Diabetes Prevention Combining CGM and Artificial Intelligence Health Education
Phase: NA
Conditions: Pre-diabetes
Sponsor: University of Southern California

G1 Continuous Glucose Monitoring and Human Behavioral Study 1 of 110       Version 1.0 
Manual of Operations and Procedures 
 
10 DECEMBER 2024 
The G1 Continuous Glucose Monitoring and 
Human Behavioral Study 
Manual of Operations and Procedures (MOP)
 
ClinicalTrials.gov identifier   
 
NCT06472297 
 
 

 
G1 Continuous Glucose Monitoring and Human Behavioral Study 2 of 110       Version 1.0 
Manual of Operations and Procedures 
 
10 DECEMBER 2024 
 
WEB LINKS 
Further Guidance on Data and Safety Monitoring for Phase I and Phase II Trials 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html) 
Implementation of NCCIH Policies for Clinical Studies 
(http://nccih.nih.gov/grants/policies) 
NIH Policy for Data and Safety Monitoring 
(http://grants.nih.gov/grants/ guide/notice-files/not98-084.html) 
Guidelines for Writing Informed Consent Documents 
(http://ohsr.od.nih.gov/info/sheet6.html) 
Clear and to the Point: Guidelines for Using Plain Language at NIH 
(http://oma.od.nih.gov/ma/customer/customerserviceplan/attachment2.htm) 
 
Open Science Framework 
https://osf.io 
 
Dexcom G6 Pro System 
https://provider.dexcom.com/products/dexcom-g6-pro/training-resources 
 
A1CNow Self-Check Tutorial Video 
https://youtu.be/uO-iMHchlKI?si=LHO2viVWm5ZKJqBm) 
 
 
 
 
 
 

 
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1. INTRODUCTION 
The goal of this project is to create a new digital health communication 
intervention that combines wearable CGM feedback technology alongside daily 
educational video clips aimed at personalized behavioral modifications in diet, 
physical activity, and glucose self-monitoring to increase glucose control and 
possibly prevent T2 Diabetes (T2D) over time among people with prediabetes 
who are underrepresented in their access to such digital health technologies. 
These video clips, tailored for watching on smartphones, will be altered using 
video-based artificial intelligence (AI) software for video to text transcoding as 
well as deep fake video transcoding of characters to multiple languages other 
than English and Spanish. Original video narrative content will be generated by 
Latino community health workers known as Promotores de Salud (PdS) who will 
use the unmasked CGM feedback system ]]. We plan to name the resulting CGM 
feedback plus digital health communication intervention ¡Mi Control! to counter 
the belief that prediabetes is uncontrollable by simple behavioral modifications 
 
2. OVERVIEW 
In this Phase 0 trial referred to as the G1 Study, we will enroll a retained sample 
of N=20 Spanish -speaking Latino PdS participants meeting positive finger prick 
screening for prediabetes. This is one of the very few studies to examine CGM 
use in Latinos with diabetes. Participants will wear CGM for a target of20 days 
while keeping daily video logs relaying experiences of CGM use and feedback 
and interpretations of contingencies between changes in variables that changes 
glucose levels. At post-assessment, video-recorded structured interviews 
between staff and participants will explore the benefits and barriers to CGM use 
in daily life during the wear period. We will use video clips from the daily video 
logs and from the structured interviews to form the basis of the short smartphone 
educational clips for our ¡Mi Control! intervention. We will then use an AI software 
tool (Descript) to transcode  the captured video clips into text to be edited . After 
the sample of video clips is reduced to capture production value, a final series 
will be generated. Aim 1 in Study 1 is to create ten 30-60 second health 
communication video clips of ¡Mi Control! to be paired with app-based CGM 
feedback to hasten learning about glucose control within 20 days. We will then 
use a different AI software to convert all video clips into multiple languages other 
than English and Spanish while retaining the visual likeness of the original 
characters in the videos. This will offer a proof of concept that the workload of 
health communication production can be reduced using this method to increase 
the capacity for message dissemination in future work.  
 
During the planning phase of the G1 study, Dr. David Black, PI, and the study 
staff drafted the study protocols to ensure that the MOP accurately described 
how the study procedures would be performed. Before developing the MOP, the 
final protocol, Electronic Case Report Form (eCRF), informed consent 
documents, and administrative forms (e.g., screening and enrollment log, 
protocol deviation log, etc.) were finalized. The development of the G1 Study and 

 
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other documents began at the end of September 2023, with recruitment starting 
on May 29, 2024. Additionally, Adriana Argaiz and Rosalba Cain conducted 
internal audits of all protocols in both English and Spanish, which were then 
submitted to the IRB for final approval prior to any trial recruitment efforts. The 
MOP will be forwarded to the NIH as part of supplemental material for the 
respective year’s annual review and made available to the public on The Open 
Science Framework (OSF) to meet the advancing guidelines for transparency in 
trials research. The MOP will be updated throughout the active study period to 
reflect any minor changes to the study protocols or consent amendments and 
refine the eCRFs and study procedures accordingly. The MOP version submitted 
to NIH will represent the final protocols used during the study. 
 
The G1 Study MOP is maintained and can be located in a three-hole binder with 
the various sections and dividers located at the USC Health Sciences Soto office. 
Please note that an MOP electronic file is located on a protected share drive for 
staff to access at any time, and printed manuals are made available upon 
request. (Staff have more access to digital files across locations than the paper 
file). All previous versions are archived with the Research Coordinator. 
 
3. MOP CONTENTS AND ORGANIZATION 
The MOP details the study procedures and describes the study-specific 
documents adapted to the G1 Study. includes the following sections: 
a. Study Protocol or Synopsis 
b. Staff Roster 
c. Study Organization and Responsibilities 
d. Training Plan 
e. Communications Plan 
f. Recruitment and Retention Plan 
g. Study Design Diagram 
h. Screening and Eligibility Criteria and Processes 
i. Informed Consent and HIPAA 
j. Study Intervention 
k. Blinding and Unblinding (Masking or Unmasking) 
l. Evaluations and Follow-up 
m. Concomitant Medications 
n. Safety Reporting 
o. Data and Safety Monitoring Responsibilities 

 
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p. Study Compliance 
q. Data Collection and Study Forms  
r. Data Management 
s. Quality Control Procedures 
t. Study Completion and Closeout Procedures 
u. Policies 
v. MOP Maintenance 
 
 
3.1 
Study Protocol 
The following section describes the study protocols and provides scientific 
rationale for the G1 Study. The final version of the study protocol with the date of 
IRB approval and version number are included in the appendix section of the 
MOP. 
 
3.2 
Study Organization and Responsibilities 
 
3.2.1 
Continuous Glucose Monitoring Study Roster 
The roster below includes the names, roles, and e-mail addresses of study staff 
members, P50 Center Personnel, USC Department Administration, and Dexcom 
staff who serve as key contacts for the study. 
 

 
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G1 Project Key 
Personnel 
Role 
Address 
Email 
David Black, PhD 
PI - Lead 
investigator 
and trialist 
KSOM Health Sciences 
Campus  
2001 N. Soto Street, SSB 
302D  
Los Angeles, CA 90033 
davidbla@usc.edu 
Lourdes 
Baezconde-G, 
PhD 
Co-I - 
Community 
engagement 
KSOM Health Sciences 
Campus  
2001 N. Soto Street, SSB 
302M  
Los Angeles, CA 90033 
baezcond@usc.edu 
Braden Barnett, 
MD 
Co-I Study 
physician 
KSOM Health Sciences 
Campus 
1333 San Pablo Street, 
BMT-B11 
Los Angeles, CA 90033 
Braden.Barnett@
med.usc.edu 
Ralph 
Weischedel, PhD 
Co-I AI 
Software 
Design and 
Application 
USC Viterbi – Computer 
Science 
4676 Admiralty Way, Suite 
1001 
Marina Del Rey, CA 90292 
weisched@isi.edu 
Marientina 
Gotsis, MFA 
Co-I Cinematic 
arts and video 
production 
USC School of Cinematic 
Arts 
3470 McClintock Ave, SCI 
201U 
Los Angeles, CA 90089-
2211 
gotsis@usc.edu 

 
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G1 Project Staff 
Role 
Address 
Email 
Ruth Flores 
Research 
Coordinator I 
KSOM Population and Public 
Health Sciences Health Behavior 
Research 
1845 N. Soto Street, Bldg SSB 
Los Angeles, CA 90032 
rflores8@usc.edu 
My Vu 
Biostatistician 
University of Southern California  
2250 Alcazar Street, CSC 200 
Los Angeles, CA 90033 
myvu@chla.usc.edu 
Nick Arce 
Research 
Assistant 
KSOM Population and Public 
Health Sciences  
2001 N. Soto Street, Bldg SSB 
Los Angeles, CA 90032 
nnarce@usc.edu 
Devin Hayden 
Undergraduate 
Research 
Assistant 
KSOM Population and Public 
Health Sciences  
2001 N. Soto Street, Bldg SSB 
Los Angeles, CA 90032 
dhayden@usc.edu 
Yunlei Liu 
Student Worker 
KSOM Population and Public 
Health Sciences  
2001 N. Soto Street, Bldg SSB 
Los Angeles, CA 90032 
yunleili@usc.edu 
Thalia Bosman 
Student Worker 
KSOM Population and Public 
Health Sciences  
2001 N. Soto Street, Bldg SSB 
Los Angeles, CA 90032 
tbosman@usc.edu 
Milena Amadeus 
Phlebotomist 
KSOM Population and Public 
Health Sciences  
2001 N. Soto Street, Bldg SSB 
Los Angeles, CA 90032 
1845 N. Soto Street  
Los Angeles, CA 90032 
milenalo@usc.edu 
Marisela Miranda 
Phlebotomist 
KSOM Population and Public 
Health Sciences  
2001 N. Soto Street, Bldg SSB 
Los Angeles, CA 90032 
marisela.miranda@us
c.edu  

 
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P50 Center 
Personnel 
(CHLA) 
Role 
Address 
Email 
Michael Goran, PhD 
Center Director of 
Shared 
Resources 
Children’s Hospital Los Angeles 
4650 Sunset Blvd. 
Los Angeles, CA 90027 
goran@usc.edu 
Alaina Vidmar, MD 
G6 CGM 
Assessment 
Children’s Hospital Los Angeles 
4650 Sunset Blvd. 
Los Angeles, CA 90027 
avidmar@chla.usc.ed
u 
Ana Velasquez 
Sr. Research 
Administrative 
Analyst 
Children’s Hospital Los Angeles 
The Saban Research Institute  
4650 Sunset Blvd. MS#178 
Los Angeles, CA 90027 
anavelasquez@chla.
usc.edu 
Anna Peare 
Center 
Coordinator 
Children’s Hospital Los Angeles 
4650 Sunset Blvd. 
Los Angeles, CA 90027 
apeare@chla.usc.ed
u 
Adriana Argaiz 
Recruitment and 
Translation 
Services 
University of Southern California  
2250 Alcazar Street, CSC  
Los Angeles, CA 90033 
adriana.argaiz@med.
usc.edu 
Rosalba Cain 
Recruitment and 
Screening of 
Promotore 
KSOM Clinical & Translational 
Sciences Institute (CTSI) 
USC Health Sciences Campus 
Los Angeles, CA 90089 
rosalba.cain@med.us
c.edu 
Juan Espinoza, MD 
Center Chief Data 
Officer 
Children’s Hospital Los Angeles 
4650 Sunset Blvd 
Los Angeles, CA 90027 
jespinozasalomon@l
uriechildrens.org 
Claudia Rios, RD 
Dietician for 
NDSR 
Assessment 
Children’s Hospital Los Angeles 
The Saban Research Institute  
4650 Sunset Blvd. MS#178 
Los Angeles, CA 90027 
clrios@chla.usc.edu 

 
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Figure _A_: Continuous Glucose Monitoring Study Roster 
USC Department 
Administration 
Role 
Address 
Email 
Jose Morales 
Study Post-Award 
Budget Manager 
KSOM Population and Public 
Health Sciences – USC Health 
Science Campus 
1845 N. Soto Street, SSB 
Los Angeles, CA 90032 
josekarl@usc.edu 
Monique Franklin 
Human 
Resources and 
Staffing 
KSOM Population and Public 
Health Sciences – USC Health 
Science Campus 
2001 N. Soto Street, SSB 300 
Los Angeles, CA 90033 
Monique.Franklin@m
ed.usc.edu 
Rosa Barahona 
Senior Project 
Manager 
KSOM Population and Public 
Health Sciences – USC Health 
Science Campus 
2001 N. Soto Street, SSB 310 
Los Angeles, CA 90033 
Barahona@usc.edu 
Janae’ Green 
Office Orders 
and Concur 
system 
 
KSOM Population and Public 
Health Sciences – USC Health 
Science Campus 
1845 N. Soto Street, SSB 
Los Angeles, CA 90032 
danieceg@usc.edu 
Ryan Wilkerson 
Department IT 
and Equipment 
Access 
KSOM Population and Public 
Health Sciences – USC Health 
Science Campus 
1845 N. Soto Street 
Los Angeles, CA 90032 
wilkerso@usc.edu 
Christina Ayala 
DORI Project 
Manager for 
Assay Lab 
KSOM USC Health Sciences 
Campus 
1975 Zonal Avenue 
Los Angeles, CA 90033 
trujillc@usc.edu 
Chanita Hughes, 
PhD 
Coordination of 
Soto research 
Activities 
KSOM Population Health & Public 
Health Sciences 
1845 N. Soto Street, SSB 
Los Angeles, CA 90032 
hughesha@usc.edu 
Dexcom Staff 
Role 
Address 
Email 
Ryan Henry 
Research 
Coordinator for G 
Sensor and 
Clarity 
Dexcom 
6340 Sequence Drive 
San Diego, CA 92121 
 
 
rhenry@Dexcom.co
m 
Paige Tosello 
Purchase orders 
from Dexcom 
Dexcom 
6340 Sequence Drive 
San Diego, CA 92121 
paige.tosello@dexco
m.com 
Christine Wazniak, 
RDN 
Education 
Specialist 
Dexcom 
6340 Sequence Drive 
San Diego, CA 92121 
christine.wozniak@d
excom.com 

 
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Ruth Flores is the Research Coordinator and will be contacted at 
rflores8@usc.edu regarding special situations and specific study-related 
questions including:  
 
● Protocol requirements 
● Reporting an adverse event (AE) 
● Request for study supplies 
● Randomizing a participant 
● Unblinding a participant (should not be done lightly). 
 
3.2.2 
Coordinating Center 
The G1 Study day-to-day activities and operations are depicted below as related 
to the study. 
 
Figure _B_: Study Team Member Acronyms 
 
The responsibilities of the Coordinating Center at the USC Soto Building include 
individuals who will oversee various study tasks: 
 
● DB is the senior manager with oversight of all study procedures. 
● RC, AA, and LGB will assist with community engagement for participant 
recruitment. 
● RF will assist with communicating with study sites, scheduling meetings and 
training 
sessions, 
and 
responding 
to 
and 
documenting 
ad 
hoc 
communications. 
● RF, DB, and DH will assist with developing and maintaining the MOP.  
● RF will coordinate daily  study activities and procedures. 
● DB, RF, NA, MV, and SV will assist with developing the data flow and 
management procedures, including data entry, error identification, and 
correction. 
G1 Study Team Members Acronyms 
Manual of Operations and Procedures (MOP) 
Institutional Review Board (IRB) 
Nutritional Data System for Research (NDSR) 
Children’s Hospital Los Angeles (CHLA) 
AA – Ariana Argaiz 
TB - Thalia Bosman 
CR – Claudia Rios 
DB – David Black 
DH – Devin Hayden 
LBG – Lourdes Baezconde-Garbanati 
 
MA – Milena Amadeus 
MG – Marientina Gotsis 
MiG – Michael Goran 
YL - Yunlei Liu 
MM – Marisela Miranda 
MV – My Vu 
 
NA – Nick Arce 
P50 - P50 Center Staff 
RC – Rosalba Cain 
RF – Ruth Flores 
SV – Sandra Vasquez 
RW – Ryan Wilkerson 

 
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● DB, RF, MG, Adverse events monitoring and reporting, processing of adverse 
events, and health events during the study. 
● The IRB will ensure oversight and store accepted protocols through site visits 
to ensure adherence to the protocol and procedures (RF will oversee audits, 
oversight, and shadow, and AA and MG will oversee videos).  
● P50 CDE protocols are reported and feedback from (P50, MiG and LBG). 
● RF, AA, MV, and MG will ensure the validity of English and Spanish 
transcription, data completeness, irrigating profiles by participant, CGM, and 
Quality control procedures. 
● RF Reports (e.g., enrollment, AEs, participant status, site performance, and 
quality control overview). 
● DB, RF, and P50 are tasked with distributing all changes, updates, and 
policies of reports and documents to all participating study sites, and the 
DSMB, as necessary. This includes ensuring that all relevant parties are 
informed of any modifications or new policies that may affect the study. 
● RF, MA, and MM will ensure that proper protocols are adhered to for the A1C 
finger prick and document results on the appropriate form at the Soto 
laboratory.  
● RW is responsible for ensuring that all computer systems at the Soto Street 
facility function correctly. This includes regular maintenance, troubleshooting, 
and addressing any technical issues that may arise during the study.CR from 
the P50 Center will complete the NDSR assessment after participants have 
completed all study visits. 
● RF, NA, MG, and AA are responsible for video content correction, revisions, 
and editing. 
3.2.3     Study Sites 
Dr. David Black, PI, submitted a request for approval of a Clinical Study Site 
application to Cort Brinkerhoff, Ed.D, at Cort.Brinkerhoff@med.usc.edu. The 
application for the Clinical Study designation was approved for the on-campus 
facility located at the Soto Building, room 302D, on September 19, 2024, per Cort 
Brinkerhoff, Ed.D. 
 
The roles and responsibilities of the investigators and study sites include: 
 
● DB is the senior manager of all research staff and procedures conducted at 
the study site. 
● DB, RF, and SV staff will maintain the MOP study binder at the Soto office. 
● RF participation in protocol finalization and preparation of study materials 
● DB, RF, and SV compliance with the protocol, MOP, IRB, Federal, and state 
regulations 
● RF, AA, RC,  recruitment, screening, and enrollment of participants 
● DB, RF, and MV protection of participants' rights - Informed Consent form 
● DB, MV, RF,  data collection and participant follow-up through study 
completion  
● RF,  conduct Semi-Structured Interviews 

 
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● DB, RF, and MV, transfer of data to Coordinating Center and resolution of all 
queries 
● DB and RF Compliance with and accountability of administration of study 
intervention 
● MA and MM - Laboratory personnel from the Soto Laboratory conduct an A1C 
finger prick at the Soto building laboratory 
● RF, MA, MM, and SV Retention of specific records (e.g., laboratory or drug 
distribution records) 
● DB, RF,  communication of questions, concerns, and observations to the 
Coordinating Center. 
● MG, NA, TB, YL assist with translating video narrative health communication 
videos 
 
3.2.4     Steering Committees  
Steering Committees are not applicable in the G1 Study as this is not a 
multicenter study. 
 
3.2.5 
Other Study Committees 
An Executive Committee is not required for the G1 Study.  
 
 
3.3 
Training Plan 
All study personnel will have up to two weeks to complete all required training, 
including the Collaborative Institutional Training Initiative (CITI) certifications. 
 

 
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Figure _C_: Training Plan  
 
Completed certifications will be verified through their USC IRB profile in the USC 
iStar system. Training must be completed before observing and participating in 
any 
study 
activities. 
Study 
personnel 
RF 
will 
contact 
TG 
at  
Tania.Guevara@med.usc.edu regarding the Keck School of Medicine (KSOM) 
Unlicensed Research Personnel application process. All requirements must be 
completed prior to having direct contact with study participants.  
 
Ruth Flores will serve as the Site Coordinator and will periodically update TG 
regarding the new registration and credentialing of research personnel who are 
anticipated to have direct participant contact. 
Continuous Glucose Monitoring Study - Training Plan               
Employees have up-to 2-weeks to complete all required trainings 
Training Course Name 
Contact Person 
Training Link 
Date 
Completed 
Welcome G1 Study Orientation 
Ruth Flores 
  
  
Unlicensed Research 
Application 
Tania Guevara 
  
  
Social and Behavioral Research 
- Best Practices for Clinical 
Research (GCP) 
  
https://about.citiprogr
am.org/ 
  
Human Research - Social 
Behavioral Human Subjects 
(HS) 
  
https://about.citiprogr
am.org/ 
  
Social Media and Research 
Recruiting 
  
https://about.citiprogr
am.org/ 
  
Information Privacy Security 
HIPAA (IPS-Research) 
  
https://about.citiprogr
am.org/ 
  
Blood Borne Pathogens 
  
http://trojanlearn.usc.
edu 
  
G1 - Study Protocol 
Ruth Flores 
  
  
G1 - Manual Base Protocol 
Ruth Flores 
  
  
Research Electronic Data 
Capture (REDCap) 
Ruth Flores &  
My Vu 
https://redcap.med.u
sc.edu/ 
  
Descrip Software Video Training 
(Correct script that the platform 
generates for recordings) 
Ruth Flores & 
Marientina Gotsis 
  
  

 
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3.4 
Communications Plan 
Ongoing communication with members of the G1 Study study is essential to 
ensure the study is on track, to discuss status updates and progress, and to 
address emerging study issues to be resolved with energetic debate.  
 
Audience 
Frequency 
Preferred 
Method 
of deliver 
Source 
Delivered 
By 
Status 
Updates 
Expected 
Results 
G1 Key 
Personnel 
As needed 
Zoom 
Meeting 
Email 
Attachme
nts 
Agenda/Sta
tus Reports 
PI 
Management  Review study 
goals/objecti
ves, 
development 
or execution 
of the G1 
research and 
project 
development  
G1 Staff 
Weekly Wed 
11:00 a.m. 
Zoom 
Meeting 
Email 
Attachme
nts 
Agenda/ 
Status 
Reports 
PI 
Completion of 
all project 
objectives 
Provide 
status on 
study 
activities, 
timeline, 
identify and 
project risks 
P50 Center 
Personnel 
(CHLA) 
Monthly 
Zoom 
Meeting 
Email 
Attachme
nts 
Agenda/ 
Status 
Reports 
PI 
Progress and 
status reports 
Provide G1 
study 
recruitment 
updates 
USC 
Department 
Administrati
on 
As needed 
Zoom 
Meeting 
Email 
Attachme
nts 
Agenda/ 
Status 
Reports 
PI 
Staff & 
Equipment 
Processing 
Provide 
action items 
follow-up, 
and 
resolutions  
Dexcom 
Staff 
As needed 
Zoom 
Meeting 
Email 
Attachme
nts 
 
PI 
Equipment 
Processing 
Update on 
Dexcom 
equipment 
for G1 study 
Figure _D_: Communication Plan 
 
3.5 
Study Intervention 
The G1 Study uses. The  a test device to prevent or change the natural course 
of a disease or condition (prediabetes to diabetes). intervention components 
includesthe CGM system, health communication video clips, and behavioral 
activities (glucose self-monitoring and self-selected behavioral modifications of 
diet, physical activity and lifestyle) 

 
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Device studies require a detailed description of the device and its intended 
use. Information on device studies is provided in the Code of Federal 
Regulations (CFR) Title 21, Parts 800 - 1299, revised as of April 1, 2000 (see 
http://www.access.gpo.gov/nara/cfr/waisidx_00/ 
21cfrv8_00.html).  
 
Device. The Dexcom G6 Pro Continuous Glucose Monitoring System 
(Dexcom G6 Pro System) is a real time continuous glucose monitoring device 
indicates users of age 2 years and older in a home environment while under 
the supervision of a healthcare professional. Interpretation of the real-time 
Dexcom G6 Pro System results should be based on the glucose trends and 
several sequential readings over time. The Dexcom G6 Pro System may also 
be used as a retrospective glucose recording device indicated for assessing 
glycemic variability in persons age 2 years and older in a home environment 
while under the supervision of a healthcare professional. Retrospective 
interpretation of data recorded by the Dexcom G6 Pro System should be 
conducted solely by a healthcare professional. The Dexcom G6 Pro System 
aids in detecting glucose excursions facilitating care plan adjustments. The 
Dexcom G6 Pro System is also intended to interface with digitally connected 
devices. The Dexcom G6 Pro System can be used alone or in conjunction 
with these digitally connected medical devices for managing diabetes or 
assessing glycemic variability  
 
3.6 
Recruitment Plan   
The initial baseline screening telephone call for the G1 Study initiated on May 
24, 2024, and the final screening was conducted on August 30, 2024.  
The target population for the G1 Study 1 are 20 individuals who have been 
working as community health workers in the last six months, diagnosed with 
prediabetes, and ideally reside in Los Angeles County. At the coordinating P50 
recruitment site (SCCLH), staff provide all recruitment material in both English 
and Spanish.  
 
3.7 
Participant Retention 
Research participants will be compensated for their efforts at the trial. The total 
compensation is $500 in the form of gift cards divided into different phases. For 
participating in the initial visit alone, research participants are compensated with 
a $100 gift card, for wearing a glucose sensor for 20 continuous days, each 
participant receives a $200 gift card. For participating in the post visit and the 
semi structured interview, participants are compensated with a $200 gift card.  
RF keeps constant communication with each research participants through 
emails, text messages and phone calls. RC provides a weekly list of new 
referrals. The list provided contains participant details such as name, last name, 
phone number and email address. Once RF obtains a new referral, she sends 
an initial text message and email to introduce herself. After participant shows 

 
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interest in the study, RF schedules a phone call with each potential participant 
within the following 72 hours. During the screening call, if a participant is deemed 
eligible for an initial in person visit, RF schedules the visit in the following 7 days 
and once the screening call ends, she sends a text message to remind each 
participant of the upcoming initial study visit. Once a participant is enrolled in the 
study, RF sends daily text messages from days 1 through 20 of sensor wear. 
Through these messages RF ensures study activities compliance and assesses 
wellbeing of each research participant. 
The PI, research coordinator, and biostatistician will convene weekly to review 
retention percentages as well as the quality and completeness of captured data. 
This will entail, at minimum, an overview of participant intake and retention 
progress, summary reports outlining participant compliance with visits, 
evaluations, interventions, and a summary evaluating the completeness and 
quality of key data elements required for characterizing participants. These 
reports will determine the data captured and process quality to facilitate 
analyses. The statistician will also update the study's master data file and 
variable codebook at this exact interval which is stored on REDCap. The 
codebook and data file will be in a format with sufficient detail to be made publicly 
and available to support research replication in the field.  
 
3.8 
Study Design  
Study 1 employs a within-subject design without CGM masking, enabling the 
measurement of glycemic variability, where participants receive feedback every 
5 minutes while wearing the CGM device. This is an observational study where 
participant glycemic data is observed when CGM feedback is available on their 
smartphone app. This design captures continuous baseline values on the 
primary study outcome across 20 consecutive days while recorded video -based 
narratives are provided by participants each day as well as during the structured 
interview.  
 
Proposed Accrual Study Timeline 
The figure below depicts the proposed timeline for the target enrollment of 
participants across three independent studies.  
 
Figure _E_: Proposed Accrual Timeline 

 
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Schedule of Assessments 
The table below represents the schedule of assessments which details each 
variable name, applied measure, data capture medium, and the timing of the 
assessment relative to the study design.  
 
 
 
Figure _F_: Schedule of Assessments 
 
Study Flow 
The G1 Study overview is depicted in a flow diagram illustrating the study’s 
major steps. (see Figure 1 below). 
Variable 
Measure 
Capture 
Screen 
Baseline 
Visit 
CGM 
Phase 
Post 
Visit 
Eligibility 
Age, sex, race/ethnicity, 
employment, zip, contact 
info, medical history, CDC 
prediabetic risk 
Phone 
x 
  
  
  
A1c% 
A1cNow test kit (5.7-6.4%) 
Staff 
  
x 
  
  
Weight, kg 
Digital scale (Tanita WB-
3000) 
Staff 
  
x 
  
x 
Height, cm 
Stadiometer (Tanita WB-
3000) 
Staff 
  
x 
  
x 
Dietary log 
G6 app daily log upon out-
of-range chime 
G6 App 
  
x 
x 
  
CGM changed 
G6 transmitter replaced 
Zoom, 
Phone 
  
  
x 
  
Glucose, mg/dL 
Dexcom G6 Pro system 
G6 
reader 
  
x 
x 
x 
Physical activity 
International physical 
activity questionnaire 
RC 
  
x 
  
x 
Narrative 
Semi-structured interview 
Video 
  
  
  
x 
Satisfaction 
CGM satisfaction survey 
RC 
  
  
  
x 
Pattern detection 
Ravens' matrices task 
Website 
  
  
  
x 
P50 CDEs 
Socio-demo and residential 
RC 
  
  
  
x 
P50 dietary recall 
NDSR external date 
Phone 
  
  
  
x 
Daily Videos: Food 
Intake 
  
  
  
  
x 
  

 
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Figure _G_: Continuous Glucose Monitoring Study Flow Diagram 
3.9 
Screening and Eligibility Criteria  
Eligibility inclusion criteria include current or recent PdS, prediabetes risk based 
on the A1C glucose measure between 5.7% up to 6.4.%, recent prediabetes 
diagnosis, aged 18 years or older adult in California, self-identified 
Latino/Hispanic ethnicity, and willing to participate in a study. 
The information below describes the instructions on screening procedures for the 
G1 Study. The information will assist the study team in determining participant 
eligibility.  
 

 
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Figure _H_ 
* Important to note that a maximum of four telephone calls will be made to make 
contact with the potential participant. In addition, telephone messages will be left 
indicating when and what time the next call will be made in efforts to speak with 
the potential participant and inquire if they are still interested in participating in 
the G1 Continuous Glucose Monitoring study. 
 
Screening by phone 
During the pre-screening phase, the P50 staff will make telephone calls to 
individuals who have been recruited and expressed an interest in the G1 Study. 
The outreach recruitment is carried out by the P50 team, AA and RC.   
The initial baseline screening process is conducted by the G1 study team at the 
USC Health Sciences Campus, Soto Building. The screening process is 
facilitated by a computer-assisted verbatim script within the RC system which 
takes approximately 20 minutes from introduction to competition. Upon 
scheduling a screening call with the participant, the administrative team will log 
into their RC account and create a new file in RC for each participant who will be 
screened. 
Once logged into the RC system, the administrative staff will navigate to "My 
Projects" > "Continuous glucose monitoring in adults - G1 study" > and select the 
"Record Status Dashboard" tab on the left-hand side of their screen. From there, 
they will click "Add new record," which will prompt a table named "Data Collection 
Instrument" to appear. Within this table, the administrative staff member will 
select the "Screening Call" option, triggering RC to automatically generate a 
unique RC ID for the participant. The staff member will input the data collected 
during the screening phone call in real time. Before submitting, the staff member 
will ensure that all data is entered accurately and complete. An example of the 
telephone script is provided in Appendix _A_. 
3.9.1 
Screening Log  
A CGM Screening Log documents all participants that are reviewed for study 
eligibility, and contains the following: 
● Participant identification number 
● Initial screening date 
● Eligible for study participation 

 
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● Date enrolled  
● Date of initial visit 
● Reason for ineligibility, if applicable 
A sample Screening Log is included in Appendix_B_.  
Note: This information is usually part of the reporting requirements for data and 
safety monitoring. 
An example of the Screening log used in the G1-Study is shown in Appendix 
_B_. 
 
3.9.2 
Eligibility Criteria 
The G1 study staff will collect information from all participants to 
produce descriptive variables (i.e., age, sex, race, race/ethnicity, zip code) as 
well as assess medical history of chronic disease, current medical diagnosis, and 
current medications to determine eligibility. Eligibility criteria include current PdS, 
prediabetes risk, aged 18 years or older adult in California, self-identified 
Latino/Hispanic ethnicity, and who are willing to participate in the study.  
Exclusion criteria are: those individuals who have been diagnosed with 
diabetes, uncontrolled psychiatric condition making participation potentially a 
risk, influential medical disorder (i.e., history of seizures, glucose related 
complications, myocardial infarction or stroke in the past 6 months, abnormal 
thyroid function) and specific medication use (systemic b-blocker regular use of 
oral corticosteroids, initiation of a non-insulin drug for glucose control during the 
past 3 months, regimented use of acetaminophen), pregnancy, current use of a 
CGM sensor, enrollment in weight loss program or current fasting regimen, and 
any current obesity treatment medication. In addition, participants who have a 
telephone device that is incompatible with the Dexcom application. Lastly, if the 
participants are travelling in the next two months, they would not be eligible for 
the study.  
 
3.10 Informed Consent 
An example of the informed consent is provided in Appendix _D_1_. 
During screening call the study staff will assent the participant using Info Assent 
form, this form can be found in Appendix_D_2_. After the participants during 
screening procedure, the study staff will explain that during the initial visit, they 
wil be given an official consent document called the Informed Consent Form. The 
project staff will send the participant the Informed Consent Form (ICF) in their 
preferred language via email at least two days before their scheduled visit. 
Conduct the informed consent process in the privacy of the Soto 302D office with 
the door closed. Have a hard copy of the ICF ready and accessible during the 
process. Before the participant starts to read the ICF the study staff will explain 
to the participant that if they decide to participate they will complete two in person 

 
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study visits, wear a CGM sensor for 20 continuous days, complete different 
surveys, record daily videos, and be provided with up to $500 compensation in 
gift cards in total if they complete  each phase of the study. 
The study staff will allow the participant to take as much time as necessary and 
encourage them to ask any follow-up questions. The study staff will give the 
option to the participant if the ICF should be read by the study staff or if they 
prefer reading the ICF on their own. Once all questions have been addressed, 
summarize by asking the participant, "Do you understand that you are 
volunteering for a research study and that you can withdraw at any time?" If the 
participant consents, the study staff will have the participant sign the paper copy 
of the ICF and electronically sign the version in RC, which will be delivered to 
their email. At the moment that the participant is reading the ICF, the study staff 
will email the Phlebotomy staff to alert them that the participant will be directed 
to the lab after signing the ICF.  If the participant does not consent, the study 
staff will record the reason in the participant chart. 
Inform the participant that the final step for eligibility is a finger prick to measure 
capillary blood glucose levels, which will be performed at the laboratory on the 
first floor of the Soto building. Additionally, inquire if they require a bathroom 
break before proceeding.   
The study staff will collect the signed ICF and place it into a red folder which will 
be filed in a locked cabinet in office 302D located at the Soto building.  
Arrival and Introduction 
The study staff will send the participant an email and a text message containing 
the address, parking instructions, a reminder to write down the participant’s email 
login with the correct password (so they can successfully have access to the 
Recap survey link sent to their email account) on a piece of paper, and a map, 
both on two days before the visit, the day before, and the morning of their 
scheduled visit. Additionally, they will provide a cell phone contact number in 
case of arriving late or rescheduling purposes. Within 24 hours of the visit, the 
participants will be contacted by phone to confirm their attendance. 
The research staff will request a daily parking pass for each participant a week 
before their arrival. The research staff will submit a request to be a requisitioner 
for Internal Service Delivery (ISD) through USC’s PPHS Portal. After the 
approval, the research staff will receive an ISD number, which will be used for 
each parking spot pass request. Through the Workday portal, the staff will go into 
the ISD section and will submit the ISD number previously provided and will input 
the number of passes they will need for that designated day. After the request is 
approved, it will provide virtual parking passes on the Off-Street Dashboard 
website. The baseline interview will be conducted at the USC Soto building. 
Participants should wait in the designated parking area upon arrival. Upon their 
arrival, the participants will be warmly greeted and thanked for coming. The study 

 
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staff will introduce themselves, present their USC ID, and specify their role in the 
"USC Glucose Study." They will verify the participant's name and ensure they 
are able to stay for the entire 2.5-hour visit. Additionally, participants will be 
provided their license plate number, and the study staff will create a parking pass 
registration for the participants vehicle. The registration will be created in the “Off 
Street” dashboard website. In the registration the participant study ID will be 
entered. Before the participant is escorted to the Soto 302D office, the study staff 
will make sure that the participant has at least 2 hours available to complete their 
visit.  
3.10.1 HIPAA Authorization 
The HIPAA authorization is not applicable for the Continuing Glucose Monitoring 
study.  
 
3.11 Randomization 
Randomization is not applicable for the Continuing Glucose Monitoring study. 
  
3.12 Blinding and Unblinding (Masking and Unmasking) 
Blinding and Unblinding is not applicable for the Continuing Glucose Monitoring 
study.  
 
3.13 Study Measurements and Procedures 
Measures 
Prediabetes status. The assessment of prediabetes risk will be conducted using 
the 
CDC 
prediabetes 
risk 
measure 
(https://www.cdc.gov/prediabetes/risktest/index.html) during the initial screening 
by the study staff, who has access to the target population. Respondents scoring 
5 or higher on this measure are deemed to exhibit probable risk of prediabetes 
and are subsequently invited to attend the study baseline interview at Soto. 
Exception: If a participant expressed during the screening call that they have 
been diagnosed with pre-diabetes by their physician, they are eligible for initial 
visit. During the initial visit, finger prick A1c scores will be reviewed and 
confirmed, 
by 
utilizing 
the 
A1cNow 
Self-test 
kit 
(https://www.totaldiabetessupply.com/products/a1c-now-4-test-kit). Non-fasting 
A1c levels will be measured via finger prick blood spot. Individuals with resulting 
scores falling within the range of 5.7 to 6.4% will be deemed eligible for 
enrollment in the study, as this level is diagnostic of prediabetes. [see Davidson 
et al (2021). Screening for prediabetes and type 2 diabetes. JAMA; Dall et al 
(2014). Detecting type 2 diabetes and prediabetes among asymptomatic adults 
in the United States, Population Health Metrics; Tentolouris et al (2013). 

 
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Screening for HbA1c-defined prediabetes and diabetes in an at-risk Greek 
population, Diabetes Research and Clinical Practice.] 
Glycemic variability. The primary outcome measure for the project is glycemic 
variability, which will be assessed using CGM automated data capture and the 
Dexcom Clarity cloud. We will utilize the Dexcom G6 Pro system 
(https://provider.dexcom.com/products/dexcom-g6-pro/training-resources) 
to 
capture glycemic variability over 14-20 complete wear days, with data recorded 
automatically every five minutes and timestamped. Participants will change the 
transmitter once on day 10, as the sensor has a wear time of 10 days. Data will 
be transferred to the Clarity cloud using an external Dexcom reader. 
Subsequently, the Clarity file will be exported and sent to the statistician for 
processing in RC software, where all variables for the complete ambulatory 
glucose profile (AGP) panel for glycemic variability will be calculated.  
Our main outcome analyses will focus on key variables related to hyperglycemia 
(high glucose outside the healthy range). Additionally, CGM data will allow us to 
generate important covariates, such as the % time worn by each participant per 
week and the number of times a participant changed the CGM sensor. 
Demographics and eligibility. We will collect information from all participants 
to produce descriptive variables (i.e., age, sex, race, race/ethnicity, zip code) as 
well as assess medical history of chronic disease, current medical diagnosis, and 
current medications to determine eligibility. Eligibility criteria include current PdS, 
prediabetes risk, aged 18 years or older adult in California, self-identified 
Latino/Hispanic ethnicity, and willing to participate in a study. Exclusion criteria 
are: ever diagnosed with diabetes, uncontrolled psychiatric condition making 
participation potentially a risk, influential medical disorder (i.e., history of 
seizures, glucose related complications, myocardial infarction or stroke in the 
past 6 months, abnormal thyroid function) and specific medication use (systemic 
b-blocker regular use of oral corticosteroids, initiation of a non-insulin drug for 
glucose control during the past 3 months, regimented use of acetaminophen), 
pregnancy, current use of a CGM sensor, enrollment in weight loss program or 
current fasting regimen, and any current obesity treatment medication. 
Body composition. Weight and height will be observed in duplicate and charted 
by the study staff using an electronic Tanita WB-3000 scale, and stadiometer 
Tanita WB-3000. Staff will capture the information in a physical body 
measurement form, in addition to entering the data into the RC body 
measurement form which will automatically calculate participants BMI to prevent 
calculation errors. An example of a Body Measurement form is provided in 
Appendix _E_. Below is the procedure for performing and capturing weight and 
height for participants who are eligible for the study.  Weight and height will be 
captured and recorded for each participant without fasting, and without shoes. 
Height and weight. For this procedure, the research staff will have in hand a 
hard copy of the Body Measurement form abstracted from the RC secure system 

 
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web-based application. The procedure will take place in workstation 302-10 in 
front of the 302D office. The research staff will ask the participant to remove their 
shoes and any heavy clothing such as jackets, phones, and wallets. While the 
participant is removing his/her accessories, the study staff will sanitize the scale 
with an alcohol wipe found next to the scale. The study staff will ask the 
participant to stand as straight as possible on top of the Tanita WB-3000 scale 
and record their height in centimeters and weight in kilograms on the participant 
chart using the stadiometer. Document the height and weight on a hard copy of 
the RC Body Measures Form. Study staff will once again sanitize the scale with 
an alcohol wipe found next to the scale. Then, request participants to put their 
shoes back on, redirect the participant back to the office and have the participant 
take a seat in the chair designated within the office. Inform them that there are 
three remaining activities including completing a survey on the computer, 
placement of the glucose monitors as well as the daily video activity.  
Finger prick protocol. The finger prick protocol can only be conducted after the 
ICF is signed by the participant. The finger pricking procedure will take place at 
the Phlebotomy Laboratory area of the Soto Building located on the first floor. 
Before directing the participant to the lab, the study staff will explain that the 
finger pricking protocol will take place downstairs at the phlebotomy lab. If the 
participant does not understand the procedure the staff will explain that a 
phlebotomist will prick the superficial skin layer of his/her finger with a 28mm 
lancet to obtain a small drop of blood and put the drop of blood in a special 
glucose analyzer to obtain their A1c levels. After answering the participant’s 
questions regarding the finger pricking procedure, the study staff will take the 
participant to the Phlebotomy Lab area and will also take the hard copy of the 
"Body Measurements” form from RC.  As soon as the study staff and participants 
arrive at the lab, the study staff will hand the Phlebotomy lab staff the hard copy 
of the Body Measurements Form. The phlebotomist will capture the A1c levels 
given by the analyzer and document on the Body Measurement form. The finger 
prick is a method to capture a droplet of blood on the tip of the finger to measure 
glucose levels to determine study eligibility.  
The instructions for the use of A1cNow Test Kit can be found in Appendix_C_.  
 
 

 
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Computer-based survey: the self-administered surveys delivered through 
each study visits are beverages survey, behavior survey, CGM satisfaction 
survey. 
 
An example of a Body Measurement form is provided in Appendix _E_ 
Below is the procedure for performing and capturing weight and height for 
participants who are eligible for study.  
● Weight and height will be captured and recorded for each participant without 
fasting, and without shoes. 
For this procedure, the research staff will have in hand a hard copy of the Body 
Measurement form of the RC platform. The procedure will take in workstation 
302-10 in front of the 302D office. The research staff will ask the participant to 
remove their shoes and any heavy clothing such as jackets, phones, and wallets. 
While the participant is removing his/her accessories, the study staff will sanitize 
the scale with an alcohol wipe found next to the scale. Nicely ask the participant 
to stand as straight as possible on top of the Tanita WB-3000 scale and record 
their height in centimeters and weight in kilograms on the participant chart using 
the stadiometer. Document the height and weight on a hard copy of the RC Body 
Measures Form. Then, request participants to put their shoes back on, redirect 
the participant back to the office and have the participant take a seat in the chair 
designated within the office. Inform them that the remaining activities include 
completing a survey on the computer and the placement of the glucose monitor. 
3.13.1 Timeline of Study Assessments 
A useful study tool that outlines the G1 schedule of variables, measurement, 
and timeline are exhibited relative to the study design. An example of a 
Timeline of Study Assessments is provided in Appendix _F_ 
3.13.2 Scope/Schema 
In this section of the MOP, each visit should be explained in detail enough so 
that a new or substitute team member can perform the visit. Step-by-step 
instructions should be provided for all study procedures. This may include 
defining the purpose of the assessment, the time of data collection, or the 
processes for handling unscheduled visits. 
Baseline visit 
Arrival and introduction 
The study staff will send the participant an email and a text message containing 
the address, parking instructions, a reminder to write down the participant’s 
email account with the correct password (so they can successfully get access 
to the Recap survey link sent to their email account) on a piece of paper, and a 
map, both on the 7th day and the day before their scheduled visit. Additionally, 
they will provide a cell phone contact number in case of transportation issues 

 
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on the day of the visit or for rescheduling purposes. Within 48 hours of the visit, 
the participant will be contacted by phone to confirm their attendance. 
The research staff will request a daily pass for each participant a week before 
their arrival. The research staff will submit a request to be a requisitioner for 
Internal Service Delivery (ISD) through USC’s PPHS Portal. After the approval, 
the research staff will receive an ISD number, which will be used for each 
parking spot pass request. Through the Workday portal, the staff will go into the 
ISD section and will submit the ISD number previously provided and will input 
the number of passes they will need for that designated day. After the request 
is approved the Transportation Office will provide manual exchange tickets that 
will need to be date-stamped and distributed to each participant upon arrival. 
These passes will be valid for any unmarked space within the Soto lot. 
The baseline interview will be conducted at the USC Soto building. Participants 
should wait in the designated parking area upon arrival. Upon their arrival, the 
participants will be warmly greeted and thanked for coming. The study staff will 
introduce themselves, present their USC ID, and specify their role in the "USC 
Glucose Study." They will verify the participant's name and ensure they are 
able to stay for the entire 2.5-hour visit. Additionally, participants will be 
provided with the designated parking pass which the study staff will indicate to 
the participant to place the ticket on top of the participant’s car dashboard.  
Before the participant is escorted to the Soto 302D office, the study staff will 
make sure that the participant has at least 2 hours available to complete their 
visit. 
Informed consent and signatures 
Send the participant the Informed Consent Form (ICF) in their preferred 
language via email 2 days before their scheduled visit. Conduct the informed 
consent process in the privacy of the Soto 302D office with the door closed. 
Have a hard copy of the ICF ready and accessible during the process. Before 
the participant starts to read the ICF the study staff will explain to the participant 
that if they decide to participate they will complete 2 in person study visits, wear 
a CGM sensor for 20 continuous days, complete different surveys, record daily 
videos, obtain a $500 compensation in total if they complete the each phase of 
the study and complete a recorded interview on their last study visit. 
Allow the participant to take as much time as necessary and encourage them to 
ask any follow-up questions. The study staff will give the option to the 
participant if the ICF should be read by the study staff or if they prefer reading 
the ICF on their own. Once all questions have been addressed, summarize by 
asking the participant, "Do you understand that you are volunteering for a 
research study and that you can withdraw at any time?" If the participant 
consents, have them sign the paper copy of the ICF and electronically sign the 
version in RC, which will be delivered to their email. While the participant is 
reading the ICF, the study staff will email the Phlebotomy staff to alert them that 

 
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the participant will be directed to the lab after signing the ICF.  If the participant 
does not consent, record the reason in the chart. 
Inform the participant that the final step for eligibility is a finger prick to measure 
capillary blood glucose levels, which will be performed on the first floor of the 
Soto building. Additionally, inquire if they require a bathroom break before 
proceeding.  
Finger prick protocol 
The finger prick protocol can only be conducted after the ICF is signed by the 
participant. The finger pricking procedure has been explained in the previous 
section. 
Height and weight 
For this procedure, the research staff will have in hand a hard copy of the Body 
Measurement form of the RC platform. The procedure will be taken in 
workstation 302-10 in front of the 302D office. The research staff will ask the 
participant to remove their shoes and any heavy clothing such as jackets, 
phones, and wallets. While the participant is removing his/her accessories, the 
study staff will sanitize the scale with an alcohol wipe found next to the scale. 
Nicely ask the participant to stand as straight as possible on top of the Tanita 
WB-3000 scale and record their height in centimeters and weight in kilograms 
on the participant chart using the stadiometer. Document the height and weight 
on a hard copy of the RC Body Measures Form. Then, request participants to 
put their shoes back on, redirect the participant back to the office and have the 
participant take a seat in the chair designated within the office. Inform them that 
the remaining activities include completing a survey on the computer and the 
placement of the glucose monitor. 
[When the baseline visit is over: log into the RC "Continuous Glucose 
Monitoring in Adults - G1" study. Navigate to the "Record Status Dashboard" 
tab on the left-hand side of the screen, where a list of all screened participants 
will be displayed in the center of the page. Verify the correct ID for the 
participant, click on "Body Measures" within that participant's record. Input the 
data such as A1c level, weight, and height from the hard copy of RC forms into 
the corresponding fields in RC.] 
Computer-based survey 
Have the participants sit in the 302D office to complete the survey. The 
research staff will send a RC invitation to the participant by email beforehand, 
at least 1 hour before the baseline visits take place. Prepare the computer and 
tell the participant to log into the email they initially gave during their screening 
call. After the participant has access to their email, ask the participant to find 
the email called “Informed Consent.” Make sure the participant has the correct 
email in place, explain to the participant that the first link will prompt out the 

 
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electronic Informed consent, explain that we need to capture their electronic 
signature as well. Another important document they will sign before starting the 
Baseline Visit surveys, is the Image Release form. The study staff will explain 
that we are kindly asking them to give us consent to be able to use their daily 
videos and video recorded interviews to be able to create educational videos 
about their CGM experience.  The study staff will then tell the participant that 
after they have given their consent, 4 surveys will prompt out and usually takes 
about 30-45 minutes to complete, and it will ask questions related to physical 
activity, current medication, vitamin use and various behaviors. After the 
participant has agreed to continue with the survey's procedures, the study staff 
will ask the participant to login into their email in the PI’s office computer. The 
study staff will ask the participant if they want the surveys to be read to them by 
the staff or if they desire to complete the surveys on their own. The study staff 
will remain in the room to make sure all questions regarding the surveys are 
answered to the participant. At the survey's completion, verify that RC shows 
that all baseline forms were completed by the participant. 
To send the participants a RC invitation/link to the survey forms of RC, the 
study staff will login into RC and choose the “Continuous glucose monitoring in 
adults - G1 study.” Click on the “Survey Distribution Tools” tab on the left-hand 
side of the RC page. Once they have clicked on the Survey Distribution tab, 
they will click on the “Participants List” tab shown on the upper center of the 
page. DO NOT click on “Public Survey Link.” Choose the survey form they want 
to send to the participant (i.e. demographics baseline). After selecting the 
survey form, they will click on the “Compose Survey Invitations” tab shown 
under the selected survey form. Fill in the date and time the email should be 
sent to the participant, from which study staff’s email will the RC system send 
the survey to the participant, a message written within the email to the 
participant. On the right-hand side of the page, a list of all the participants' 
emails will appear. After the study staff verifies the correct email associated 
with the participant, they will then select the participant's email address. Once 
they have reviewed and confirmed that each section is filled in with the correct 
information, the study staff will proceed to email the invitation/link to each 
participant. 
CGM application 
The staff will guide participants to download the Dexcom G6 app and the 
Dexcom – Clarity app onto their personal smartphone. The staff will help in 
creating a username for their Dexcom app and completing the login process. 
The Dexcom G6 app will request the participant to create a Dexcom username 
and password. When creating the Dexcom account, the staff will make sure 
that the participant is only using the initials of their name (e.i. RF). After the 
participant logs into their account, the study will ask the participant to turn on 
their smartphone's Bluetooth, this step is needed for the sensor to be able to 
link with their smartphones. 

 
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The study staff will assist participants in applying the G6-Pro sensor to the back 
of their arm. This procedure will occur in room 302D with the door closed. 
Before beginning, the research staff will explain the main steps using the G6 
instructions and address any participant questions. Participants should be 
comfortably seated. After the participant is seated, the study staff will show a 
Dexcom sensor application video beforehand, this way the participant will have 
a visual example of what the procedure will be like. The video that will be 
shown to the participant can be accessed by following the link below: 
https://youtu.be/eHKFDyrd-Ls?si=91yNAG8RcfP2Fwcl 
After seeing the video, the study staff will answer questions asked by the 
participant regarding the sensor application. The study staff will then gather the 
Dexcom G6 Pro kit, which includes the applicator, transmitter, and receiver. 
The study staff will guide the participant to open their Dexcom G6 PRO box and 
explain each supply found within the box: 1 sheet with the sensor transmitter 
code, 1 sheet with a visual representation of each step of the sensor 
application, 2 alcohol wipes, 1 applicator containing the sensor and the Dexcom 
transmitter. The explanation that will be given by the participant will be 
demonstrated by the study staff using an old Dexcom G6 PRO Kit. The 
explanation given is the following: or applying the sensor, begin by using an 
alcohol wipe to clean a 3-inch diameter area around the intended placement 
spot. Position the applicator firmly against the skin on the underside of the back 
of the arm. After placing the adhesive on the skin, the study staff will guide the 
participant to fold to the side and break off the trigger safety guard; then press 
the release trigger. Instruct the participant to apply pressure with their finger to 
the sensor against the skin for 10 seconds. Afterward, use circular motions to 
firmly rub the adhesive tape around the transmitter-sensor patch, ensuring a 
secure hold. After the sensor has been applied, the study staff will guide the 
participant to grab the transmitter and place it in the transmitter slot found in the 
sensor adhesive. The staff will hold a mirror in front of the participant, that way 
the participant has a clear view of the sensor and transmitter. A visual 
description of this procedure is shown on the next page. 
After the participant has applied their sensor, the participant will login into the 
newly created Dexcom account logs, and the study staff will ask the participant 
to turn on their smartphone's Bluetooth, this step is needed for the sensor to be 
able to link with their smartphones. After creating their account, the app will 
prompt for the transmitter Serial Number, located on the “Start Here” page 
found in the Dexcom box and on the two stickers in the Dexcom Kit box. Enter 
this number and affix the provided sticker onto the participant's chart for record-
keeping purposes. After entering the transmitter serial number, the user will 
click on the “Save” icon found in the upper right corner of their screen. The 
smartphone will then prompt a question to confirm the Transmitter Code, after 
the study staff has verified that the participant entered the correct Transmitter 
code, the user will be guided to click “Confirm”. The G6 App will take about 5 
minutes to recognize it. After the smartphone has recognized the sensor, a new 

 
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question will appear on the screen, asking the user if they want to pair the 
transmitter to the smartphone, the study staff will then guide the participant to 
click on “Pair New”. Once the App has linked with the sensor, the app will show 
a sign saying that the sensor will warm up for 3 hours and that no glucose data 
will be shown until the sensor has completely warmed up. After the pairing has 
been successful, the study staff will ask the participant to go to the “settings” 
Icon found in the upper right corner of the G6 App, and they will click on the 
“Alerts” section. After the alerts page prompts out, the study staff will turn off 
the “Low” alerts and will click on the “High” tab to place 140mg as the level of 
high glucose alerts. Explain to the participant that the G6 App cannot be closed, 
that way all collected data is not lost. The study staff will make the remark that 
the participant's smartphone's Bluetooth always must be on. After completely 
setting up the G6 App, the study staff will then ask the participant to open the 
Dexcom Clarity app and the app will ask the participant to login with their 
Dexcom username and password. After login into the Dexcom Clarity app, the 
study staff will guide the participant to go into the “profile” section of their app, 
after touching that section the app will prompt a page where it will show a 
section called “Manage Data Sharing,” the study staff will ask the participant to 
select that section and the app will then ask the participant to “Share your CGM 
data with your clinic” and the participant will be guided to touch the “Continue” 
tab. After selecting the “continue” tab, the app will ask the user to “Enter clinic 
code.” The clinic code that will be used for the G1-study is: g1studyusc. After 
entering the G1-study clinic code, the participants' CGM data will appear on the 
Clarity platform after the sensor has warmed up. 
After the study staff has made sure that the participant has linked their 
smartphone to the CGM sensor, the staff will then link the applied sensor to the 
G6 PRO receiver. To do so, the staff will grab the G6 PRO reader and click the 
“On/off” button. After the receiver has turned on, the receiver will ask the user 
to enter the 4-digit sensor code. The study staff will enter the 4-digit code found 
in the adhesive backings of the applied sensor applicator. Once the study staff 
has entered the code. The receiver will take about 5 minutes to link the sensor 
to the receiver. 
The study staff will then congratulate the participant for successfully applying 
the sensor and pairing the sensor to their smartphone. After words of 
encouragement have been given, the staff will then explain to the participant 
that they will complete daily videos in which they will answer questions that the 
study staff will send through a text message every day, within those videos they 
will sincerely share their experience with the Dexcom sensor. The study staff 
will explain that on the days they obtain “high glucose” alerts, they will create a 
video describing in what situation the participant was in when the alarm was 
received; they will describe what foods they ingested before obtaining the alarm 
as well. 

 
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The final step of this procedure involves explaining to participants the signs and 
symptoms they should report to the research staff regarding the sensor. These 
include swelling, redness, bruising or bleeding. Participants must notify the 
research staff if the transmitter falls off or if any errors occur within the app. The 
study staff will make the remark that the participant cannot remove the sensor 
unless it is instructed by the study staff. Additionally, participants should be 
reminded that the transmitter-sensor is effective for 10 consecutive days. 
Provide each participant with a yellow folder to store the used transmitters. 
Remind the participant they are to bring their transmitters with them on their 
return visit. 
Before the participant puts his/her smartphone away, the study staff will ask the 
participant if they already have a Zoom App and Zoom account and explain that 
this app is needed for the sensor replacement video call. If the participant does 
not have a Zoom account, the study staff will help and guide the participant to 
download the Zoom app and with the creation of a Zoom account. 
Instructions for G6-Pro placement and transmitter attachment 
 
 
1. 
After the sensor is inserted and the transmitter has been snapped into 
the sensor pod, open the G6 app and follow prompts to create a 
username and password. Log in to the app and follow the set-up 

 
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wizard. Refer to the unblinded CGM patient handout that is included in 
your box. 
a. 
The study staff will keep the adhesive backings of the applicator 
because this adhesive contains the 4-digit code that will be 
entered into the receiver/reader.  
**Special instruction: 
Turn off low alerts of 70 for prediabetes. 
Set up high alert at 140 for prediabetes 
Then be sure to turn off all alerts after you have started up - go to settings on 
G6 app home page and turn always sound to off. 
 
  
 
2. 
In your box you will find an invitation to share your data. Follow the 
instructions on how to accept the invitation. 
a. 
Download the Dexcom Clarity App into the participant’s 
smartphone 
b. 
Enter the G1-Study clinic code: G1Study. By doing so the system 
will automatically populate the participant’s glucose data into the 
Clarity system. 
3. 
In 10 days, your G6 Pro sensor session will end. The app will let you 
know when it has finished. Peel off the entire sensor with a transmitter 
(like peeling off a Band-Aid) and place in the zip-lock bag and then 
place in the envelope provided. 

 
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4. 
Return transmitter to research team. 
5. 
Be sure to keep your phone within 20 feet to retain transmission and do 
not swipe close the app at any time as this will stop transmission of 
CGM data. 
An example of the Dexcom Training Checklist is provided in the 
Appendix_G_. 
G6 Reader 
The reader, also known as a receiver, is the device from the Dexcom G6 Pro 
kit that helps the user verify that the session has started. The reader will not 
show any real time CGM data. The manufacturers describe this device as a 
compatible data extraction tool, this will help the research staff to upload 
patient data to Dexcom Clarity. In a blinded study scenario, the reader will be 
the only device receiving the data from the Dexcom transmitter. After the 
application of the Dexcom sensor-transmitter, the study staff will turn on the 
reader and the reader will ask for the serial number associated with the 
transmitter. The serial number is on the box, one of the inserts and the bottom 
of the transmitter. When you turn on the Reader and select “Download Data”, 
the first thing it asks for is the transmitter serial number.  
Each G6Pro box has an insert that comes with 2 stickers which are the serial 
number. One sticker will be placed into the patient chart. If you are doing it 
electronically. We will keep a study record of the serial number of the 
transmitters by participant ID as shown below. 
Study ID   
 
Transmitter_1  
 
Transmitter_ 2 
    001          
      xxxx  
 
        xxxx 
  
Daily videos recording 
An email will be sent automatically one day after the participant signs the ICF. 
The email will contain a RC link in which the participant will be able to upload 
their daily videos. 
After the application of the sensor, the study staff will reiterate to the 
participant that as mentioned during the ICF process, the participant will 
create daily videos using their smartphones. The study staff will explain that 
the participant will create a video after obtaining a “high glucose” alert, in 
which they will describe what foods they ingested before receiving the alarm 
and they will describe in what situation they were in in the moment that they 
obtain the alert. The study staff will explain in addition, the participant will 
receive a daily text with 2 questions that the participant will answer on a video 
at the end of the day at approximately 6:00 p.m. The study staff will clarify 
that the purpose of the daily videos is to record their entire experience with 
the Dexcom sensor throughout the CGM wear phase. The study staff will 

 
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explain that every day at 6pm they will also receive an email containing a link 
with instructions on how to record themselves, and a section link where they 
will upload their daily videos. 
Video Upload Practice 
An email will be sent automatically after the participant signs the ICF. The 
email will contain a RC link in which the participant will be able to upload a 
practice video during the visit. 
After providing a clear explanation, the study staff and the participant will 
create a practice video in which the staff will explain to the participant the 
importance of the lighting for the video, and that the participant’s face should 
be clearly seen. The staff will inform the participant to make their videos in 
silent places, to eliminate other noises on their video’s audio. 
The study staff will kindly ask the participant to check their email to ensure 
that they have received an email titled “Video Upload.” If the participant 
cannot locate the email, the study staff will help locate the email either in the 
participant’s email inbox or in the spam folder. If the study staff is unable to 
locate the email, the study staff will check the email address that the 
participant provided during their screening call. After checking the correct 
email address, the study staff will immediately contact the study’s statistician, 
so that the participant can receive the video upload link. 
Compensation 
The study staff will provide $100 gift card compensation to all participants 
attending the baseline interview and complete the protocols. Since this is the 
last procedure, the participant will be involved with for this visit, the study staff 
will provide an envelope to the participant. The envelope will be labeled with 
the name of the study, the research coordinator’s name and contact number. 
In the envelope the participant will locate two Ziploc baggies, 1 for each worn 
sensor. Each baggie will be labeled as “sensor 1” and “sensor 2;” the baggie 
will also contain one of the stickers designated for each sensor (these stickers 
will be found within the Dexcom G6 Pro kit box). The study staff will explain to 
the participant that the bag labeled “Sensor 1” is for them to put in the sensor 
that has been recently applied on the 10th day and the bag labeled “Sensor 2” 
is designated for the 2nd sensor they will apply on their own once they have 
completed the 20 days (about 3 weeks) of the CGM phase. 
Data entry 
The study staff will ensure to transfer the baseline data collected from the 
participant's chart into the RC system on the same day as the baseline visit. 
This will ensure that the main data capture system remains up to date. 
CGM Wear Phase 

 
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The CGM wear phase will span 20 consecutive days. Throughout this period, 
we will gather data from the participants on a weekly basis. The sensor will be 
replaced once on day 10. Each morning, participants will receive text prompts 
to log dietary behaviors that triggered high out-of-range alarms; these logs will 
be recorded directly in the app by the participant. During the Zoom-supported 
sensor replacement call, the staff will replace the sensor and inquire about 
any adverse events or serious adverse events related to the sensor. 
Additionally, study staff will conduct Zoom sessions with participants on the 
10th day of wearing transmitters during the CGM phase. 
Dietary logs 
The research staff will send one text per day to each participant, reminding 
them to report on their daily videos what foods they ingested right before they 
obtained a “high glucose alert” from the Dexcom G6 app. These reminder 
texts will be sent at 6pm every day of CGM wear. They will prompt 
participants to document the type of food consumed on a short video 
captured by their smartphones. These videos will be made after the 
participant has received a “high glucose” alert on their Dexcom G6 app and at 
the end of the day so they can answer questions that will be send out through 
a text message by the study staff daily. Within their daily text messages, the 
study staff will text daily questions which will vary throughout the 20 days of 
the CGM phase.  The study staff will provide a video prompt to the 
participant's email. The video prompt that will be sent will be the following: 
“Hi Mrs X, 
Thank you for your participation in the G1 Study! As you wear the Dexcom G6 
CGM sensor for the next 20 days, we would like to understand your 
experiences and journey with the device. To do so, we would like you to 
record a video of yourself answering a few questions using your mobile 
device’s front camera. We will send out the questions at 1pm everyday via 
email. This handout is to guide you through recording yourself on the front 
camera of a mobile device. We will also include how to upload the videos at 
the end of the handout. 
Recording Tips 
Posture 
It may be helpful to be seated while you are recording yourself. Sitting will 
allow you to have your back straight to properly project your voice and ensure 
your body does not fidget or move around too much. In the frame, include 
your head, neck, and part of your shoulders. Extend your arm in front of you 
to hold the mobile device. Hold the mobile device far enough away to include 
these but close enough to ensure the focus is still on your face. The recording 
should be vertical. 

 
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Framing 
Frame yourself so your eyes are roughly ⅓ of the way down your screen but 
above the middle of your screen. This framing will ensure your head, neck, 
and part of your shoulders are in the frame. See the example below. 
Lighting/background 
Avoid filming in places where the background is brighter than you are (i.e., 
with a light source or a window behind). Instead, have a light source (from a 
lamp, for instance) pointed at you or sit by a window. Lighting in front of you 
will ensure you are visible in the video. 
Audio 
Record the video in a quiet place with little to no outside noise. Ensure as 
best as possible that your voice is the only noise captured. You can test how 
your voice sounds with a test recording. Make sure your voice is audible in 
the test recording. Most microphones on mobile phones can pick up voice 
very well. If your audio does not sound clear, you can use headphones to 
capture the audio. 
Practice 
To make it easier to remember the question, we advise writing it down or 
having the question open in front of you. Additionally, jotting down a few notes 
for points you would like to cover before the recording can help organize your 
thoughts. If it is easier to read from your notes, feel free to do so (just make 
sure you look at the camera occasionally)! It may also help to do more than 
one take, but typically the one of the first two takes is the best. 
Video capture 
You will receive an email at [insert time that was set up on REDcap] in which 
you will find a link called “Video upload” to upload the video. After you click on 
the link a page will pop up in which you will type in today’s date and under the 
date section you will find a section with green letters that reads “Upload file,” 
click on that green section and a box that reads “Choose file” will appear. 
After clicking “choose file” the page will let you choose the App in which you 
have your videos saved, select the app in which you have stored your video 
[ex. Gallery app]. Then you will select the video you created on this day and 
after selecting the video, click on the “Upload File” blue box. The uploading 
process may take 1 to 5 minutes. 
Daily Videos Capture 
With the help of the study’s statistician, we will develop a link on the REDcap 
platform, this link will be set up to be sent through an email to the participants 

 
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daily at the same time every day. The steps in which the participant will take 
to upload the video will be sent on the same Uploading Video Email in which 
the study staff will explain how the participants will record themselves on their 
videos. 
G6 sensor replacement 
The research staff will send a text message to the participant to remind them 
the date and time they scheduled the sensor replacement 48h before the 
sensor replacement. The research staff will conduct a Zoom phone call with 
each participant on day 10 to assist with sensor replacement. The 
replacement Zoom will be scheduled during the baseline visit. Additionally, 
participants will be asked about any adverse events related to the CGM 
sensor as listed on the RC survey form, including inputting AE and SAE. 
Three days before the scheduled call, the research staff will send each 
participant a G6-Pro application video tutorial. On the 10th day of wearing the 
CGM, the research staff will meet with participants via Zoom to guide them 
through the process of changing the G6-Pro sensor. During this meeting, the 
research staff will provide a step-by-step explanation of the sensor 
replacement procedure, allowing participants to ask any questions they may 
have and receive support from the research team. Participants will be 
reminded not to discard the used transmitter-sensor; instead, they will be 
instructed to place it in the envelope provided by the research staff during the 
baseline visit. 
Before the zoom call takes place, the study staff will login into their RC 
account and select the G1-Study project to be able to access the participants' 
charts of the G1-Study. After the website takes the staff to the study page, the 
staff will select the tab called “Record Status Dashboard” found on the left 
hand of their screen. The platform will then show the list of each participant 
and with each form/survey involved in each phase of the study. For this 
activity, the study staff will choose the only survey found on the “CGM Phase” 
column. The study staff will have this survey open throughout the zoom call 
and will complete the form after the participant has successfully removed the 
old sensor and replaced the new G6 PRO sensor. An example of the Sensor 
Replacement Telephone script is provided in the Appendix _H_. 
Compensation 
For the CGM phase, each participant will receive $200 compensation, which 
will be given as gift cards. The first $100 gift card is assigned to the first 7-10 
days of successful wear, and $100 is applied to the second 7-10 days of wear 
after replacement. Both gift cards are given to the participant at their post 
visit.  
Post-Visit 

 
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The Post visit will take place on days 21-30, 1 to 10 days after the sensor 
placement date. The procedures that will take place are measuring the 
participants height and weight, the participant will fill out a physical activity, 
beverage intake, residential history, and P50 questionnaire; they will 
participate in a narrative semi-structured in-depth interview, fill out a CGM 
satisfaction survey, and self-report habit index. 
The day before the visit, the study staff will send the participant an email and 
a text message containing the address, parking instructions, instructions to 
bring a piece of paper with their email address and correct password written 
in it, and a Google map directions link. Additionally, they will provide a study 
staff’s cell phone contact number in case of transportation issues on the day 
of the visit or for rescheduling purposes. Within 48 hours of the visit, the 
participants will be contacted by phone to confirm their attendance. 
Participant Arrival 
The morning in which the Post visit takes place, the study staff will text to 
remind them at what time they have scheduled their visit for that day, remind 
the participant to bring the two worn sensors, a piece of paper with the 
participant’s email username and correct password, specify to the participant 
that they can park at any unreserved parking spot at the Soto parking lot, and 
a google map link of the USC-Soto Campus. 
The post visit will be conducted at the USC Soto building. Participants should 
wait in the lobby area upon arrival. Upon their arrival, the participants will be 
warmly greeted and thanked for coming. The study staff will again introduce 
themselves, present their USC ID, and remind the participant their role in the 
"USC Glucose Study." The study staff will verify the participants' names and 
ensure they are able to stay for the entire 2-hour visit. The participant will be 
escorted to the Soto 302D office. 
Upon arrival at the 302D office, the study staff will explain to the participants 
the dynamics involved within the Post Visit (video recorded interview, Ravens 
Assessment, capture of body measurements and redcap surveys) and will 
make a remark that the visit will take up to 2-hours of their time. The study 
staff will reassure the participant is willing to go along with the Post Visit 
procedures. 
Semi-structured in-depth interview. The interview will take place in the PI’s 
office. The interviewer will explain to the participants that the main purpose of 
the interview is to capture a narrative of their personal experience with the 
CGM transmitter, about how their experience with the CGM sensor changed 
their normal behavior towards their daily diets and physical activity. The 
interviewer will make the remark that we are not expecting specific answers, 
and that we want them to give us unmasked feedback from their experience 
within the study. The way the interviews will be structured is described on 

 
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pages 14 and 15. The research staff will use the Zoom app to record the 
interviews. The interviews will be recorded on the Zoom-Outlook cloud. 
Before the study staff starts recording the interview on the Zoom meeting, the 
study staff will make sure the participant fits perfectly in the camera frame, the 
only thing that can be shown in the background is the green screen behind 
the participant, the office’s door must be completely shut, and all 
smartphones should be placed on “mute.” The interview will last 
approximately 30 minutes.  
An example of the Post-Visit Interview questions is provided in the Appendix 
_I_. 
Anthropometric measures. The research staff will take height and weight 
measurements from each participant after they have completed each RC 
survey and have taken the Ravens task. These measurements will be taken 
at  workstation 302-10 located in front of the PI’s office where the 
scale/stadiometer will be placed. The measurements collected will be 
captured on a hard copy RC Body Measurements form.   
Raven's Matrices Task 
The study staff will create a Raven’s Assessment for the participant and will 
utilize the following instructions: 
The following steps apply to creating a single examinee/individual and 
administering the assessment one-on-one in person. These steps were 
created for the G1 study. 
The study staff will add new participants to Q-Global: 
-Select “New Examinee.” 
Fill in the following text boxes: 
-First name: First Initial of first name 
-Last name: First Initial of last name 
-ID: REDCap ID 
-Email 
-Gender 
-Birthdate 
-Save 

 
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The study staff will assign Raven’s 2 assessment to the new 
participant/examinee: 
- Click on the checkbox associated with the participant 
-Select “Assign Assessment.” 
-Click on “Assign New Assessment.” 
-Type “Raven” in the text box 
-Select “Raven’s 2 Digital LONG form 
-Click on Delivery Option “In Person (On-Screen)” (left of screen) 
-Click on “Save and Launch Later” (right of screen 
Before the participant arrives for their visit, the study staff will login to the G1-
study Q-Global account and on the “Examinee” page, they will search for the 
participant’s previously created assessment. To choose the correct 
assessment, the study staff will check the Examinee’s initials and study ID 
shown in the Examinee’s list. After clicking the correct examinee, the page 
will show a “Launch Assessment” tab, which the study staff will click once the 
participant is ready to start the Raven’s Assessment. The study staff will 
explain to the participant that the ravens Assessment is a non-verbal multiple-
choice assessment that helps exercise abstract reasoning. It contains 24 
multiple choice questions that are listed in order of increasing difficulty. This is 
a pattern recognition task. The instructions that the study staff will follow to 
administer the Raven’s Assessment are shown below: 
1. Open Q-Global 
2. Select the individual by clicking on the name or anywhere in the row 
3. Select the assessment name, or click anywhere in the row 
4. You are now ready to “Launch Assessment”. Before initiating the 
assessment, provide the participant with the following instructions: 
 Assessment Instructions: 
1. Before launching the assessment, the study staff will read the following 
script to the participant: 
“You will now begin the pattern exercise. First, you will see three animated 
samples that demonstrate how to select options to complete the pattern. 
Next, you will have three practice attempts to do it yourself. Once you 
complete the three practice samples, I will instruct you to begin the task. 
The task is to select the image that best completes the pattern. 
When the sound icon appears between animation and practice samples, wait 
for the arrow and proceed to the next screen. 
You will have 20 minutes to complete 24 questions. 
Upon completion, you will be prompted to close the window.” 

 
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2. Launch Assessment when ready to begin. 
If there are wrong answers and/or questions during the sample questions 
(i.e., A, B, C), provide the participant with the following assistance: 
Sample A: 
Study staff will say, “The blue square (point to response option 4) goes here 
(point to question mark) because these are both blue (point across bottom 
row of stimulus area) and because these are both squares (point down the 
right column of stimulus area).” 
Sample B: 
Next, the study staff will say, “The little red circle (point to response option 2) 
should come next in order (point across stimulus from left to right, then point 
to question mark).” 
Sample C: 
Finally, the study staff will say, “This piece (point to response option 3) 
finishes the picture (point to question mark).” 
3. Once the participant has completed the third sample question and before 
clicking the forward arrow, say the following: 
“Now you know what to do. There are more pictures with missing pieces. 
Click the piece that finishes the picture. When the arrow turns blue, click it to 
see the next picture.” 
Begin 20-minute Timer. 
If the participant is not finished within 20 minutes, kindly ask the participant to 
close the window. (Do not click forward through the arrows) 
Once the window is closed, the Raven’s Assessment is complete. 
Computer-based surveys. The study staff will have the participants seated 
in the 302D office to complete the survey. The research staff will turn off the 
ring light and microphone, then accommodate the monitor, keyboard, and 
mouse in front of the participant, so the surveys can be completed in a 
comfortable position. The research staff will send a RC invitation to the 
participant by email beforehand, 1 day before the baseline visits occur. The 
study staff will kindly ask the participant to log into the email they initially gave 
during their screening call. After the participant has access to their email, ask 
the participant to find the email called “Post Visit” Make sure the participant 
has the correct email in place. After the participant has access to the Redcap 
surveys, select the participant’s preferred language on the Redcap platform. 

 
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The surveys the participant will complete are a physical activity survey, 
beverage intake survey, P50 CDC form, and residential history.  
CGM Satisfaction Survey. The last survey that will prompt out is a 
satisfaction survey. The survey's purpose is to obtain a specific review from 
each participant about their entire study participation. The survey form will be 
captured on the RC platform. 
Dietary Interview Request Form. After completing all the post visit activities, 
the study staff will fill out the NDSR Interview Request Form provided by the 
SCCLH team, which is the following: 
https://forms.office.com/pages/responsepage.aspx?id=HVNizmW2rkqhdQq1F
BwZ2ryFXCgLS5hMj4r325rFPwlUNkw1OE9VQzRRTEJJTjk3ME1MVjRDSkk
0VyQlQCN0PWcu 
P50 NDSR Dietary Call  
The P50 staff will conduct a separate NDSR telephone-based interview with 
the participant following the completion of the post-visit. This interview will 
involve dietary recording prompts based on standardized protocols developed 
by the USDA for use in National Surveys of food intake. Claudia Rios will hold 
a separate interview to conduct this 45-minute assessment, utilizing 2-
dimensional food models to guide portion size estimates. 
Compensation. Before the study staff initiates the compensation procedure, 
the staff will ask the participant to return the two worn sensors. The study staff 
will ensure that both sensors are provided inside of each designated Ziploc 
baggie. The participants who participate in the entire post-visit procedures will 
receive two $100.00 gift cards as compensation for the completion of the Post 
Visit. Besides obtaining the Post Visit compensation, the participant will 
receive another $100.00 in gift cards for replacing the first sensor, and an 
additional $200 in gift cards to compensate the participant for their sensor 
wear for 20 continuous days. In total the participant will receive $500 in a form 
of gift cards to complete their entire study compensation.  Throughout the 
study, the research staff will obtain gift cards from vendors already affiliated to 
USC. 
G1-Continuous Glucose Monitoring Gift Card Log 
To track efficient detailed records of each purchased and delivered gift card, 
the research staff will create a gift card log on an excel spreadsheet. When 
issuing a gift card to a participant, the study staff will kindly ask the participant 
to sign the gift card log including details on the gift card number, name of gift-
card vendor, date, time, and the participant’s ID that the gift card was issued 
to. An example of the Gift Card Log is provided in the Appendix _J_. 
 

 
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3.13.3 Final Study/Early Discontinuation Evaluations. 
Participants should be actively followed through all study visits until the final 
visiIt is important to note that if a study participant is discontinued from 
treatment, he/she should still be followed to the end of the study. 
Evaluations for the final study/early discontinuation visit should be described 
in this section. 
The Post visit will take place on days 21-30, 1 to 10 days after the second 
sensor has been removed. The procedures that will take place are measuring 
the participants height and weight, the participant will fill out a physical 
activity, beverage intake, residential history, and P50 questionnaire; they will 
participate in a narrative semi-structured in-depth interview, and complete the 
CGM satisfaction survey, and self-report habit index. 
The day before the visit, the study staff will send the participant an email and 
a text message containing the address, parking instructions, instructions to 
bring a piece of paper with their email address and correct password written 
in it, and a Google map directions link. Additionally, they will provide a study 
staff’s cell phone contact number in case of transportation issues on the day 
of the visit or for rescheduling purposes. Within 48 hours of the visit, the 
participants will be contacted by phone to confirm their attendance. 
P50 dietary recall.  The P50 staff will conduct a separate phone-based 
interview with the participant following the completion of the post-visit. This 
interview will involve dietary recording prompts based on standardized 
protocols developed by the USDA for use in National Surveys of food intake. 
Claudia Rios will hold a separate interview to conduct this 45-minute 
assessment, utilizing 2-dimensional food models to guide portion size 
estimates. 
3.14 Concomitant Medication 
Concomitant medication is not applicable with the Continuing Glucose 
Monitoring study. 
3.15 Safety Reporting Guidelines 
This section of the MOP details the definitions of and procedures for reporting 
AEs. 
The Guidelines provide: 
● Definitions of AEs, serious AEs, and unanticipated problems 
● Responsibilities of investigators 
● Description of terms used in reporting. 
This section should delineate the AEs, as related to the study, serious AEs, 
and safety reporting procedures. 

 
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There is a potential for study participants to experience unexpected side 
effects. These side effects will be closely monitored by the study staff during 
any interaction involving the Continuous Glucose Monitoring (CGM) device or 
research protocol. The research coordinator will be readily available by phone 
in the event of a study-related participant emergency. If participant adverse 
events occur, the study physician will review adverse events (AEs) within two 
workdays and serious adverse events (SAEs) within two workdays, as well as 
treatment retention rates and reasons for active withdrawal. Safety information 
for this study will be reported to the study physician in an unblinded manner 
because the physician will not prepare nor analyze study data for analysis. All 
relevant information for each SAE, including event details and outcomes, 
concomitant medications, the subject’s medical history, current conditions, and 
pertinent glucose data, will be reported to both the study physician and the 
Institutional Review Board (IRB) within two workdays. Subsequently, this 
information will undergo thorough review by the physician to determine its 
potential relevance to the study protocols. The physician will provide feedback 
about protocol alterations based on any relevant information generated from 
the comprehensive review of the adverse events. 
There is a potential for study participants to experience unexpected side 
effects. These side effects will be closely monitored by the study staff during 
any interaction involving the CGM device or research protocol. The research 
coordinator will be readily available by phone in the event of a study-related 
participant emergency. If participant adverse events occur, the study physician 
will review adverse events (AEs) within four workdays and serious adverse 
events (SAEs) within two workdays, as well as treatment retention rates and 
reasons for active withdrawal. Safety information for this study will be reported 
to the study physician in an unblinded manner because the physician will not 
prepare nor analyze study data for analysis.  
Reporting processes 
All relevant information for each SAE, including event details and outcomes, 
concomitant medications, the subject’s medical history, current conditions, and 
pertinent glucose data, will be reported to both the study physician and the 
Institutional Review Board (IRB) within two workdays. Subsequently, this 
information will undergo thorough review by the physician to determine its 
potential relevance to the study protocols. The physician will provide feedback 
about protocol alterations based on any relevant information generated from 
the comprehensive review of the adverse events. 
3.16 Study Compliance 
Protocol deviations include, but are not limited to the following: 
● Randomization of an ineligible participant 
● Failure to obtain Informed Consent 
● Enrollment of a participant into another study 
● Failure to keep IRB approval up to date 
● Wrong treatment administered to participant 

 
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● Outcome measurement not performed 
This section should describe what constitutes protocol deviations and the 
process for reporting such deviations to appropriate parties, including the 
study chair and site investigator, the Coordinating Center, NCCIH, and the 
DSMB or safety officer, within 24 hours of occurrence if possible, or as soon 
as they are discovered. Investigators need to follow their IRB requirements for 
reporting protocol deviations to the Board. In addition, if monitors discover 
any of these deviations during a site visit, they should list any such 
occurrence in their monitoring report. The Coordinating Center (for the study) 
and the study coordinator (for the site) should maintain a log of all protocol 
deviations and should report them routinely to the DSMB or safety officer. 
While there may be rational clinical reasons for an occasional deviation, a site 
with continuous problems is at risk for losing its funding. A log for recording 
protocol deviations should also be included in this section. 
To track compliance from each participant of the study, the research 
coordinator will keep an up-to-date participant activity log. In this log, the 
coordinator will capture all phases completed an non completed from all 
participants that passed the prescreening phase. Each participant will be 
added in the Activity Log, as soon as they have prescreen passed and they 
have scheduled an initial visit. This log will be shared with the study’s PI on a 
weekly basis. An example of the Participant Activity Log can be found in 
Appendix_K_.  
3.17 Data Collection and Study Forms 
This section describes the study’s data collection and data management 
procedures and should include copies of all forms. Alternatively, they could be 
maintained in a separate binder. 
Data Collection 
The data collector plays a crucial role in this study by establishing rapport with 
participants and ensuring the confidentiality of their information, as outlined in 
the informed consent form.  
The team will collect data using various methods, including computer-assisted 
telephone screening by the SCLLH recruiter, in-person interviews at the Soto 
lab by study staff, observational charting by study staff, A1c testing by study 
staff, CGM Clarity cloud database capture by study PI, and self-administered 
surveys through both computer and text-based formats. To integrate all this 
data into a unified dataset, we will utilize the REDCap (RC) system. The RC 
project, entitled the G1 Study “CGM Monitoring in Adults,” acts as the central 
repository for our data. Study staff members are granted data entry rights to 
input information into the RC project, which has been designed by 
biostatistician My Vu. My Vu has exclusive rights to recode data post-capture 
to prevent errors in data files. Additionally, the P50 center common data 

 
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elements (CDEs) have been incorporated into the RC system to support center-
level data collection for the P50 center. 
Once the participant returns the 2 sensors worn during the CGM phase, the 
coordinator will retrieve glucose data from each transmitter attached to the 
worn sensors. To obtain glucose data from the worn sensors, participants will 
return all sensors during their post-visit. The study staff will ensure that the 
glucose data is retrieved from the sensors within 20 days of the sensor being 
removed from the participant’s arm.To collect the data, the study staff will look 
up the correct transmitter code, which can be found in the participant's RC 
records. For Sensor 1, the code will be obtained from the Baseline Visit's Body 
Measurement form. For Sensor 2, the code will be obtained from the Sensor 
Replacement Call form. 
Once the study staff has retrieved the correct sensor-transmitter code, they will 
turn on the reader device and select the "Upload Data" option. The reader will 
then prompt the staff to enter the sensor-transmitter code. After entering the 
code, it may take up to 2 minutes for the reader to upload the data from the 
sensor. 
After the glucose data is uploaded to the reader, the study staff will connect the 
reader to the office computer using the reader’s USB cable and log in to the 
Clarity Cloud website used for the G1-Study. After accessing the G1-Study 
clinic's account, a list of enrolled participants will appear. The study staff will 
search for the participant's ID, ensuring that the ID from the sensors matches 
the ID in the Clarity list. After selecting the correct participant, the study staff 
will click on the "Upload Data" option, and the data will begin transferring from 
the reader to Clarity Cloud. 
To verify that the glucose data was successfully uploaded to Clarity, the study 
staff will check the participant’s record on Clarity. If the data was uploaded 
correctly, a new session will appear in the participant’s Clarity record. 
Monitoring data quality 
On a monthly basis, the PI, research coordinator, and biostatistician will 
convene to review the quality and completeness of data. This will entail, at 
minimum, an overview of participant intake and retention progress; summary 
reports outlining participant compliance with visits, evaluations, and 
interventions; and a summary evaluating the completeness and quality of key 
data elements required for characterizing participants. These reports will serve 
to judge data capture and processing quality to facilitate analyses. The 
statistician will also update the study's master data file and variable codebook 
at this same interval. The codebook and data file will be in a format that has 
sufficient detail to be made publicly available to support research replication in 
the field. The P50 staff will have access rights limited to CDE items and will 
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We are committed to protecting the confidentiality of our participants and their 
sensitive data. All project and data files will be stored securely in locked office 
files on USC secure servers and labeled with numeric codes when not being 
used for the study. Communication about the study will be conducted 
exclusively through our secure USC email system. A master list containing 
names and IDs will be kept in a separate, secure location for tracking purposes 
and data-sharing agreements. Access to this master list, which links names 
and code numbers, will be restricted to senior project staff only. The entire staff 
will closely monitor all assessment and treatment procedures. Since this study 
involves a low-risk non-clinical population and uses a within-subject case series 
methodology, there is no need to establish a Data and Safety Monitoring Board 
(DSMB) committee. We will implement an interval data and safety monitoring 
process instead. 
3.17.1 Source Documentation 
A source document is any document on which study data are initially 
recorded. These data are then transcribed to a paper CRF or electronic CRF 
(eCRF) to document study-specific data elements.  
The study staff will maintain hard copies of signed Informed Consent Forms 
(ICF), USC-Image Release Form and Body Measurement forms completed at 
each Baseline and Post Visit. Every survey and study form will also be 
available as an electronic Case Report Form (eCRF) within the REDCap 
platform. The source documents that will be captured throughout the study 
will be the following:  
Informed Consent Form: Two hard copies of the ICF will be available for each 
participant, one will be given to the participant to take home and the other will 
be. After the participant signs the ICF, the study staff will write down exact 
date and time of consent. Upon giving physical signed consent, the study staff 
will guide the participant to find the link to the electronic ICF in a previously 
sent email. Once the participant leaves the Soto Building, the study staff will 
place the signed ICF inside of a red folder titled with the participant’s study ID. 
Image Release Form: A physical Image Release form will be administered 
after the participant has agreed and consented to take part in the study. A 
physical and electronic copy of this form will be signed by each participant. 
Once the participant leaves the Soto Building, the study staff will place the 
signed Image Release Form inside of the red folder titled with the participant’s 
study ID. An example of this form can be found in Appendix_L_. 
Body Measurement Form: This form will be physically completed during 
baseline and post visits. It contains specific parameters such as weight, 
height, A1c levels, current medication intake, and date of when data was 
collected. During the baseline visit, both physical and electronic CRFs will 
capture weight and height data. The phlebotomy lab will record A1c glucose 
levels on the hard copy of the Body Measurement Form, after which study 
staff will transfer this data to the eCRF.  

 
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Self-Administered surveys: Different measurements will be collected 
throughout the study. Before the collection of various measurements, each 
participant had carefully read the ICF and gave voluntary written and 
electronic consent. These measurements will be presented as self-
administered surveys will be completed using the office’s computer. The 
study statistician has created a system in REDcap that allows study staff to 
email participants a unique link, which prompts various surveys upon clicking. 
The surveys that will be administered during the baseline visit will be the 
Physical Activity survey, Demographics Survey, Beverage survey, and a 
Behavior survey. During the Post Visit the surveys that will be administered 
are the Physical Activity survey, Behaviors survey, Beverages survey, CGM 
satisfaction survey, and a Residential History Questionnaire. The data 
collected from these surveys will be efficiently captured in the electronic data 
capture system previously mentioned.  
Gift Card Log: The study staff will have a hard copy of a Gift Card Log that will 
detail specific information of each purchased gift card such as: name of 
vendor, sequential card number, amount, participant ID, participant’s 
signature, date and time in which the gift card was given. All gift card logs will 
be kept inside of a yellow manila folder titled: G1-Study Gift Card Log. This 
folder will be put in a locked cabinet of the Research Coordinator. A sample of 
what the log will look like is found in Appendix_J_.  
Screening Log: The SCCLH team will provide a weekly list of interested 
potential participants, including their email addresses and phone numbers. 
Study staff will create an Excel sheet with a unique screening ID for each 
participant. The Excel log will contain the participant's name, phone number, 
dates of four contact attempts, the date of screening, and the outcome of the 
screening call. This screening log will be accessible only to the Principal 
Investigator (PI) and the study coordinator. It will be securely stored in USC’s 
OneDrive files. A sample of what the log will look like is found in 
Appendix_B_. 
Participant Activity Log: Once participants have passed the initial screening 
call and a baseline visit has been scheduled by the study coordinator, they 
will be added to the Participant Activity Log. This log will include the 
participant's study ID, which will also correspond with the REDCap study ID. 
The coordinator will use the activity log to record the date of the initial visit, 
whether the participant was enrolled in the study, the date of the Sensor 
Replacement Zoom Call, the date of the Post Visit, any Adverse Events 
presented by the participant, and the date of the event. A sample of this log 
can be found in the Appendix. Like the screening log, this log will only be 
accessible to the PI and the study coordinator and will be stored in USC’s 
secured OneDrive files. Upon completion of the study, the coordinator will 
print a copy of the completed log and store it in a manila folder labeled "G1-
Study Participant Logs. A sample of what the log will look like is found in 
Appendix_L_. 
 

 
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3.17.2 Participant Binder 
All essential study documents are stored and filed by the study staff in a red 
participant folder containing the participant study ID, and stored in a locked 
cabinet in the PI’s office Soto building 302D. The folder contains the following 
documents: 
● Body Measurement Form (e.g., height, weight, A1C results, transmitters, 
etc.)  
● Signed Informed consent form (ICF) 
● Signed Image Release form 
● Two-transmitters labeled “1” and “2” 
● Hard copies of surveys for the participants that cannot access their 
electronic surveys.  
 
3.17.3 Study Forms 
Data must be collected consistently across participants and sites so that any 
variability is limited to participants’ individual responses to the intervention. 
Study CRFs provide the vehicle for consistent data collection. In this section 
of the MOP, please provide: 
● Study forms and their collection schedule 
● Description of each study form and questionnaire 
● Format for forms production and distribution along with contact person 
● Forms maintenance. 
Throughout different phases of the G1-study the team will collect different 
forms using various methods. To integrate this various data into a unified 
dataset, the REDCap (RC) system will be utilized. The RC project, titled "The 
G1 Study: CGM Monitoring in Adults," serves as the central data repository. 
Study staff members have data entry rights to input information into the RC 
project, which has been designed by a biostatistician. 
The study staff will maintain hard copies of signed Informed Consent Forms 
(ICF), USC-Image Release Form and Body Measurement forms completed at 
each Baseline and Post Visit. Every survey and study form will also be 
available as an electronic Case Report Form (eCRF) within the REDCap 
platform. 
Screening phase 
During the screening procedure the study staff will fill out the Screening form 
through the electronic data capture system used in this study. This form 
collects demographic, anthropometric, and information from all participants to 
produce descriptive variables (i.e., age, sex, race, race/ethnicity, zip code) as 
well as assess medical history of chronic disease, current medical diagnosis, 
and current medications to determine eligibility. A sample log is presented 
in…  

 
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Baseline Visit 
Different forms will be collected throughout this visit. Before the collection of 
various measurements, each participant will carefully read the ICF and give 
voluntary written and electronic consent. These forms will be presented as 
self-administered surveys and will be completed using the office’s computer. 
The study statistician has created a system in REDcap that allows study staff 
to email participants a unique link, which prompts various surveys upon 
clicking. The forms administered during this initial visit are the following:  
1. Informed Consent Form: Two hard copies of the ICF will be available for 
each participant, one will be given to the participant to take home and the 
other will be signed by the participant and by the staff that oversees the 
consent process. The ICF gives detailed information regarding all the 
study’s activities, the purpose of the study, benefits from participating, 
potential risks upon participation, duration of their participation in the study 
and total compensation for their participation. After the participant signs 
the ICF, the study staff will write down exact date and time of consent. 
Upon giving physical signed consent, the study staff will guide the 
participant to find the link to the electronic ICF in a previously sent email. 
This email will contain a link that will initially prompt out electronic ICF. 
The study staff will ensure that each participant gives electronic consent 
as well. Once the participant leaves the Soto Building, the study staff will 
place the signed ICF inside of a red folder titled with the participant’s study 
ID. 
2. USC-Image Release Form: Throughout the study, each participant will be 
asked to volunteer and contribute to the creation of video content. 
Participants will be asked to submit daily videos describing their food intake, 
glucose levels, and behaviors during the glucose sensor wear phase. 
During the final visit, each participant will participate in a video-recorded 
interview. For this purpose, an Image Release form will be administered 
after the participant has agreed and consented to take part in the study. 
This form establishes an agreement between the participant and the study 
team, outlining that any video content shared by the participant will be 
reviewed by the G1-study team and may be used in the future for 
educational purposes. A physical and electronic copy of this form will be 
signed by each participant. Once the participant leaves the Soto Building, 
the study staff will place the signed form inside of a red folder titled with the 
participant’s study ID. 
3. Body Measurement Form: This form will be physically completed during 
baseline and post visits. It contains specific parameters such as weight, 
height, A1c levels, current medication intake, and more. During the 
baseline visit, both physical and electronic CRFs will capture weight and 
height data. The phlebotomy lab will record A1c glucose levels on the hard 
copy of the Body Measurement Form, after which study staff will transfer 
this data to the eCRF. 
4. Demographic Survey: Study team will collect information from all 
participants to produce descriptive variables (i.e., age, sex, race, 

 
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race/ethnicity, zip code) as well as assess medical history of chronic 
disease, current medical diagnosis, and current medications to determine 
eligibility. Eligibility criteria include current PdS, prediabetes risk, aged 18 
years or older adult in California, self-identified Latino/Hispanic ethnicity, 
and willing to participate in a study. This measurement will be presented 
as self-administered surveys will be completed using the office’s 
computer. The study statistician has created a system in REDcap that 
allows study staff to email participants a unique link, which prompts 
various surveys upon clicking. A sample of this form can be found in 
Appendix_M_. 
5. Beverage Survey: This assessment will be presented as a self-
administered survey completed using the office computer. The survey will 
inquire about the participant's intake of various beverages over the past 
seven days. Participants will respond using a multiple-choice format, 
selecting answers that range from 0 days to 7 days for each specific 
beverage. The survey data will be recorded in the previously mentioned 
electronic data capture system. A sample of this form can be found in 
Appendix_N_. 
6. Behaviors Survey: This assessment will be presented as a self-
administered survey completed using the office computer. The survey will 
inquire about the participant's various behaviors over the past seven days. 
The different behaviors listed in the survey are meditation activities, pain 
relieve intake, vitamin C intake, prescribed medication intake, alcoholic 
drinks intake, use of cigarettes or vape and yoga activities. Participants will 
respond using a multiple-choice format, selecting answers that range from 
0 days to 7 days for each specific behavior. The survey data will be recorded 
in the previously mentioned electronic data capture system. A sample of 
this form can be found in Appendix_O_. 
7. Physical Activity Survey: The International Physical Activity Questionnaire 
(IPAQ) is a self-reported tool designed to assess physical activity levels in 
adults aged 18-65 years. IPAQ collects information on the frequency, 
duration, and intensity of physical activities across four domains: work-
related activities, transportation-related activities, domestic and household 
chores, and leisure-time activities, including recreational and sports 
activities. Participants recall their physical activity behaviors over the past 7 
days, reporting the time spent in various activities at different intensity 
levels: vigorous-intensity activities, moderate-intensity activities, and 
walking. Total physical activity levels are calculated by summing the 
duration and frequency of activities across all domains. This assessment 
will be presented as a self-administered survey completed using the office 
computer. The survey data will be recorded in the previously mentioned 
electronic data capture system. A sample of this form can be found in 
Appendix_P_. 
CGM Phase 

 
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The sensor wear phase can last up to 20 continuous days. During this phase 
various forms can be collected. The forms pertaining to this phase are the 
following:  
1. G6 Replacement Call: The research staff will conduct a Zoom phone call 
with each participant on day 10 to assist with sensor replacement. Before 
the zoom call takes place, the study staff will login into their RC account 
and select the G1-Study project to be able to access the participants 
charts of the G1-Study. Once the study staff has access to the specific 
participant chart; the study staff will then click on the form labelled “G6 
Replacement Call” in the REDcap project. This form collects information 
regarding date and time in which the Zoom call takes place, if the sensor 
was removed and replaced by the second sensor. If the sensor was not 
replaced, the study staff will type the reason in the comment section that 
prompts out after selecting that the participant did not replace the G6 
sensor. The form also collects the transmitter code of the second sensor 
and contains a section to specify where the participant stored the glucose 
sensor kit prior to the sensor replacement. A comment section is added at 
the end of the form in which the study staff will be able to add any other 
related information or data collected throughout the Zoom call with the 
participant. A sample of this form can be found in Appendix_Q_. 
2. Adverse Event form: This form will be used in case of any untoward 
unexpected event is reported by the participants. The events that will be 
captured in this form are signs or symptoms that the participants report 
throughout the study, CGM errors that participants present throughout the 
CGM wear phase including glucose sensor detachment. In cases where a 
participant reports any symptoms or any CGM related issue, the research 
staff will reach out to the participant via phone call. During this call, the 
study staff will ask for details about the errors shown in the Dexcom Apps. 
The study staff will fill out an Adverse Event/CGM Error form in the RC 
platform. In this form, the study staff will specify the date and time when 
the CGM error started and when the error or issue was resolved. This 
form includes a comment section in which the study staff will type a 
detailed explanation of the symptoms or issues that the participants 
express throughout the phone call. Once the issue has been resolved, the 
study staff will reach out to the PI within 24 hours to report that an 
AE/CGM error form was completed for a participant and describe the case 
to the PI. A sample of the form can be found in Appendix_R_. 
Post Visit 
Different forms will be collected throughout the last visit. These forms will be 
presented as self-administered surveys and will be completed using the 
office’s computer. The forms administered during this initial visit are the 
following: 
1. Body Measurement Form: This form will be physically completed during 
baseline and post visits. It contains specific parameters such as weight, 
height and current medication intake. During the baseline visit, both physical 

 
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and electronic CRFs will capture weight and height data. After the 
participant leaves the Soto building, the study staff will transfer this data to 
the eCRF. 
2. Physical Activity Survey: This assessment will be presented as a self-
administered survey completed using the office computer. Details of what 
this survey entails can be found in page 54.  
3. Beverage Survey: This assessment will be presented as a self-
administered survey completed using the office computer. Details of what 
this survey entails can be found in page 54. 
4. Behaviors Study: This assessment will be presented as a self-
administered survey completed using the office computer. Details of what 
this survey entails can be found in page 54. 
5. Residential History Survey: This assessment will be presented as a self-
administered survey completed using the office computer. This survey 
collects data regarding residential status of each participant. Questions 
regarding current and previous home address will be found in the survey. 
A sample of this survey can be found in Appendix_S_. 
6. P50 CDC questionnaire: This assessment will be presented as a self-
administered survey completed using the office computer. The survey 
data will be recorded in the previously mentioned electronic data capture 
system. This survey is a national health survey. It will cover a wide range 
of health topics, including doctor visits, medical conditions, health 
insurance, and physical activity. This questionnaire has three parts: a core 
component, optional modules, and state-added questions. The core 
component includes questions on demographic characteristics and current 
health behaviors. A sample of this form can be found in Appendix_T_. 
7. CGM Satisfaction Survey: A post-survey will record the number of times a 
Dexcom app was viewed. The survey consists of multiple-choice 
questions to quantify % answers correct out of 20 questions that make 
direct reference to the CGM .app to verify if it was understood. 
Additionally, it asks for qualitative feedback on the videos and if there are 
any recommendations for further improvement. This assessment will be 
presented as a self-administered survey completed using the office 
computer. The survey data will be recorded in the previously mentioned 
electronic data capture system. A sample of this form can be found in 
Appendix_U_. 
 
3.17.4 General Instructions for Completing Forms 
According to ICH Good Clinical Practice (GCP) guidelines, all data recorded 
on study forms must be verifiable in the source documents maintained by the 
study site(s). Instructions for completing CRFs ensure quality and consistency 
in data collection. In this section of the MOP, please provide a set of 
instructions for completing CRFs. Some useful and frequently used examples 
are listed below: 
Sample instructions: 

 
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When completing paper study forms, PRINT IN CAPITAL LETTERS using 
black ink. Note, participants must not be identified by name on any study 
document submitted with the forms (e.g., ECG tracing, lab reports). Replace 
the participant’s name with the participant initials and ID number. 
● Header: Complete the header information on EVERY page, including 
pages for which no study data are recorded. 
● Participant ID: The participant ID must be recorded on EVERY page, 
including pages for which no study data are recorded. 
● Time: Use a 24-hour clock (e.g., 14:00 to indicate 2 p.m.) unless 
otherwise specified. 
● Dates: All dates must be verifiable by source documents. Historical dates 
are sometimes not known (e.g., date of first symptom); therefore, 
conventions for missing days and/or months should be described (e.g., 
UNK or 99). 
● Abbreviations: Use of abbreviations not specifically noted in the 
instructions for completing the forms can be problematic and should be 
held to a minimum. 
● Correcting errors: If an error has been made on the study forms, place a 
single line through the erroneous entry and record the date and your 
initials. Indicate the correct response. 
● Skipping items: Do not skip any items. Some items may carry "Unknown" 
or "Not Applicable" response choices which should be selected when 
necessary. 
● Incomplete data: Data may not be available to complete the form for 
various reasons. Circle the item for which information is not available and 
indicate the reason near the appropriate field: 
- If an evaluation was not done, write ND and provide a reason. 
- If the information is not available, but the evaluation was done, write NAV. 
- Note: Only in rare circumstances, as in the case of lost 
documentation, should NAV be recorded on the form. Every effort should 
be made to obtain the information requested. 
- If an evaluation is not applicable, write NA. 
- Incomplete or Illegible forms: Incomplete forms that do not have 
adequate explanation (as described above) compromise the integrity of 
the entire study. Errors, such as incomplete or illegible forms, are 
problems that require time and energy to resolve. 
In this section of the MOP, a set of guidelines for incomplete or illegible forms 
must be included. For example: 
● If an entire page of the form cannot be completed (e.g., no parts have any 
responses), and it is unlikely that it will be completed, draw a diagonal line 

 
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through the form and write NOT DONE, NOT AVAILABLE, or NOT 
APPLICABLE, as appropriate. 
● The header information must be completed even though no data are 
recorded on the form. If a form can only be partially completed at the time 
of monitoring, but will be completed when the information becomes 
available, follow the direction of the clinical monitor. 
● Do not leave forms incomplete or unused without explanation. 
During the screening call, the study team logged into the RC system. The 
administrative staff navigated to "My Projects" > "Continuous Glucose 
Monitoring in Adults - G1 Study" and selected the "Record Status Dashboard" 
tab on the left-hand side. From there, they clicked on "Add New Record," 
prompting a table labeled "Data Collection Instrument" to appear. Within this 
table, the administrative staff selected the "Screening Call" option, triggering 
the generation of a unique RC ID for the participant. The staff member then 
input the data collected during the screening call in real time, ensuring all 
entries were accurate and complete before submission. 
During the baseline visit, three source documents were collected by the study 
staff: two completed by each participant and one by G1 staff. Before the 
participant's arrival, the study staff printed two hard copies of the IRB-
approved ICF form, one copy of the USC-Image Release form, and one copy 
of the Body Measurement form from the RC platform. After participants 
agreed to participate, the study staff guided them to sign sections of the ICF 
and Image Release form designated for participants. Once signed, the study 
staff reviewed the forms to ensure accuracy and then signed the "Collected 
by" section. 
For data collection on the Body Measurement form, study staff prepared hard 
copies and using a black or clue inked pen would correctly enter the 
participant ID, date, and time of data collection. A1c levels were obtained by 
G1-study trained phlebotomists. Before providing the Body Measurement 
form to the phlebotomy staff, the RC system was used to input the participant 
ID, date, and time. Following A1c collection, participants returned to the 
office, where height and weight were measured using the Tanita-3000 scale 
and stadiometer. The study staff recorded these measurements on the Body 
Measurement form. Participants were then asked about any prescribed 
medications, which were documented with correct dosages. The study staff 
also collected a sticker containing the sensor code from each Dexcom G6-Pro 
kit. 
During the post-visit, the Body Measurement form was completed, except for 
A1c levels and glucose sensor codes, which were marked as "Not 
Applicable." 
 

 
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3.18 Data Flow 
It is the site’s responsibility to ensure that all forms are complete, intact, and 
transmitted to the data manager in a single site study or to the Coordinating 
Center, as appropriate. More recently, in some studies, data are directly 
entered into an eCRF. 
This section of the MOP describes the: 
● Disposition of study forms or data entry into the computer system 
● Schedule for completion and transmission of forms 
● List of forms for which copies are to be maintained at the site and forms to 
be submitted for data entry 
● Data flow, data entry, and data correction procedures. 
Data is collected in REDCap and Dexcom Clarity. All variables in REDCap 
are marked as “required” where user will not be able to save the page if 
required fields are incomplete to minimize missing data. Most variables in 
REDCap are configured as checkboxes or radio buttons to avoid data entry 
errors.  
The forms that will always be physically available at the study site are hard 
copies of signed Informed Consent Forms (ICF), USC-Image Release Form 
and Body Measurement forms completed at each Baseline and Post Visit. 
Every survey and study form will also be available as an electronic Case 
Report Form (eCRF) within the REDCap platform. 
Data Flow:  
 
Figure _I_ G1 Study Data Flow 
 
 
 

 
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3.19 Administrative Forms 
Administrative forms provide documentation of study processes and assist 
with study operations. They may include the following, as relevant: 
● Telephone Contact Log—serves as a record of all conversations 
regarding the study and study participants. 
● Screening Log—is a record of all individuals screened for participation in 
the study. It should be arranged chronologically and be kept up to date at 
all times. 
● Participant Identification Code List—is a record of the participant's 
name, medical record number, randomization number, and study entry 
and exit dates. Due to the confidential nature of this information, it should 
be maintained in a secure location, apart from other forms and data files at 
the study site. The information contained in the list must be maintained by 
the site for a period stipulated by NCCIH, the site institution, or other 
relevant body. 
● Protocol Deviation Log—is used to document deviations from the 
protocol as they are identified by participants. 
● Study Drug Accountability Record—should be maintained in the 
Pharmacy by the research pharmacist and must not be shared with other 
members of the study team. 
● Record of Destruction of Clinical Product—is a log used to document 
the destruction of any unused study drug. The date and time of 
incineration as well as how many vials/pills were incinerated must be 
recorded. This record should be attached to the Study Drug Accountability 
Record. 
● CRF Transmittal Sheet—serves as a cover page for each packet of 
CRFs submitted for data entry. It provides an inventory of the forms that 
are included in each mailing. 
● Signature Log—contains the signature of all members of the site study 
team. It is the responsibility of the PI and/or clinical research coordinator to: 
- Designate individuals authorized to perform outcome measurements, 
make form entries and changes, and 
- Note the date when any study team member is removed from the team for 
any reason. 
● Site Visit Log—records individuals visiting the site. The most common 
reasons for visits are site initiation, monitoring, training, and closeout. 
The administrative forms will be completed by the coordinator of the study 
and will be shared with the study’s PI. The administrative forms that are used 
throughout the study are the following: 

 
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Prescreening Log: The SCCLH team will provide a weekly list of interested 
potential participants, including their email addresses and phone numbers. 
Study staff will create an Excel sheet with a unique screening ID for each 
participant. The Excel log will contain the participant's name, phone number, 
dates of four contact attempts, the date of screening, and the outcome of the 
screening call. This screening log will be accessible only to the Principal 
Investigator (PI) and the study coordinator. It will be securely stored in USC’s 
OneDrive files. 
Participant Activity Log: Once participants have passed the initial screening 
call and a baseline visit has been scheduled by the study coordinator, they 
will be added to the Participant Activity Log. This log will include the 
participant's study ID, which will also correspond with the REDCap study ID. 
The coordinator will use the activity log to record the date of the initial visit, 
whether the participant was enrolled in the study, the date of the Sensor 
Replacement Zoom Call, the date of the Post Visit, any Adverse Events 
presented by the participant, and the date of the event. A sample of this log 
can be found in the Appendix. Like the screening log, this log will only be 
accessible to the PI and the study coordinator and will be stored in USC’s 
secured OneDrive files. Upon completion of the study, the coordinator will 
print a copy of the completed log and store it in a manila folder labeled "G1-
Study Participant Logs. 
Gift Card Log: The study staff will have a hard copy of a Gift Card Log that will 
detail specific information of each purchased gift card such as: name of 
vendor, sequential card number, amount, participant ID, participant’s 
signature, date and time in which the gift card was given. All gift card logs will 
be kept inside of a yellow manila folder titled: G1-Study Gift Card Log. This 
folder will be put in a locked cabinet of the Research Coordinator. A sample of 
what the log will look like is found in Appendix…  
Video Content Editing Progress: All of video content collected from all the 
participants will be edited using the Descript platform. The coordinator has 
created an editing progress log in which details how many transcript files 
have been obtained from the Descript app after video content upload, what 
transcript files have been reviewed and corrected by the coordinator. This 
logs also captures specific problems found in the transcript files such as audio 
quality and grammar errors. This log will be share with the study PI and G1-
study cinematic arts staff through a USC secured One Drive file. A sample of 
what the log will look like is found in Appendix_V_. 
 
 
3.20 Retention of Study Documentation 
The length of time all study files are to be maintained is specified in this 
section. NIH policy requires that studies conducted under a grant retain 
participant forms for 3 years, while studies conducted under contract must 
retain participant forms for 7 years. Individual IRBs, institutions, states, and 

 
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countries may have different requirements for record retention. Investigators 
should adhere to the most rigorous requirements and should retain forms and 
all other study documents for the longest applicable period. 
 
3.21 Data Management 
This section should describe the computer system and data management 
approach that will be used to support the study and details on how data are to 
be collected, entered (e.g., if eCRFs are used), edited, and corrected. For 
studies that involve a large number of sites and/or participants, the 
investigators may wish to consider a computerized approach for data 
collection. 
Whether using a computerized approach or manual procedures, investigators 
should consider utilizing systems or procedures that encompass the following 
functions: 
● Data Tracking—to provide the status of enrollment, number of forms 
completed at the sites and number of forms transmitted to a Coordinating 
Center or lead site, as appropriate 
● Data Entry—that is easy to use and minimizes errors, such as facsimiles 
of the forms 
● Data Editing—that identifies out-of-range and missing entries, errors in 
dates and logical inconsistencies (e.g., first treatment date precedes 
protocol start date or protocol specifies an examination before 
randomization, but the examination form is missing) 
● Updating—to correct data and maintain an audit trail of all data changes 
● Reporting—to describe and account for accrual, forms entered and 
completed, etc. 
● Statistical Analysis—mechanism to transmit data to statistical analysis 
packages (e.g., SAS). 
Investigators should involve staff or colleagues with data management 
experience to assist with the determination of the data flow, transfer of data 
from sites in a multicenter study, error identification and resolution, 
development of useful reports, and deriving a frozen, analytic database from 
edited or "clean" records. These areas should be discussed in this section. 
A Users Guide may need to be developed as a separate document to aid the 
study staff with data management tasks. 
Investigators should be aware that computerized systems used in studies that 
will be submitted to the FDA must be documented and validated. Guidance 
for electronic systems is found on the FDA Web site, Title 21 Code of Federal 
Regulations (21 CFR Part 11) Electronic Records; Electronic Signatures 
http://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm. 

 
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Data is collected in REDCap and Dexcom Clarity. All variables in REDCap 
are marked as “required” where user will not be able to save the page if 
required fields are incomplete in order to minimize missing data. Most 
variables in REDCap are configured as checkboxes or radio buttons to avoid 
data entry errors. However, for free text fields such as heights, weights, 
dates, etc., there are built-in validation checks (i.e., appropriate ranges) 
where possible. These are ‘soft limits’ in which out-of-range values are 
identified and the data enterer is alerted to correct the values immediately. 
 
A series of additional data checks will also be conducted external to REDCap. 
Every week, all data will be downloaded from REDCap using the REDCap 
API. R scripts will be run by study statistician to tabulate missing data and to 
perform cross-form consistency checks. If inconsistencies or queries are 
noted, the statistician will inform the study staff to make necessary 
corrections. Errors will be fixed directly in REDCap. 
 
3.21.1 External Data 
External data refers to data sent to or collected at a study organizational 
component other than a clinical site (e.g., central laboratory, imaging facility, 
etc.) This section of the MOP should describe how this information will be 
collected, labeled, handled, shipped, tracked and reconciled, so that study 
data are not lost. As stated in the HIPAA guidelines, personal identifiers such 
as name, geographic location, social security number, and 15 other specific 
individual identifiers should not be used. Therefore, it is important to specify 
how participant materials will be coded (e.g., by participant identification 
number) during transmission. 
External Data is not applicable for the Continuing Glucose Monitoring study. 
 
3.22 Quality Control Procedures 
Data integrity and study credibility depend on factors such as ensuring 
adherence to the protocol, obtaining complete followup information on all 
participants enrolled, and using quality control measures to establish and 
maintain high standards for data quality. A quality control plan should be 
developed before the study starts and adhered to through completion. It may 
include standard operating procedures (SOPs), data and forms checks, onsite 
monitoring, numerous reports, and problem correction procedures. This 
section should detail the various aspects of the plan and describe any training 
and certification procedures. 
Data Integrity Procedure: As mentioned in previous section on a weekly 
basis, the PI, research coordinator, and biostatistician will convene to review 
the quality and completeness of data. This will entail, at minimum, an 
overview of participant intake and retention progress; summary reports 

 
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outlining participant compliance with visits, evaluations, and interventions; 
and a summary evaluating the completeness and quality of key data elements 
required for characterizing participants. These reports will serve to judge data 
capture and processing quality to facilitate analyses. The statistician will also 
update the study's master data file and variable codebook at this same 
interval. The codebook and data file will be in a format that has sufficient 
detail to be made publicly available to support research replication in the field. 
The P50 staff will have access rights limited to CDE items and will review 
data quality separately.  
Personnel Training: Staff training is important to quality control. Once a new 
staff has been integrated to the G1-Study, prior to delegation of study related 
activities the new staff will complete trainings that have been listed in page 15 
of this manual. On a Monthly basis the coordinator will review the iStar 
system to review that the G1-study staff has up-to-date trainings. 
 
3.22.1 Standard Operating Procedures 
One aspect of site quality control is a set of SOPs. They describe a site’s 
generic procedures that may have been developed to assist with 
standardization across studies. SOPs may include laboratory and pharmacy 
procedures, and storage of study documents. As relevant, SOPs should be 
developed by a site to ensure quality studies and study staff should be trained 
on them. The SOPs should be in a central location and made easily available 
to staff for reference. 
SOPs that relate to conduct of clinical trials should be listed in this section of 
the MOP. Note: printed SOPs should not be inserted in the MOP, as printed 
versions of SOPs should be limited in order to maintain version control. The 
location of each SOP (i.e., electronic file name) can be included in this 
section. 
Details of each study visit activities such as consent process, self-
administered baseline visit surveys, glucose sensor application, Dexcom 
applications Bluetooth pairing and compensation procedure can be found in 
the file G1. Study Manual. The research coordinator and phlebotomist created 
a protocol for finger pricking protocol called A1cNow Protocol. For the Ravens 
assessment delivery, the G1-study staff created a file with detailed 
instructions that guides the research staff to deliver this assessment. The 
protocol of Ravens assessment can be found in the G1_Q-Global_Ravens 
file. 
 
3.22.2 Data and Form Checks 
Data and form checks depend upon the complexity of the study. Data quality 
control checks may identify potential data anomalies such as: 
● Missing data or forms 

 
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● Out-of-range or erroneous data 
● Inconsistent and illogical over-time dates 
● Fields on a "completed form" are actually not completed; or no reason for 
missing data is provided. 
If the study is using electronic data forms, provide a summary of data and 
form checks that will be implemented for data quality control. 
CGM data will be checked periodically throughout the week by study 
statistician and study staff via Dexcom Clarity to ensure participants’ CGM 
data is being transmitted. If there are any gaps in the data, study staff will 
contact participants to obtain information on reasons for missing data and 
resolve any issues within the next day (connectivity, sensor error and failure, 
etc.). At the post visit, study staff will collect participants’ transmitters. Data 
from transmitters will then be uploaded into Clarity using readers to ensure 
CGM data completeness. 
 
3.22.3 Double Data Entry 
In recent years, there have been several articles written on the value of 
double data entry. While conventional wisdom used to insist upon double data 
entry, it may be of questionable value, especially if the data entry system 
provides edits as data are entered. Double data entry is still recommended for 
cases in which data entry staff enters data “heads down” or with no edits 
flagged as the data are entered. 
As mentioned in previous section CGM data will be checked periodically 
throughout the week by study statistician and study staff via Dexcom Clarity 
to ensure participants’ CGM data is being transmitted. If there are any errors 
in the data, study staff will contact participants to obtain information on 
reasons for missing data and resolve any issues within the next day 
(connectivity, sensor error and failure, etc.). At the post visit, study staff will 
collect participants’ transmitters. Data from transmitters will then be uploaded 
into Clarity using readers to ensure CGM data completeness.  
 
3.22.4 Site Monitoring 
In multisite studies, a Coordinating Center may conduct periodic site 
monitoring visits during the study. 
The purposes of monitoring visits are to: 
● Ensure the rights and safety of participants 
● Confirm that the study is conducted in accordance with GCP guidelines 
● Ensure maintenance of required documents 
● Verify adherence to the protocol 

 
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● Monitor the quality of data collected 
● Ensure accurate reporting and documentation of all AEs and unanticipated 
problems. 
During monitoring visits, the data recorded on CRFs are reviewed and verified 
against source documents to ensure: 
● Informed consent has been obtained and documented in accordance with 
IRB/FDA regulations 
● The information recorded on the forms is complete and accurate 
● There are no omissions in the reports of specific data elements 
● Missing examinations are indicated on the forms 
● Participant disposition when exiting the study is accurately recorded. 
Site investigators must ensure that the monitor has access to all study 
documents, including informed consent forms, intervention accountability 
records, and source documents. 
Once the site visit is complete, a site monitoring report is drafted to provide 
feedback regarding any problems or issues that may have been uncovered 
during the visit. The report should state the problems uncovered during the 
visit and describe recommendations to correct them. A timeline should be 
agreed upon and included in the report to ensure that followup of the issues is 
completed and implemented into the study’s procedures. 
In this section of the MOP, please describe the monitoring plan, including a 
planned monitoring timeline. 
Not applicale for G1-Study, is not a multi-site study.  
3.23 Reports 
Once a study begins, routine reports prepared by the Coordinating Center or 
study statistician are an important quality control tool. Monthly reports may 
describe target and actual enrollment by site and in aggregate, individuals 
screened with reasons for screen failure, and participant disposition (enrolled; 
active, completed, and discontinued treatment; and lost to followup). Monthly 
reports can also list or summarize AEs and SAEs. Administrative reports can 
list the forms completed, entered, and missing and/or erroneous data and 
forms. DSMB/independent monitor(s) and NCCIH will specify the type and 
frequency of reports they wish to receive. Other reporting requirements (e.g., 
to local IRBs and other regulatory bodies) should also be described. 
In this section of the MOP, please discuss the types and frequency of the 
reports that will be prepared, and the members of the study team who are 
responsible for their completion. 
 

 
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On a weekly basis, the PI, research coordinator, and biostatistician will convene 
to review the quality and completeness of data. This will entail, at minimum, an 
overview of participant intake and retention progress; summary reports 
outlining participant compliance with visits, evaluations, and interventions; and 
a summary evaluating the completeness and quality of key data elements 
required for characterizing participants. These reports will serve to judge data 
capture and processing quality to facilitate analyses.  
 
The participants will reach out to the research coordinator to report any Adverse 
Event or CGM error. The research coordinator will then report every Adverse 
Event or CGM error to the PI in the first 24 hours after a participant has reported 
any untoward event. The PI and research coordinator will meet on a weekly 
basis to review Adverse Events reported throughout the week and what 
prevention plan will be implemented to ensure the well-being of all the G1-study 
participants. All CGM related events will be reported during this meeting.  
 
Any issue related with the glucose sensor equipment will be reported to the 
Dexcom contact to ensure accurate glucose data collection from participants. 
No glucose, personal or identifiable data from participants will be shared with 
Dexcom personnel. Any updates or changes in the sensor system will be 
shared by the Dexcom personnel to the study’s PI. 
 
Annually during the study, the PI, Center PI, and study physicians will prepare 
a summary report of its findings regarding safety and quality based on data 
received to that point in the study. This report will include a summary of all 
safety findings and an assessment of protocol compliance and data quality. 
Any recommendations to improve participant safety, protocol adherence, or 
data quality will be made in the annual report. A copy of the annual report will 
be sent to the local IRBs along with the annual renewal. The PI will maintain 
all IRB continuing reviews and keep documents up to date with IRB. 
 
3.24 Data and Safety Monitoring Activities 
We commit to safeguard the confidentiality of participants and their protected 
data. Project and data files, when not in transit for study purposes, must be 
stored exclusively in locked office files, on USC secure servers, and/or 
identified by numeric codes. Communication regarding the study should be 
conducted solely through our secured USC email system. A master list 
containing names and IDs will be maintained in a separate, secure location as 
required for tracking purposes and data sharing agreements. Access to this 
master list, which links names and code numbers, will be restricted to senior 
project staff only. The entire staff will closely monitor all assessment and 
treatment procedures. Given that this lower-risk study involving a non-clinical 
population utilizes a within-subject case series methodology, there is no need 

 
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to establish a Data and Safety Monitoring Board (DSMB) committee. We will 
apply an interval data and safety monitoring process in this respect.  
Safety monitoring activities by the DSMB or independent monitor(s) include: 
reviewing the protocol with emphasis on data integrity and participant safety 
issues, monitoring AEs, protecting the confidentiality of the data, and making 
recommendations to NCCIH and the PI regarding the study and its progress. 
This section of the MOP should present a data and safety monitoring plan 
and name the members of the monitoring body. 
To assist in preparing a monitoring plan, generic monitoring plans for studies 
requiring a DSMB or independent monitor(s) are available on the NCCIH Web 
site. The generic plans describe the monitoring procedures required by 
NCCIH. 
The study statistician will conduct series of periodical data checks to REDCap 
system. Every week, all data will be downloaded from REDCap using the 
REDCap API. RC scripts will be run by study statistician to tabulate missing 
data and to perform cross-form consistency checks. If inconsistencies or 
queries are noted, the statistician will inform the study staff to make 
necessary corrections. Errors will be fixed directly in REDCap. 
The study statistician and the coordinator will meet on a weekly basis to 
review all forms collected from each participant. This review will ensure that 
each study form has accurate data and that there is no missing information on 
each completed form. Additionally, the statistician and coordinator will log into 
the Clarity platform to check that glucose data is being collected from all 
active participants. If any errors are shown on glucose data, the coordinator 
will reach out to participant to ask what errors are preventing data collection 
and the coordinator with the help of the PI will guide each participant to solve 
CGM errors that block glucose data collection.  
 
3.25 Study Completion and Closeout Procedures 
Study closeout activities are performed to confirm that the site investigator’s 
study obligations have been met and post-study obligations are understood. 
This section of the MOP should briefly outline the study completion and 
closeout procedures. Details should be included in the subsequent sections. 
Examples of closeout activities include, but are not limited to, the following: 
● Verification that study procedures have been completed, data have been 
collected, and study intervention(s) and supplies are returned to the 
responsible party or prepared for destruction 
● Comparison of the investigator’s correspondence and study files against 
the Coordinating Center's records for completeness 
● Assurance that all data queries have been completed 

 
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● Assurance that correspondence and study files are accessible for external 
audits 
● Reminder to investigators of their ongoing responsibility to maintain study 
records and to report any relevant study information to NCCIH 
● Assurance that the investigator will notify the IRB of the study’s completion 
and store a copy of the notification 
● Preparation of a report summarizing the study’s conduct 
● Participant notification of the study completion 
Before determining that the study has been completed, the PI, statistician and 
research coordinator will confirm that appropriate source documentation is 
present for all subjects. To do so the research coordinator will review each 
participant file to ensure that all CRFs have been completed, collected, and 
the proper legible copies are present in study files.  
The G1-study statistician will confirm that all electronic CRFs have been 
completed and submitted to the REDcap platform. The statistician will confirm 
as well that all data is entered into the database and will ensure that all AEs, 
UPs, and SAEs have been captured, followed, and resolved per protocol, and 
reported to the appropriate parties.  
The PI, statistician and research coordinator will meet to confirm that all data 
was collected appropriately and that there is no missing data before the study 
closeout.  
 
3.25.1 Participant Notification 
The PI and study staff or Coordinating Center should develop a letter to notify 
participants that the study is completed, ask whether they would like to be 
informed of the results, and thank them for their participation. 
In this section of the MOP, please describe a plan for notifying participants 
about completion of the study 
Upon completion of the study, the study staff will reach out to participants 
through an email. In the email, the study staff will notify the participants that 
the study has been completed. Participants will be notified that the results of 
the study are found in clinicaltrial.gov website. The study staff will thank each 
participant for their participation and will share link to clinical trials website. 
  
3.25.2 Site Procedures 
The study leadership may also wish to provide certificates of appreciation to 
sites that met or exceeded their recruitment goals, provided high quality data, 
and ensured adequate participant retention. 
After the completion of the study, the PI will reach out to the CHLA staff 
through an email, within this email, the PI will congratulate the CHLA team for 

 
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their community engagement efforts throughout the G1-study. The PI will 
share that the desired population was enrolled and completed all of the study 
activities. The PI will ask for any advice from the CHLA for the possible 
continuation of the study. 
 
3.26 Policies 
The MOP also contains the study's policies, such as confidentiality and 
publication policies. 
Please provide these policies in this section of the MOP. 
 
3.26.1 Confidentiality Procedures 
It is the responsibility of the study leadership to outline and enforce participant 
and study data confidentiality policies. Study staff should be instructed in their 
responsibilities regarding data safeguards and cautioned against the release 
of data to any unauthorized individuals, unless such a release is approved by 
the study leadership and NCCIH and is not in violation of applicable Federal 
and state laws. 
This section of the MOP will discuss the safeguards that have been put in 
place by the Steering Committee to ensure participant confidentiality and data 
security. 
The following is a list of study participant confidentiality safeguards: 
● Data flow procedures: Data identifying participants should not be 
transmitted from study sites to the Coordinating Center. 
● Electronic files: Data identifying participants that are stored electronically 
should be maintained in an encrypted form or in a separate file. 
● Forms: Forms or pages containing personal identifying information should 
be separated from other pages of the data forms. 
● Data listings: Participant name, name code, hospital chart, record 
number, Social Security Number, or other unique identifiers should not be 
included in any published data listing. 
● Data distribution: Data listings that contain participant name, name code, 
or other identifiers easily associated with a specific participant should not 
be distributed. 
● Data disposal: Computer listings that contain participant-identifying 
information should be disposed of in an appropriate manner. 
● Access: Participant records should not be accessible to persons outside 
the study without the express written consent of the participant. 
● Storage: Study forms and related documents retained both during and 
after study completion should be stored in a secure location. If computers 

 
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are used to store and/or analyze clinical data, the Coordinating Center or 
the investigator should address the following elements of computer 
security to ensure that the data remain confidential: 
- Passwords: Passwords provide limitations on general access to 
computer systems and to the functions that individuals can use. 
Passwords should be changed on a regular basis. 
- User training: Study staff with access to clinical computer systems should 
be trained in their use and in related security measures. Training should 
include explanations of how to access the system and a discussion of the 
need for, and importance of, system security. 
- System testing: Prior to the use of a new computer system, and 
subsequent to any modifications, the system should be tested to verify 
that it performs as expected. Testing should verify that the password-
activated access system performs as intended. 
- System backups: Backup copies of electronic data should be made at 
specified intervals. Backups should be stored in file cabinets or secure 
areas with limited access. Storage areas should have controlled 
temperature and humidity so that the backup tapes are not damaged. 
The G1-study team is committed to protect the confidentiality of each 
participant and their sensitive data. All data files are stored securely in locked 
cabinet inside of a locked and secured office in the USC-Health Sciences 
Soto research building in a restricted area, where only G1-study staff has 
access to enter the area. Communication about any study activity will be 
conducted exclusively through our secure USC email system. A master list 
containing names and IDs will be kept in a separate, secure file for tracking 
purposes and data-sharing agreements. Access to this master list, which links 
names and code numbers, will be restricted to project staff only. The entire 
staff will closely monitor all assessment and treatment procedures. Since this 
study involves a low-risk non-clinical population and uses a within-subject 
case series methodology, there is no need to establish a Data and Safety 
Monitoring Board (DSMB) committee. We will implement an interval data and 
safety monitoring process instead. 
 
3.27 MOP Maintenance 
The Manual of Operations and Procedures (MOP) will be maintained and 
updated throughout the Continuing Glucose Study (CGS).  
The MOP content will be reviewed and updated with changes, edits, or 
modifications, including the version number, date, and page numbers. The 
MOP will be distributed to the entire team by an appointed staff member on a 
continuous basis to ensure that the operating policies and procedures are 
described accurately.  A printed copy will be available at the USC Health 
Sciences Soto building for review as well  

 
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If any procedures have been changed or modified, the MOP should be 
updated—and the appropriately modified pages distributed, with instructions, 
for replacement in the MOP. A MOP template for changes is included in 
Appendix_W_. 
 
 

 
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4. REFERENCES  
References are embedded directly within the text to improve readability. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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APPENDIX A: RECRUITMENT TELEPHONE SCRIPT 
 
Date of the recruitment call: _______________ 
Actions required prior to the interview: 
Recruiter will open REDCap (RC), a secure web-based application to create a 
participant ID number and capture Continuous Glucose Monitoring (CGM) research 
study data. 
Background information - to be gathered before the interview: 
Name of the person(s) interviewed: 
Contact telephone number: 
Participant ID number: 
Introduction: 
 Hello, [Participant's Name]. This is [Staff Name] calling from the University of Southern 
California Keck School of Medicine. I hope you are doing well today. 
The reason for my call today is to see if you might be interested in participating in a 
research study. Our study focuses on wearing a continuous glucose monitor to better 
understand blood sugar levels. 
This study is designed to evaluate the levels of glucose (sugar) in your body.  
Purpose: 
This study's purpose is to understand whether the use of a continuous glucose 
monitoring system is acceptable to users, understand your experience with the glucose 
feedback, and to capture your explanation of your personal experience.  
Eligibility: 
 If you meet our inclusion criteria based on this interview, you will be scheduled for a 
study visit. 
At the study visit, the research staff will perform one more procedure before being 
chosen as a participant, that procedure is finger pricking to obtain your A1c results. 
Consent Forms: 
If you meet study eligibility, you will be asked to sign a consent form if you want to 
participate. This provides the full details of the study and your participation.   
Confidentiality: 
Some of these questions are personal questions, however, anything we discuss is 
confidential and will only be shared with research staff associated with this study.  

 
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Study Visit Procedures: 
Once you sign the informed consent, a finger prick will be performed on your hand 
without fasting to determine your level of A1c, a measure of glucose in your body. 
Research staff will ask you to complete a series of surveys during the first study visit, 
asking about your background, your medical history, medications you are taking, eating 
behavior, physical activity, personality, subjective measures of well-being, and 
satisfaction with the intervention. 
Subsequently, with your consent, a small glucose sensor will be placed in your arm to 
monitor your blood sugar levels. 
You will complete a second study visit about 2 weeks later, during that visit you will be 
asked if you are willing to participate in a video-recorded interview and you will out a 
satisfaction survey form   
Duration of your participation in this study: 
You will be provided with two Dexcom sensors free of charge to use for up to 20 
consecutive days. On the 10th you will change the first CGM sensor at home with the 
help of the study staff through a zoom call. 
 After completing the CGM, the research staff will schedule your last post visit a week 
later after completing the CGM phase.    
Compensation: 
For your participation in this project, you will receive up to a total of $500 in the form of 
gift cards, depending on how many sections of the study you complete. 
If you only complete the first study visit and are not eligible, you will be given a $100 gift 
card for your participation in the first visit.   
Survey: 
If you are eligible, are you still interested in participating in the study? If so, I need to ask 
you a few questions to determine your eligibility. We ask that you please answer each 
question honestly so as not to alter the results of this eligibility section. 
[Recruiter will read RC items verbatim and input responses in RC in real time] 
 

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APPENDIX B: SAMPLE SCREEN LOG  
 
 
Study: 
 
Site:  
 
Investigator:  
 
 
Screening 
Number 
Name 
Email 
adress 
Phone 
number 
Preferred 
language 
Contact 
attempt 1 
Contact 
attempt 2 
Contact 
attempt 3 
Screening 
Date 
Eligible  
G1xxx 
Glucose 
study 
gstudy@xx
x.com 
xxx-xxx-
xxxx 
☐ English 
☐ Spanish 
mm/dd/yyyy 
mm/dd/yyyy 
mm/dd/yyyy 
 
mm/dd/yyyy 
☐ Yes 
☐ No 
 

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APPENDIX C: FINGER PRICK INSTRUCTIONS 
Finger prick process   
1.  One of the phlebotomists designated for this study will have              
the participants wash and dry their hands with Chlorhexidine soap then sit down.  
2.   Place the A1cNow kit on the table. 
3.   Put on sterile surgical gloves before opening the A1cNow kit 
4.   Open the A1cNow kit, separate the analyzer, the lancet, blood  
collector, shaker body, and test cartridge on the table next to  
the participant. 
5.    Open the pouch labeled with the number 1. 
6.   Ask the participant to choose middle or ring finger on the  
  
 hand  
they prefer the test 
7.  Gently massage the palm of the hand and rub toward the   
selected finger for 30 seconds 
8.    Remove the cap from the lancet and depress the lancet to  
  the side of the finger 
9.    Remove the lancet and massage toward the fingertip once  
  again 
10.  Clean the puncture site with a 70% isopropyl alcohol swab. 
11.  Dry the area with a gauze before puncturing the skin with the   
  lancet. 
12. Produce a large droplet of blood by finger pricking with the  
 lancet and collect that blood with the collection tube by gently  
 touching the tip of the blood collector to the blood drop to fill it.     
 Tilt the blood collector at a low angle for easy collection 
13. The Phlebotomy lab staff will then take the shaker body (of  
 the blood collecting device) and will fully insert the blood   
 collecting device into the shaker doing a pushing and twist   
 movement. 
14. The Phlebotomy lab staff will apply a sterile cotton to finger  
 prick. 
15. Ensure there is no gap between the blood collector and the  
shaker body. Vigorously shake it for 5 seconds (about 6 to 8 times) then place the  shaker 
with the blood collector piece on the table standing upright. 
16. After placing the body shaker that contains the participant’s  
blood sample on a table, the cartridge will be collected from  
the pouch labeled with the number 2 
17.Confirm that the code found in the lower left corner of the  
  
cartridge matches the code of the analyzer, which is also  
found in its lower left corner. 
18. Insert the cartridge into the analyzer by clicking it into place. 
19. Place the analyzer on the table and do not move it around. 
20. A Wait (WAIT) sign will appear on the analyzer to perform a  
  
 self-check 

 
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21. After the analyzer is completed with the self-check, the  
 analyzer will give a Sample signal (SMPL) to place the blood  
 sample from the shaker into the device (cartridge) 
22. The Phlebotomy lab staff will remove the base of the shaker  
 body and push the open end of the shaker into the analyzer in  
 avertical position (a section within the cartridge once it is  
 connected to the analyzer). To apply the sample a simple  
 depression of the shaker into the analyzer will be made. 
23.  After the blood sample is applied, remove the shaker, and the  
 analyzer will give a running signal (RUN) 
24.  Leave the analyzer on the table and a 5-minute timer will start  
 on the analyzer 
25. After 5 minutes have passed, the analyzer will give the A1c  
 results. 
26. Place the lancet and any soiled waste in the biohazardous red  
 waste medical containers. 
27. Write down the A1c result on the Body Measurement hard  
   
 copy form. 
28.  The analyzer will show how many tests are left on the  
 analyzer. [make sure to throw away analyzers that have no  
 tests left] 
29. The Phlebotomy lab staff will place the cotton balls and  
 surgical gloves used in the biohazardous red waste bag. 
30. Explain that side effects from finger pricking need to be   
 reported to the RC. 
a.   Painful redness around the whole tip of the finger not resolved  
 in 48 hours. 
b.   Swelling of the entire finger. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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APPENDIX D_1_: INFORMED CONSENT FORM 
 
 
 
 
 
 
 
 
 

 
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APPENDIX D_2_: INFO ASSESSMENT DOCUMENT 
 
 

 
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APPENDIX E: BODY MEASUREMENT FORM 
 
 
 
 
 
 
 
 
 
 
 
 

 
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APPENDIX F: TIMELINE OF ASSESSMENTS 
 
Variable 
Measure 
Capture 
Screen 
Baseline 
visit 
CGM 
phase  
Post 
visit 
Eligibility 
Age, sex, race/ethnicity, 
employment, zip, contact 
info, medical history, CDC 
prediabetic risk 
Phone 
x 
 
 
 
A1c% 
A1cNow test kit (5.7-6.4%) 
Staff 
 
x 
 
 
Weight, kg 
Digital scale (Tanita WB-
3000)  
Staff 
 
x 
 
x 
Height, cm  
Stadiometer (Tanita WB-
3000)  
Staff 
 
x 
 
x 
Dietary log  
G6 app daily log upon out 
of range chime 
G6 App 
 
x 
x 
 
CGM 
changed 
G6 transmitter replaced 
Zoom, 
Phone 
 
 
x 
 
Glucose, 
mg/dL 
Dexcom G6 Pro system 
G6 
reader 
 
x 
x 
x 
Physical 
activity 
International physical 
activity questionnaire 
RC 
 
x 
 
x 
Narrative 
Semi-structured interview 
Video 
 
 
 
x 
Satisfaction 
CGM satisfaction survey 
RC 
 
 
 
x 
Pattern 
detection  
Ravens' matrices task 
Website 
 
 
 
x 
P50 CDEs 
Socio-demo and residential  RC 
 
 
 
x 
P50 dietary 
recall 
NDSR external date 
Phone 
 
 
 
x 
Daily 
Videos: 
Food Intake 
 
 
 
 
x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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APPENDIX G: DEXCOM TRAINING CHECKLIST 
 
1. Introduce CGM and review patient expectations 
o   What is professional CGM, purpose of 10-day session and the importance of a follow-up 
visit for interpretation. 
2. Insert sensor and attach transmitter 
o   Follow instructions on Blinded or Unblinded handout to insert the sensor and attach the 
transmitter. 
3. Check status 
o   Check status using Dexcom G6-Pro Reader. 
4. Record Transmitter SN 
o   Use Patient Tracking Form (or your office form) to record the transmitter SN. Found on 
Start Here guide in box. 
5. Train patient using appropriate handout located in Dexcom G6 Pro box 
o   Choose one method below - based on HCP recommendation: 
● Blinded Mode* (Use Blinded CGM Patient Handout) 
● Unblinded Mode* (Use Unblinded CGM Patient Handout) 
6. Download and interpret clarity data 
o   Choose one of the following options to access data: 
7. Access data via reader (Blinded or Unblinded mode) 
● With transmitter in 20 feet range, choose Download Data on reader, enter recorded 
transmitter serial number, and follow steps on reader. Note: Transmitter must be 
uploaded within 30 days of session start. 
                      
 In Dexcom Clarity: 
● 
 Add or select patient from Patient List 
● Upload data under patient 
● Print/Save report. 
 
8. Access data via Dexcom clarity app (Unblinded mode only) 
o       For unblinded patients already sharing data with Dexcom Clarity via Dexcom G6 app: 
● Click on Patient Name in Dexcom Clarity and see Sharing is ON. 
● Confirm desired amount of data captured (accessing data via reader will allow full data 
capture).  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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APPENDIX H: SENSOR REPLACEMENT TELEPHONE SCRIPT 
 
“Hello Mr./Mrs.____________, 
Thank you for joining me on this call. How are you doing today? 
I am so glad to hear that. As we discussed during your Baseline Visit, we scheduled this 
call for 2 main reasons. 
One reason is that the sensor that you applied during the BV expires on this day, 
therefore, you must remove it and replace it with a new Dexcom sensor on this day. 
I am also going to guide you through the entire procedure of your sensor replacement. 
I want to remind you that your participation in this study is completely voluntary. Would 
you still like to continue with your participation in this phase of the study? 
[After the participant agrees to continue with their participation] 
Excellent! Before we start with the entire process, I want to show you a short video that 
will help you gain more knowledge about the Dexcom sensor application. 
[The study staff will share the video by sharing their screen on the Zoom platform. The 
video shown will be the following: https://www.youtube.com/watch?v=dWWKa3Fjd9Y 
from minute 1:44 until minute 3:17] 
Now that we have watched the video, do you have any questions regarding the sensor 
application? 
[Study staff will address every question that the participant has at that moment] 
Excellent Mr./Mrs._______ We will now start the process of removing and replacing 
your sensor. I will show you the supplies you will need for these activities. 
[Study staff will show on screen the following: manila envelope, labeled Ziploc baggies 
found within the envelope; Dexcom G6 PRO box containing the applicator with the 
sensor, the 2 alcohol pads, and the transmitter] 
Do you have this equipment on hand? 
[If not, give time to the participant to gather every equipment needed for the procedures. 
Make the participant show on their screen all their equipment] 
We will now start by removing your sensor. Localize your sensor, pick one of the 
corners of the sensor’s adhesive, and start gently peeling off the adhesive as if you are 
peeling off a band-aid. 
  

 
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[After the participant removes the sensor, tell the participant to show you on screen the 
removed sensor] 
Great job on removing your sensor Mr./Mrs.______, now please grab one of the Ziploc 
baggies found within the envelope labeled -Sensor 1- and place the worn sensor in the 
Ziploc baggie, then place the Ziploc baggie inside the manila envelope. 
Now, it is time for you to apply your new sensor. Please open your Dexcom G6 PRO 
box, and the first thing you will find is a sheet with the label of the sensor transmitter 
code. Please place that sheet on the table and have it ready at the end so you can pair 
your new sensor with your smartphone. 
The second thing you will find in your box is a sheet of paper with the visual 
representation of each step of the G6 PRO sensor application. You can place it on the 
table so you can use it as a visual guide for this procedure. 
You will now find the alcohol pads, the applicator and the transmitter device. Please 
grab the applicator and take it out of its container. Ok Mr./Mrs._________, show me 
what area you are choosing to place the new transmitter. Remember, you will not place 
the sensor on the same arm that was used for the last sensor. You will place the sensor 
on the base of the back of your arm. To locate this spot, try to draw an imaginary line 
from your elbow up to your shoulder; you will aim to place the sensor right in the middle 
section of the imaginary line. Raise your arm and show me where you will place the 
sensor. 
[the staff will make sure that the participant is aiming in the right area of the back of the 
arm] 
Excellent! Now, please open one of the alcohol pads and clean the area where this 
sensor will be placed. Use circular motions starting from the center of the area. 
[The staff will show the circular motions to the participant] 
Now that you have cleaned the area, pick up the applicator and peel off the adhesive 
backing. Do this carefully and try not to touch the adhesive. 
Amazing. Now place the adhesive on top of the area you chose for the sensor 
application. Once you have successfully placed the applicator onto your skin, fold the 
safeguard to the side and break it off. 
[Staff will ask the participant if the safeguard came off] 
Now that you have removed the safeguard, push the orange button on the applicator. 
[The applicator will make a sound] 
Remove the applicator. As you can see, the adhesive with the sensor has been applied 
to your skin. Now, pick up the transmitter and slide it into the sensor slot. These 

 
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instructions are under the section entitled “Transmitter Insertion”. You may refer to 
these visual aids if you’d like. 
After sliding the transmitter, push it onto the sensor from the circular end. The 
transmitter will make a clicking noise. 
[Ask the participant if they have inserted the transmitter, if so, ask if the transmitter 
made a clicking noise] 
Now that you have successfully inserted the transmitter, rub the sides of the adhesive 
with circular motions. Rub it at least 4 times. 
Great job Mr./Mrs.__________, you have successfully applied your new sensor. Let’s 
now start to pair your new sensor with your smartphone. Unlock your smartphone and 
go into the Dexcom G6 App. Within your App, touch the settings icon found in the upper 
right-side corner of your screen 
[Show on screen to the participant the settings icon of the app]. 
Now touch the fifth tab called “Transmitter”. You will see a section called “Pair New” on 
your screen. 
[Show once again to the participant on screen the Pair New section] 
Select that tab and hit the “continue” tab. The app will give you the option to either enter 
the Transmitter Code manually or scan the QR code. I’d like you to choose the QR code 
option. The app will open the camera so you can capture the QR code found on the 
sheet I mentioned at the beginning containing the sensor’s code. 
[Show on screen once again the sheet with the QR code]. 
After you scan the code, the app will automatically pair your new sensor with your 
smartphone. The sensor will take up to 2 hours to warm up. After the 2 hours have 
passed, the G6 app will show you your glucose levels graph. 
Amazing job, Mr./Mrs.________. You successfully replaced and paired your new 
Dexcom G6 PRO sensor. We will now finish this zoom call with a short survey. Are you 
okay if we complete this now or do you need to take a 3-minute break? 
[Once the participant has accepted to go on with the survey, the staff will go into the RC 
page that was set up from the beginning of the zoom meeting and will enter the correct 
data into the RC platform. Within this survey the study staff will schedule the date and 
time of the Post Visit. After finishing the survey, the staff will answer the participant’s 
questions and will thank them for their participation] 
Thank you so much for participating in this phase of the study. Remember that if you 
have any problems with your sensor or the Dexcom app, feel free to contact me so I can 
help you solve the problem. 

 
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Before we go, I want to kindly remind you to continue making the daily videoclips so we 
can capture your entire experience with the glucose sensor." 
 
 

 
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APPENDIX I: POST-VISIT INTERVIEW QUESTIONS 
 
1. How would you describe your experience with the CGM to someone else? 
2. Can you please list the top 3 things you liked about the CGM? 
3. What did you not like about it? 
4. How did wearing the CGM feel? 
5. When would you look at your device typically? 
6. If I wanted to check my historic glucose readings, where would I look? How would I 
interpret this? 
7. If I wanted to check my current glucose readings, where would I look? How would I 
interpret this? 
8. In your opinion, are these different readings easy to understand? 
9. When did you notice you were having high alarms? What do you believe could have 
caused this and why? 
10. Were there any changes to your eating habits after wearing the CGM? 
11. Were there any changes to your exercise habits after wearing the CGM? 
12. What is something you would improve about the CGM experience? 
13. What are three of your favorite apps on your phone you use in the past 3 months? 
14. What do you like about app X? Is there something you don't like about it? 
15. Is there something you learned about this experience 
16. Would you recommend this to someone else? Why? 
17. Were you able to create a general rule about how glucose is related to diet? 
 
 
 
 
 
 
 
 
APPENDIX J: G1- Continuing Glucose Monitoring Gift Card Log 

 
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Batch # _______ 
 
Vendor 
Card Seq 
Number 
Amount 
Date 
Participant 
ID 
Participant’s 
Initial 
Participant’s 
Signature 
Time 
Given 
Baseline 
Visit 
Post-
Visit 
Amazon 
 
$100.00 
 
 
 
 
 
 
 
Target 
 
$100.00 
 
 
 
 
 
 
 
Walmart 
 
$100.00 
 
 
 
 
 
 
 
 
 

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APPENDIX K: PARTICIPANT ACTIVITY LOG 
 
Participant 
ID 
Screening 
Date 
Baseline 
visit date 
Enrolled 
If not, why? 
Date of 
sensor 
replacement 
Post visit 
date 
Adverse 
event 
Date of AE 
Completed 
G1xxx 
Mm/dd/yyyy 
Mm/dd/yyyy 
☐ Yes 
☐ No 
Reason 
Mm/dd/yyyy 
Mm/dd/yyyy 
☐ Yes 
☐ No 
Mm/dd/yyyy 
☐ Yes 
☐ No 
 
 
 
 
 
 
 
 
 
 
 

 
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APPENDIX L: IMAGE RELEASE FORMS 
 
 
 
 
 
 
 
 
 

 
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APPENDIX M: DEMOGRAPHICS SURVEY 
 
 

 
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APPENDIX N: BEVERAGE SURVEY 
 
 

 
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APPENDIX O: BEHAVIORS SURVEY 
 
 

 
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APPENDIX P: PHYSICAL ACTIVITY IPAQ 
 
 
 
 

 
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APPENDIX Q: SENSOR REPLACEMENT CALL SURVEY 
 
 
 

 
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APPENDIX R: ADVERSE EVENTS OR ERRORS DOCUMENT 
 
 
 
 

 
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APPENDIX S: RESIDENTIAL HISTORY QUESTIONNAIRE 
 
 

 
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APPENDIX T: P50 CDE SURVEY 
 
 
 
 

 
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APPENDIX U: SATISFACTION SURVEY 
 
 
 

 
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APPENDIX V: VIDEO EDITING PROGRESSION LOG 
 
Participant 
ID 
Video 
download 
DV 
Spanish 
Transcript 
DV English 
Transcript 
Interview Spanish 
Transcript 
Interview  
English Transcript 
Gxxxx 
Completed 
Completed 
Completed 
Completed 
Completed 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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APPENDIX U (APP. W): SAMPLE MOP MODIFICATION LOG (REPLACE WITH WHAT IS BEING USED) 
MOP MODIFICATION LOG 
Section 
# 
Version # 
Date 
Modified 
Page # 
Text 
Location 
Brief Modification Summary 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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APPENDIX ?: SAMPLE PROTOCOL DEVIATION LOG (REPLACE WITH WHAT IS CURRENTLY BEING USED) NO DEVIATION 
LOG FOR G1 
Protocol Name:________________________________________________________________________ 
 
Protocol 
Deviation Code: 
Participant Initials 
Participant 
ID# 
Date Deviation 
Occurred: 
mm/dd/yyyy 
Date Protocol 
Deviation Form 
Completed: 
mm/dd/yyyy 
Contact Person 
(if applicable) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SAMPLE PROTOCOL DEVIATION CODES
Consent Form: 
1. Missing or not obtained 
2. Not signed and dated by participant 
3. Does not contain all required signatures 
4. Outdated, current IRB-approved version not used   
5. Not protocol-specific 
6. Does not include updates or information required by the 
IRB 
Randomization: 
7. Ineligible participant enrolled and/or randomized 
8. Participant randomized prior to determining whether 
eligible for study  
9. Occurs outside protocol window 
IRB: 
10. Not reporting a serious complication within 24 hours; 
11. Approvals not kept up to date 
12. Enrollment and/or treatment occurs prior to IRB approval 
or during period when on “on hold” 
13. Reportable serious adverse events not reported to IRB 

 
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  Participant 
14. Receives wrong treatment 
15. Visits occur outside expected follow-up window  
16. Entered into another study 
Study Data and/or Forms 
17. Missing data and/or forms 
18. Missing radiology and/or operative reports 
19. Forms or data not sent from clinical site to coordinating 
center