2 
Participant Discontinuation/Withdrawal from the Study ___________________________ 25 
8.3 
Lost to Follow-Up ___________________________________________________________ 25 
9 
STUDY ASSESSMENTS AND PROCEDURES_____________________________ 26 
9.1 
Endpoint and Other Non-Safety Assessments ____________________________________ 26 
9.2 
Safety Assessments _________________________________________________________ 27 
9.3 
Adverse Events and Serious Adverse Events _____________________________________ 27 
9.4 
Unanticipated Problems _____________________________________________________ 27 
9.4.1 
Definition of Unanticipated Problems _________________________________________________ 27 
9.4.2 
Unanticipated Problems Reporting ___________________________________________________ 28 
9.4.3 
Reporting Unanticipated Problems to Participants ______________________________________ 28 

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10 
STATISTICAL CONSIDERATIONS _____________________________________ 28 
10.1 
Statistical Hypotheses _______________________________________________________ 28 
10.1.1 
Primary Endpoint: ______________________________________________________________ 28 
10.1.2 
Secondary Endpoints: ___________________________________________________________ 29 
10.2 
Sample Size Determination ___________________________________________________ 29 
10.3 
Populations for Analyses _____________________________________________________ 29 
10.4 
Statistical Analyses __________________________________________________________ 29 
10.4.1 
General Approach ______________________________________________________________ 29 
10.4.2 
Analysis of the Primary Endpoint(s) ________________________________________________ 30 
10.4.3 
Analysis of the Secondary Endpoint(s) ______________________________________________ 30 
10.4.4 
Safety Analyses ________________________________________________________________ 30 
10.4.5 
Baseline Descriptive Statistics ____________________________________________________ 30 
10.4.6 
Planned Interim Analyses ________________________________________________________ 30 
10.4.7 
Sub-Group Analyses ____________________________________________________________ 31 
10.4.8 
Tabulation of Individual Participant Data ____________________________________________ 31 
10.4.9 
Exploratory Analyses ____________________________________________________________ 31 
11 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
 
31 
11.1 
Regulatory, Ethical, and Study Oversight Considerations ___________________________ 31 
11.1.1 
Informed Consent Process _______________________________________________________ 31 
11.1.2 
Consent/assent and Other Informational Documents Provided to participants ______________ 31 
11.1.3 
HIPAA Compliant Systems Employed for Informed Consent and Enrollment Process _________ 33 
11.1.4 
Recruitment / Consent / Enrollment / Placement & Follow Up Workflow and Documentation _ 34 
11.1.5 
Study Discontinuation and Closure_________________________________________________ 41 
11.1.6 
Confidentiality and Privacy _______________________________________________________ 42 
11.1.7 
Future Use of Stored Specimens and Data ___________________________________________ 43 
11.1.8 
Key Roles and Study Governance __________________________________________________ 43 
11.1.9 
Safety Oversight - DSMB _________________________________________________________ 44 
11.1.10 
Clinical Monitoring _____________________________________________________________ 44 
11.1.11 
Quality Assurance and Quality Control ______________________________________________ 44 
11.2 
Data Handling and Record Keeping _____________________________________________ 45 

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11.2.1 
Data Collection and Management Responsibilities ____________________________________ 45 
11.2.2 
Protocol Deviations _____________________________________________________________ 45 
11.2.3 
Publication and Data Sharing Policy ________________________________________________ 46 
11.2.4 
Conflict of Interest Policy ________________________________________________________ 46 
12 
Additional Considerations ____________________________________________ 46 
13 
Abbreviations and Special Terms _____________________________________ 46 
14 
Protocol Amendment History _________________________________________ 49 
15 
Subject-Facing Materials and Scripts _________________________________ 51 
15.1 
Step 1: Recruitment Letter ___________________________________________________ 51 
15.2 
Step 2: Candidate Opt-In _____________________________________________________ 53 
15.2.1 
Step 2a.1: Recruitment Landing Page at GogyUp.com __________________________________ 54 
15.2.2 
Step 2a.2: Online Intake Form ____________________________________________________ 57 
15.2.3 
Step 2b: eMail Contact Scripts ____________________________________________________ 60 
15.2.4 
Step 2c: Voice Contact __________________________________________________________ 62 
15.2.5 
Step 2d: SMS Contact ___________________________________________________________ 63 
15.3 
Step 3: Disclosure of Information and Consent Information Prescreening _____________ 64 
15.3.1 
Step 3a: Study Disclosure Document and Prescreening Form ____________________________ 67 
15.3.1.2 
Study Disclosure Document and Prescreening Form __________________________ 68 
1. 
Key Information ____________________________________________________________________ 68 
2. 
Background and Purpose _____________________________________________________________ 68 
3. 
What Will Happen in This Study? _______________________________________________________ 68 
4. 
Expectations for Participation _________________________________________________________ 69 
5. 
Risks, Side Effects, and/or Discomforts __________________________________________________ 70 
15.3.2 
Step 3b: Candidate Reviews Disclosure Document and Consent FAQs as PDF _______________ 84 
15.3.3 
Step 3c: Intake Interview Script ___________________________________________________ 87 
15.3.4 
Step 3d: Schedule Intake Interview ________________________________________________ 88 
15.4 
Step 4: Consent Interview and Signatures _______________________________________ 89 
15.4.1 
Step 4A: Schedule Consent Interview _______________________________________________ 89 
15.4.2 
Step 4b: Consent Interview - Assessing Comprehension ________________________________ 90 
15.4.3 
Step 4c: Informed Consent Signature _______________________________________________ 93 

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15.5 
Step 5: Enrollment & Assignment _____________________________________________ 111 
15.6 
Step 6: Baseline Assessment and Procedures ___________________________________ 112 
15.6.1 
1 Day Baseline Assessment – SMS Appointment Reminder ____________________________ 113 
15.6.2 
Script for Baseline Assessment - Phone or Online Meeting _____________________________ 113 
15.6.3 
Both Groups – Confirm Follow-Up Appointment and Schedule Follow-Up Assessment ______ 114 
15.6.4 
For Intervention Group (GogyUp Reader) Participants ________________________________ 114 
15.6.5 
For Control Group (Paper Documents) Participants __________________________________ 115 
15.6.6 
Missed Base Appointment Scripts and Procedure ____________________________________ 115 
15.6.7 
Intervention Group – Onboarding for GogyUP Reader ________________________________ 117 
15.7 
Step 7: Provision Participant _________________________________________________ 118 
15.7.1 
Intervention Group – Welcome Letter _____________________________________________ 120 
15.7.2 
Intervention Group – GogyUp Reader Quick Start Sheet _______________________________ 121 
15.7.3 
Intervention Group - Tablet _____________________________________________________ 121 
15.7.4 
Control Group – Welcome Letter _________________________________________________ 123 
15.7.5 
Enrollment Notification to Provider _______________________________________________ 124 
15.8 
Step 8: Follow-Up Assessment _______________________________________________ 125 
15.8.1 
1 Day SMS Appointment Reminder - Follow-Up Assessment ___________________________ 125 
15.8.2 
Script for Follow-Up Assessment - Phone or Online Meeting ___________________________ 125 
15.8.3 
Missed Follow-Up Appointment Scripts and Procedure _______________________________ 126 
15.8.4 
SMS Script: Missed FOLLOW-UP Appointment ______________________________________ 126 
15.9 
Baseline and Follow-Up Assessments __________________________________________ 127 
15.9.1 
Assessment Landing Page _______________________________________________________ 128 
15.9.2 
HLQ Text  – Part One ___________________________________________________________ 129 
15.9.3 
HLQ Text  – Part Two___________________________________________________________ 132 
15.9.4 
Baseline: Demographic Questions ________________________________________________ 134 
15.9.5 
Follow-Up: Perceived Diabetes Self-Management Scale (PSDMS) _______________________ 135 
15.9.6 
Follow-Up: User Experience Questions (Intervention Group Only): Likert _________________ 137 
15.9.7 
Follow-Up: User Experience Questions (Intervention Group Only): Open Ended ____________ 138 
15.10 
Diabetes Education Materials ______________________________________________ 139 
5. 
REFERENCES ________________________________________________________ 141 
 
 

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1 STATEMENT OF COMPLIANCE 
The study will be conducted in accordance with International Council on Harmonisation 
Good Clinical Practice (ICH GCP), applicable United States (US) Code of Federal 
Regulations (CFR), and the National Institute of Nursing Research Terms and 
Conditions of Award. The Principal Investigator will assure that no deviation from, or 
changes to the protocol will take place without prior agreement from the funding agency 
and documented approval from the Institutional Review Board (IRB), and the 
Investigational New Drug (IND) or Investigational Device Exemption (IDE) sponsor, if 
applicable, except where necessary to eliminate an immediate hazard(s) to the trial 
participants. All personnel involved in the conduct of this study have completed Human 
Subjects Protection and ICH GCP Training. 
The protocol, informed consent form(s), recruitment materials, and all participant 
materials will be submitted to the IRB for review and approval. Approval of both the 
protocol and the consent form(s) must be obtained before any participant is consented. 
Any amendment to the protocol will require review and approval by the IRB before the 
changes are implemented to the study. All changes to the consent form(s) will be IRB 
approved; a determination will be made regarding whether a new consent needs to be 
obtained from participants who provided consent, using a previously approved consent 
form. 
 
 

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1 INVESTIGATOR’S SIGNATURE 
The signature below constitutes the approval of this protocol and provides the necessary 
assurances that this study will be conducted according to all stipulations of the protocol, 
including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable US federal regulations and ICH guidelines, as 
described in the Statement of Compliance above. 
Principal Investigator or Clinical Site Investigator: 
Signed: 
 
Date: 01/06/2023 
 
Name*: 
Ned Zimmerman-Bence 
 
Title*: Co-Founder / CEO 
Investigator Contact Information 
 
Affiliation:GogyUp Inc 
Address: 825 Washington Ave SE 
Suite 220 
Minneapolis, MN 55414 
Telephone:  
Main: 612-460-5358 
Direct: 651-402-9780 
Email: ned.zb@gogyup.com 
 
 
 

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2 PROTOCOL SUMMARY 
2.1 
SYNOPSIS  
Title: Increasing Health Equity Through In-The-Moment Reading 
Assistance for Adults with Diabetes Served at Community Health 
Centers 
Grant 
Number:  
 
1R43NR020340 
Study 
Description: 
This protocol describes a pilot randomized controlled trial to test 
the primary hypothesis that a mobile application, GogyUp Reader, 
will result in higher health literacy in understanding print diabetes 
patient education materials than print patient education and care 
plan materials alone. 
Objectives*: 
 
The primary objective of this study is to conduct a pilot trial of the 
effect of the GogyUp Reader app on health literacy. 
The secondary objectives are to assess the effect of GogyUp 
Reader on perceived diabetes self-management. 
Endpoints*: Primary Endpoint: three-month (follow-up) scores on two 
subscales of the Health Literacy Questionnaire: Subscale 9: 
Understanding health information well enough to know what to do 
(“Understanding health information”); Subscale 2: Having sufficient 
information to manage my health (“Having sufficient information”). 
Secondary Endpoints: three-month (follow-up) score on the 
Perceived Diabetes Self-Management Scale (PDSMS) 
Study 
Population: 
The maximum sample size is up to 200 individuals, with 
expectation of potential non-contact by patients after a recruitment 
mailing, screening failures and refusal bringing likely sample size 
down to approximately 120-160. The target population are 
individuals aged 18-85 diagnosed with type 2 diabetes mellitus 
seen at clinics serving large proportions of low-income patients 
(e.g., safety net clinics). We will attempt to sample up to 200 
individuals from the MHealth Fairview health system in the seven-
county Twin Cities Metropolitan area. 
Phase* or 
Stage: 
Although the proposed trial is not of a pharmaceutical or other 
therapeutic treatment, it most resembles a phase 2 trial in that we 
have early preliminary data of use and feasibility and are testing 
initial efficacy. 
Facilities 
Enrolling 
Participants: 
Study activities will not take place in any clinical sites; participants 
will be identified based on having been seen for a clinic visit to a 
primary care clinic within the partnering health system and will 
receive a mailing from the health system providing contact 

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information for the researchers; patients will themselves contact 
the research team if they choose. The study will not include sites 
outside of the United States.   
Description of 
Study 
Intervention / 
Experimental 
Manipulation: 
The study intervention is the GogyUp Reader app for three months 
(up to study follow up). The app is self-led; users will choose when 
(and if) to use it. Delivery will be at the individual level. 
Study 
Duration*: 
The study is expected to take up to 12 months, but if recruitment 
exceeds expectation, may take less time. 
Participant 
Duration: 
Individual participant duration is expected to be three months, with 
the possibility of one additional month if follow-up measures take 
unexpectedly long to obtain/complete. 
 
 
 

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2.2 
SCHEMA  
 
 
 
Total maximum n: 200; Total likely n: 120-160 
 
Initial recruitment mailer (interested participants will contact the research team) 

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2.3 
SCHEDULE OF ACTIVITIES  
 
 
Pre-consent: 
Health system 
sends mailing 
based on 
eligibility 
Consent 
(by research 
coordinators
) 
Visit 1 
Day 1 
Visit 2 
Day 90 +/- 
15 days 
Unscheduled Visit 
EMR Review Eligibility 
X 
 
 
 
 
Informed Consent 
 
X 
 
 
 
Demographics 
 
 
X 
 
 
Outcome Evaluation 
 
 
 
 
 
Randomization 
 
 
X 
 
 
Control & Experimental 
Interventions – GogyUp 
Reader app. 
 
 
X 
X 
 
Outcomes assessments 
 
 
X 
X 
 
Adverse Events 
Reporting 
 
 
X 
X 
X 
 
 
 

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3 INTRODUCTION 
3.1 
STUDY RATIONALE  
Type 2 Diabetes Mellitus (T2DM) affects over 30 million Americans and requires patients 
to competently manage their conditions at home. However, the majority of diabetes self-
management education (DSME) and aftercare print materials remain overly complicated, 
with excessively high reading difficulty and fall short in supporting readiness for self-
management at home, especially for the 18% of U.S. adults unable to read beyond a 
second-grade level. 1 – 2, 4 - 6  
The research team will determine whether the GogyUp Reader app facilitates patient 
understanding for managing T2DM when compared to the established standard for after-
visit care (print materials alone). Specifically, the project will investigate GogyUp’s 
potential to: 
1.  
expand patient capacity to understand DSME materials, 
2.  
increase T2DM self-management adherence. 
3.  
reduce, at a scale, disparate outcomes in a chronic disease. 
The study’s aim is to conduct a pilot trial of GogyUp’s embedded, in the moment, 
assistive-reading technology for improving health literacy. We will assess GogyUp’s 
potential effectiveness to increase patient knowledge and the feasibility of conducting a 
larger, multicenter trial by conducting a pilot randomized trial with a randomized, pre-post 
design.  
Primary outcomes will include two aspects of health literacy measured by two validated 
subscales of the Health Literacy Questionnaire, Subscale 9: understanding health 
information well enough to know what to do (“Understanding health information”) and 
Subscale 2: Having sufficient information to manage my health (“Having sufficient 
information”).52 The secondary outcome will be the Perceived Diabetes Self-Management 
Scale (PDSMS) .  Participants in the intervention arm will also be asked to provide user 
experience feedback but only after they complete the follow-up assessments. 
End-user data from individual app users and adult education pilots indicate broad uptake 
among 1,600+ all-volunteer user base in several use cases. A focused, randomized trial 
is needed to assess the technology’s potential impact on health literacy specifically and 
its applicability for reducing health disparities.  
This real-world application and assessment of the GogyUp Reader app for T2DM will 
inform system improvements and provide initial data for a Phase II project as a fully 
powered, multi-year randomized controlled trial to evaluate GogyUp’s assistive reading 
technology on patient health literacy.53 
3.2 
BACKGROUND  
Type two diabetes mellitus (T2DM) affects over 30 million Americans and requires 
patients to competently manage their condition at home. 1 However, health care supports 
for patients fall short in supporting functional readiness for day-to-day T2DM self-

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management. 16 Despite decades of research, supportive or educational print materials 
for patients remain overly complicated, with excessively high reading difficulty. Efforts to 
improve this have been project-limited rather than systemic, and adaptive measures such 
as teach-back techniques have diminishing, short-term effects.17–20  
Compounding the difficulty of print materials are endemic barriers that further impede 
patients’ capacity for health literacy (ability to process health information to make 
decisions), including low print literacy, and limited English proficiency. 4-5 For instance, 
nearly 1 in 5 (19%) of adults in the United States are unable to read at the most basic 
level, including medicine labels or identify information from written directions, and 
upwards of 53% of U.S. adults have low health literacy, but less than 5% of the adult 
population with low print literacy has access to literacy instruction.6-7, 22, 24  
Because print materials for patients remain overly complicated, and systems to increase 
patients’ literacy remain out of reach, this proposal aims to test an alternative paradigm: 
to provide in-the-moment support via assistive technology. Integrated adult literacy is a 
proven strategy that provides comprehensive approaches to ensuring delivery and 
understanding of information. 12-15  
In our proposed model, and implemented in the technology we propose to test, patients 
can have immediate, in-the-moment access to assistive-reading technology, designed 
specifically for adults with limited literacy or English proficiency, that they carry with them 
to support and improve their capacity to understand information and follow self-
management care protocols.  
While many mobile and online applications for diabetes exist, we are not aware of any 
that apply in-the-moment, assistive-reading technologies to immediately convert existing 
education materials into interactive teaching aids.  The GogyUp Reader app incorporates 
these technologies to amplify the patients’ capacity to read and understand difficult written 
materials required to understand how to successfully adhere to T2DM self-care 
management. The lack of low-cost, highly responsive, and flexible assistive-reading 
technologies represents a gap in serving a large percentage of patients’ needs and 
presents an opportunity to understand the potential benefits of assistive-reading 
technology on patient understanding. 
GogyUp Inc developed the GogyUp Reader app with immigrant and native-born adults 
possessing limited print literacy, English proficiency, and digital skills. The app’s in-the-
moment reading assistance makes GogyUp Reader an “in-pocket tutor” that converts 
previously inaccessible material into interactive, autonomous, and personalized training, 
including vocabulary instruction and no-fail comprehension questions. For users not yet 
proficient in English, GogyUp’s reading assistance includes word-by-word multimedia 
translations (currently in fifteen languages prevalent in the Midwest) and pronunciation 
instruction optimized for the user’s preferred language. 
GogyUp’s “content agnostic” approach provides for broad application across multiple 
patient education use cases with instant context-specific assistance, whenever and 
wherever it’s needed. Three years of internal app data from over a thousand users and 
multiple use cases have validated the system’s engagement value and suggest efficacy. 
A sister app developed by GogyUp, Snap Reader, employs similar technologies used in 

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GogyUp Reader that, at the time of this submission, is used by over 3,500 weekly, 
recurring end-users. The proposed study will build on those data to examine the feasibility 
for implementing GogyUp with T2DM after-visit educational materials and its potential 
effectiveness for health literacy. 
This real-world implementation and assessment of the GogyUp Reader for a prevalent 
health problem (T2DM) will provide the evidence to develop a fully powered randomized 
controlled trial across a larger, regional network of Federally Qualified Health Centers in 
rural, suburban, and urban settings, to test the app in a Phase II SBIR grant. Potential 
outcomes include widespread adoption of a highly scalable and low-cost technology with 
potential to improve patient capacity and reduce health disparities through improved 
understanding. 
3.3 
RISK/BENEFIT ASSESSMENT  
3.3.1 KNOWN POTENTIAL RISKS  
 
• Immediate risks. We do not anticipate any immediate risks other than risks to 
confidentiality in the event of a data security breach prior to assigning study 
numbers (rather than identifiable information) for individuals. As such, our data 
security plan includes research training for use of secure, HIPAA compliant data 
storage, and access to identifiable data limited within the study team. 
• Long-term risks. We do not anticipate any long-term risks other than risks to 
confidentiality in the event of a data security breach prior to assigning study 
numbers (rather than identifiable information) for individuals. As such, our data 
security plan includes the use of secure, HIPAA compliant data storage and access 
to identifiable data limited within the study team. 
 
3.3.2 KNOWN POTENTIAL BENEFITS  
 
• Immediate potential benefits. The study intervention (a literacy-focused mobile 
software application that provides immediate reading assistance) is designed to 
support and increase users’ functional print literacy, which in turn is intended to 
support engagement with print self-care and educational materials. As such, there 
is a potential, though speculative, that literacy, health literacy, or diabetes self-care 
mastery may have modest improvements. We do not identify any other direct 
potential benefits. 
• Long-term potential benefits. Long-term benefits are also speculative as well, 
pertaining mainly to the potential for the intervention to modestly or moderately 
improve functional print literacy, health literacy, and/or self-care mastery. Benefits 
beyond those, such as actual control of diabetes (measured via improved 

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hemoglobin A1C levels), are further removed, and so we will not claim any other 
long-term or downstream benefits at this time. 
3.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
• We found this study justifiable given the balance between potential, if speculative, 
improvements in print literacy, health literacy, and diabetes self-care mastery and 
measures taken to prevent against the primary risk of data confidentiality. 
• Given that the primary risk to participants is confidentiality, data security including 
a summary of the ways that risks to participants were minimized in the study design 
• The information gathered as part of this study could point to the beginning of a 
paradigm shift away from existing efforts (e.g., in-clinic patient education, online 
training) that require primarily knowledge retention to support health literacy toward 
in-the-moment support through assistive technology to do the same. Because we 
are able to take steps to limit risks to confidentiality (the primary risk here), we felt 
the value of such information to inform patient self-management support was 
worthwhile for this study.

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4 OBJECTIVES AND ENDPOINTS  
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
PUTATIVE MECHANISMS OF ACTION 
P
ri
m
a
ry 
The primary 
objective of this 
study is to conduct a 
pilot trial of the 
effect of the GogyUp 
Reader app on health 
literacy. 
 
The primary endpoint are 
the three-month (follow up) 
values of two validated 
subscales of the Health 
Literacy Questionnaire: 
Understanding health 
information well enough to 
know what to do 
(“Understanding health 
information”); and having 
sufficient information to 
manage my health (“Having 
sufficient information”).. 
This study’s main objective is to study 
the effect of GogyUp on aspects of 
health literacy that relate   the ability 
to understand and use written health 
information as the  most proximal 
effect of in-the-moment support. As 
such, these two subscales are the most 
direct measures; the three-month time 
frame reflects (a) a brief follow-up as 
part of a pilot trial; and (b) is 
reasonable because of the use of this 
proximal  outcome based on putative 
mechanisms. 
The mechanism of action is a chain whereby 
improved in-the-moment capacity to interact 
with print patient education materials and 
care instructions improves the ability to use 
and understand written health information.  
S
e
c
o
n
d
a
ry 
The 
secondary 
objectives 
are 
to 
assess the effect of 
GogyUp Reader on 
participants’ 
ability 
to self-manage their 
diabetes. 
The secondary endpoint is 
the three-month (follow up) 
value 
of 
the 
Perceived 
Diabetes Self-Management 
Scale (PDSMS). . 
The PDSMS and self-management 
generally are less proximal to the 
intervention 
but 
reflect 
a 
more 
pragmatic outcome further along the 
causal chain toward actually affecting 
health outcomes. 
Health literacy (primary outcomes) is a 
foundational hurdle to understanding self-
management needs and expectations. While 
our focus is that most proximal outcome 
focused on ability to use/understand written 
materials (primary endpoints), this secondary 
endpoint will indicate whether GogyUp Reader 
has effects that are closer to actually impacting 
outcomes 
(i.e., 
health 
literacy 
and 
understanding  may or may not lead to 
improved self-management activities to better 
control diabetes). 

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5 STUDY DESIGN 
5.1 
OVERALL DESIGN 
Hypotheses: 
H1: GogyUp Reader app use with written patient education materials or self-care 
instructions will result in better health literacy in understanding health information 
compared with print patient education or care plan materials alone. 
H2: GogyUp Reader app use with written patient education materials or self-care 
instructions will result in better health literacy in reporting having enough information 
compared with print patient education or care plan materials alone. 
H3: GogyUp Reader app use with written patient education materials or self-care 
instructions will result in better diabetes self-management compared with print patient 
education or care plan materials alone. 
5.1.1 PHASE OF STUDY/TRIAL: 
This study examines a non-medical intervention (self-directed software application). 
However, while a pilot trial, it occurs within normal clinical practice, is not limited to healthy 
volunteers, and is supported by early data on use and feasibility of the app. It therefore 
has aspects of phase II and phase III trials. However, because we are testing initial 
efficacy, it likely fits best within a phase II trial study. 
5.1.2 STUDY INTERVENTION: 
The study intervention is the use of the GogyUp Reader app. The GogyUp Reader is a 
software app that can be used on mobile phones, tablets, and on PC’s with any widely 
available, Chromium-based web browser (e.g., Google Chrome, Microsoft Edge, etc.). It 
is designed to provide both in-the-moment support for interacting with written materials, 
combined with activities designed to address overall functional adult literacy. This is 
intended to address personal capacity to deal with complex written patient education or 
care plan materials on an as-needed, low-cost/free and low-burden basis. 
5.1.3 TYPE/DESIGN OF TRIAL: 
This is a randomized, pre-post superiority trial with two arms: GogyUp Reader app for 
use with patient education or care plan materials (or other written health information) 
compared with the same written materials alone. We are using a randomized study design 
because our overall goal for this study is to ascertain efficacy estimates in a clinical 
population with diabetes and randomization (with sufficient sample size and other study 
procedures in place) is the best way for us to address potential confounding. 
Individual study duration (baseline to follow up) is planned to be three months, although 
up to one additional month may be needed if follow-up measures take too long to obtain. 

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Due to rolling recruitment, the full study is expected to take up to 12 months, although if 
recruitment is faster than expected, the overall study may take less time. 
Randomization is detailed below. In brief, we will randomize participants 1:1 at the 
individual level at enrollment using pre-generated trial allocation sequence from the 
National 
Cancer 
Institute’s 
Clinical 
Trial 
Randomization 
Tool 
service 
(https://ctrandomization.cancer.gov/tool/) at recruitment Study staff not involved in 
analysis will refer to an externally generated allocation sequence for intervention or 
comparison allocation. To avoid or limit randomization errors, the crosswalk file and the 
binary indicator for allocation arm will be known /available to study staff but not 
investigators involved in analysis or interpretation (until analyses are complete). 
This study will include multiple primary care clinic sites in the sense that recruitment will 
occur at a health-system level in collaboration with Fairview research/trial support and 
therefore eligible patients can come from many clinics. However, recruitment, consent, 
pre-screening, data collection, and trial intervention itself are all remote– they do not occur 
in a clinical site.  
Our planned analyses, also discussed in section 9, include an interim analysis 
approximately five to six months after the beginning of recruitment and data collection to 
provide preliminary data and feasibility/design information for a later Phase II SBIR 
application to NIH. This analysis will include all planned endpoints. 
5.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
Existing written patient education and care plan materials for patients with type 2 diabetes 
mellitus are typically overly complex. Most existing interventions to address this either (a) 
rely on in-clinic coaching or education (which can erode or lose effectiveness over time 
due to recall issues, etc.), (b) rely on other materials or technology which themselves 
require good functional reading literacy and good health literacy, or (c) require heavy 
burdens in patient coaching and management over the phone or through mobile 
technology. These incur high costs, patient and health system burden, and typically do 
not offer support when it is most needed, and overall show mixed or eroded effectiveness 
in supporting patients’ health literacy. Given that GogyUp Reader is intentionally designed 
to provide both in-the-moment support with written materials (beyond its literacy-building 
activities), our approach in using this low-risk intervention is akin to the use of assistive 
technology for functional problems– the intervention provides support exactly when it is 
needed. To the degree that this assistive technology approach can improve health 
literacy—specifically,  the ability to understand health information and having all the 
information needed to manage one’s condition –it could provide an as-needed support 
for patients’ capacity  in the same way assistive technology helps to offset many other 
functional capacity limitations or difficult tasks. This is a paradigm shift in the approach to 
health literacy in that we have not seen an in-the-moment capacity support or assistive 
technology approach to health literacy in diabetes in the same way in previous literature.  
Three years of initial feasibility and app usage data for GogyUp Reader (submitted/under 
review) indicates that users can find, install and use GogyUp Reader on their own and 
without training. We have also applied it to other use cases, including citizenship class 
participants and have had good app usage numbers. 

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5.3 
JUSTIFICATION FOR INTERVENTION 
Intervention delivery via mobile software app is precisely central to the potential benefit 
of the intervention: in-the-moment support for patients’ capacity to interact with complex 
written patient materials. We will only have two actual study contacts beyond recruitment 
and pre-screen/consenting: baseline and follow-up at three months, which will only 
include obtaining outcome measurement administration necessary to analyze data to 
meet our study objectives. We will have app usage data (internal to GogyUp) that can 
provide any indication as to whether lack of differences between arms in an intent-to-treat 
analysis is simply due to low app usage (this would provide a finding, and inform future 
study design, rather than being a failure).  
5.4 
END-OF-STUDY DEFINITION 
Participants will be considered to have completed the study if they have completed the 
baseline and three-month follow-up assessments.  
The end of the study is defined as completion of the 3-month follow-up assessment shown 
in the Schedule of Activities (SoA), Section 2.3.] 
 
 

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6 STUDY POPULATION 
6.1 
INCLUSION CRITERIA 
In order to be eligible to participate in this study, an individual must meet all of the 
following criteria: 
1. Provision of signed and dated informed consent form 
2. Males and females; Aged 18-85 years 
3. Documented diagnosis of type II diabetes mellitus 
4. Has had a visit to an MHealth Fairview clinic in the past year (November 2021-
November 2022); can include a telehealth visit  
6.2 
EXCLUSION CRITERIA 
An individual who meets any of the following criteria will be excluded from participation in 
this study: 
1. Currently enrolled in another treatment or intervention study (at pre-screen)  
2. Pregnancy (because pregnancy becomes the primary condition of interest in 
treatment) 
3. Blind 
Note: Although it is assumed that most participants placed in the GogyUp Reader 
group will have access to necessary resources for participating in a technology-based 
intervention (i.e., computer, smartphone, internet access) such access will NOT be a 
criterion - GogyUp will make a limited supply of hardware and data plans available to 
participants without consistent, reliable internet access. 
6.3 
LIFESTYLE CONSIDERATIONS 
During this study, participants are not asked to maintain any additional lifestyle alterations 
or considerations. 
6.4 
SCREEN FAILURES 
Screen failures are defined as participants who consent to participate in this study but are 
not subsequently assigned to the study intervention or entered in the study. Individuals 
who do not meet the criteria for participation in this trial (screen failure) because of 
meeting one or more exclusion criteria will not be rescreened.  
6.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
We plan on asking our clinical partner, MHealth Fairview, to sample 2,000 individuals, 
with the understanding that some may fail pre-screening, to reach our needed sample 
size (our maximum sample size with no screening failures would be 200). Given that our 
sampling frame is patients in a health system serving communities within the Twin Cities 
metro region, with a focus on clinics serving relatively high proportions of low-
income/publicly insured patients, and given some non-response and pre-screen failures 

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might occur, we anticipate an enrollment sample size of 160 individuals, evenly divided 
by gender, with most participants 45 years old or older (possibly a median age of 55, with 
a possible range of the full 18-85 age range); with approximately 50 to 60 percent of our 
sample being White and non-Hispanic/Latino, 20 to 30 percent Black non-Hispanic, 10-
15 percent Hispanic/Latino, and another 10-15 percent of other groups. We do plan to 
prioritize diversity of racial and ethnic groups in our sample in collaboration with our 
research/trial support partner at the point of sample identification and recruitment 
(prioritizing sample identification and recruitment contact to oversample Black, 
Indigenous, Hispanic/Latino, Asian and Pacific Islander, and multiracial ethno-racial 
categories. 
Due to the ongoing COVID-19 pandemic, potential future waves of infection, and limited 
clinic capacity to accommodate studies, a clinic site-based recruiting approach is both 
inefficient and less likely to succeed within the study timeframe, would require additional 
considerations for participants’ privacy and safety, and potentially limit the diversity of the 
available patient pool.   
For recruitment, we have contracted with a local health system, M Health Fairview, to 
send out a letter mailer to patients meeting the inclusion and exclusion criteria noted in 
Section 5.1 and 5.2. The letter invites these patients to the study and to contact our 
research coordinators by call, email, or text or by visiting a website with a contact form. 
Upon initial contact by interested patients, GogyUp’s research coordinators will perform 
the remote consent / enrollment / placement workflow. 
Candidates who enroll and are placed in the intervention group will be asked to use their 
personal devices. If a participant placed in the intervention group does not have regular, 
consistent access to an Internet-connected device will be provided a cellular-enabled 
tablet with an active SIM card for the duration of their participation.  Participants who use 
their own intent-connected devices will be sent a $25 gift card at baseline to offset network 
expenses. 
All participants, whether they are in the control group or are in the intervention group, will 
receive a $25 gift card in compensation at the end of the study period.  These measures 
will assist both with ensuring that the intervention is not hindered by technological or 
network access barriers and also provide both an incentive to stay enrolled, helping to 
ensure retention. We will also obtain multiple forms of contact information from consented 
participants to ensure we can contact them at follow-up. We believe our proximal outcome 
and short follow-up will further ensure retention and completion. 
7 STUDY INTERVENTION(S) OR EXPERIMENTAL 
MANIPULATION(S) 
7.1 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION 
7.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
The study intervention is the use of the GogyUp Reader app. The GogyUp Reader is a 
software app that can be used on mobile phones, tablets, and PCs. and is designed to 

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provide both in-the-moment support for interacting with written materials, combined with 
activities designed to address overall functional adult print literacy. This is intended to 
address personal capacity to deal with complex written patient education or care plan 
materials on an as-needed, low-cost/free and low-burden basis. This mechanism (in-the-
moment support with written materials) is supported theoretically by Co-PI Shippee’s 
theoretical model of patient complexity, the Cumulative Complexity Model, which posits 
that problems with patient access to care and self-care or adherence arise from an 
interaction between the work that patients are asked to do (in life and in caring for their 
conditions) and the capacity they have to do it. This model has been supported all or in 
part in both systematic reviews and intervention designs. In brief, complex patient written 
materials add burden to the workload of being a patient with diabetes– and without 
sufficient capacity, patients are not in a position to use those patient education or care 
plan materials in the way they need to– the definition of functional health literacy. While 
other interventions are designed to increase patients’ capacity through either in-clinic 
sessions, additional materials or differently designed materials, or time-and resource-
intensive coaching, the mechanism of action with GogyUp Reader as an intervention is 
that the support for capacity is available exactly when patients need it, allowing them to 
understand materials and successfully enact self-care. The control condition will consist 
of the written materials (and other clinical guidance) that patients normally receive 
(essentially a usual care arm), without GogyUp Reader. 
7.1.2 ADMINISTRATION AND/OR DOSING 
Given that this study involves assistive-reading technologies, administration and dosing 
are problematic concepts. However, to specify: participants will install GogyUp Reader 
app onto their devices (or devices supplied by GogyUp upon request) at baseline. A brief 
tutorial will be given by GogyUp staff trained in the protocol. The analog to “dosing” here 
is the degree to which participants might be expected to use the app or, if in the control 
group, review the paper documents. We are not requiring any particular level of app 
usage; our preliminary app usage data (GogyUp internal app data) have indicated 
consistent levels of self-directed app usage data in past applications and, to the degree 
intervention participants did not use the app, GogyUp would be able to see that in the 
app’s activity data (or lack thereof).  Of course for the control group, activity data is not 
measurable. 
7.2 
FIDELITY 
7.2.1 INTERVENTIONIST TRAINING AND TRACKING 
The protocol objectives for this study do not depend on consistent administration of the 
study intervention beyond the baseline visit. To date, the GogyUp Reader app has been 
used for multiple sessions, and in some cases over months and years, by over 1,500 
adult learners with minimal digital literacy and a wide range of print literacy and English 
proficiency. The majority of these adults installed the app on their own while a minority 
need brief training while enrolled an adult basic education setting. To ensure consistent 
onboarding and app usage, a standard script for downloading the app onto devices will 

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be used during a brief tutorial at the baseline visit to ensure standard initial introduction 
of the GogyUp Reader (study intervention).  Technical support will also be provided by 
trained GogyUp personnel through email and a dedicated phone number capable of 
receiving voice calls and text messages. 
7.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
We will use a random allocation sequence from the National Cancer Institute’s Clinical 
Trial Randomization  Tool (https://ctrandomization.cancer.gov/tool/). Study staff will refer 
to the allocation sequence to determine allocation arm for each newly recruited 
participant.. As such, study staff not involved in analysis will not be blinded because they 
will provide initial access to the GogyUp Reader app. Lastly, using an encrypted Microsoft 
Excel file for which only study staff not involved in analysis will have the password, study 
staff will create and enter the study id and trial arm into two crosswalk files: the first, a 
crosswalk identifying study id number with study arm (for unblinding following blinded 
analysis), and a crosswalk file linking intervention-arm study identification numbers to a 
separate id number from GogyUp internal data (for assessments of adherence; see 
above). Study staff will then enter name, contact information, study id and baseline 
variables into REDCap. Investigators (Drs. Shippee, Rogers, and Peterson and Mr. 
Zimmerman-Bence) will be blinded to participants’ status, only have access to the 
REDCap file prior to analysis, and indeed will not have contact with participants. To 
support interim analysis, all procedures above will be followed, but for participants 
recruited during the first three months, an additional study id variable (interim study id) 
and REDCap trial arm indicator (interim indicator) will be used– these will ensure that the 
interim analysis (see above) does not effectively unblind the full analysis. After interim 
analysis, study staff will use the encrypted file to inform the investigators which random 
study arm number indicated which study arm. After final analyses, study staff will provide 
the password for the encrypted crosswalk files to the investigators for unblinding. The 
criterion for unblinding will be that all participants have had a final follow-up visit and 
(masked/blinded) comparative analyses are complete. In the unlikely event of an 
unplanned unblinding/breaking of randomization indicators, because investigators have 
no contact with participants and this protocol will be registered publicly, instigators will 
simply report the unplanned breaking and reasons for it in all subsequent publications for 
transparency. 
 
As noted above, study staff cannot be blinded but staff and investigators will have no 
other contact with participants other than staff administration of follow-up questionnaires. 
Staff enrolling and administering baseline and follow-up assessments will not have a role 
in analysis and investigators will not have access to blinded materials until after analysis 
nor have contact with participants.  
7.4 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
Adherence in this study is easy to assess in that GogyUp has internal data indicating 
users’ interactions with the Reader app across its functionalities, including timestamps, 
functionality or activity used, and whether a user conducted a reading activity 

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successfully.  We will assign study numbers so that adherence data can be linked to other 
study data later (while maintaining participant confidentiality). We will be able to assess 
the degree to which intervention adherence (regular or continued use of the GogyUp 
Reader app) has occurred and whether this may explain differences found or not found 
between the intervention and control arms. 
7.5 
CONCOMITANT THERAPY 
As noted above regarding exclusions, we do not have any exclusions for concomitant 
therapy– only for the exclusions listed above and for being part of any treatment or 
intervention study. 
7.5.1 RESCUE THERAPY 
N/A 
8 STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
 
8.1 
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
Other than participant withdrawal (self-decided for any reason), we do not have any 
specific circumstances that would lead us to discontinue participants from the study. 
Because the intervention is a mobile app that participants will use on a self-directed, as-
needed basis, it will be available to participants regardless of moves, or other changes in 
circumstance. In the case of adverse events, we would not revoke a participants’ access 
to the app, but it could mean issues with loss to follow up, which we will address below. 
8.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants are free to withdraw from participation in the study at any time upon request. 
As noted above, we have no explicit reasons, as the research team/investigators, to 
withdraw participants. We may of course have issues if people are highly non-adherent 
or we are not able to follow up with them, but we will address these as either empirical 
questions (see intervention adherence above) or analytically (see lost to follow-up below).  
The reason for participant discontinuation or withdrawal from the study will be recorded 
in an electronic Case Report Form (CRF). Subjects who sign the informed consent form 
and are randomized but do not receive the study intervention may be replaced. 
Subjects who sign the informed consent form, and are randomized and receive the study 
intervention, and subsequently withdraw, or are discontinued from the study, will not be 
replaced and lost to follow-up will be addressed analytically. 
8.3 
LOST TO FOLLOW-UP 

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A participant will be considered lost to follow-up if contact fails for the three-month follow-
up assessment and study staff are unable to contact the participant after at least 3 
attempts using a mixture of voice calls and SMS texts, spaced over several days.  
The following actions must be taken if a participant fails to attend or answer a follow-up 
research visit or call: 
● Before a participant is deemed lost to follow-up, the research coordinator or study 
staff will make every effort to regain contact with the participant (where possible a 
mix of 3 telephone calls and text messages and, if necessary, a certified letter to 
the participant’s last known mailing address or local equivalent methods). These 
contact attempts will be documented in a study file.  
● Should the participant continue to be unreachable, he or she will be considered to 
have withdrawn from the study with a primary reason of “lost to follow-up.” 
 
9 STUDY ASSESSMENTS AND PROCEDURES 
9.1 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
Assessments for this study will include eligibility assessment and initial contact for pre-
screening, as well as baseline and follow-up measures. We will also extract internal app 
data for the study period to assess adherence in the intervention arm (and to ensure no 
contamination in the control arm). 
To ensure a focus on equitable representation and on a sample reflective of our interest 
in low income (publicly or non-insured) patients, the study team and health system 
research support staff determined that initial contact with recruiting materials (see above) 
will be prioritized to individuals seen at primary care clinics in the health system that see 
the largest proportions of publicly insured or non-insured patients. Iterative mailings will 
continue to prioritize patients from these clinics as well as patients in historically excluded 
and underrepresented groups (e.g., Black or Indigenous patients) among those fitting 
initial eligibility criteria (see above). Health system staff will conduct pre-screening 
procedures including identifying a potential sample and sending recruitment mailings (see 
Recruitment Collateral below).  To ensure candidates are fully opted-in, GogyUp and 
study staff will not have access to any potential participants until participants contact 
GogyUp by filling out an online intake form or calling, texting, or emailing the GogyUp 
Research Coordinator through a study-designated phone number and email address 
listed on the recruitment letter.  
Once eligible participants are consented by the GogyUp Research Coordinator, 
enrollment and baseline assessments will take place within an expected two-week 
(maximum) timeframe. Baseline assessments will include study staff administration 
(remotely via phone or video call) of the validated Health Literacy Questionnaire 
subscales 9 and 2, ”Understanding health information” and “Having sufficient 
information,” as well as the secondary outcome of the PDSMS. At three months post-
baseline, study staff will conduct follow-up administration of the same outcomes. Based 
on our theoretical mechanism of action (see above), health literacy is the primary set of 

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outcomes, with diabetes self-management as the secondary outcome. Although we will 
conduct standard training and include standard scripts for study staff for the baseline and 
three-month follow-up appointments, study staff administering these assessments will not 
have specific training or degree requirements. They will use a time stamp of “time 0” for 
the baseline survey date. 
9.2 
SAFETY ASSESSMENTS 
N/A 
9.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
As noted in 3.3.1, the primary risks to participants are a breach of data prior to assigning 
study numbers (rather than identifiable information) for individuals.  Should a data breach 
occur, the research staff will respond according to GogyUp’s Privacy Policy and University 
of Minnesota procedures.  These include notification of the data breach in accordance 
with the United States Department of Health and Human Services HIPAA Breach 
Notification Rule, 45 CFR §§ 164.400-414, section 13407 of the HITECH Act and the 
information previously reviewed in the Study Disclosure Document and Informed Consent 
Form. 
Upon discovery of a breach, GogyUp technical staff will immediately evaluate data 
systems to identify the source of the leak and determine whether the vulnerability can be 
removed.  If the vulnerability is determined to be a continued risk, then study enrollment 
and/or activity will be halted - dependent on which systems were impacted by the 
vulnerability, whether the vulnerability has been verified to have been removed and 
patches to the GogyUp’s data systems have been successfully implemented and tested, 
and if continuing the study would be in accordance with the Univeristy of Minnesota 
policies.   
9.4 
UNANTICIPATED PROBLEMS 
9.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
This protocol uses the definition of Unanticipated Problems as defined by the Office for 
Human Research Protections (OHRP).  OHRP considers unanticipated problems 
involving risks to participants or others to include, in general, any incident, experience, or 
outcome that meets all of the following criteria: 
• Unexpected in terms of nature, severity, or frequency given (a) the research 
procedures that are described in the protocol-related documents, such as the 
Institutional Review Board (IRB)-approved research protocol and informed 
consent form; and (b) the characteristics of the participant population being 
studied; 
• Related or possibly related to participation in the research (“possibly related” 
means there is a reasonable possibility that the incident, experience, or outcome 
may have been caused by the procedures involved in the research); and 

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• Suggests that the research places participants or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized.] 
9.4.2 
 UNANTICIPATED PROBLEMS REPORTING  
The investigator will report unanticipated problems (UPs) to the reviewing Institutional 
Review Board (IRB) and to the lead research co-principal investigator (Co-PI Shippee). 
The UP report will include the following information: 
• Protocol identifying information: protocol title and number, PI’s name, and the IRB 
project number 
• A detailed description of the event, incident, experience, or outcome  
• An explanation of the basis for determining that the event, incident, experience, or 
outcome represents an UP 
• A description of any changes to the protocol or other corrective actions that have 
been taken or are proposed in response to the UP 
To satisfy the requirement for prompt reporting, UPs will be reported using the following 
timeline:   
• UPs that are serious adverse events (SAEs) will be reported to the IRB and to the 
funding agency within 24 hours of the investigator becoming aware of the event  
• Any other UP will be reported to the IRB and to the funding agency within 36 hours 
of the investigator becoming aware of the problem  
• All UPs should be reported to appropriate institutional officials (as required by an 
institution’s written reporting procedures), the supporting agency head (or 
designee), and the Office for Human Research Protections (OHRP) within 7 days 
of the IRB’s receipt of the report of the problem from the investigator 
9.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
N/A 
10 STATISTICAL CONSIDERATIONS  
We will publicly register this protocol with ClinicalTrials.gov prior to study recruitment; it 
contains all details regarding statistical analysis and so there will be no separate statistical 
analysis plan. 
10.1 STATISTICAL HYPOTHESES 
10.1.1 PRIMARY ENDPOINT:  
We hypothesize that GogyUp Reader app use with written patient education materials or 
self-care instructions will result in better health literacy compared with print patient 

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education or care plan materials alone. Alternatively, our null hypothesis is that there will 
be no difference in health literacy. 
10.1.2 SECONDARY ENDPOINTS: 
We hypothesize that GogyUp Reader app use with written patient education materials or 
self-care instructions will result in better patient self-management of diabetes compared 
with print patient education or care plan materials alone. Alternatively, our null hypothesis 
is that there will be no differences in secondary endpoints. 
10.2 SAMPLE SIZE DETERMINATION 
Due to lack of literature on meaningful effect size for our primary effectiveness outcome , 
our power calculation is based on a general effect size, the standardized mean difference 
(SMD). SMD consists of the mean difference in the outcome between arms, divided by 
the standard deviation of the outcome in the control arm, with moderate effect size being 
SMD=0.5 and large effect size being SMD=0.7. Based on information in the original 
validation paper, mean Understanding subscale summary score was 3.85, standard 
deviation 0.74. With 60 subjects per arm (a low estimate), we will have 78% power to 
detect a moderate effect size (a between-group difference of .37 on the scale, SMD=0.5) 
and 97% power to detect a large effect size (SMD=0.7, difference of .52) based on 
performing a two-sample t-test comparing the treatment arms. With differences in post 
means of 0.3 and 0.5, power will be 60% and 96%, respectively. However, we want to 
help insure against difficult recruitment as well as, in particular, a potentially smaller effect 
size, which can have a large impact on sufficient power. Therefore, our targeted 
enrollment is 80 per arm (n=160), which would support 73% power for a .3 difference in 
post means (modest of SMD of .405), with attempted recruitment of up to 200 (given a 
possible 20 percent recruitment/screening failure rate). Individuals who withdraw or 
otherwise lost to follow-up will be included in the analysis (see below re: attrition). 
Regarding our other primary endpoint, for the having sufficient information subscale, 
(mean 2.98, standard deviation .54), 80 participants per arm would provide 72% power 
to detect a modest SMD of .40 and 60 participants would provide 78% power to detect a 
SMD of .5. For our secondary outcome, the perceived diabetes self-management scale 
(mean 2.585, standard deviation .455), 80 participants per arm would provide 72% power 
to detect SMD=.4, and 60 participants would likewise provide .78 power to detect 
SMD=.5. 
10.3 POPULATIONS FOR ANALYSES 
Study population will include only intention-to-treat (as randomized).  
10.4 STATISTICAL ANALYSES 
10.4.1 GENERAL APPROACH 
For descriptive statistics, we will present percentages for binary variables, and medians 
and means (with standard deviations and overall ranges) for continuous variables. For 

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inferential tests, marginal p-value and confidence intervals for statistical significance 
(using two-tailed tests) will be p<.05 and 95% confidence, respectively. We will specify 
covariate and other design information below. 
10.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
We will specify the primary outcome as three-month follow-up level of the Health Literacy 
Questionnaire subscales 9 and 2 (understanding written information and having enough 
in enough information) as single endpoints (not repeated measures).. 
We will compare the mean outcomes at follow-up between the treatment arms using 
analysis of covariance (ANCOVA), which compares follow-up outcome values between 
study arms while controlling for the baseline levels to gain power to detect an effect. The 
primary analysis will be an intent-to-treat (ITT); for non-monotonic missing (e.g., missing 
a baseline value), we will use multiple imputation with pattern mixture model adjustments 
in sensitivity analyses allowing for plausible differences among the missing–the 
justification for this is that pattern mixture models allow for a Missing Not At Random 
assumption, which is plausible in this case because we will not have measures for all 
likely variables associated with missingness. Pattern mixture models allow for us to set 
plausible values for missingness at both high or low levels to obtain a range of outcome 
estimates allowing for plausible missing data scenarios. For any monotonic missing– i.e., 
attrition (withdrawal or other lost to follow-up), we will use last observation carried forward 
but will also conduct sensitivity analyses using pattern mixture models under plausible 
assumptions of missing data patterns. We will present results using adjusted (least-
squares) means with standard errors, p-values, and 95% confidence intervals. Baseline 
levels of endpoint outcomes will be included as a covariate to gain power to detect an 
effect, a standard use of ANCOVA. 
10.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
The secondary endpoint will be analyzed and presented in the same manner as the 
primary endpoint, with the same model assumptions and the same approach to missing 
data. The analysis will not depend on findings or analysis of the primary endpoint. 
The secondary endpoint, like the primary endpoints, is a continuous score. 
10.4.4 SAFETY ANALYSES 
N/A 
10.4.5 BASELINE DESCRIPTIVE STATISTICS 
We will compare study arms descriptively across baseline levels of endpoints, age, 
gender, and race without inferential analysis. 
10.4.6 PLANNED INTERIM ANALYSES  

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We will conduct an interim analysis of the primary endpoints to provide data for a SBIR 
Phase II application, likely six months into the study period. The analysis, while lower-
powered, will be the same analysis as described in 2.4.2 above. The interim analysis will 
not prompt study discontinuation or participant withdrawal by the investigators. Type I 
error will be addressed in the final analysis as described in 2.4.2. 
10.4.7 SUB-GROUP ANALYSES 
We do not plan any sub-group analyses; the study is not powered for stratified analyses. 
10.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
We will not tabulate individual participant data. 
10.4.9 EXPLORATORY ANALYSES 
We will conduct an exploratory analysis of association between study adherence (level of 
use, by number of sessions, cumulative length of time of use of GogyUp Reader) and 
primary endpoint.  
11 SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
11.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
11.1.1 INFORMED CONSENT PROCESS 
The COVID-19 pandemic presents unique challenges to patient and staff safety.  Diabetic 
patients in particular are more susceptible to infection. Potential partner clinics have 
expressed concern of hosting additional personnel during the recruitment, consent, and 
enrollment phases. The team has therefore decided to conduct consent through the e-
consent procedures described below. A benefit to this approach is the opportunity to 
leverage assistive technology and communication tools to tailor the recruitment / consent 
/ enrollment process to different candidate preferences and needs for reviewing 
information and interacting with the research coordinator.  
11.1.2 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO PARTICIPANTS 
To ensure each candidate is fully informed about the study expectations and risks, 
candidates may select from a menu of options that provide various modes of 
communication to accommodate individual candidate’s preferences and allow the 
greatest amount of access to consent information, support for understanding and 
opportunities to demonstrate their understanding – at scale. 
Prior to enrollment, each candidate will meet with the research coordinator through either 
a teleconference or a video conference to confirm each candidate is fully informed about 

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the purpose, risk, and expectations for involvement in the study.  At multiple stages, a 
comprehensive study disclosure document detailing the study intervention, study 
procedures, and risks will be available to the participant.  Signed informed consent will be 
completed prior to starting the study intervention. 
To accommodate individual candidate preference, English proficiency, as well as varying 
technology literacy and print literacy skillsets, candidates will be able to choose from 
several options to receive disclosure information, engage with the study’s research 
coordinators, and proceed through the recruitment / consent / enrollment process.  
Regardless of the candidate’s chosen option, the process will progress through these 
steps: 
1) Outreach Letter via postal mail. (Recruitment) 
2) Provide Contact Information via HIPAA compliant intake form. 
3) Review Disclosure Information 
4) Confirm Consent 
5) Enrollment & Assignment 
6) Baseline Assessment 
7) Participant Provisioning 
8) Follow-Up Assessment 
9) Thank You 
All recruitment and consent materials are submitted with this protocol under section 15 
and are presented through one or more systems listed in the table below. 
 
 

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11.1.3 HIPAA COMPLIANT SYSTEMS EMPLOYED FOR INFORMED CONSENT AND ENROLLMENT 
PROCESS 
System 
Function 
HIPAA Compliance 
JotForm 
Candidate Intake 
Disclosure Information  
Signature: Informed Consent 
Baseline Assessment 
Follow-Up Assessment 
Candidate / Participant Database 
Appointment Scheduling 
https://www.jotform.com/hipaa/ 
Google 
Workspace 
Business  
HIPAA compliant e-mail 
HIPAA compliant telephone and SMS (Google 
Voice) 
Device management (for tablets requested 
by participants without intent access or 
computing device). 
HIPAA Business Associate Agreement 
Covered Services 
Zoom 
Video Conferencing for interviews and any ad 
hoc information requests candidates / 
participants might have. 
HIPAA Business Associate Agreement 
Figure 1, Study Participant Workflow, illustrates how the candidate’s engagement options 
and study disclosure and consent materials are interconnected and presented to potential 
study participants.  

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11.1.4 RECRUITMENT / CONSENT / ENROLLMENT / PLACEMENT & FOLLOW UP WORKFLOW AND DOCUMENTATION 

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Step 
Description 
Documents & Scripts 
1 
Recruitment Letter 
Research staff at M Health Fairview, the health system we are partnering with for 
recruitment, will pre-screen and develop a list of 2,000+ qualified study candidates 
based on the inclusion and exclusion criteria described previously. 
M Health Fairview mails the Candidate Recruitment Letter to those candidates.  
The letter contains top level information about the study and presents several 
ways to learn about the study and contact GogyUp’s research coordinator through 
SMS text, voice call, email, or scanning a QR code to visit the landing page for the 
study on gogyup.com (step 2a.1). 
Candidate Recruitment Letter  
 
2a.1 
Candidate Recruitment Landing Page: gogyup.com/study 
To prevent individuals not in the candidate pool from engaging with the study, the 
study’s recruitment landing page is only accessible through the QR code on the 
Recruitment Letter, the URL listed in the recruitment letter, or if individually 
provided to candidates / participants through scripted communications. The page 
is also hidden from search engines, the gogyup.com homepage and gogyup.com 
site index.  
Study Landing Page: 
gogyup.com/study 
2a.2 
Candidates may access disclosure information about the study and GogyUp Reader 
prior to choosing to contact the research coordinator through email, phone, or 
SMS texting or opting to continue on to Step 2a.2 - the intake form. 
The Candidate Intake form captures basic contact information and provides three 
options to review disclosure information, described further below in these 
sections: 
● Online review of disclosure information online and pre-
screen their level of understanding for each section (Option 
3a). 
● Receive the disclosure information as a PDF attachment via e-
mail (Option 3b). 
● Request that the research coordinator initiate a phone call 
with the candidate (Option 3c). 
● Schedule an intake call via a Zoom videoconference or phone 
conference with the research coordinator (Option 3d). 
Candidate Intake Form 
Online Disclosure Information 
& Candidate Pre-Screen Form 
 

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Step 
Description 
Documents & Scripts 
2b 
to 
2d 
Initial Candidate Contact 
If candidates choose to contact the research coordinator directly, these scripts 
serve to standardize the conversation and ensure equitable and equal access to 
information: 
● Inbound SMS text response and Outbound follow-up 
response if no reply 
● Inbound voice call script 
● Outbound voice call to candidate and follow-up script  
o Outbound voicemail message (no answer / no reply 
follow-up) 
● Inbound eMail response script (automated)  
● Outbound eMail response follow-up if no reply (automated) 
o both email messages will contain links to the Online 
Disclosure Document and Consent Form 
All communication with an individual candidate and participant is captured in a 
HIPAA-compliant JotForm database record for that individual.   
Study Landing Page: 
gogyup.com/study 
 
Scripts: 
● SMS Response 
● SMS Follow-Up 
● Incoming Call 
● Voicemail Greeting 
● Outbound Follow-Up 
● Voicemail Follow-Up 
– 1st Message 
● Voicemail Follow-Up 
– 2nd Message / No 
Response 
● Outbound eMail 
Response 
(automated) 
● Outbound eMail – No 
Response 
(automated) 

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Step 
Description 
Documents & Scripts 
3a 
Study Disclosure Document and Pre-Screening Form 
The Study Disclosure Document and Pre-Screening Form is modeled off of Pearl 
Pathways’ consent documentation: the All-in-One Consent Form and the Federally 
Required Elements for Consent.  
Disclosure information is arranged thematically. To ensure equitable access to 
information, each content section contains a verbatim audio recording of the text 
content.  Following each section is a screening question that asks the candidate to 
indicate whether they understand the information covered in each disclosure 
document section or if the candidate needs additional information: 
Prompt: Do you understand [ topic ]? 
A) Yes. 
B) I have a question. 
C) I want this explained to me 
We will assume that candidates answering with choice C may be indicating they do 
not understand the information and the research coordinator should be prepared 
to explain the topic during the consent interview. 
Each section also lists the contact information for the research coordinator (text 
messaging / phone / email) should the candidate want to stop and ask questions 
directly. 
Please note:  the screening questions are not designed to exclude candidates from 
the study.  Rather, their purpose is to provide the research coordinator with 
advance knowledge of each candidate’s depth of understanding in order to 
facilitate an efficient and productive consent interview (step 4). 
 
Online Study Disclosure 
Document & Pre-Screening 
Form 
3b 
Review Consent via Email 
The Study Disclosure Document and Screening Form will be sent as a password-
protected, PDF attachment to the candidate’s email address in 2a – d.  Each 
attachment will have a unique identifier and will be pre-filled with the candidate’s 
contact information.   If candidate chooses to respond to prompts within the PDF, 
the candidate’s study database record will be updated with the candidate’s 
responses.  
eMail text contains: 
● contact information for research coordinator 
● option to schedule an intake call for 1:1 consent review 
● option to complete consent review online 
Password to access the document will be texted or shared in a follow-up call with 
the candidate. 
Study Disclosure Document 
(PDF) 
Script: 
● eMail – Outgoing 
eMail – Disclosure 
Review 
 

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Step 
Description 
Documents & Scripts 
3c 
Research Coordinator Calls Candidate 
Candidate chooses this option by indicating their preference on the intake form 
accessed through gogyup.com/study. 
Research Coordinator (RC) is notified via automation from JotForm and schedules 
the call, when possible, according to preferred time windows the candidate 
indicated on the intake form. 
During the call, the RC will review and complete the Online Disclosure Document 
and Prescreening Form (Option 3a) with the Candidate.  The candidate will receive 
a copy of the disclosure document and form responses via email which will also be 
automatically added to the candidate’s database record. 
If the candidate chooses to proceed, the call may continue to Step 4, 5, 6, and 7 
with the option to switch to an online video session through Zoom. 
Online Study Disclosure 
Document & Prescreening 
Form 
Script: 
● Step 
3c: 
Intake 
Interview Script  
 
3d 
Schedule Intake Call with Research Coordinator 
Candidate chooses this option by selecting the Intake Call option on the intake 
form, choosing an open timeslot in the JotForm form and whether the call should 
be a tele- or videoconference.  
As with Step 3c, the research coordinator will review the Online Disclosure 
Document and Pre-Screening Form with the Candidate in real time and the 
candidate will receive a copy of the form via email to review prior to the Consent 
Confirmation step.  
If the candidate chooses to proceed, the call may continue to Step 4, 5, 6, and 7 
with the option to switch to an online video session through Zoom. 
Online Study Disclosure 
Document & Pre-Screening 
Form 
Jotform Intake page 
Scripts: 
eMail opt-in confirmation  
eMail opt-in  
4 
Consent Interview & Signatures 
After the candidate has had the option to review the study disclosure 
information, this step is to provide consent authorization. 
This step is broken into three sub-steps: 
4a: Schedule Interview 
4b: Consent Interview 
4c: Consent Signature 
Depending on their choices through the workflow, candidates may not experience 
all three. 
Online Consent Form 
4a 
Schedule Interview 
Ideally, this step is needed only if the candidate does not have the time (10 to 15 
minutes) to review the study disclosure information with the researcher 
coordinator. This option is designed to efficiently schedule a follow-up session 
with the candidate. 
JotForm Consent Interview 
page 
Scripts: 
eMail: opt-in confirmation  
eMail: opt-in reminder email 

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Step 
Description 
Documents & Scripts 
4b 
Consent Interview 
This interview is a scheduled online / over-the-phone session between the 
research coordinator, the candidate. 
Once the candidate joins the phone or online conference, the coordinator: 
1. Reviews with the candidate’s unanswered questions noted 
on the online disclousre document and consent form.  
2. Asks open-ended questions to assess the depth of the 
candidate’s comprehension of the study and the activity the 
candidate is consenting to. 
If the coordinator confirms the candidate has demonstrated understanding, the 
candidate is invited to sign the consent form (step 4c). 
Note: the script outlines two sub-procedures if the candidate does not 
demonstrate sufficient depth of comprehension: 
1 
If the candidate states they are unable to read the information in the Online 
Disclosure Document or responses indicates their level of literacy or English 
proficiency would prevent understanding, a witness will be added. 
2 
To ensure the most inclusive study population, candidates have the option 
to reschedule if they need more time and interaction with the coordinator 
to understand the research and the risks and benefits involved. 
Online Study Disclosure 
Information and Prescreening 
Form 
Script: Step 4b - Consent 
Confirmation Interview 
4c 
Consent Signature 
To gather the candidate’s consent signature, the research coordinator launches a 
video conference in ZOOM, an accessible and HIPAA-compliant video / audio 
conferencing and screen sharing program and shares the conference link as well as 
a link to the online JotForm form to be signed.  
 
 
Script: Step4c – Consent 
Signature 
Online Consent Form 
5 
Enrollment & Assignment 
The research coordinator verifies the participant’s contact information and mailing 
address where the participant may securely receive packages. 
The research coordinator then refers to the allocation sequence to determine 
intervention or comparison arm for the newly recruited participant. 
Depending on the result, the participant in placed in the control or GogyUp Reader 
group. 
If the participant is out of time, the RC schedules a baseline assessment with the 
participant prior to officially enrolling the participant. 
Script: Step 5 - Enrollment & 
Assignment 
Randomization Allocation 
Sequence 

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Step 
Description 
Documents & Scripts 
6 
Baseline Assessment & Onboarding 
Research coordinator (RC) conducts the baseline assessment (remotely and 
preferably through Zoom video conference) of the Health Literacy Questionnaire 
(HLQ) with additional demographic questions for patient age in years, gender, 
self-identified race and ethnicity, and duration of diabetes diagnosis.  
Before the participant signs-off, the RC will schedule and/or confirm the Follow-
Up assessment, ideally scheduled close to any follow-up appointment the 
participant has scheduled with their provider.  
The script for this step includes procedures for if the participant misses the 
appointment.  After 3 attempts (or 4 attempts if we are towards the end of the 
recruitment phase), the RC will mark the participant as inactive and then mark the 
participant as “discontinued” if a new candidate is enrolled in the previous 
participant’s place. 
If there is enough time and the participant has a mobile device, the RC will walk 
the participant through how to download GogyUp and create an account on their 
device or access GogyUp’s webapp. 
Scripts: 
● Baseline 
Assessment 
(Phone or Online 
Meeting) 
● SMS Script – 1 Day 
Reminder 
● Voicemail – 
Missed 
Appointment 
● SMS Script – 
Missed 
Appointment 
Online Health Literacy 
Questionnaire (HLQ) 
Online Demographic 
Questionnaire 
7 
Provisioning 
RC will enroll the participant in the assigned group. 
An administrative assistant will send out: 
Intervention 
Control 
● Directions for 
downloading the 
mobile app or accessing 
the webapp. 
● Directions for creating a 
GogyUp account and 
signing into the study’s 
walled library. 
● Enrollment Notice to 
Provider 
● Packet of reading 
materials sent weekly 
● Enrollment Notice to 
Provider 
RC will be provided daily activity reports by the administrative assistant. If a 
participant’s account as no activity at the start of the study period, the RC will 
contact the participant to ensure they have access to GogyUp and are able to log 
in. 
Scripts:  
● Shipment 
Notification SMS / 
eMail  
. 
● Enrollment Notice 
to Provider 

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Step 
Description 
Documents & Scripts 
8 
Follow-Up Assessment 
RC conducts the follow-up assessment (remotely via phone or video call) of the 
HLQ. 
The script for this step includes procedures for if the participant misses the 
appointment.  After 3 attempts (or 4 attempts towards the end of the 
recruitment phase), the RC will mark the participant as “lost to follow up”. 
If the participant was supplied with a GogyUp tablet supplied, the RC will ask if 
the participant would prefer to hold on to the tablet instead of a gift card. 
. 
Scripts:  
● Follow-Up 
Assessment 
(Phone or Online 
Meeting) 
● SMS Script – 1 Day 
Reminder 
● Voicemail – 
Missed 
Appointment 
● SMS Script – 
Missed 
Appointment 
Health Literacy Questionaire 
(HLQ) 
9 
Thank You Procedure and Notices 
The RC will send participants who completed the Follow-Up Assessment and 
Follow-Up Appointment thank you note that either contains a $25 gift card to 
reimburse network expenses / thank you for participating (if control group) or a 
notice that the tablet is now unlocked as may be used by the participant for their 
personal use. 
Scripts:  
● Thank You Note 
11.1.5 STUDY DISCONTINUATION AND CLOSURE 
This study may be temporarily suspended or prematurely terminated if there is sufficient 
reasonable cause. Written notification, documenting the reason for study suspension or 
termination, will be provided by the suspending or terminating party to study participants, 
funding agency, and regulatory authorities. If the study is prematurely terminated or 
suspended, the Principal Investigator (PI) will promptly inform study participants, the 
Institutional Review Board (IRB), and sponsor/funding agency and will provide the 
reason(s) for the termination or suspension. Study participants will be contacted, as 
applicable, and be informed of changes to study visit schedule. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
● Determination of unexpected, significant, or unacceptable risk to participants 
● Insufficient compliance of study staff to the protocol (i.e., significant protocol 
violations) 
● Data that are not sufficiently complete and/or evaluable 

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The study may resume once concerns about safety, protocol compliance, and data quality 
are addressed, and satisfy the funding agency, sponsor, IRB, or other relevant regulatory 
or oversight bodies (OHRP, DSMB). 
11.1.6 CONFIDENTIALITY AND PRIVACY  
Participant confidentiality and privacy is strictly held in trust by the participating 
investigators, staff, and the funding agency. This confidentiality is extended to the data 
being collected as part of this study. Data that could be used to identify a specific study 
participant will be held in strict confidence within the research team. No personally 
identifiable information from the study will be released to any unauthorized third party 
without prior written approval of the funding agency. All research activities will be 
conducted in as private a setting as possible. 
Authorized representatives of the funding agency, or representatives of the Institutional 
Review Board (IRB) may inspect all documents and records required to be maintained by 
the investigator 
The study participant’s contact information will be securely stored for internal use during 
the study. At the end of the study, all records will continue to be kept in a secure location 
for as long a period as dictated by the reviewing IRB, Institutional policies, or 
sponsor/funding agency requirements. 
Study participant research data, which is for purposes of statistical analysis and scientific 
reporting, will be transmitted to and stored in a secure server maintained by the University 
of Minnesota Academic Health Center Information Exchange or by University of 
Minnesota Information Technology office; the storage and access space for the data will 
be HIPAA compliant and include  Includes encryption, activity logging, Duo Two-Factor 
Authentication, and access controls such as view-only access..\ This will not include the 
participant’s contact or identifying information. Rather, individual participants and their 
research data will be identified by a unique study identification number. The study data 
entry and study management systems used by research staff will be secured and 
password protected. At the end of the study, all study databases will be de-identified and 
archived at the Data Repository for the University of Minnesota (DRUM). 
Measures Taken to Ensure Confidentiality of Data Shared per the NIH Data Sharing 
Policies  
It is NIH policy that the results and accomplishments of the activities that it funds should 
be made available to the public (see https://grants.nih.gov/policy/sharing.htm). The PI will 
ensure all mechanisms used to share data will include proper plans and safeguards for 
the protection of privacy, confidentiality, and security for data dissemination and reuse 
(e.g., all data will be thoroughly de-identified and will not be traceable to a specific study 
participant). Plans for archiving and long-term preservation of the data will be 
implemented, as appropriate.  
11.1.6.1 CERTIFICATE OF CONFIDENTIALITY  
To further protect the privacy of study participants, the Secretary, Health and Human 
Services (HHS), has issued a Certificate of Confidentiality (CoC) to all researchers 

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engaged in biomedical, behavioral, clinical or other human subjects research funded 
wholly or in part by the federal government.  Recipients of NIH funding for human subjects 
research are required to protect identifiable research information from forced disclosure 
per the terms of the NIH Policy (see https://humansubjects.nih.gov/coc/index). As set 
forth in 45 CFR Part 75.303(a) and NIHGPS Chapter 8.3, recipients conducting NIH-
supported research covered by this Policy are required to establish and maintain effective 
internal controls (e.g., policies and procedures) that provide reasonable assurance that 
the award is managed in compliance with Federal statutes, regulations, and the terms 
and conditions of award. It is the NIH policy that investigators and others who have access 
to research records will not disclose identifying information except when the participant 
consents or in certain instances when federal, state, or local law or regulation requires 
disclosure. NIH expects investigators to inform research participants of the protections 
and the limits to protections provided by a Certificate issued by this Policy. 
11.1.7 FUTURE USE OF STORED SPECIMENS AND DATA  
Data collected for this study will be analyzed and stored in a secure server maintained by 
the University of Minnesota Academic Health Center Information Exchange or by 
University of Minnesota Information Technology office; the storage and access space for 
the data will be HIPAA compliant and include encryption, activity logging, Duo Two-Factor 
Authentication, and access controls such as view-only access. After the study is 
completed, the de-identified, archived data will be transmitted to and stored at the Data 
Repository for the University of Minnesota (DRUM), for use by other researchers including 
those outside of the study. Permission to transmit data to the DRUM will be included in 
the informed consent.  Access to study data will be provided through the DRUM. 
 
11.1.8 KEY ROLES AND STUDY GOVERNANCE 
 
Principal Investigator 
Principal Investigator 
Independent Safety Monitor: Data 
Safety 
and 
Monitoring 
Board 
(DSMB) 
Nathan 
Shippee, 
PhD, 
Associate Professor 
Ned Zimmerman-Bence, CEO / 
Co-Founder 
TBD; see DSMB in 11.1.9. 
University of Minnesota 
GogyUp Inc 
 
D375 Mayo Building MMC 
729 
University of Minnesota 
420 Delaware Stree SE 
Minneapolis, MN 55455 
825 Washington Ave SE 
Suite 220 
Minneapolis, MN 55414 
 
 
612-624-3579 
612-460-5358 
 

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nshippee@umn.edu 
ned.zb@gogyup.com 
 
11.1.9 SAFETY OVERSIGHT - DSMB 
Safety oversight will be under the direction of a Data and Safety Monitoring Board (DSMB) 
composed of individuals with the appropriate expertise, including trial conduct and 
research data storage and use. Members of the SMC will be independent from the study 
conduct and free of conflict of interest. The SMC will meet at least semiannually to assess 
safety and efficacy data from each arm of the study. The SMC will operate under the rules 
of an approved charter that will be written and reviewed at the organizational meeting of 
the DSMB. At this time, each data element that the SMC needs to assess will be clearly 
defined. The DSMB will provide its input to National Institutes of Health staff. 
 
11.1.10 
CLINICAL MONITORING 
Despite being a randomized controlled trial, this study will take place outside of the clinical 
environment and examines an intervention that is used outside of any clinical site. The 
research team also does not have access to clinical information for monitoring and the 
research team has no specific clinical role or clinical access with the possible exception 
of Dr. Rogers in general terms as a practicing clinician-researcher.  
11.1.11 
QUALITY ASSURANCE AND QUALITY CONTROL 
The investigator team will perform internal quality management of study conduct, data 
collection, documentation and completion.  
Quality control (QC) procedures will be implemented as follows: 
Informed consent --- Study staff will review both the documentation of the consenting 
process as well as a percentage of the completed consent.  This review will evaluate 
compliance with GCP, accuracy, and completeness.  
Source documents and the electronic data --- Data will be initially captured on source 
documents (see Section 11.2, Data Handling and Record Keeping) and will ultimately 
be entered into the study database. To ensure accuracy, study staff will compare a 
random sample of source data documents against the database, targeting key data points 
in that review. 
Intervention Fidelity — Consistent delivery of the study interventions will be monitored 
throughout the intervention phase of the study. Procedures for ensuring fidelity of 
intervention delivery are described in Section 7.2.1, Interventionist Training and 
Tracking.  
Protocol Deviations – The study team will review protocol deviations on an ongoing 
basis and will implement corrective actions when the quantity or nature of deviations are 
deemed to be at a level of concern. 

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Should independent monitoring become necessary, the PI will provide direct access to all 
trial related sites, source data/documents, and reports for the purpose of monitoring and 
auditing by the sponsor/funding agency, and inspection by local and regulatory 
authorities. 
11.2 DATA HANDLING AND RECORD KEEPING  
11.2.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection will be the responsibility of the study staff under the supervision of the 
principal investigators. The investigators will be responsible for ensuring the accuracy, 
completeness, legibility, and timeliness of the data reported.  
All source documents will be completed electronically with timestamped activity. End-user 
data generated in GogyUp Reader will be stored internally by GogyUp by study id and 
merged with other participant data for exploratory analysis of “adherence” and literacy. 
Data recorded in the electronic case report form (eCRF) derived from source documents 
will be consistent with the data recorded on the source documents.  
Source document data will be exported from JotForm HIPAA compliant webforms via 
CSV and be entered into REDCap, a 21 CFR Part 11-compliant data capture system 
available to the study team through the University of Minnesota’s Clinical and 
Translational Sciences Institute. The data system includes password protection and 
internal quality checks, such as automatic range checks, to identify data that appear 
inconsistent, incomplete, or inaccurate. Clinical data will be entered directly from the 
source documents.  
11.2.1.1 STUDY RECORDS RETENTION  
Any source document records containing HIPAA PHI will be maintained for a minimum of 
6 years after the end of the study in REDCap (follow-up assessments complete or lost to 
follow up met for all participants) AND Federal Financial Report (FFR) submission.  Other 
records will be maintained for a minimum of 3 years. 
11.2.2 PROTOCOL DEVIATIONS   
This protocol defines a protocol deviation as any noncompliance with the clinical trial 
protocol, International Council on Harmonisation Good Clinical Practice (ICH GCP), or 
Manual of Procedures (MOP) requirements. The noncompliance may be either on the 
part of the participant, the investigator, or the study site staff. As a result of deviations, 
corrective actions will be developed by the site and implemented promptly.  
These practices are consistent with ICH GCP:  
• 
Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3  
• 
Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1  
• 
Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2.  

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It will be the responsibility of the investigators to use continuous vigilance to identify and 
report deviations within three working days of identification of the protocol deviation. All 
deviations will be addressed in study source documents, reported to NINR Program 
Officer and sent to the reviewing Institutional Review Board (IRB) per their policies. The 
site investigator will be responsible for knowing and adhering to the reviewing IRB 
requirements.  
11.2.3 PUBLICATION AND DATA SHARING POLICY  
This study will be conducted in accordance with the following publication and data sharing 
policies and regulations: 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public 
has access to the published results of NIH funded research. It requires scientists to submit 
final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive 
PubMed Central upon acceptance for publication. 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination 
of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results 
Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and 
results information from this trial will be submitted to ClinicalTrials.gov. In addition, every 
attempt will be made to publish results in peer-reviewed journals. Data from this study 
may be requested from other researchers 5 years after the completion of the study period 
by contacting Co-PI Shippee. Considerations for ensuring confidentiality of these shared 
data are described in Section 10.1.3. 
11.2.4 CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence is critical. 
Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. 
Furthermore, persons who have a perceived conflict of interest will be required to have 
such conflicts managed in a way that is appropriate to their participation in the design and 
conduct of this trial. The study leadership in conjunction with the NINR has established 
policies and procedures for all study group members to disclose all conflicts of interest 
and will establish a mechanism for the management of all reported dualities of interest. 
12 Additional Considerations 
N/A 
13 Abbreviations and Special Terms 
 
A1c 
A1C is a blood test for type 2 diabetes and prediabetes. 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 

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CFR 
Code of Federal Regulations 
CLIA 
Clinical Laboratory Improvement Amendments 
CMP 
Clinical Monitoring Plan 
COC 
Certificate of Confidentiality 
CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DRUM 
Data Repository for the University of Minnesota 
DSMB 
Data Safety Monitoring Board 
DRE 
Disease-Related Event 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act of 2007 
FFR 
Federal Financial Report 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
GWAS 
Genome-Wide Association Studies 
HIPAA 
Health Insurance Portability and Accountability Act  
IB 
Investigator’s Brochure 
ICH 
International Council on Harmonisation  
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ITT 
Intention-To-Treat 
LSMEANS 
Least-squares Means 
MedDRA 
Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
NIH IC 
NIH Institute or Center 

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NINR 
National Institute for Nursing Research 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
RC 
Research Coordinator 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
TBD 
To be determined 
UP 
Unanticipated Problem 
US 
United States 
 
 
 

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14 Protocol Amendment History 
The table below is intended to capture changes of IRB-approved versions of the protocol, 
including a description of the change and rationale. A Summary of Changes table for 
the current amendment is located in the Protocol Title Page.  
Version 
Date 
Description of Change  
Brief Rationale 
1.1 
11/06/2023 
Removed collection of A1c 
Switched 
health 
literacy 
measure to  Health Literacy 
Questionairre 
Collecting 
A1c 
was 
determined 
to 
be 
unnecessary for measuring 
outcomes. 
 
Health 
Literacy 
Questionairre 
provides 
broader 
measure 
of 
participant health literacy. 
1.2 
12/26/2023 
Revised allocation 
Revisions better 
accommodate remote 
enrollment. 
1.3 
01/06/23 
Revised assent procedure. 
Alignment with University 
of Minnesota’s standard 
practice. 
1.4 
02/10/2023 
Revised 
ICF 
to 
include 
language required by UofMN 
IRB 
Alignment with University 
of Minnesota Institutional 
Review Board 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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15 Subject-Facing Materials and Scripts 
15.1 STEP 1: RECRUITMENT LETTER 
Our recruitment partner, M Health Fairview, will develop a list of 2,000 or more candidates 
based on the inclusion and exclusion criteria (Sections 6.1 and 6.2) and then mail the 
letter displayed on the next page to that candidate pool.  GogyUp will not have access to 
the information contained in the list of candidates and will only be able to communicate 
with candidates who opt to contact GogyUp through any of these methods: 
● Phone 
● SMS Text 
● E-Mail 
● Visiting the study’s landing page gogyup.com/study. 
o Please note – gogyup.com/study is hidden from search engine indexing and 
gogyup.com’s site map. Only candidates who received a letter from M 
Health Fairview or contact the research coordinator will have the URL 
address. 

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15.2 STEP 2: CANDIDATE OPT-IN 
The candidate opt-in process begins with the candidate selecting how to respond to the 
recruitment letter: 
A. Scan the QR code or use the URL www.gogyup.com/study, both listed on the 
recruitment letter, to access the study’s landing page. The Landing Page provides 
an abbreviated study summary and provides choices for how the candidate may 
proceed:  
1. Complete an online intake form. 
2. Set up an appointment to speak with the research coordinator (3d). 
3. Contact the research coordinator directly through email, phone, or text.  
B. Email the research coordinator (2b) 
C. Call the research coordinator (2c). 
D. Text the research coordinator (2d). 
 
 

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15.2.1 STEP 2A.1: RECRUITMENT LANDING PAGE AT GOGYUP.COM  
Candidates who scan the recruitment letter’s QR code or enter the URL 
gogyup.com/study into a browser will land on the landing page, responsive to phone, 
tablet, and PC screens (full text is listed in section 15.2.1.1 below).   
 
 
 
Figure SEQ Figure \* ARABIC2: Recruitment Landing Page - 
 
Figure 3: Recruitment Webpage - Mobile Client View 

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15.2.1.1 LANDING PAGE TEXT 
The following landing page text is the same for both desktop and mobile views and uses 
the same language as a candidate would have encountered in the candidate recruitment 
letter: 
Welcome to Our Study! 
Your participation will help determine if reading diabetes information in the GogyUp Reader: 
● Makes the information easier to understand. 
● Helps patients improve their knowledge of how to care for diabetes. 
As a participant, you will: 
● Read information on type 2 diabetes using print materials or the GogyUp Reader 
app.  
● Meet twice with research staff to fill out short surveys on your health knowledge.  
● Receive compensation for cellular data and/or gift cards for participation. No phone? 
No problem! A limited number of tablets with cellular data will be available. 
Interested in joining? Need more information? 
Please fill out this form.  
~ or ~ 
Schedule an intake interview with our research coordinator.  
~ or ~ 
Text / call our research coordinator at 612-208-3078 
 
Questions? 
Please feel free to contact our research coordinator anytime: 612-208-3078 or 
research@gogyup.com 
You may also review the consent information here. 
A note from M Health Fairview: 
  
At M Health Fairview, we are dedicated to helping researchers who look for new and better 
ways to deliver healthcare. We work together across our hospitals, clinics, and research 
teams to provide our patients the option to participate in research projects.  The decision to 
participate is completely up to you.  
If you do not want to be contacted about future studies, contact the Fairview research office 
at 651.326.4450 or researchscreening@fairview.org and request that your medical record is 
labeled "Research Opt Out". 
 
This study has been registered at clinictrials.gov and assigned national clinical trial number: 
NCT05337306 
Direct link to JotForm 
schedule page. 
Direct link to the 
intake form. 
Google Voice (HIPAA 
compliant) number to 
receive text and voice 
calls. 
Direct link to study on 
clincialtrials.gov 

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Research is supported by the National Institute Of Nursing Research of the National 
Institutes of Health under Award Number R43NR020340. The content is solely the 
responsibility of the GogyUp and does not necessarily represent the official views of the 
National Institutes of Health.   
 
 

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15.2.2 STEP 2A.2: ONLINE INTAKE FORM 
The online intake form is developed within the HIPAA 
compliant JotForm system (as indicated in Figure 3 
Intake Form Screenshot – see bottom right had 
corner).  Both sections of the form have audio 
playback available should a candidate prefer to have 
the information read to them. 
The intake form’s full text is posted below. 
A critical step occurs is the form’s step 2: the 
candidate is prompted to choose how to review the 
study disclosure information: 
A. Review the Study Disclosure Document and 
answer preliminary screening questions to 
indicate their understanding of the disclosure 
information 
– 
step 
Option 
3a 
below.  
 
Please note: Asking the candidate to indicate 
their level of understanding is not intended to 
be the only indicator of understanding or to 
screen out candidates. Rather, it is to 
streamline the process and flag any potential 
issues for the research coordinator to cover 
during the consent interview.  
B. Have the Study Disclosure Document sent via 
email as a PDF.  The candidate will be given 
the opportunity to follow a link to an online 
version with audio descriptions for each 
section. 
C. Request the research coordinator call the 
candidate to review the disclosure information 
together. 
D. Schedule an intake interview to review the 
disclosure information together. 
If the candidate choses to contact the research 
coordinator directly through email, text, or by phone, 
the research coordinator will use the intake form to 
capture the candidate’s contact information and 
provide the candidate with the same options for 
reviewing the study disclosure information. 
 
 
 
Figure  SEQ Figure \* ARABIC 3 Intake Form 
S
h t

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15.2.2.1 ONLINE INTAKE FORM TEXT
GogyUp and University of Minnesota   
Assistive-Reading Technology and Diabetes Study 
 
Dear Candidate, 
Thank you for your interest in 
our study! If you decide 
to participate, you will help determine if GogyUp’s assistive-reading technologies can: 
● Make diabetes education materials easier to understand. 
● Help patients improve their understanding of how to care diabetes.  
Next Steps:  
1. Provide us some contact information. 
2. Review information to help you decide if you want to participate in the study. 
3. Attend a short phone or online interview to review the study's goal, your role in the study and 
answer any questions.  
 
A note from M Health Fairview:  
At M Health Fairview, we are dedicated to helping researchers who look for new and better ways 
to deliver healthcare. We work together across our hospitals, clinics, and research teams to 
provide our patients the option to participate in research projects.  Your medical records show 
that you may be able to take part in a new study.   
The decision to participate is completely up to you. If you do not want to be contacted about future 
studies, contact the Fairview research office at 651.326.4450 or researchscreening@fairview.org 
and request that your medical record is labeled "Research Opt Out". 
Step 1: Your Contact Information 
Note: GogyUp will never share your information unless you give us permission. 
What name do you prefer we call you? * 
 
How would you like us to pronounce your preferred name? 
 
What is your legal name? * 
 
 

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Prefix 
First Name 
Last Name 
Suffix 
Phone Number * 
 
Please enter a valid phone number. 
What are the best times to reach you Monday to Friday? * 
c 
8:00 AM to 11:00 AM 
c 
11:00 AM to 1:00 PM 
c 
1:00 PM to 4:00 PM 
c 
4:00 PM to 7:00 PM 
Can you receive text messages at {phoneNumber}? * 
o Yes - you may send text messages. 
o No -  do not send me text messages. 
Your Email Address * 
 
 
Step 2: Disclosure and Informed Consent 
FAQ 
Thank you, {preferredName}!  
We (GogyUp Inc and the University of Minnesota researchers) are asking if you would like to be in a 
research study.  
It is therefore our job to provide you (to disclose) with as much information as possible to help you decide 
if you want to participate in our study.   
Informed consent is the process to make sure you have the information you need to decide if you want to 
participate. 
Before you decide to provide your consent to participate, there is specific information you will need to learn 
about the study.  
How do you want to review the information about the study? * 
o Review online. 
o Download and review on my own. 
o Have the research coordinator call me. 
o Meet with the research coordinator over the phone or online.
 
 
 
 

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15.2.2.2 EMAILED CONFIRMATION OF INTAKE INFORMATION  
Once the candidate submits their information on the intake form, they will receive the 
following email confirmation - sent to the address the candidate provided.   
 
Figure 4: Email Notification to Candidate - Summary Intake & Next Steps 
 
 
15.2.3 STEP 2B: EMAIL CONTACT SCRIPTS 
Direct link to online disclosure information and 
screening form. 
Direct link to disclosure information in PDF form.  
Direct link to intake interview scheduling page. 
Lists the choice candidate made on intake form. 
Provides link to requested resources (e.g., link to 
online consent information form). 

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If the candidate chooses to contact the research coordinator by email, the following scripts 
will be used to respond. 
15.2.3.1 OUTGOING EMAIL RESPONSE TO INTEREST 
SUBJECT: GogyUp / U of MN Research 
Hello, 
I am [your name], the GogyUp Research Coordinator, responding to your interest in our 
study.     
I want to be sure I answer any questions you might have about the study.  
Can we schedule a time to meet online or over the phone or online in Zoom?  
If you decide to join study after we talk, I can help you with our enrollment process.  
Please let me know: 
1) A time and day to meet for 10 to 15 minutes.  
2) If you prefer a phone call or to meet online.  
You can also schedule a time here: gogyup.com/intake 
I have attached a document that has the information we will cover in our meeting. 
You are not expected to read it before we meet. 
Thank you, [INSERT PARTICIPANT NAME].  I look forward to meeting with you 
soon! 
Sincerely, 
[ YOUR NAME HERE] 
GogyUp Research Coordinator 
Phone / Text:  612-208-3078 
NOTE TO RESEARCH COORDINATOR: Record contact attempt in JotForm database. 
 
The following email is sent if the research coordinator has not received a response from 
the candidate after a 3 to 5 business days. 
15.2.3.2 OUTGOING EMAIL – FOLLOW UP FOR NO RESPONSE 
Hello, this is [ YOUR NAME ], the GogyUp Research Coordinator.   
Thank you so much for you contacting us earlier about our study! Are you still interested? 
If you are, lease either: 
● schedule a time for 10 – 15 minute intake interview here: gogyup.com/intake 
● respond to this message with a few days and times that is convenient for 
you. 

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I re-attached the consent information document.  You are not expected to read it 
before we meet. 
If you are not interested, no problem! Please let me know so that I stop trying to contact 
you.  
Thank you, [INSERT PARTICIPANT NAME].   
I hope to meet with you soon! 
Sincerely, 
[YOUR NAME HERE] 
GogyUp Research Coordinator 
Phone / Text: 612-460-5358 
NOTE TO RESEARCH COORDINATOR: Record contact attempt in JotForm database. 
15.2.4 STEP 2C: VOICE CONTACT 
If the candidate chooses to contact the research coordinator by phone, the following 
scripts will be used to respond. 
15.2.4.1 ANSWERING INCOMING CALL 
Hello, this is [your name] – GogyUp Research Coordinator.   
How may I help? 
If a candidate indicates they are interested in participating in the study: 
1. Capture their information using the online Intake form – Step 2a.2. 
2. Review the Online Disclosure Document and Candidate Response Form with 
them – Step Option 3a – preferably through a Zoom video sharing session. 
3. Reference the Online Disclosure Document when answering questions about 
study. 
4. If appropriate and the candidate has the time, move onto Step 4 – Consent 
Interview 
15.2.4.2 VOICEMAIL GREETING 
Hello, this is [your name] – GogyUp Research Coordinator.   
I am sorry I am not able to answer your call right now.   
If you are interested in participating in or have questions about our type 2 diabetes study, 
please leave your name, number, and a few times that would be convenient for me to 
return your call.   
You may also find answers and complete an intake form at gogyup.com slash study.  
That’s g o g y u p dot com slash s t u d y. 

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Thank you! 
If caller left contact information: 
 
1) Review JotForm database to check if candidate already filled out an intake form. 
a. Add any additional info caller has left. 
b. If no record has been created for the candidate, add information. 
c. Return candidate’s call according to any suggested window.  
2) Forward any non-candidate voice messages to Ned Zimmerman-Bence: 
ned.zb@gogyup.com 
 
15.2.4.3 VOICEMAIL FOLLOW UP – 1ST MESSAGE 
Hello, this is [your name], the GogyUp Research Coordinator responding to a message 
you left about our study.   
I am sorry I missed you.  When you have a moment, please try calling me again or you 
may also text me at 612-208-3078.   
You may also find answers and complete an intake form at gogyup.com slash study.  
That’s g o g y u p dot com slash s t u d y. 
Thank you! 
NOTE TO RESEARCH COORDINATOR: Record contact attempt in JotForm database. 
15.2.4.4 VOICEMAIL SCRIPT FOLLOW-UP – 2ND MESSAGE / NO RESPONSE 
Hello, this is [your name], the GogyUp Research Coordinator.   If you are interested in 
our study, I’m available to answer any questions. Please try calling me again or you may 
also text me at 612-208-3078.   
You may also find answers and complete an intake form at gogyup.com slash study.  
That’s g o g y u p dot com slash s t u d y. 
Thank you! 
NOTE TO RESEARCH COORDINATOR: Record contact attempt in JotForm database. 
 
15.2.5 STEP 2D: SMS CONTACT 
If the candidate chooses to contact the research coordinator by text messaging, the 
following scripts will be used to respond. 
15.2.5.1 SMS RESPONSE SCRIPT 
Hello, this is [your name] – GogyUp Research Coordinator.   

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Are you interested in the GogyUp / U of MN study?   
If individual expresses interest in the study, ask how they heard about it.   
 
Great!  How did you hear about the study? 
Proceed only if they state they heard about it through a letter mailed to them.   
 
Do you have any questions I can answer?    
Reference the Online Disclosure Document (in JotForm) when answering questions 
about study. 
 
If individual expresses interest in enrolling, ask for their first name, last name and 
explain the next steps: 
Excellent.  The next step is to review some information about the study before you provide 
consent to participate.  Do you have 10 to 15 minutes now to meet online or by phone?  
If the individual can’t meet at the moment, send them the gogyup.com/intake link to 
establish a time to meet online.  
 
If individual can meet now, determine whether they prefer to meet over the phone or 
online.  Send the link to the Zoom meeting environment or use Google Voice to call the 
candidate.  
 
Follow the script for Step 3c – Outgoing Call.  
 
NOTE TO RESEARCH COORDINATOR: Capture text record and add it to candidate’s 
record in the JotForm database.   
 
15.2.5.2 SMS FOLLOW UP – NO RESPONSE 
Hello, this is [your name] – GogyUp Research Coordinator.   
We received a text from this number. Are you were interested in the GogyUp / U of MN 
study?   
Do you have a question about the study?   
If individual responds, follow the SMS Response Script (see above) from here. 
15.3 STEP 3: DISCLOSURE OF INFORMATION AND CONSENT INFORMATION PRESCREENING  

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Process Overview: The research coordinator will use these steps for orienting a 
candidate to the research and help each candidate decide whether they will participate. 
The main objective is to fully explain the study to the candidate, providing all pertinent 
information (purpose, procedures, risks, benefits, alternatives to participation), and allow 
the candidate ample opportunity to ask questions. 
NOTE: "Sufficient time" can range from minutes to days, depending on how long it 
reasonably takes to evaluate the procedures, risks, potential benefits, and alternative 
treatments. If it is clear that the participant may need longer than a scheduled phone or 
online conversation, arrange for a follow up call or to take questions via email and text 
messaging, depending on candidate preference. 
Candidates are given four options for reviewing the disclosure document prior to 
providing consent:  
 
● Option 3A: The candidate continues on to review the online Study Disclosure 
Document and completes the Prescreening Form independently, confirming whether 
they understand or do not understand a section through a multiple-choice question 
before continuing on to the next session. 
 
Each section in the document has a verbatim recording (in English) to ensure the 
candidate understands each of the section of the disclosure document. 
 
The candidate’s answers will be recorded in JotForm and available to the Research 
Coordinator to review prior to calling the candidate and proceeding to Step 4: 
Consent Interview and Signatures. 
 
At the end of the form, the candidate will schedule a Consent Confirmation Interview 
(Step 4) with the Research Coordinator. 
 
● Option 3B: A PDF containing a copy of the online Study Disclosure Document and 
Prescreening Form will be emailed to the candidate for the candidate to review 
offline.  The email will also contain a link for the candidate to review the Study 
Disclosure Document and complete the Prescreening Form online and a second link 
to schedule the Consent Confirmation Interview.  
● Option 3C: The research coordinator will call the candidate directly to review the 
Informed Consent Form together. If the candidate declares themselves ready to 
provide consent, this step then moves to the Consent Interview (Step 4b – see 
section 15.4.2 below).  
 
● Option 3D: The candidate schedules a meeting with the research coordinator 
through the to walk through the Informed Consent Form (see section 15.4.3) 
together. 
 

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For options 3C and 3D, attendance via Zoom should be encouraged to review the 
disclosure information with the candidate to ensure the candidate is reviewing the correct 
information. 
 

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15.3.1 STEP 3A: STUDY DISCLOSURE DOCUMENT AND PRESCREENING FORM 
The Study Disclosure Document and Prescreening Form content is an exact duplicate 
of the content in the Informed Consent Form. Both are accessible on any mobile device 
or PC with a browser and intent connection and are hosted on the HIPAA compliant 
JotForm system.  
The live form may be reviewed online here: 
https://hipaa.jotform.com/221136037340140.  
The Study Disclosure Document and Prescreen Form will be used if the candidate 
chooses to review on their own.   
Should the candidate prefer to review 1:1 with the research coordinator, the Informed 
Consent Form will be used.  
A screenshot of the Study Disclosure Document and Prescreening Form’s first page is 
posted below along with the document and form’s full text. The information is divided 
into 5 topical sections. Each section contains discrete pieces of content or questions.  
Each content section has a verbatim audio recording in English to assist with 
comprehension. 
Following each content section, a question will ask candidates to indicate whether they 
understand the content with three choices: 
● Yes.  
● I have a question.  
● I want this explained to me.  
These responses will be recorded in JotForm and available to the research coordinator 
to review prior to conducting the Consent Interview (see 15.4.2 below). Responses 
other than a “yes” will be flagged in an individual report for each candidate so that they 
may be addressed during the Consent Interview. 
Note: Asking the candidate to indicate their level of understanding is not intended to be 
the only indicator of understanding or to screen out candidates. Rather, it is to 
streamline the process and flag any potential issues for the research coordinator to 
cover during the consent interview. 
15.3.1.1 DIRECTIONS FOR RESEARCH COORDINATOR 
If the candidate chooses to review the Study Disclosure Document and Prescreening 
Form independently, they will indicate understanding through the “Yes / I have a 
question / I need more information” multiple-choice questions: 
The candidate’s responses will be captured in the candidate’s JotForm database record. 
Prior to contacting the candidate for the Consent Interview, review the candidate’s 
responses to prepare answers to questions marked as “have a question” or “don’t 
understand”. 

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As noted earlier, each section of the Study 
Disclosure Document and Prescreening Form 
will have a verbatim audio recording in case the 
candidate prefers to have each section read 
aloud. 
 
15.3.1.2 STUDY DISCLOSURE DOCUMENT AND PRESCREENING FORM 
Key Information 
You are invited to take part in a research study.  
GogyUp Inc is sponsoring the research study. 
Please review this document carefully.  
Reviewing this form and talking to the study’s research coordinator may help you decide 
whether to take part or not.  
Take your time and ask the research coordinator as many questions as you would like. 
The research coordinator can explain words or information that you do not understand.   
You may click a “ ► “ button to have the text read to you. 
Background and Purpose 
You are invited to participate in the study because you are receiving care for diabetes.  
The study’s purpose is to research if the GogyUp Reader app improves how patients 
understand diabetes information.  
Do you understand the study’s key information, background and purpose? * 
o 
Yes. 
o 
I have a question. 
o 
I want this explained to me. 
 
What Will Happen in This Study? 
The study will last between three and four months. 
 
0 00/ 0 05

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In order to participate, you will be asked to read, sign, and date this consent form.  
If you decide to take part in this study, you will:  
1. Meet with the research coordinator to complete a baseline assessment and 
provide some demographic information. 
2. Each week, read about diabetes in the GogyUp Reader app or from standard 
print documents. 
3. After three months, meet with the research coordinator again to complete 
another assessment and, if you are placed in the GogyUp Reader group, a 
questionnaire about the app. 
About 200 subjects will participate in this study. The participants will be equally divided 
into two groups.  Both groups will have access to the same information.  
You will be randomly assigned by chance (like the flip of a coin) to either group. You will 
have a 50% (1 in 2) chance of being placed in the group using the GogyUp Reader and 
a 50% (1 in 2) chance of using the print materials.  
The group assigned to the GogyUp Reader will have access to on-demand reading 
assistance technologies such as text-to-speech, translation for any term, optional 
comprehension quizzes, and an alternative method for displaying information. 
We assume GogyUp Reader participants will use their own mobile device or PC to 
download the GogyUp Reader. If you do not have Internet access, GogyUp has a limited 
number of tablets with Internet access you can borrow for the study.  
Each week you will receive new materials about diabetes produced by the United States 
Centers for Disease Control and Prevention. 
IMPORTANT: the diabetes information in this study is only meant to supplement your 
regular care. If you have specific questions about diabetes during the study, you should 
consult with your primary health care provider. 
Do you understand what will happen in the study, how long the study will take, and how 
you will be assigned to a study group? * 
o 
Yes. 
o 
I have a question. 
o 
I want this explained to me. 
 
Expectations for Participation 
You will be expected to complete three activities:  

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1. Assessment. At the beginning of the study, you will take an assessment given 
by the research coordinator. 
2. Review Care Information: You will use the GogyUp Reader app or printed 
patient materials to read information about diabetes. 
3. Follow-Up Assessment: At the end of the study period, you will take another 
assessment given by the research coordinator. 
 
If you are assigned to the GogyUp Reader group, you will be expected to follow GogyUp 
Reader’s Terms of Service while using the GogyUp Reader.   
The Terms of Service may be reviewed here: https://www.gogyup.com/serviceterms 
Do you understand the expectations for participating in the study? * 
o 
Yes. 
o 
I have a question. 
o 
I want this explained to me. 
 
Risks, Side Effects, and/or Discomforts 
There are no expected side effects or discomforts. 
You participation will have very little risk.  The risk is similar to reading a newspaper or 
using a mobile device to look at information.  
Do you understand the study's risk for harm, potential side effects and/or discomforts? * 
o 
Yes. 
o 
I have a question. 
o 
I want this explained to me. 
 
Alternatives to Participation 
This research study is for just for research. The only alternative is to not participate in this 
study. 
 

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Do you understand the alternatives to taking part in the study? * 
o 
Yes. 
o 
I have a question. 
o 
I want this explained to me. 
New Findings 
We will notify you if new important information is discovered during the study that might 
change whether you want to continue to participate. 
Do you understand if new information will be shared with you? * 
o 
Yes. 
o 
I have a question. 
o 
I want this explained to me. 
Benefits 
You may benefit from participating in the study. But there is no guarantee that you will 
benefit. Information learned from the research may help other people in the future.  
Do you understand the potential benefits to participating in the study? * 
o 
Yes. 
o 
I have a question. 
o 
I want this explained to me. 
Compensation for Participation 
You will receive a $25.00 gift card if you complete all three study activities.  
If you have any questions about the compensation, please contact the study research 
coordinator: 612-208-3078 or research@gogyup.com.   
If you are placed in the GogyUp group, you will receive an additional $25.00 at the end of 
the study for the use of your network access. To receive the network reimbursement, your 
activity data should show you used and accessed the GogyUp for at least one session 
each week. 

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Do you understand how you will be compensated for your participation? * 
o 
Yes. 
o 
I have a question. 
o 
I want this explained to me. 
Confidentiality and Your Data 
Key Points:  
● The researchers have a duty to protect your data.  
● The researchers will store all data collected about you in secure systems and 
locations. 
● The researchers will only share data that can identify you if required by law.   
If you sign this form, you will permit us to use and share your data with other research if 
it cannot identify you. 
Detailed Information: 
Records of your participation in this study will be held confidential except when sharing 
the information is required by law or as described in this informed consent. The 
Investigator, the sponsor or persons working on behalf of the sponsor, and under certain 
circumstances, the National Institutes of Health (NIH) and the Institutional Review Board 
(IRB) will be able to inspect and copy confidential study-related records which identify you 
by name. This means that absolute confidentiality cannot be guaranteed. If the results of 
this study are published or presented at meetings, you will not be identified. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This Web site will not include information that can identify you. At 
most, the Web site will include a summary of the results. You can search this Web site at 
any time. 
Your study records including confidential information about you collected during the study 
will be kept at a secure location and on a 21 CFR Part 11-compliant data capture system. 

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While every effort will be made to protect the privacy of your information, absolute 
confidentiality cannot be guaranteed. This does not limit the duty of the researchers and 
others to protect your privacy. 
By signing and dating this informed consent form, you consent to the collection, access, 
use and disclosure of your information as described above. 
Do you understand who how your data will be kept confidential and protected? * 
o 
Yes. 
o 
I have a question. 
o 
I want this explained to me. 
Is this research covered by a Certificate of Confidentiality (CoC)? 
 
Key Points: 
● Your information can be released only if you agree. 
● If you do not agree, the researchers cannot release your information. 
● Researchers must release your information if they are required by law to do so. 
Detailed Information: 
This research is covered by a CoC from the National Institutes of Health. This means that 
the researchers cannot release or use information, documents, or samples that may 
identify you in any action or suit unless you have agreed. They also cannot provide them 
as evidence unless you have agreed. This protection includes federal, state, or local civil, 
criminal, administrative, legislative, or other proceedings. An example would be a court 
subpoena. 
There are some important things that you need to know regarding the CoC. 
The Certificate DOES NOT stop reporting that federal, state, or local laws require. Some 
examples are laws that require reporting of child or elder abuse, some communicable 
diseases, and threats to harm yourself or others. 

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The Certificate CANNOT BE USED to stop a sponsoring United States federal or state 
government agency from checking records or evaluating programs. 
The Certificate DOES NOT stop disclosures required by the federal FDA. 
The Certificate also DOES NOT prevent your information from being used for other 
research if allowed by federal regulations. 
Researchers may release information about you if you provide them permission to do so. 
For example, you may give them permission to release information to insurers, medical 
providers or any other persons not connected with the research. 
The CoC does not stop you from willingly releasing information about your involvement 
in this research. It also does not prevent you from having access to your own information. 
Do you understand what it means that the research is covered by a Certificate of 
Confidentiality? * 
o Yes. 
o I have a question. 
o I want this explained to me. 
 
What data are will be collected and who will have access to your data? 
 
Your consent allows the researchers to collect this personal health information (PHI) 
about you: 
• 
Your first and last name, 
• 
Your age 
• 
Your diabetes diagnosis 
Only research staff assigned to work on the study will have access to your PHI.  

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Data that is not PHI may be collected while using the GogyUp Reader as described in 
GogyUp’s Terms of Use and Privacy Policy. 
• 
Terms of Use: gogyup.com/serviceterms  
• 
Privacy Policy: gogyup.com/privacy 
Do you understand who will have access to your data? * 
o 
Yes. 
o 
I have a question. 
o 
I want this explained to me. 
Will my data be used for profit?  
Data from the GogyUp Reader will help improve and design products that could 
result in a profit.  Study participants will not share in profits earned from products 
improved by this study. 
Do you understand data from your participation will not entitle you to a share in profits 
resulting from this research? * 
o 
Yes. 
o 
I have a question. 
o 
I want this explained to me. 
What if I change my mind about participating or sharing my data?  
Key Points: 
● Participation is completely voluntary. 
● You have the right to not sign this form. 
● There is no penalty if you do not sign this form. 
● You cannot participate in the study if you do not sign this form. 
● You can choose to leave the study at any time. 
● You will not lose any benefits if you stop participating. 
● You will not be penalized if you stop participating. 
● All data collected before you changed your mind may still be used by the researchers. 
 

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Detailed Information: 
You may change your mind and revoke (take back) this authorization at any time by 
withdrawing from the study. 
 
To withdraw, please write to: 
Ned Zimmerman-Bence, Co-PI 
825 Washington Ave SE Suite 220 
Minneapolis, MN 55414 
ned.zb@gogyup.com 
 
PHI collected before you withdraw your authorization will still be used and reported to 
the extent that those noted above have taken action in reliance of this authorization, 
including as necessary to maintain the integrity of the research or to conduct 
investigations or to report adverse events (bad effects).  
If you revoke this authorization, you may no longer be allowed to participate in the 
research. 
Participation is voluntary in the study is completely voluntary and refusal to participate 
will involve no penalty or loss of benefits to which you are otherwise entitled.  
You may discontinue participation at any time without penalty or loss of benefits to 
which you are otherwise entitled. 
You have a right to not to sign this form. You will not be penalized if you do not sign the 
form. Your health care treatment and your health care benefits will not be affected.  
However, you will not be able to participate in the research if you do not sign the consent 
form. 
Do you understand what to do and what will happen if you want to leave the study or stop 
sharing your PHI or other data? * 
o 
Yes. 
o 
I have a question. 
o 
I want this explained to me. 
Access to Information.  

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Organizations that may inspect and copy your information include the University of 
Minnesota Institutional Review Board (IRB) which is a committee that provides ethical 
and regulatory oversight of research, and other representatives of the University of 
Minnesota, including those that have responsibilities for monitoring or ensuring 
compliance, such as the Quality Assurance Program of the Human Research Protection 
Program (HRPP). 
The study doctor and study staff may share your information with representatives of the 
University of Minnesota and M Health. These people may use your information to provide 
oversight and administrative support for the research, conduct evaluations and reviews, 
and perform other activities related to the conduct of the research. 
Do you understand who will have access to your information? * 
o 
Yes. 
o 
I have a question. 
o 
I want this explained to me. 
 
Costs 
There is no cost to participate in the study.  
The GogyUp Reader app, and all study activities will be provided at no charge to you. 
Your primary health care provider and your insurance company will not be billed. 
If you are placed in the GogyUp Reader group, you will receive a $25.00 gift card for 
network access after you complete the baseline assessment.  If you do not have access 
to the Internet, you may be able to borrow a tablet with internet service from GogyUp. 
Please contact the research coordinator for details. 
Do you understand that there is no charge to participate and how internet access will be 
compensated? * 
o 
Yes. 
o 
I have a question. 

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o 
I want this explained to me. 
 
Future Research Studies 
Your consent allows GogyUp to use or share study data for future research studies. Any 
data used or shared for future studies will be anonymized and will not identify you.  
Do you understand how your information may be shared with other researchers or in 
future studies? * 
o 
Yes. 
o 
I have a question. 
o 
I want this explained to me. 
 
Are there any conflicts of interest reported for this study?  
Key Points: 
• 
Mr. Zimmerman-Bence owns part of GogyUp. He is a researcher in the study. 
• 
Mr. Zimmerman-Bence’s role in the study will not affect the research. 
• 
Pearl Pathways IRB does not find Mr. Zimmerman-Bence’s role to create a conflict 
of interest. 
Detailed Information: 
Mr. Zimmerman-Bence is a Co-Founder and part owner of GogyUp and is serving as Co-
PI on the study.  
GogyUp, the study's sponsor, is receiving funding from the National Institute of Nursing 
Research. The outcome of this research study could be of interest to GogyUp and help 
develop products that may generate a profit in the future. This investigator does not and 
will not participate in the recruitment, obtaining of informed consent, enrollment, or 
assignment for this research.  

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The IRB oversees the conflict-of-interest policies. In accordance with these policies, the 
IRB has determined that Mr. Zimmerman-Bence’s interests create no significant risk to 
the welfare of participants in this study or to the integrity of the research. If you would like 
more information about this, please contact Pearl Pathways IRB at (317) 899-9341 or 
support@pearlirb.com. 
Do you understand the potential conflicts of interest reported for this study?* 
o 
Yes. 
o 
I have a question. 
o 
I want this explained to me. 
 
What if something changes?  
Any significant, new information that may affect you will be explained to you in a timely 
manner. Such information may help you decide if you want to stay in the study. 
Do you understand how you will be notified if there are changes? * 
o 
Yes. 
o 
I have a question. 
o 
I want this explained to me. 
 
Who do I contact if I have questions about this study? 
Contact the research coordinators for general questions about the study: 
research@gogyup.com or 612-208-3078. 
The study’s Primary Investigators are: 
● Ned Zimmerman-Bence, GogyUp: 612-460-5358 or ned.zb@gogyup.com  
● Dr. Nathan Shippee, University of Minnesota: nshippee@umn.edu 
 
Contact either Primary Investigator if you have a concern about the study or a question 
about:  

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• 
Your compensation. 
• 
Your study responsibilities. 
• 
How you can participate. 
 
Pearl Pathways is the institutional review board (IRB) responsible for protecting your 
rights as a research subject. Please contact them if you have questions about your rights 
as a research subject: 
(Monday through Friday 9-5 EST/EDT): 
● By mail: 
Pearl IRB 
29 East McCarty Street 
Suite 100 
Indianapolis, IN  46225 
https://www.pearlirb.com/ 
● or call:  
 
317-899-9341 (main) 
● or fax:  
 
317-602-6554 (fax)  
● or by email:  support@pearlirb.com 
 
Contact your primary care provider for questions about your medical care. 
Do you understand who to contact if you have concerns or questions about the study? * 
o 
Yes. 
o 
I have a question. 
o 
I want this explained to me. 
 
 
 
Research Participant Advocate Line. 
To share feedback privately with the University of Minnesota Human Research Protection 
Program (HRPP) about your research experience, call the Research Participants’ 
Advocate 
Line 
at 
612-625-1650 
(Toll 
Free: 
1-888-224-8636) 
or 
go 
to 
z.umn.edu/participants. You are encouraged to contact the HRPP if: 

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● Your questions, concerns, or complaints are not being answered by the research team. 
● You cannot reach the research team. 
● You want to talk to someone besides the research team. 
● You have questions about your rights as a research participant. 
● You want to get information or provide input about this research. 
The University of Minnesota HRPP may ask you to complete a survey that asks about 
your experience as a research participant. You do not have to complete the survey if you 
do not want to. If you do choose to complete the survey, your responses will be 
anonymous. If you are not asked to complete a survey, but you would like to share 
feedback, please contact the study team or the University of Minnesota HRPP. 
Do you understand you may contact the University of Minnesota’s Research Participant 
Advocate Line and that the HRPP may ask you to complete a survey? * 
o 
Yes. 
o 
I have a question. 
o 
I want this explained to me. 
 
 
 
Voluntary Participation / Withdrawal  
Your participation is voluntary.  
You may choose to leave the study for any reason and without any penalty.  
Any information collected before you leave the study cannot be removed from the study. 
A Primary Investigator or the sponsor can stop your participation at any time without your 
consent for the following reasons: 
● If you do not follow directions for participating in the study. 
● You do not meet the study requirements. 

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● If the study is canceled. 
● For administrative reasons. 
Do you understand that your decision to participate is voluntary, that you may withdrawal 
without penalty, and that the investigator can stop your participation? * 
o 
Yes. 
o 
I have a question. 
o 
I want this explained to me. 
15.3.1.3 EMAIL CONFIRMATION OF PRESCREENING RESPONSES 
The following two screenshots depict the email that candidates will receive once they 
complete the online disclosure review form.  Information in the curly brackets will be 
populated with the candidate’s responses. 

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Figure 5: Email Confirmation of Answers Submitted for Consent Prescreening 
Google Voice (HIPAA compliant) 
number to receive text and voice 
calls. 
Direct link to JotForm page for scheduling a 
consent interview page: gogyup.com/consent 

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Figure 6: Email Confirmation of Answers Submitted for Consent Prescreening (cont) 
15.3.2 STEP 3B: CANDIDATE REVIEWS DISCLOSURE DOCUMENT AND CONSENT FAQS AS PDF 

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PREP: 
● Automated eMails (below) are sent to the candidate with Online Disclosure 
Document and Consent FAQs attached as a PDF. 
● Candidate may schedule a call or just call the research coordinator to continue to 
Step 4: Consent Interview 
● If candidate does not contact the RC after a 2nd email is sent, the database will 
flag the candidate for you to follow up via phone or email. 
15.3.2.1 OUTGOING EMAIL – DISCLOSURE REVIEW 
SUBJECT: GogyUp / U of M Study Please Review This Disclosure Document 
Hello,  
Thank you for your interest in participating in our study! 
Attached is the study disclosure information for you to review. At any time, please feel free to call or text 
me with any questions: 612-208-3078.  
For the next step, please either 
● 
Schedule an interview to review the information with me: gogyup.com/consent.  
● 
Simply reply to this email. 
● 
Call me at 612-208-3078.  
Thank you, [INSERT CANDIDATE NAME].  I look forward to meeting with you soon! 
Sincerely, 
[ YOUR NAME HERE] 
GogyUp Research Coordinator 
Phone / Text:  612-208-3078 
Contact attempt recorded in the candidate’s database record. 
 
 

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15.3.2.2 2ND ATTEMPT EMAIL 
If there is no response from the first email in 4 business days after being sent, this email 
is sent. Contact attempt recorded in the candidate’s database record. 
SUBJECT: GogyUp / U of MN Research 
Hello,  
I’m checking in whether you are still interested in participating in our study.  I’ve re-attached the disclosure 
information for you to review. Please feel free to call me with any questions. 
If you are no longer interested, that’s fine! Just reply to this email so I can take you off our list. 
If you decide to join our study, please: 
● 
Schedule an interview to review the information with me: gogyup.com/consent.  
● 
Contact me by replying to this email. 
● 
Call me at 612-208-3078 to set up an intake interview.  
Thank you, [INSERT PARTICIPANT NAME].   
Sincerely, 
[ YOUR NAME HERE] 
GogyUp Research Coordinator 
Phone / Text:  612-208-3078 
 
 

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15.3.3 STEP 3C: INTAKE INTERVIEW SCRIPT  
Prep: 
● If the candidate previously filled out Online Disclosure Document, have the 
responses available prior to calling and the candidate’s database record ready to 
add any notes / log questions that were not answerable. 
● If candidate does not answer or is not available, refer to the Voicemail Follow Up 
script below. 
Hello.  This is [name] with GogyUp.  Is [name] available? 
Wait for confirmation that you at speaking with the candidate. 
I am calling about your interest in the GogyUp / University of Minnesota Type 2 Diabetes 
study. Are there any questions that I can answer for you? 
If candidate has questions, refer to the Online Disclosure Document and answer any 
before moving on.   
If you believe the candidate’s questions were fully addressed and the candidate 
indicates interest, ask if they would like to consider providing consent to enroll and 
participate at this moment.  
Does participating in the study sound interesting to you?  
If yes, then ask:   
May we begin the consent and enrollment processes with you now? It might take 
anywhere between 10 and 15 minutes. Of course, we can take as much time as we need 
to answer any questions you may have as we go thought the process.   
Wait for confirmation that candidate has the time. If the candidate wants to proceed 
now, skip  
If they do not have time now, use the online schedule intake form [ gogup.com/intake ] 
to schedule a follow up time. 
If no, then say:   
That is, of course, fine.  Would you like me to put you on our “do not contact” list or 
would you just a like a little more time to consider joining the study? 
Note the candidate’s choice in the JotForm record.  Depending on the answer, thank 
them for their time and (if appropriate) mention you will contact them in a week to check 
in. 
 

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15.3.4 STEP 3D: SCHEDULE INTAKE INTERVIEW 
Candidates who choose to schedule an intake interview via the study’s landing page or 
from within an email or text correspondence with the research coordinator will be brought 
to this page to choose from available slots in the research coordinator’s calendar.   
 
A field is provided for questions or notes the participant would like to cover during the 
intake interview.  
 
The intake interview will be automatically 
scheduled on the Research Coordinator’s 
calendar.  If the candidate opts-in, reminder 
emails (see below) will be sent to the 
candidate 48 hours and 2 hours before the 
scheduled meeting. 
15.3.4.1 AUTOMATED EMAIL / SMS: SCHEDULED 
INTERVIEW CONFIRMATION  
SUBJECT: GogyUp Study Interview: [ DATE AND 
TIME of INTERVIEW ] 
Hi [ Firstname]! I’m looking forward to meeting with 
you on [ DATE AND TIME of INTERVIEW ]. 
If you need to change your appointment, please 
reply to this message or reschedule here: [ LINK to 
RESCHEDULE ]. 
Sincerely, 
[YOUR NAME] - GogyUp Research Coordinator 
15.3.4.2 AUTOMATED 
EMAIL 
SCHEDULED 
INTERVIEW REMINDER  
SUBJECT: Reminder: GogyUp Study Interview – 
[TIME] Tomorrow! 
Hi [ Firstname]! I’m looking forward to meeting with 
you tomorrow at [TIME]. 
If you need to change the time, please reply to this 
message 
or 
reschedule 
here: 
[ 
LINK 
to 
RESCHEDULE ]. 
Sincerely, 
[YOUR NAME] 
GogyUp Research Coordinator 
 

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15.4 STEP 4: CONSENT INTERVIEW AND SIGNATURES 
The Consent Interview provides the final verification whether the candidate has reviewed 
and fully understands the study’s purpose and the information disclosed in the Online 
Disclosure Document – which the candidate might have reviewed on their own online or 
with a PDF version or in a synchronous phone or video conversation with the research 
coordinator. 
15.4.1 STEP 4A: SCHEDULE CONSENT INTERVIEW 
Depending on the candidate’s “path” to move 
through the steps for intake (2) and disclosure 
(3), the candidate may need to schedule a 
consent interview to review the disclosure 
information with research coordinator prior to 
providing consent and PHI authorization. 
Consent Interview scheduling is handled through 
JotForm with a page similar to the Intake 
interview.  Again, the candidate may opt-in  to 
receive email reminders and leave specific 
questions to be answered. 
 
15.4.1.1 AUTOMATED EMAIL SCHEDULED INTERVIEW 
CONFIRMATION  
SUBJECT: GogyUp Study Interview: [ DATE AND TIME of 
INTERVIEW ] 
Hi [ Firstname]! I’m looking forward to meeting with you on 
[ DATE AND TIME of INTERVIEW ]. 
If you need to change your appointment, please reply to 
this 
message 
or 
reschedule 
here: 
[ 
LINK 
to 
RESCHEDULE ]. 
Sincerely, 
[YOUR NAME] 
GogyUp Research Coordinator 
15.4.1.2 AUTOMATED 24-HOUR EMAIL SCHEDULED 
INTERVIEW REMINDER  
SUBJECT: Reminder: GogyUp Study Interview – [TIME] 
Tomorrow! 
Hi [ Firstname]! I’m looking forward to meeting with you 
tomorrow at [TIME]. 
If you need to change the time, please reply to this message or reschedule here: [ LINK to RESCHEDULE 
]. 
Sincerely, 

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[YOUR NAME] 
GogyUp Research Coordinator 
15.4.2 STEP 4B: CONSENT INTERVIEW - ASSESSING COMPREHENSION 
The research coordinator (not the candidate / participant) has the responsibility for 
ensuring that a candidate understands the research and the risks and benefits involved. 
The coordinator should use these steps to assess participant understanding: 
Answer questions but also ask questions to further the discussion and elicit questions 
from the candidate. The coordinator’s questions should be open ended to prompt the 
candidate to think more carefully about the study.  
Open-ended questions are those that begin with “who,” "what," "when," "where," “why,” 
and "how often," or "please describe.” 
Do not use close-ended questions that are answerable with a “yes” or “no” answers. 
PREP: 
● Access record in JotForm database. 
● If the candidate submitted the Prescreening form, review it to note any items the 
candidate marked as “I do not understand” or “I have a question.” Find 
appropriate section in the Informed Consent Form to go over with candidate. 
● Check that participant’s contact information is recorded in database record. 
● Launch ZOOM for screensharing. 
● Copy ZOOM link to online meeting to share with candidate. 
● Load consent JotForm Step 3 document and form for screensharing. 
● Prep assessment (see section 14.3.5a – Enrollment) 
 
15.4.2.1 OUTGOING VOICE CALL TO CANDIDATE 
Hello.  This is [name] with GogyUp.  Is [name] available? 
Wait for confirmation that you at speaking with the candidate. 
I am calling to thank you for your interest in the GogyUp / University of Minnesota Type 2 
Diabetes study and to confirm if you are still interested in participating.     
Wait for confirmation that candidate is still interested. 
Should we begin enrolling you? It can take anywhere between 5 and 10 minutes. Of 
course, I can take as much time as we need to answer any questions.   
Wait for confirmation that candidate has the time. If not, schedule a follow up time now. 
If candidate has questions, refer to the Online Disclosure Document before moving on. 

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Informed consent is the process for telling our potential research participants the key aim, 
the information we will collect, and what your participation will involve.  This process is 
required to ensure you are being treated ethically and in accordance with Federal law.  
The consent process includes providing a written disclosure document and consent form 
that contains required information and then reviewing that information with you. 
15.4.2.2 ADD WITNESS TO CALL (IF APPLICABLE) 
Note to Research Coordinator: If the candidate states they are unable to read the 
information in the Online Disclosure Document or responses indicates their level of 
literacy or English proficiency would prevent understanding, explain that a witness will 
be needed. 
As part of the consent process, we often need to have a witness available to confirm your 
understanding and consent. Is there someone over the age of 18 who could join the call 
– either physically by you or reachable by phone?  
If a witness is not available, propose using another GogyUp team member not affiliated 
with the study as a witness.   
We do need a witness to make sure you have understood everything we are about to go 
over.  Would it be alright if I included a colleague to join our call? 
If candidate prefers their own witness, establish another time to call and review the form 
and mark the candidate as “Waiting on Witness” in the study database.  
Ask for the witness contact number to call or text. 
With the candidate still in the meeting, contact the witness and ask that they join the 
meeting in progress: 
 
Hi, [ NAME OF WITNESS ].  This is [ YOUR NAME ], the research coordinator at GogyUp.   
[ NAME OF CANDIDATE ] asked me to contact to you.  [ NAME OF CANDIDATE ] is 
considering joining a study we are conducting and would like you to act as a witness and 
confirm that [ NAME OF CANDIDATE ] understands what will happen during the study.  
Your role will be just to listen in on the meeting and, if you agree that [ NAME OF 
CANDIDATE ] understands the study requirements, provide your verbal agreement that [ 
NAME OF CANDIDATE ] understands. 
Are you available for 5 to 10 minutes to listen in on my call with [ NAME OF CANDIDATE 
]?      
Send screenshare link to participant and witness (if in a different location). Coach 
candidate and witness through accessing the screenshare. 
Confirm candidate and witness can see screenshare.   
15.4.2.3 EXPLAIN INFORMED CONSENT 
Informed consent is the process for telling our potential research participants the key aim, 
the information we will collect, and what your participation will involve.  This process is 

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required to ensure you are being treated ethically and in accordance with Federal law.  
The consent process includes providing a written disclosure document and consent form 
that contains required information and then reviewing that information with you. 
 
15.4.2.4 REVIEW INFORMED CONSENT FORM 
Display the Informed Consent Form in 15.4.3 below. 
Review the form with candidate, pausing for any question, up until Section 3 – Participant 
Signature.  
 
15.4.2.5 COMPREHENSION CONFIRMATION INTERVIEW 
To be sure you understand what it means to participate in the study, I need to ask you a 
few questions. 
Open-ended questions to use: 
1. “Describe in your own words the purpose of the study.” 
2. “How would you explain to others what you will have to do in the study?” 
3. “What is the possible benefit to you if you participate in this study? What are the 
possible risks?” 
4. “How long does your participation in this study last?” 
5. “Who do you contact if you have questions?” 
 
Based upon the candidate’s responses, decide whether the candidate adequately 
understands the study.  
15.4.2.6 PROCEDURE FOR WHEN COMPREHENSION ISSUES ARE DETECTED 
If you believe the candidate does not understand the study disclosure information 
enough to provide informed consent, offer to review the information again – touching on 
the areas that you believe the candidate doesn’t understand.   
 
Thank you so much for your time. At this point, I think there are a few points we still need 
to review before it is safe to proceed.  Would you like to review the material again or 
schedule another time to meet?  
If candidate prefers to schedule another meeting, establish the time and day with the 
candidate. Update candidate’s JotForm record to “Waiting On – Consent 2nd Try”. 
Review the appropriate sections of disclosure information. 
Mark the candidate as “Not Ready” in the candidate’s JotForm record.  

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15.4.3 STEP 4C: INFORMED CONSENT SIGNATURE 
 
The live form may be reviewed online here: 
https://hipaa.jotform.com/221085579452158  
The form is divided into sections: 
1) About Informed Consent 
2) Study Disclosure Information 
3) Candidate Signature Page. 
4) Witness Signature Page (if applicable) 
5) Investigator Verification Page 
As with the Study Disclosure Document and Prescreening Form, the form also has 
verbatim audio should the candidate prefer to review to each section spoken at their 
preferred pace. 
 
The form is also available for download as a PDF and a physical copy may be mailed to 
the candidate’s address for the candidate to review and sign a time convenient for them.  
 
Confirm that candidate can still see your screen. 
 
Explain the final step in enrolling the candidate: 
1) Signing the consent form. 
2) Collecting contact information.  
 
I’m so glad you’re able to join the study!  The last step is for you to sign the consent form 
so we have documentation that we’ve answered your questions.  
Display the Informed Consent Form.  
 
Confirm that the candidate is able to see the form.  
 
Briefly review sections 1 and 2, pausing for any questions. 
 
Provide computer control via ZOOM to candidate.  Explain to the candidate how to navigate to 
the signature section and provide their signature. 
 
Prompt the candidate to sign the consent form. 
 

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Follow Up Tasks after Consent Interview is finished:   
1) JotForm will email the participant an enrollment confirmation with a link to the signed form.   
2) Print and mail the participant’s practioner notification if participant consents to the 
notification on the form. 
3) Notify GogyUP’s admin assistant to mail participant a hardcopy of the signed form. 
 
NOTE: both the print copy and emailed notification will contain: 
1)  A link to a version of the Study Disclosure Document (without prescreening 
questions) so the participant may refer to the verbatim audio for additional help in 
referring back to the information. 
2) Contact information for the research coordinator. 
 
 

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15.4.3.1 INFORMED CONSENT FORM - SECTION 1 
 

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15.4.3.2 INFORMED CONSENT FORM – SECTION 2 
Note: each content section will have an audio narration available for the candidate to listen to at 
their own pace. 
Key Information 
You are invited to take part in a research study.  
GogyUp Inc is sponsoring the research study. 
Please review this document carefully.  
Reviewing this form and talking to the study’s research coordinator may help you decide 
whether to take part or not.  
Take your time and ask the research coordinator as many questions as you would like. 
The research coordinator can explain words or information that you do not understand.   
To participate in this study, you must sign your name to provide consent to participate in 
the study in the next section. 
If you choose to sign this form, a physical copy will be sent to your street address. 
 
Background And Purpose  
You are invited to participate in the study because you are receiving care for diabetes.  
The study’s purpose is to research if the GogyUp Reader app improves how patients 
understand diabetes information.  
 
What Will Happen During the Study? 
The study will last between three and four months. 
In order to participate, you will be asked to read, sign, and date this consent form.  
If you decide to take part in this study, you will:  
1. Meet with the research coordinator to complete a baseline assessment and 
provide some demographic information. 
2. Each week, read about diabetes in the GogyUp Reader app or from standard 
print documents. 
3. After three months, meet with the research coordinator again to complete 
another assessment and, if you are placed in the GogyUp Reader group, a 
questionnaire about the app. 
About 200 subjects will participate in this study. The participants will be equally divided 
into two groups.  Both groups will have access to the same information.  

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You will be randomly assigned by chance (like the flip of a coin) to either group. You will 
have a 50% (1 in 2) chance of being placed in the group using the GogyUp Reader and 
a 50% (1 in 2) chance of using the print materials.  
 
The group assigned to the GogyUp Reader will have access to on-demand reading 
assistance technologies such as text-to-speech, translation for any term, optional 
comprehension quizzes, and an alternative method for displaying information. 
We assume GogyUp Reader participants will use their own mobile device or PC to 
download the GogyUp Reader. If you do not have Internet access, GogyUp has a limited 
number of tablets with Internet access you can borrow for the study.  
Each week you will receive new materials about diabetes produced by the United States 
Centers for Disease Control and Prevention. 
IMPORTANT: the diabetes information in this study is only meant to supplement your 
regular care. If you have specific questions about diabetes during the study, you should 
consult with your primary health care provider. 
Expectations for Participation 
You will be expected to complete three activities:  
1. Assessment. At the beginning of the study, you will take an assessment given 
by the research coordinator. 
2. Review Care Information: You will use the GogyUp Reader app or printed 
patient materials to read information about diabetes. 
3. Follow-Up Assessment: At the end of the study period, you will take another 
assessment given by the research coordinator. 
 
If you are assigned to the GogyUp Reader group, you will be expected to follow GogyUp 
Reader’s Terms of Service while using the GogyUp Reader.   
The Terms of Service may be reviewed here: https://www.gogyup.com/serviceterms 
 
Risks, Side Effects, and/or Discomforts 
There are no expected side effects or discomforts. 
You participation will have very little risk.  The risk is similar to reading a newspaper or 
using a mobile device to look at information.  
 
Alternatives to Participation 
This research study is for just for research. The only alternative is to not participate in this 
study. 
 

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New Findings 
We will notify you if new important information is discovered during the study that might 
change whether you want to continue to participate. 
 
Benefits 
You may benefit from participating in the study. But there is no guarantee that you will 
benefit. Information learned from the research may help other people in the future.  
 
Compensation for Participation 
You will receive a $25.00 gift card if you complete all three study activities.  
If you have any questions about the compensation, please contact the study research 
coordinator: 612-208-3078 or research@gogyup.com.   
If you are placed in the GogyUp group, you will receive an additional $25.00 at the end of 
the study for the use of your network access. To receive the network reimbursement, your 
activity data should show you used and accessed the GogyUp for at least one session 
each week. 
Confidentiality and your Data 
Key Points:  
● The researchers have a duty to protect your data.  
● The researchers will store all data collected about you in secure systems and 
locations. 
● The researchers will only share data that can identify you if required by law.   
If you sign this form, you will permit us to use and share your data with other research if 
it cannot identify you. 
Detailed Information: 
Records of your participation in this study will be held confidential except when sharing 
the information is required by law or as described in this informed consent. The 
Investigator, the sponsor or persons working on behalf of the sponsor, and under certain 
circumstances, the National Institutes of Health (NIH) and the Institutional Review Board 
(IRB) will be able to inspect and copy confidential study-related records which identify you 
by name. This means that absolute confidentiality cannot be guaranteed. If the results of 
this study are published or presented at meetings, you will not be identified. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This Web site will not include information that can identify you. At 

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most, the Web site will include a summary of the results. You can search this Web site at 
any time. 
Your study records including confidential information about you collected during the study 
will be kept at a secure location and on a 21 CFR Part 11-compliant data capture system. 
While every effort will be made to protect the privacy of your information, absolute 
confidentiality cannot be guaranteed. This does not limit the duty of the researchers and 
others to protect your privacy. 
By signing and dating this informed consent form, you consent to the collection, access, 
use and disclosure of your information as described above. 
 
Is this research covered by a Certificate of Confidentiality (CoC)? 
 
Key Points: 
• 
Your information can be released only if you agree. 
• 
If you do not agree, the researchers cannot release your information. 
• 
Researchers must release your information if they are required by law to do so. 
Detailed Information: 
This research is covered by a CoC from the National Institutes of Health. This means that 
the researchers cannot release or use information, documents, or samples that may 
identify you in any action or suit unless you have agreed. They also cannot provide them 
as evidence unless you have agreed. This protection includes federal, state, or local civil, 
criminal, administrative, legislative, or other proceedings. An example would be a court 
subpoena. 
There are some important things that you need to know regarding the CoC. 
The Certificate DOES NOT stop reporting that federal, state, or local laws require. Some 
examples are laws that require reporting of child or elder abuse, some communicable 
diseases, and threats to harm yourself or others. 
The Certificate CANNOT BE USED to stop a sponsoring United States federal or state 
government agency from checking records or evaluating programs. 
The Certificate DOES NOT stop disclosures required by the federal FDA. 
The Certificate also DOES NOT prevent your information from being used for other 
research if allowed by federal regulations. 
Researchers may release information about you if you provide them permission to do so. 
For example, you may give them permission to release information to insurers, medical 
providers or any other persons not connected with the research. 
The CoC does not stop you from willingly releasing information about your involvement 
in this research. It also does not prevent you from having access to your own information. 
 

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What data are will be collected and who will have access to your data? 
 
Your consent allows the researchers to collect this personal health information (PHI) 
about you: 
• 
Your first and last name, 
• 
Your age 
• 
Your diabetes diagnosis 
Only research staff assigned to work on the study will have access to your PHI.  
Data that is not PHI may be collected while using the GogyUp Reader as described in 
GogyUp’s Terms of Use and Privacy Policy. 
• 
Terms of Use: gogyup.com/serviceterms  
• 
Privacy Policy: gogyup.com/privacy 
 
Will my data be used for profit?  
Data from the GogyUp Reader will help improve and design products that could result in 
a profit.  Study participants will not share in profits earned from products improved by this 
study. 
 
What if I change my mind about participating or sharing my data?  
Key Points: 
● Participation is completely voluntary. 
● You have the right to not sign this form. 
● There is no penalty if you do not sign this form. 
● You cannot participate in the study if you do not sign this form. 
● You can choose to leave the study at any time. 
● You will not lose any benefits if you stop participating. 
● You will not be penalized if you stop participating. 
● All data collected before you changed your mind may still be used by the researchers. 
 
Detailed Information: 
You may change your mind and revoke (take back) this authorization at any time by 
withdrawing from the study. 
 
To withdraw, please write to: 
Ned Zimmerman-Bence, Co-PI 

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825 Washington Ave SE Suite 220 
Minneapolis, MN 55414 
ned.zb@gogyup.com 
 
PHI collected before you withdraw your authorization will still be used and reported to 
the extent that those noted above have taken action in reliance of this authorization, 
including as necessary to maintain the integrity of the research or to conduct 
investigations or to report adverse events (bad effects).  
If you revoke this authorization, you may no longer be allowed to participate in the 
research. 
Participation is voluntary in the study is completely voluntary and refusal to participate 
will involve no penalty or loss of benefits to which you are otherwise entitled.  
You may discontinue participation at any time without penalty or loss of benefits to 
which you are otherwise entitled. 
You have a right to not to sign this form. You will not be penalized if you do not sign the 
form. Your health care treatment and your health care benefits will not be affected.  
However, you will not be able to participate in the research if you do not sign the consent 
form. 
Access to Information.  
Organizations that may inspect and copy your information include the University of 
Minnesota Institutional Review Board (IRB) which is a committee that provides ethical 
and regulatory oversight of research, and other representatives of the University of 
Minnesota, including those that have responsibilities for monitoring or ensuring 
compliance, such as the Quality Assurance Program of the Human Research Protection 
Program (HRPP). 
The study doctor and study staff may share your information with representatives of the 
University of Minnesota and M Health. These people may use your information to provide 
oversight and administrative support for the research, conduct evaluations and reviews, 
and perform other activities related to the conduct of the research. 
 

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Costs 
There is no cost to participate in the study.  
The GogyUp Reader app, and all study activities will be provided at no charge to you. 
Your primary health care provider and your insurance company will not be billed. 
If you are placed in the GogyUp Reader group, you will receive a $25.00 gift card for 
network access after you complete the baseline assessment.  If you do not have access 
to the Internet, you may be able to borrow a tablet with internet service from GogyUp. 
Please contact the research coordinator for details. 
 
Future Research Studies  
Your consent allows GogyUp to use or share study data for future research studies. Any 
data used or shared for future studies will be anonymized and will not identify you.  
 
Are there any conflicts of interest reported for this study?  
Key Points: 
• 
Mr. Zimmerman-Bence owns part of GogyUp. He is a researcher in the study. 
• 
Mr. Zimmerman-Bence’s role in the study will not affect the research. 
• 
Pearl Pathways IRB does not find Mr. Zimmerman-Bence’s role to create a conflict 
of interest. 
Detailed Information: 
Mr. Zimmerman-Bence is a Co-Founder and part owner of GogyUp and is serving as Co-
PI on the study.  
GogyUp, the study's sponsor, is receiving funding from the National Institute of Nursing 
Research. The outcome of this research study could be of interest to GogyUp and help 
develop products that may generate a profit in the future. This investigator does not and 
will not participate in the recruitment, obtaining of informed consent, enrollment, or 
assignment for this research.  
The IRB oversees the conflict-of-interest policies. In accordance with these policies, the 
IRB has determined that Mr. Zimmerman-Bence’s interests create no significant risk to 
the welfare of participants in this study or to the integrity of the research. If you would like 
more information about this, please contact Pearl Pathways IRB at (317) 899-9341 or 
support@pearlirb.com. 
 
What if something changes?  
Any significant, new information that may affect you will be explained to you in a timely 
manner. Such information may help you decide if you want to stay in the study. 

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Who do I contact if I have questions about this study? 
Contact the research coordinators for general questions about the study: 
research@gogyup.com or 612-208-3078. 
The study’s Primary Investigators are: 
● Ned Zimmerman-Bence, GogyUp: 612-460-5358 or ned.zb@gogyup.com  
● Dr. Nathan Shippee, University of Minnesota: nshippee@umn.edu 
 
Contact either Primary Investigator if you have a concern about the study or a question 
about:  
• 
Your compensation. 
• 
Your study responsibilities. 
• 
How you can participate. 
 
Pearl Pathways is the institutional review board (IRB) responsible for protecting your 
rights as a research subject. Please contact them if you have questions about your rights 
as a research subject: 
(Monday through Friday 9-5 EST/EDT): 
● By mail: 
Pearl IRB 
29 East McCarty Street 
Suite 100 
Indianapolis, IN  46225 
https://www.pearlirb.com/ 
● or call:  
 
317-899-9341 (main) 
● or fax:  
 
317-602-6554 (fax)  
● or by email:  support@pearlirb.com 
 
Contact your primary care provider for questions about your medical care. 
 
Research Participant Advocate Line. 
To share feedback privately with the University of Minnesota Human Research Protection 
Program (HRPP) about your research experience, call the Research Participants’ 

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Advocate 
Line 
at 
612-625-1650 
(Toll 
Free: 
1-888-224-8636) 
or 
go 
to 
z.umn.edu/participants. You are encouraged to contactthe HRPP if: 
● Your questions, concerns, or complaints are not being answered by the research team. 
● You cannot reach the research team. 
● You want to talk to someone besides the research team. 
● You have questions about your rights as a research participant. 
● You want to get information or provide input about this research. 
The University of Minnesota HRPP may ask you to complete a survey that asks about 
your experience as a research participant. You do not have to complete the survey if you 
do not want to. If you do choose to complete the survey, your responses will be 
anonymous. If you are not asked to complete a survey, but you would like to share 
feedback, please contact the study team or the University of Minnesota HRPP. 
 
 
Voluntary Participation / Withdrawal  
Your participation is voluntary.  
You may choose to leave the study for any reason and without any penalty.  
Any information collected before you leave the study cannot be removed from the study. 
A Primary Investigator or the sponsor can stop your participation at any time without your 
consent for the following reasons: 
● If you do not follow directions for participating in the study. 
● You do not meet the study requirements. 
● If the study is canceled. 
● For administrative reasons. 
 
 
 

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15.4.3.3  INFORMED CONSENT FORM – SECTION 3 - PARTICIPANT SIGNATURE 
Participant Signature 
To be completed by individual consenting to participate in the study. 
May the researchers contact you after your participation is over to invite you to participate 
in other research studies? Your answer does not impact your eligibility to participate in 
this study.* 
o Yes 
o No 
I have read and understand the information in this informed consent document.* 
o Agree 
o Disagree 
I have had an opportunity to ask questions and all of my questions have been answered 
to my satisfaction.* 
o Agree 
o Disagree 
I voluntarily agree to participate in this study until I decide otherwise.* 
o Agree 
o Disagree 
I understand that I do not give up any of my legal rights by signing and dating this consent 
document.* 
o Agree 
o Disagree 
I understand that will receive a copy of this signed and dated consent document.* 
o Agree 
o Disagree 
I consent to having my primary health care provider notified by the study team of my 
participation in this study (please check yes or no).* 
o Yes 
o No 

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15.4.3.4 INFORMED 
CONSENT 
FORM – SECTION 4 – 
WITNESS 
SIGNATURE 
(WHEN APPLICABLE) 
 
 

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15.4.3.5 INFORMED CONSENT FORM – SECTION 5 - INVESTIGATOR VERIFICATION PAGE  
 
 

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15.4.3.6 ENROLLMENT CONFIRMATION EMAIL TO PARTICIPANT 
Once the signature pages are complete, the participant will receive the following email 
with the signed forms attached. A physical copy will also be sent to the address the 
participant provided on the intake form. 
The letter also provides a link to a version of the Study Disclosure Document (without the 
prescreening questions) that has a verbatim audio recording for each section.  
 
{preferredName}, 
Welcome aboard and thank you for joining our study! 
We will mail your signed consent form to this address: 
{physicalAddress} 
If you need it sent to a different location, please contact us: 
● Call or text our research coordinator at 612-460-5358. 
● eMail us: research@gogyup.com 
Next: 
1) Your baseline assessment is scheduled for {BaselineAssessmentDate}. If you
need change the date, please contact the research coordinator. schedule that here.
2) If you are in the group using GogyUp Reader, we will send a gift card to reimburse
network costs and instructions for getting and using the app. 
3) Important!  Please be sure you continue to contact your health provider if you
have questions about diabetes or your health.. 
Thank you, 
The GogyUp Study Team 
 
 

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15.5 STEP 5: ENROLLMENT & ASSIGNMENT 
Review contact information with participant and double check participant information is 
correctly entered in JotForm database: 
 
● First name 
● Last name 
● Contact phone number 
● eMail address 
And if the participant consented to provider notification: 
● Primary provider’s name 
● Primary provider’s street address 
● Primary provider’s phone number 
 
Revise as necessary the contact information in the candidate’s JotForm record. 
Mark the participant as “enrolled” in the JotForm database. 
15.5.1.1 STEP 5A: ASSIGNMENT & NEXT STEPS 
 
Thank the participant for enrolling in the study and explain the assignment process.  
Review procedure detailed in section 6.3 of the study protocol to assign participant to a 
study arm: intervention or control.  
I am going to unseal this envelop that contains your assignment. 
Unseal the envelope and show the card to the camera so that the participant may view 
the assignment. 
15.5.1.2 STEP 5A-1: CONTROL GROUP ASSIGNMENT 
If participant is assigned to the control group (content only), state: 
Oh, great! You are assigned to what we’re calling “the control group” – this is the group 
that will use standard, printed diabetes education materials.  I will send them to you in the 
postal mail and they should arrive in 2 – 3 days. 
Note assignment in candidate’s JotForm record and send materials in the postal mail. 
15.5.1.3 STEP 5A-2: INTERVENTION GROUP ASSIGNMENT 
If participant is assigned to the intervention group (GogyUp Reader App), state: 
Ok – you’ve been assigned to the GogyUp Reader app group. 

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Do you have a device – either a mobile phone, tablet, or computer, that you can access 
regularly?  Does this device have regular intent access?  
If so, we will send you a  $25 gift card to help cover the cost of your network access during 
the study after you’ve completed a baseline assessment.  Once you complete a follow-
up assessment at the end of the three months, we will send you another $25 gift card to 
thank you for your participation..  
If participant mentions that they do not have internet cell service or access to a 
computer or mobile device, explain that we can provision a internet-connected tablet 
while they are enrolled in the study. 
15.5.1.4 
STEP 5B: SCHEDULE FOLLOW-UP APPOINTMENT AND BASELINE ASSESSMENT 
 
The very last items we need to do is to set up an appointment to take a survey together 
to help establish some base line information.  
 
If there is enough time and the participant is willing, conduct the baseline assessment 
now. Otherwise, set up baseline and follow-up assessment appointments.  
 
Note for Intervention Group Participants: 
● If participant is in Intervention group, explain that the data plan compensation or 
tablet will be sent once the baseline assessment has occurred.  
 
 
Ok – great!   Next, we need to set up a time to meet for 10 – 15 minutes to take a 
survey together. If you have the time, we could do that now.  Otherwise, what days and 
times would work with your schedule? 
 
Again, thank you so much for joining the study.  Over the next few months, always free 
to contact me if you have any questions about the study, how to access GogyUp 
Reader, etc..  
 
IMPORTANT:  Assign the participant a study number and note the assignment in the 
candidate’s record in the JotForm database and whether to follow up.    
You will need the participant’s study number for the GogyUp training. 
15.6 STEP 6: BASELINE ASSESSMENT AND PROCEDURES  
Notes: 

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● A participant’s ability to follow through and keep the baseline assessment 
appointment may indicate whether the participant will remain active or 
become inactive.   
● For participants in the control group, education materials should be mailed 
once the baseline assessment is confirmed.  Ideally, the follow-up 
appointment should be confirmed as well. 
● For participants in either group who miss their baseline assessment 
appointment, at least three attempts (which can be a mix of voice call / 
voicemail and SMS messages) should be made to contact and reschedule. 
● For participants in the intervention (GogyUp Reader) group, data plan 
reimbursement should be made available only after the baseline assessment 
has been completed and a follow-up appointment has been confirmed. 
o If a participant mentions they do not have internet access or an 
internet-enabled device, notify GogyUp’s administrative assistant to 
provision a tablet for the participant. 
● After the baseline assessment is complete, follow the script for onboarding 
participants in the intervention group. 
 
15.6.1 1 DAY BASELINE ASSESSMENT – SMS APPOINTMENT REMINDER  
Hi, this is [your name] – the GogyUp Research Coordinator.   
I’m looking forward to taking the survey together on [ APPOINTMENT DATE AND TIME].   
We’re planning to meet [ Online / Over the phone ]. 
If the participant signed up for an online meeting, text the link. Otherwise confirm you’ll 
call them at this phone number.  
Here is the link for us to meet: [ ZOOM LINK ]. 
Record each contact attempt must in the participant’s database record. 
15.6.2 SCRIPT FOR BASELINE ASSESSMENT - PHONE OR ONLINE MEETING 
If the baseline assessment appointment is schedule as a phone meeting: 
 
Hello.  This is [YOUR NAME] FROM GogyUp.  Is [NAME OF PARTICIPANT] available? 
Wait for confirmation that you at speaking with the participant. 
I am calling to take our GogyUp / University of Minnesota Type 2 Diabetes survey with 
you.  Is this still a good time? 
Wait for confirmation that participant is ready, then explain why we’re administering the 
assessment. 

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Great!  Ok – the reason why we’re taking this questionnaire now is to establish every 
participant’s current understanding of health and diabetes. 
Before we begin, do you have any questions for me about the survey or the study? 
Answer any questions that the participant has, referring to the Study Disclosure 
Document as necessary. 
Questions that cannot be addressed by the Study Disclosure Document should be 
forwarded to the Primary Investigators. 
If you’re meeting via Zoom, display the JotForm Baseline Assessment form and 
administer the Health Literacy Questionnaire (HLQ) and Baseline Demographic 
Questions according to the directions in the JotForm form. Record participant score in 
the JotForm form.  Add any other notable questions asked to the comments area in the 
participant’s database area. 
15.6.3 BOTH GROUPS – CONFIRM FOLLOW-UP APPOINTMENT AND SCHEDULE FOLLOW-UP 
ASSESSMENT 
Make every effort to schedule and confirm their follow-up assessment appointment.  
Display the scheduling page to provide 3 to 4 options for the participant to choose from. 
 
We have scheduled our follow-up call for [ TIME and DATE of APPOINTMENT]. Is that 
still convenient? 
 
15.6.4 FOR INTERVENTION GROUP (GOGYUP READER) PARTICIPANTS 
If participant is in the GogyUp Reader group, explain the first gift card to reimburse 
network access will be mailed in the next day or so.  Confirm the mailing address. 
 
If the participant requested to use a tablet, explain that it should arrive in a few days and 
confirm that the mailing address can securely receive packages.  
 
Lastly, I want to make sure we have the best address to send the [ TABLET / DATA 
PLAN REIMBURSEMENT / DIABETES HEALTH MATERIALS ] to you.  I have [ 
PROVIDE THE PARTICIPANT’S ADDRESS ] – is that the correct location to send it? 
 
Thank the participant for their time. Note interactions, questions, and appointments in 
the participant’s database record. 
 

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15.6.5 FOR CONTROL GROUP (PAPER DOCUMENTS) PARTICIPANTS 
If participant is in the control group, confirm the mailing address to receive the packet of 
materials. 
 
Lastly, I want to make sure we have the best address to send the DIABETES HEALTH 
MATERIALS to you.  I have [ PROVIDE THE PARTICIPANT’S ADDRESS ] – is that the 
correct location to send it? 
 
Thank the participant for their time. Note interactions, questions, and appointments in 
the participant’s database record.   
 
15.6.6 MISSED BASE APPOINTMENT SCRIPTS AND PROCEDURE 
If a participant misses a baseline appointment and is unresponsive to three contact 
attempts (mix of voice mail and SMS messages) sent in intervals of 2 days between 
messages, then mark the participant as “inactive” and move to enroll another candidate.   
 
If another candidate is identified and attends the baseline appointment, then mark the 
inactive candidate as “replaced” in the participant database. 
 
 

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15.6.6.1 VOICEMAIL SCRIPT: MISSED BASELINE APPOINTMENT 
Hi, this is [YOUR NAME] from GogyUp.  I’m calling to leave a message for [NAME OF 
PARTICIPANT].   
[NAME OF PARTICIPANT], please call or text me when you have a moment at [612-208-
3078 
]. That’s 6 … 1 … 2 …2 …ZERO…8….3…ZERO….7….8 
Record each contact attempt and outcome in the comments area of the participant’s 
database record. 
 
15.6.6.2 SMS SCRIPT: MISSED BASELINE APPOINTMENT 
Hi [ NAME OF PARTICIPANT ]!  This is [ YOUR NAME ]  from GogyUp.  We were going 
to meet [ TIME AND DAY OF MEETING ].  When would be a good day and time to 
reschedule? 
 
Record each contact attempt and outcome in the comments area of the participant’s 
database record. 
 
 

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15.6.7 INTERVENTION GROUP – ONBOARDING FOR GOGYUP READER 
After the baseline assessment is completed, display the quick start guide (see section 15.7.2) 
and ask if the participant is ready to try GogyUp Reader. 
 
If the participant does not have the time or access to an internet-connected device, explain that 
they will receive a quick start guide with their network access reimbursement. If they would like 
help with accessing the app, they are always welcomed to contact the research coordinators.   
 
If the participant is ready and available, walk through these steps. 
 
1) Point to step 1 in the Quick Start Guide and point out that the GogyUp Reader can be 
used on any Android or iOS device – or on a PC with a Chrome or Edge web browser. 
2) Ask the participant which device they plan to use and verify they are able to find the 
GogyUp Reader on their device’s app store (or through their browser). 
3) Point to step 2 and state that the next step is to fill out a GogyUp profile.  This 
information is used to sync progress so that if they want to use GogyUp on another 
device, they can.   
a. Note that they don’t have to use their real name.  
b. For the UserName they should use their assigned Study Number. 
4) Point to step 3 in the Guide and note that if the participant has a preferred language 
other than english, they may select from the options to have an individual word 
translated into that preferred language. 
5) Point to step 4 and emphasize that the participant should put in “ninr1” in the invite 
code box – this is needed so that the participant has access to the content library for the 
study. 
6) Guide the participant to tap “Save profile” and then point out the different features in 
the app: 
a. Points A&B in the Guide’s Features section: Touch any word to launch the “word 
menu” 
i. Request that the word be spoken, defined, or translated. 
ii. Point out the “hear sentence” button if the participant wants the entire 
sentence spoken. 
iii. Note that some words will have a “practice” button – this is a quick, 
optional spelling activity and isn’t related to the study. 
b. Point C: Demonstrate how the EZText button can instantly re-format the text so 
that it fits better on smaller screens and enables individuals to focus on 
individual words and phrases. Point out how the participant can increase the 
font size. 
7) Point out how to close the “x” in the upper right to go back out to the page where the 
participant can access the help menu and get technical support. 
 
 

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15.7 STEP 7: PROVISION PARTICIPANT 
Following completion of the baseline assessment, provisioning participants will be 
dependent on the group each is enrolled in. 
Depending on the participant’s assignment, send one of the following via postal mail: 
● Control Group: the set of education materials and welcome letter. 
● Intervention Group - Network Access:  the $25 gift card to cover their network 
expense and instructions for downloading and signing-in to the GogyUp Reader 
app. 
● Intervention Group - Tablet: If the participant requested a tablet, instructions for 
powering on the tablet and accessing the materials in the GogyUp Reader app.  
Accessing GogyUp on the tablet will be a “one click” experience – the GogyUp app 
and GogyUp account required to access the materials will be pre-provisioned with 
the end-user’s information. 
Depending on IRB guidance, each participant’s provider will also be sent an enrollment 
notification via postal mail. 
 
 

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15.7.1 INTERVENTION GROUP – WELCOME LETTER 
 
 
 

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15.7.2 INTERVENTION GROUP – GOGYUP READER QUICK START SHEET 
This information sheet will be included with the welcome letter sent to study participants 
enrolled in the intervention (GogyUp Reader) group.  This is meant as a supplement to 
the brief training provided by the research coordinator. 
 
15.7.3 INTERVENTION GROUP - TABLET 

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If the participant requests to use a GogyUp-provided tablet, follow this procedure:  
 
1. Connect with GogyUp Admin Assistant for tablet to be drop-shipped to 
participant. 
2. Note tablet shipped date and serial number in participant’s Study Database 
record. 
3. Share estimated arrival date with participant via text and/or email: 
15.7.3.1 SHIPMENT NOTIFICATION SMS / EMAIL 
Hi, this is [your name] – GogyUp’s Research Coordinator.   
The tablet should arrive on [ ARRIVAL DATE AND TIME].  
Please text / call / or email me when you receive it and have turned it on.    
The tablet will be already configured to launch GogyUp – all you should need to do is turn it on! Of 
course, please contact me or contact me or GogyUp’s technical support if you need help: 
eMail: support@gogyup.com 
SMS / Phone: 612-460-5358 
 
 
 
1 
Tap on “My Library” to see the readings. 
Then tap on a reading to open it. 
2 
3 

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15.7.4 CONTROL GROUP – WELCOME LETTER 
 
Use the following letter template to mail the hardcopy reading materials to study participants 
in the control group. 
 
 
 
 

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15.7.5 ENROLLMENT NOTIFICATION TO PROVIDER 
Should either Institutional Review Board require it, the following notice will be sent to the 
participant’s provider indicated on the intake form. 
 
 
 

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15.8 STEP 8: FOLLOW-UP ASSESSMENT 
Notes: 
● If a participant misses a follow-up assessment appointment, make at least 
three attempts (which can be a mix of voice call / voicemail and SMS 
messages) to contact and reschedule.   
● Participants in the control (non-intervention) group will complete both the HLQ 
and the Perceived Diabetes Self-Management Scale (PDSMS). 
● Participants in the intervention (GogyUp Reader) group will complete the 
HLQ, PDSMS, and User Experience Questions. 
15.8.1 1 DAY SMS APPOINTMENT REMINDER - FOLLOW-UP ASSESSMENT 
Hi, this is [your name] – the GogyUp Research Coordinator.   
I’m looking forward to taking the survey together on [ APPOINTMENT DATE AND TIME].   
We’re planning to meet [ Online / Over the phone ]. 
If the participant signed up for an online meeting, text the link. Otherwise confirm you’ll 
call them at this phone number.  
Here is the link for us to meet: [ ZOOM LINK ]. 
Record each contact attempt must in the participant’s database record. 
15.8.2 SCRIPT FOR FOLLOW-UP ASSESSMENT - PHONE OR ONLINE MEETING 
If the follow-up assessment appointment is schedule as a phone meeting: 
 
Hello.  This is [YOUR NAME] FROM GogyUp.  Is [NAME OF PARTICIPANT] available? 
Wait for confirmation that you at speaking with the participant. 
I am calling to take our GogyUp / University of Minnesota Type 2 Diabetes survey with 
you.  Is this still a good time? 
Wait for confirmation that participant is ready, then explain why we’re administering the 
assessment. 
 
Great! Before we begin, do you have any questions for me about the survey or the 
study? 
 
Answer questions that the participant has, referring to the Online Disclosure Document 
as necessary. 

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Display the JotForm assessment. 
 
Administer the HLQ and PDSMS according to directions posted on the JotForm site. 
 
For participants in the intervention group, administer the User Experience Questions 
after the HLQ and PDSMS.  Record participant scores using the online form.  If the 
participant asks additional questions or provides additional feedback, record in the 
comments area of the participant’s database record. 
15.8.3 MISSED FOLLOW-UP APPOINTMENT SCRIPTS AND PROCEDURE 
If a participant misses a follow-up appointment and is unresponsive to three contact 
attempts (mix of voice mail and SMS messages) sent in intervals of 2 days between 
messages, then mark the participant as “inactive” and move to enroll another candidate.   
 
If another candidate is identified and attends the follow-up appointment, then mark the 
inactive candidate as “replaced” in the participant database. 
15.8.3.1.1.1 
VOICEMAIL SCRIPT: MISSED FOLLOW-UP APPOINTMENT 
Hi, this is [YOUR NAME] from GogyUp.  I’m calling to leave a message for [NAME OF 
PARTICIPANT].   
[NAME OF PARTICIPANT], please call or text me when you have a moment at [612-208-
3078 
]. That’s 6 … 1 … 2 …2 …ZERO…8….3…ZERO….7….8 
Record each contact attempt and outcome in the comments area of the participant’s 
database record. 
 
15.8.4 SMS SCRIPT: MISSED FOLLOW-UP APPOINTMENT 
Hi [ NAME OF PARTICIPANT ]!  This is [ YOUR NAME ]  from GogyUp.  We were going 
to meet [ TIME AND DAY OF MEETING ].  When would be a good day and time to 
reschedule? 
 
Record each contact attempt and outcome in the comments area of the participant’s 
database record. 
 
 

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15.9 BASELINE AND FOLLOW-UP ASSESSMENTS  
The majority of the Baseline and Follow-Up Assessments is the 44 question Health 
Literacy Questionnaire (HLQ) divided into 2 sections.  Each assessment will begin with a 
landing page (sample below) to help orient the participant. Following the landing page, 
the participant will be presented with each section of the HLQ. The research coordinator 
will read each HLQ question and record the participant’s response. 
The Baseline Assessment also has a demographic that serves a few purposes: 
1) Capture important information that may have dissuaded candidates from initially 
enrolling (e.g., gender, age, preferred language, etc.) but would allow the team to 
compare any intervention effect across different sub-groups. 
2) Pilot a question concerning whether GogyUp impacts a participant’s confidence in 
using a smartphone or tablet to learn new health information. 
3) In addition to the HLQ, the Follow-Up Assessment includes the Perceived Diabetes 
Self-Management Scale (PSDMS) and 14 questions to capture end-user Gather 
information about the user experience for GogyUp’s development team 
(administered to the GogyUp Reader group only). 
 
 
 

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15.9.1 ASSESSMENT LANDING PAGE 
Both the Baseline and Follow-Up Assessment pages will be as follows: 

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Figure 8: Baseline Assessment Landing Page 
15.9.2 HLQ TEXT  – PART ONE 
 

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15.9.3 HLQ TEXT  – PART TWO 
 

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15.9.4 BASELINE: DEMOGRAPHIC QUESTIONS
 
1) Birth month and year: 
      /      / 
 
      
 
2) Which gender do you identify with? 
 □ Female    □ Male       
□ Non-binary 
 □ Prefer to self-describe: 
□ Prefer to not answer. 
 
3) In which country were you born? 
____________________________ 
 
4) What is your current zip code?  
______________________________ 
 
5) Which language do you most often use 
at home?  
c 
English 
c 
Spanish 
c 
Somali 
c 
Hmong 
c 
Vietnamese 
c 
Arabic 
c 
Other (Please specify) 
 
 
 
 
 
 
 
6) How do you most often access  the 
internet? 
c 
Smartphone with a cellular 
network. 
c 
Smartphone with Wi-Fi 
c 
Tablet with Wi-Fi 
c 
Laptop or desktop with Wi-Fi 
c 
Laptop or desktop and a dial-up 
telephone line 
c 
Other: (Please specify) 
c 
I don’t have access to the internet 
 
7) How confident are you using a 
smartphone or tablet to learn new 
information?   
c Very confident 
c Fairly confident 
c Somewhat confident 
c Slightly confident 
c Not at all confident 
 
8) Please indicate your highest level of 
education. (Check only one box): 
c 
Less than 8 years 
c 
8 through 11 years 
c 
High school diploma 
c 
GED / Adult Diploma 
c 
2-year technical degree 
c 
4-year college degree 
c 
Postgraduate degree (Masters or 
PhD)
 

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15.9.5 FOLLOW-UP: PERCEIVED DIABETES SELF-MANAGEMENT SCALE (PSDMS) 
INSTRUCTIONS: This is a questionnaire designed to determine how well you, yourself, 
feel you manage your diabetes. Each item is a belief statement with which you may agree 
or disagree. Next to each statement is a scale which ranges from strongly disagree to 
strongly agree. Please respond to each of the following items by choosing one number 
for each statement. Try to respond to each statement separately in your mind from each 
other statement. Choose your responses thoughtfully and make them as true FOR YOU 
as you can. Please respond to every statement. 
1. It is difficult for me to find effective 
solutions for problems that occur with 
managing my diabetes. 
c Strongly disagree  
c Disagree 
c Neutral 
c Agree 
c Strongly agree 
 
2. It is difficult for me to find effective 
solutions for problems that occur with 
managing my diabetes. 
c Strongly disagree 
c Disagree 
c Neutral 
c Agree 
c Strongly agree 
 
3. I handle myself well with respect to my 
diabetes. 
c Strongly disagree 
c Disagree 
c Neutral 
c Agree 
c Strongly agree 
 
4. I am able to manage things related to 
my diabetes as well as most other 
people. 
c Strongly disagree 
c Disagree 
c Neutral 
c Agree 
c Strongly agree 
 
5. I succeed in the projects I undertake to 
manage my diabetes. 
c Strongly disagree 
c Disagree 
c Neutral 
c Agree 
c Strongly agree 
 
6. Typically, my plans for managing my 
diabetes don’t work out well. 
c Strongly disagree 
c Disagree 
c Neutral 
c Agree 
c Strongly agree 
 

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7. No matter how hard I try, managing my 
diabetes doesn’t turn out the way I 
would like. 
c Strongly disagree 
c Disagree 
c Neutral 
c Agree 
c Strongly agree 
 
8. I’m generally able to accomplish my 
goals with respect to managing my 
diabetes. 
c Strongly disagree 
c Disagree 
c Neutral 
c Agree 
c Strongly agree
 
 

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15.9.6 FOLLOW-UP: USER EXPERIENCE QUESTIONS (INTERVENTION GROUP ONLY): LIKERT
1) I am confident using a smartphone or 
tablet to learn new information.   
c Strongly disagree 
c Disagree 
c Neutral 
c Agree 
c Strongly Agree 
 
2) The app is easy to use.  
c Strongly disagree 
c Disagree 
c Neutral 
c Agree 
c Strongly agree 
 
3) It is easy to navigate within the app. 
c Strongly disagree 
c Disagree 
c Neutral 
c Agree 
c Strongly agree 
 
4) The information on the app is credible. 
c Strongly disagree 
c Disagree 
c Neutral 
c Agree 
c Strongly agree 
 
 
5) The 
information 
on 
the 
app 
is 
trustworthy. 
c Strongly disagree 
c Disagree 
c Neutral 
c Agree 
c Strongly agree 
 
6) How likely are you to recommend this 
app to a friend or family member? 
c Strongly disagree 
c Disagree 
c Neutral 
c Agree 
c Strongly agree 
 
7) I will likely use the app in the future. 
c Strongly disagree 
c Disagree 
c Neutral 
c Agree 
c Strongly agree 
  
8) I find the app to be attractive. 
c Strongly disagree 
c Disagree 
c Neutral 
c Agree 
c Strongly agree
 

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9) The app has a clean and simple presentation. 
c Strongly disagree 
c Disagree 
c Neutral 
c Agree 
c 
Strongly agree 
 
15.9.7 FOLLOW-UP: USER EXPERIENCE QUESTIONS (INTERVENTION GROUP ONLY): OPEN ENDED 
1) Describe what you like most about the app and why. 
 
2) Describe what you found frustrating and why. 
 
3) Describe what your primary motivation might be for downloading the app. 
 
4) What features did you frequently use on the app? 
 
5) Under what circumstances would you continue to the app? 
 
 

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15.10 DIABETES EDUCATION MATERIALS 
All diabetes materials will be sources from the Center for Disease Control’s Fact 
Sheets, English editions, available at: 
https://www.cdc.gov/diabetes/library/factsheets.html#managing 
 
The materials will include: 
About Diabetes/General Information 
● At A Glance 2018 
● Diabetes and Prediabetes Fact Sheet 
 
Complications 
● Take Charge of Your Diabetes: Your Medicines 
● What You Need to Know About Diabetes and Adult Vaccines   
● Take Charge of Your Diabetes: Healthy Eyes 
● Take Charge of Your Diabetes: Healthy Feet 
● Take Charge of Your Diabetes: Healthy Teeth 
● Take Charge of Your Diabetes: Healthy Ears 
● Diabetes and Hepatitis B Vaccination   
● Smoking and Diabetes   
● Take Care of Your Kidneys and They will Take Care of You   
 
 
Lifestyle 
● Choosing Healthy Foods on Holidays and Special Occasions 
● Tips for Eating Healthy with Diabetes 
● Tips for Being Active with Diabetes 
 
Managing Diabetes 
● Steps to Help You Stay Healthy With Diabetes 
● 5 Questions to Ask Your Health Care Team 

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● Managing Diabetes: Medicare Coverage and Resources 
 
 

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