Empowering Medicare Patients to Self-Manage Their Type 2 Diabetes Using Continuous Glucose Monitoring (CGM) - Investigational Device Pilot (SMA Investigational Device)
Phase: NA
Conditions: Type2 Diabetes
Sponsor: Savvysherpa, Inc.

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1. General Information  
Title: Empowering MedicarePatients to Self-Manage Their Type 2 Diabetes Using Continuous Glucose 
Monitoring (CGM) – Investigational Device Pilot (SMA Investigational device) 
Protocol Number: 
 
 
CGM_IRB_003 
Date:  
 
 
 
October 19, 2017 
Program Sponsor:  
Savvysherpa, Inc. 
6200 Shingle Creek Pkwy., Suite 400 
Brooklyn Center, MN 55430 
Principal Investigator:  
Jared Jones, Ph.D. 
Savvysherpa, Inc. 
tel. 763-549-3540 x 8116 
email: JaredJones@savvysherpa.com 
Co-Investigators/Medical Advisors:  
Kevin Kapov, DO 
Southwest Medical Associates (SMA) 
270 W. Lake Mead Pkwy 
Henderson, NV 89015 
tel: 702-242-7603 
email: Kevin.Kapov@optum.com 
 
Linda Johnson, MD 
 
 
 
 
Southwest Medical Associates 
4750 W. Oakey Blvd 
 
2nd Floor 
Las Vegas, NV  89102 
tel: 702-352-2758 
email: Linda.Johnson1@optum.com 
 
Study Doctor: 
Dr. Rogelio Machuca 
 
Machuca Family Medicine 
 
1501 South Eastern Avenue 
 
Las Vegas, NV 89104 
 
6110 Elton Avenue 
 
Las Vegas, NV 89107 
 
tel: (702) 778-7770 
 
Research Team: 
Shane Hoversten, PhD 
Grant Weller, PhD 
Amy Okaya, MPH, MBA 
Steve Priem, JD 
Elena Fultz 

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Paul Boswell, PhD 
Ben Griffith, JD 
Savvysherpa, Inc. 
 
 

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2. Background Information  
Diabetes is a disease which increases health risks for many other health conditions (Ramsey, 1999) and 
carries a large social and economic toll (Zhou, 2014; American Diabetes Association, 2013). 
Strict glycemic control reduces risks for the development of microvascular and macrovascular 
complications in patients with diabetes. In the United Kingdom Prospective Diabetes Study (UKPDS), 
each 1% reduction in glycosylated hemoglobin (A1C) was associated with a 37% decrease in the risk for 
microvascular complications and a 21% decrease in risk for any end point or death related to diabetes 
(Stratton, 2000). In turn, improved blood glucose control can reduce the costs associated with the 
treatment and long-term complications of diabetes. 
Given the serious consequences of poor glycemic control, tight glucose management has become 
today’s standard of care. However, only half of patients with diabetes are achieving the level of control 
recommended by the American Diabetes Association (Lipska 2017). The reasons for poor control are 
numerous and complex (Skyler, 2000). They include lack of patient motivation, denial of disease, 
inability to afford test strips, discomfort from repeated finger sticks, and difficulties caused by co-morbid 
conditions.  
Effective management of diabetes requires constant management of diet, physical activity and 
specialized glucose-lowering medications (Armstrong, 2017). The most effective diabetes management 
programs are delivered in-person (Polonsky, 2011; Cox, 2013; LeFevre, 2014; Ratner, 2005), and involve 
self-monitoring of glucose levels along with personalized health feedback to enhance patient motivation 
and promote positive behavior change (Polonsky, 2015; Cox, 2016). Increasingly, new diabetes 
management programs are being designed and evaluated that seek to deploy these best practices using 
web and mobile-based technology (Ralston, 2009; McMillan, 2017; Simenerio, 2010; Quinn, 2011; Philis-
Tsimikas, 2014). 
While hemoglobin A1C measurements are widely used by clinicians to evaluate management of type 2 
diabetes (T2D), a growing body of evidence suggests that post-prandial plasma glucose (PPG) 
(Temelkova-Kurktschiev, 2000) and glucose variability (GV) (Takao, 2011) are risk factors for 
complications of T2D, independent of fasting plasma glucose (FPG) or A1C levels. Further, poorly 
controlled nocturnal glucose (NG) is common in individuals with T2D, and is associated with obstructive 
sleep apnea (Priou, 2015). PPG, GV, and NG therefore provide additional target metrics for management 
of glucose in individuals with T2D. In a practical sense, however, these metrics are difficult if not 
impossible for patients to monitor by measuring their blood glucose. 
Real-time Continuous Glucose Monitoring (RT-CGM) for Type 2 Diabetes Patients 
In developing an effective mobile diabetes management program RT-CGM has emerged as an effective 
educational tool for patients with diabetes to achieve tight glycemic control. Previous studies have 
found that T2D patients are better able to control their glucose levels using RT-CGM compared to blood 
glucose meter readings (Yoo, 2008; Cox, 2016) and that this effect is sustained even after 
discontinuation of RT-CGM use (Vigersky, 2012). By observing their plasma glucose levels in the context 
of daily life, patients can see how their levels (including important indices such as post prandial glucose 
(PPG), glucose variability (GV), and nighttime glucose (NG)) are affected by diet, exercise, medications, 
stress, and other personal factors. In addition, the ability of Dexcom’s RT-CGM system allows for sharing 

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of data with a patient’s health coach, thus enabling the effective delivery of a mobile diabetes 
management program. 
Recognizing the value of CGM for T2D patients, we have developed a novel, integrated lifestyle 
modification program for those with T2D that leverages the real-time nature of CGM technology to 
provide a personalized educational experience for patients in their daily life to better manage their 
glucose levels.  
3. Study Purpose 
The purpose of this study is to evaluate an integrated, CGM-based lifestyle modification program for 
glucose management in patients with T2D. The study’s primary aim is to collect implementation process 
measures regarding participant recruitment, program delivery, and device use.  The secondary aim is to 
evaluate the impact of the program on the glucose management of people with T2D. 
This pilot study will employ an investigational CGM system which has not been approved by the FDA. 
The system is a variant of the Dexcom G6 CGM system which received an investigational device 
exemption (IDE) from the FDA in 2016. In 2017 this investigational CGM system was designated by 
Chesapeake IRB as a Non-Significant Risk device for our research protocol Pro00021722. 
4. Program Goal and Objectives 
This program integrates CGM and state-of-the-art diabetes management education. It builds on 
previous and ongoing CGM-based program development work at Savvysherpa (see Appendix A for 
results of a preceding quality improvement initiative). 
The goal of the program is to ensure that patients with T2D receive the tools, information, and support 
needed to use CGM effectively, and as a result become better at managing their glucose levels. The 
program is designed to overcome current barriers to CGM utilization. 
The program will achieve its goal by helping patients 
1. Access CGM technology 
2. Use their CGM systems1 
3. Understand in real time how their behaviors impact their glucose levels 
4. Improve glycemic control through sustainable behavior change 
5. Program Description 
All program participants will receive a smartphone-connected CGM system. This system will allow 
participants to view their glucose levels in real time and observe how their behaviors impact their 
glucose levels. Participants will also be assigned a personal coach who will provide support via phone to 
help patients problem solve, reflect on observations, learn and practice skills, and form healthy habits. 
One major contributor to complication risk among patients with type 2 diabetes is medication non-
adherence (Polonsky and Henry, 2016). CGM can help make the importance of medication adherence 
                                                          
1 In the context of this study, a CGM system is defined as a CGM sensor, applicator, transmitter, and mobile app 
that is accessed through a smartphone. 

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more salient for patients by allowing them to directly observe the effects of medication on their glucose 
levels. Similarly, a recent review (Chacko, 2016) and meta-analysis (Savvysherpa internal analysis) 
suggests that appropriately-timed post-prandial activity can significantly reduce the rise in plasma 
glucose following a meal. Patients wearing CGM systems will have the ability to see exactly when and 
how their glucose levels are affected by variations in duration, frequency, and intensity of physical 
activity after a meal. Through coaching, patients can be guided and supported in making these 
observations and drawing connections to their daily lives. 
Coaches will focus on four key aspects of T2D management:  
i. 
Medication optimization 
Using CGM, patients will be able to see the impact of medication adherence on their glucose 
levels. 
ii. 
Impact of diet on glucose 
Through CGM and coaching, the program will help participants understand the relationship 
between PPG levels and the types and amounts of food eaten. 
iii. 
Strategic physical activity to reduce PPG spikes 
The program will encourage participants to track their post-meal activity via a wearable activity 
tracker. By observing their activity tracker data in tandem with their CGM data, patients will 
learn how they can use physical activity to help manage their glucose levels. 
iv. 
Nighttime glucose management 
Use of CGM will make it possible for participants to observe their NG levels. Coaches will help 
participants identify strategies to manage nighttime glucose.  
 
6. Methods and Procedures 
The proposed program represents a new, comprehensive education approach to T2D self-management 
that is centered around the patient experience. The program will take place outside of the clinic setting. 
This will allow participants to observe their glucose 24-7 under a wide range of conditions.  
 
Distinctive features of the program include: 
• 
Program access for all eligible patients 
• 
A ready-to-use smartphone that provides an enhanced data display and allows for greater 
patient interaction with data and educational resources that will be preloaded on the 
smartphones 
• 
Pre-pairing of CGM system devices to minimize set-up required by patient 
• 
Enhanced assistance with CGM device set-up and application 
• 
An activity-tracking system that allows patients to observe the relationship between physical 
activity and glucose levels 
• 
Individualized coaching to help patients understand their CGM data and make appropriate 
behavior changes 
• 
Data-sharing with program staff 
Compared to current clinical practice for T2D CGM use, the program offers numerous advantages (see 
figure 1).   

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CGM Process 
Component 
Current Clinical Practice 
Using CGM for T2D 
(infrequently employed) 
Drawbacks to Current 
Practice 
Proposed Program 
Advantages of Proposed 
Program 
Selection/Recruitment 
Physician identifies 
individual patient 
candidates for CGM 
• Identification of 
suitable candidates is 
ad hoc within a 
physician visit. 
Eligible patients are 
identified through their 
health plans and invited 
to participate in the 
CGM-based glucose 
monitoring program. 
• 
No visit required 
• 
No time required of 
physician 
• 
All qualified patients 
have an opportunity 
to use CGM 
Consent/ 
Prescription 
Physician discusses CGM 
with patient during a 
patient visit. 
Physician prescribes CGM 
system for patient. 
• Requires physician’s 
time at each 
encounter to explain 
CGM to patient. 
Patient is provided with 
information related to 
CGM and program 
consent, and has the 
ability to discuss any 
related questions and 
concerns with program 
staff. Patients with 
medical questions 
related to their 
participation are 
referred to their 
providers. 
 
Under IRB-approved 
research, no 
prescription will be 
needed for eligible 
patients to receive a 
CGM device. 
• Increased 
information and 
support available to 
ensure informed 
consent. 
Laboratory measure 
Usual monitoring of A1C 
levels (recommended 
every 3 or 6 months). 
• A1C levels reflect 
overall trends, 
providing limited 
information to help 
patients understand 
impact of specific 
decisions and 
behaviors. 
Usual monitoring of A1C 
levels (recommended 
every 3 or 6 months). 
• 
Patients will be able 
to observe how 
their A1C levels may 
change as a result of 
their participation in 
the program.  
• 
Patients will also be 
able to observe 
additional and more 
immediate effects 
of lifestyle changes 
to supplement their 
A1C measures. 
Devices 
Commercially-available 
CGM systems 
• Commercial CGM 
systems can be 
challenging for 
patients to apply and 
use. 
Patients will receive an 
investigational CGM 
system, including a 
smartphone with the 
investigational app. 
Patients will also receive 
an activity tracker to 
measure activity in 
conjunction with CGM. 
• 
The investigational 
CGM incorporates 
design changes to 
improve usability 
compared to 
commercially-
available CGM 
systems. 
• 
The activity tracker 
extends patient 
tools to understand 
the role of activity 
in glucose 
management. 
Distribution 
Patient sends 
prescription to a 
wholesaler, which then 
ships the CGM system to 
the patient. The system 
consists of a CGM sensor, 
a transmitter, and a 
receiver. 
 
• Requires that the 
patient take action to 
fill prescription 
Program houses stock of 
CGM systems. System is 
provided to patient 
along with program 
materials.  
• 
After the consent 
form is signed, no 
action required by 
patient in order to 
receive device.  
 

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CGM system set-up and 
application 
Patient applies device in-
home, using 
manufacturer’s 
instruction book, video, 
and technical assistance 
by phone. 
• Technical hurdles of 
system set-up and 
device application are 
especially challenging 
for seniors. 
Program sets up apps 
and links program 
devices on behalf of 
patient before patient 
receives the system. 
Resources and 
instruction will be 
available in written 
form, video, telephone, 
and/or in-person to help 
patients with device 
application and system 
usage. 
• 
Minimal system set-
up required of 
patient 
• 
Expanded, 
personalized 
resources are 
provided to help 
patient learn to 
apply device and 
use system. 
CGM-based education 
Patient learning is self-
directed 
• Benefit of using CGM 
may be limited by 
patients’ capacity to 
understand and 
interpret data, 
literacy, sense of self-
efficacy, or other 
factors. 
Patients receive 
provider-approved 
materials and guidance 
from a coach to help 
them 1) understand how 
to interpret CGM data 
and 2) observe and 
determine in real-time 
how diet, medication, 
exercise, and other 
lifestyle choices may 
help them better control 
their glucose levels. 
Coaches will be able to 
view patient glucose 
data in order to provide 
support tailored to 
individual patients’ data 
and circumstances. 
• 
Increased likelihood 
that patients will 
benefit from using a 
CGM system. 
Integration of CGM into 
practice 
Patients visit their PCPs 
every 3 or 6 months. 
Physicians may access 
patient CGM data online, 
although this is often 
difficult given time 
constraints. 
• Physicians must 
proactively take 
action to view patient 
CGM data online 
• Physician guidance 
typically limited to 
patient visits 
Patients use CGM data 
to understand and 
integrate best practices 
in diabetes self-
management. 
• Empowers patients to 
self-manage their 
diabetes 
• Ensures consistent 
oversight of patient 
device usage 
• Adjunctive to 
patients’ normal 
medical care 
Figure 1. CGM for Type 2 Diabetes Patients: Current Practice and Proposed Program Features 
 
Program process 
The program will be implemented as described below. The stages of program enrollment are 
summarized in figure 2. 
Recruitment 
Study participants will be recruited from UnitedHealthcare members in the Las Vegas area who are 
enrolled in a Medicare Advantage plan (Senior Dimensions®). To be eligible for the program, patients 
must meet specific inclusion/exclusion criteria.2   
All eligible patients will be invited to participate in a CGM-based educational program that will consist of 
10 weeks of CGM system use and activity tracker use with coaching. After using the devices for 10 
                                                          
2 Inclusion/exclusion criteria have been determined by Dr. Kevin Kapov and Dr. Linda Johnson,  
Co-Investigators and Senior Medical Directors at Southwest Medical Associates. 

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weeks, patients may be offered the opportunity to continue to wear the activity tracker and upload their 
data with the smartphone through August 31, 2018. 
Patients will be recruited to the program through targeted invitations.  
Targeted invitations will be made to patients determined to be eligible based on patient medical claims. 
These patients will receive a letter of invitation from the program on behalf of UnitedHealthcare, 
followed by a second reminder letter. Interested patients will be directed to call study staff or fill out the 
online form for more information, and will consequently be called by a program representative. After 
the first invitation letter has been sent, a program representative will call the patient to offer a verbal 
invitation. 
Patients at Southwest Medical Associates (SMA) in Las Vegas who may be appropriate study candidates 
may be given a program brochure by SMA physicians, staff, and/or program staff. If interested these 
patients may visit the program website and fill in an online form requesting a call, or call the program 
representative themselves. Physicians and staff may also call and invite potential study candidates to 
obtain study materials and to learn about the study by attending a meeting with program staff at the 
clinic, contacting program staff by phone or by filling out an online form to request a call from a program 
representative. 
When speaking with the program representative, if patients express an intention to participate in the 
program, patients will be invited to meet with program staff in person to learn more about the program, 
have the consent form reviewed with them, and get started in the program if they so choose. Patients 
will have the option to meet with staff via a home visit, at a class, or in-clinic.  
For patients that prefer to start using the system on their own without in-person assistance, the 
program representative will seek to ascertain whether these patients have experience with 
smartphones and apps and feel confident enough to apply the CGM system by themselves. If at any time 
these patients require additional assistance with set-up, they will have access to their coach. During the 
set-up period, these patients can also call the program to request in-person assistance. 
All patients interested in participating in the study will receive a consent packet that contains a cover 
letter from the program, a program brochure, a copy of the program eligibility criteria, two copies of the 
consent and authorization form (one to sign and return and one to keep), an information sheet on CGM, 
a Fitbit sizing guide and a program survey.  
 

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Figure 2. Type 2 diabetes CGM education program enrollment 
 

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Consent 
Because the claims data used to assess patient eligibility will lag by two months (and thus may not 
capture very recent events or diagnoses) patients will be asked in the consent form to review the 
eligibility criteria and confirm that they meet it before signing the form. 
To assure informed consent, prospective patients who receive study materials in the mail will be given 
at least two days to review the consent form and the opportunity to talk with a program representative 
who has been trained in human subjects research. Patients who attend an educational class, receive a 
home visit, or come to the clinic to learn about the study will be given ample time to read the consent 
form, the opportunity to take the consent form home (if applicable), and as much time as needed to talk 
with a program representative about the study. Patients with any medical concerns that they feel may 
affect their participation will be referred to their providers.  
Patients will also be provided with a manufacturer resource phone number should they have any 
technical support questions related to the CGM system. Patients can call their coach or request in-
person assistance on how to apply and setup the CGM system. The consent form itself will contain 
safety information related to study devices. Patients will also receive web links to the CGM system and 
activity tracker terms and conditions and privacy policies that they may view prior to providing consent. 
We will ask patients to review and agree to these terms prior to receiving their devices so that patient 
accounts can be created for the smartphone apps, thus reducing the set-up burden for the participant. 
Once participants receive their devices, this link will also be accessible on the smartphones for 
reference. 
Patients will be able to provide consent either by signing a paper copy and returning it in the mail or in 
person (e.g. at a class, during a home visit, or at an in-clinic meeting). Patients will not receive devices 
prior to completing the informed consent. 
Program Length 
Participating patients will be asked to use a CGM system and an activity tracker for 10 weeks.  After the 
10 weeks, patients may be offered the opportunity to continue to use their smartphones and activity 
trackers as long as they continue to sync the tracker at least every three weeks through August 31, 2018. 
Inventory and distribution 
Dexcom will ship the investigational CGM systems to Savvysherpa, Inc. (Sponsor). Activity trackers will 
be obtained from Fitbit. All inventory will be accounted for and distributed according to good 
manufacturing practices. All devices will be stored in a secured environment with access limited to 
authorized personnel. After receiving a patient’s signed and dated consent form, the CGM system and 
related program devices and materials will be provided to the patient. 
Normally as per FDA regulations, a receiver that displays the patient’s glucose data must be provided to 
the patient when an individual CGM prescription is filled. In this program, a smartphone, instead of a 
receiver, will be loaded with needed software applications and assigned to a patient. Use of a 
smartphone instead of a receiver will also help reduce the CGM system cost which may further help 
improve affordability and T2D patient access to this technology going forward. 
The sensor and transmitter of the CGM system, the smartphone and the activity tracker each have 
unique identification numbers that will be assigned to an individual patient. This information will be 

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combined and stored with the assigned patient’s name, device username, study identification number, 
etc. This information will also be securely sent to Dexcom for newly consented participants,  allowing 
Dexcom to provide any needed technical support. 
The Dexcom, Glucose Guide, and Fitbit app accounts will be set up on behalf of each patient in the 
study. The patient’s first and last name along with a unique assigned username and password will be 
used to create accounts in all apps. The username and password will be printed on literature that only 
the patient receives. Patients’ usernames and passwords will be stored on Savvysherpa’s secure servers. 
System set-up and application 
All participants will receive a smartphone pre-loaded with apps associated with elements of the study 
program. These apps include the Dexcom CGM system app, the Fitbit app, and the Glucose Guide app 
created for this program to support patient coaching and research (e.g. texting, CGM secondary display).  
In addition, the Dexcom transmitter will be paired to the Dexcom app for each patient. Each of these 
steps by staff--app pre-loading, pre-registration and device pairing--will reduce the patient burden and 
allow program participants to begin the program by focusing on the fundamentals of using their devices.  
Patients who choose to start using their CGM systems at home on their own will be asked to first review 
the instructional materials and videos. Patients who receive their devices in person will be provided with 
information and instruction at that time. 
Program resources and instructions will be accessible to patients in written form, in person, via 
telephone, and via video to help them with device application and system usage. 
CGM-based education and coaching 
This part of the study will be implemented by coaches who have undergone diabetes management 
training that incorporates device information, educational content, and techniques based on behavioral 
discussion and patient self-learning/empowerment. Coaches will also be equipped to help patients use 
activity data in conjunction with their CGM use. Coaches will receive training regarding human research 
subjects to insure the ethical treatment and safety of all participants. All training will be reinforced 
during contact with study staff.  
The information contained in the Standard of Care document has been approved by the study’s Medical 
Directors (co-investigators) as providing fundamental diabetes self-management information to patients 
with T2D. In the Standard of Care document, patients are instructed that this information does not 
replace individual guidance given to patients from their providers. 
Each participant will be assigned a coach who will provide education and support by phone and secure 
text messaging. During weeks when patients are using the CGM system, they will be scheduled to 
receive a weekly phone call from their coach. Otherwise, patients can reach out to their coach by leaving 
a voicemail for the coach. Coaches will return calls within two business days. Education will be centered 
around the four educational objectives (food intake and PPG, walking to reduce PPG, medication 
adherence, and nighttime glucose monitoring) and reinforcement of messages in the patient standard of 
care document. The coach will provide education on how to optimally use the RT-CGM system for self-
discovery, focusing on effective times to look at the RT-CGM and behaviors that are likely to impact the 
CGM (outlined above). Coaches will assist participants in setting personalized goals and act as a 

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sounding board for participants to discuss their self-discoveries. Coaches will review with patients the 
Rule of 15 to deal hypoglycemic episodes. 
Integration with patient care 
Throughout the program, patients will be instructed to follow their normal care plan as directed by their 
physicians and as consistent with ADA 2017 standard-of-care guidelines. This includes taking 
medications as prescribed; engaging in physical activity—especially walking after meals; eating a diet 
that optimizes glucose control through food choice and timing; responding to hypoglycemia symptoms 
with a fingerstick and consuming a pre-determined amount of glucose; and monitoring emotional 
wellness. By providing a continuous graph of each participant’s glucose, the CGM system illustrates how 
the above-described glucose management behaviors impact the participant’s glucose.  
Should patients in the course of the program experience any health problems associated with the use of 
their CGM devices, they will be directed to contact the study doctor’s clinical research coordinator. The 
coordinator will assess the severity and relatedness of the event and arrange for appropriate care. 
Should patients mention a potential study-related health concern to their coach, the coach will actively 
work to assure the patient speaks with the study doctor, either through a warm transfer or callback. 
Program devices 
Dexcom CGM System 
Patients in this study will employ an investigational-use only (IUO) CGM system manufactured by 
Dexcom, Inc. (San Diego, CA). The devices in this system (a sensor with auto-applicator, a transmitter, 
and a mobile application) represent a variation of the Dexcom G6 CGM system which received approval 
by the FDA under an investigational device exemption (IDE) on April 28, 2016. In 2017, Chesapeake IRB 
designated the device as a Non-Significant Risk device for our research protocol Pro00021722. The ways 
in which these study devices vary from the G6 system and the commercial G5 system are described here 
as well as in the attached Investigator’s Brochure. 
The investigational system represents several improvements over the commercially-available Dexcom 
CGM systems. The investigational applicator is designed to improve ease of use and reduce the risk of 
user error compared to Dexcom’s G5 commercial device by simplifying the application process. While 
the commercial device requires the user to perform multiple actions to deploy the sensor-delivery 
needle, retract the needle, and release the applicator from the transmitter holder, the investigational 
applicator performs all of these steps with just one action by the user.  
The investigational sensor has a lifetime of 10 days, as opposed to the 7-day lifetime of Dexcom’s 
commercial G5 sensor. As a result, users will not need to change their sensors as often, further reducing 
risk for any difficulties or inconvenience associated with sensor application. The sensor has also been 
redesigned to reduce sensor error associated with the use of acetaminophen, thus improving the 
reliability of sensor readings. 
Compared to the Dexcom G6 transmitter, the IUO transmitter has a lower design profile to improve 
everyday wearability. 
The mobile (smartphone) app displays glucose information in real-time. To maintain the accuracy of 
these readings, the system must be calibrated periodically based on fingerstick readings from a blood 
glucose meter. After initial calibrations, the investigational app requires less frequent calibrations than 

13 
 
the commercial device. While the commercial system requires calibration every 12 hours, after the first 
day the investigational system requires calibration every 24 hours. This improvement is expected to 
further improve the usability and acceptance of the CGM system. 
During CGM wear, a sterile disposable glucose sensor is applied on the abdomen and held in place with 
an adhesive. The wire-like sensor is not significantly thicker than the needles used in syringes for insulin 
injection. The needle insertion depth ranges from 0.35 – 0.55 inches.  
Once in place, the sensor pod consists of a glucose oxidase-based electrochemical sensor placed 
subcutaneously to measure interstitial glucose concentrations over a 40-400 mg/dL range. The 
transmitter attached to the sensor pod will wirelessly send the sensor’s glucose measurements via 
Bluetooth to a smartphone for display of trends and continuous glucose readings every 5 minutes. 
Readings will also be stored in the cloud. In using cloud storage, the smartphone also permits protected 
sharing of data with coaches and other authorized study staff. The smartphone also provides a more 
user-friendly interface, including larger text. Alerts, alarms, and reminders will be set to minimize 
disruption for the patient while still supporting proper use of the device and allowing for patient 
customization.  
Participants will need to calibrate their CGM systems using a commercially available blood-glucose 
meter per manufacturer instructions.  
As part of the system’s instructions for use, users are informed of the following:  
• 
The system does not replace blood glucose measurements. 
• 
Blood glucose values may differ from sensor glucose readings and the value from the 
blood glucose meter should be used for treatment decisions. 
• 
Symptoms of high and low glucose should not be ignored. If sensor readings do not fit 
with symptoms, blood glucose should be measured with a blood glucose meter. 
Upon completion of 10 weeks of CGM and activity tracker use, patients will be asked to return their 
CGM transmitters and unused sensors. Patients may be offered the opportunity to continue to use their 
smartphones and activity trackers as long as they continue to sync the tracker at least every three weeks 
through August 31, 2018. During the study, patients can reach out to their coaches as desired by phone 
and secure text messaging. Likewise, coaches can reach out to patients by phone and secure text 
messaging. Automated text messages will also be sent to patients as part of the program. Patients will 
return their smartphones and activity trackers at the end of the program. 
Blood-Glucose Meter 
An over-the-counter blood-glucose meter will be used to approximate levels of glucose in the blood to 
calibrate the Dexcom CGM System. The battery-powered blood glucose meter will consist of an on/off 
switch, a display, and an opening for test strips. Patients are expected to already own their own blood 
glucose meters as part of their normal standard-of-care. Patients who do not have a glucose meter will 
be provided one to use and keep following the study. 

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Activity Tracker System 
To help patients observe how physical activity impacts glucose levels, patients will be provided with a 
Fitbit Charge 2 wrist-worn activity tracker. This activity tracker will display in real-time the cumulative 
number of steps taken by the patient each day.3 The patient will also be able to view his/her step history 
via an app on the smartphone. The Fitbit activity tracker system consists of an activity tracker, a 
compatible charging cable, and an associated smartphone app that syncs step data to the Cloud. 
Patients will be invited to wear the activity tracker from the start of the program.  
Per protocol, patients will be asked to use their activity trackers for 10 weeks during the same period of 
CGM use. Afterwards, patients may be given the opportunity to use their activity trackers through 
August 31, 2018, if patients sync their tracker data at least once every three weeks. Patients will return 
the tracker and the smartphone at the end of the study. 
Training of site staff 
Registered nurses will provide in-person assistance to patients in the application and use of the CGM. 
These nurses, along with program representatives, and all study staff interacting with patients will also 
be trained to answer any questions patients may have related to providing informed consent, and will 
be trained by the Sponsor in their respective roles. All research staff (excluding clinic staff) who interact 
with patients will receive training on the ethical treatment and safety of human research subjects. 
7. Selection and Withdrawal of Subjects  
Study participants will be recruited from UnitedHealthcare members in the Las Vegas area who are 
enrolled in a Medicare Advantage plan (Senior Dimensions®). To be eligible for the program, patients 
must meet specific inclusion/exclusion criteria. All Medicare Advantage patients who meet this criteria 
will be invited to participate in the program regardless of their latest A1C test. 
We intend to enroll 500 program participants (defined as those to whom program materials and devices 
have been delivered). When 500 participants have been enrolled, any patients that have been recruited 
but who have not yet been enrolled (including those who may have signed a consent form) will be asked 
if they would like to be notified of any other upcoming study opportunities for which they may be 
eligible. 
Inclusion Criteria 
To be included in the study, patients must: 
• 
Be diagnosed with type 2 diabetes 
• 
Be able to read, speak and understand English 
• 
Have access to a telephone 
• 
Have a Medicare Advantage plan through Senior Dimensions® 
                                                          
3 The Fitbit may also record and display distance walked, calories burned, active minutes, hourly activity, stationary 
time, heart rate, and sleep stages, duration, and consistency; and contain tools to help users meet their personal 
health and fitness goals. 

15 
 
Exclusion Criteria 
Patients will not be eligible if any of the following criteria pertain to them: 
• 
Pregnant 
• 
Blind 
• 
Deaf 
• 
Receiving chemotherapy or radiation therapy to treat cancer (either now or within the last six 
months) 
• 
Misusing any drugs (including alcohol, painkillers, hallucinogens, or others) 
• 
Critically ill 
• 
Diagnosed with or experiencing: 
o Kidney disease stages 4 and 5 
o End stage renal disease 
o Severe liver disease 
o Dementia 
o Schizophrenia 
o Bipolar disorder 
o Autism 
o An intellectual or learning disability 
o Arrhythmias other than atrial fibrillation  
o Congestive heart failure 
• 
Has had a: 
o Myocardial infarction within the last 6 months 
o Stroke within the last 6 months  
o Stroke that resulted in significant disability (e.g., unable to write clearly or walk) 
When a patient is referred to the program by the clinic and this patient is not eligible due to a diagnosis 
of congestive heart failure, one of the study’s medical advisors will make a clinical judgement as to 
whether the severity of the patient’s congestive heart failure warrants exclusion from the study.  
 
Initial eligibility will be determined using medical and pharmacy claims data. Since these claims will not 
address all inclusion and exclusion conditions, patients will confirm their eligibility by reviewing the 
eligibility criteria provided in the consent packet and the consent form, and attesting to their eligibility 
by signing the consent form.  
If during the study a patient’s status changes such that s/he is no longer eligible to participate, the 
patient will be removed from the study and will be asked to return all devices (with the exception of 
used sensors, the used transmitter, and the glucometer if the patient received one). 
Patient Participation 
All program participants will participate at-will and have the freedom to terminate their participation at 
any time. Participants, including those who intend to withdraw from the program or those who have 
withdrawn will be able to access program coaches for assistance with any program-related questions or 
issues. 

16 
 
During the time that patients use the CGM system, coaches will schedule weekly calls with them. If 
patients demonstrate by their actions that they no longer want to participate in the study by no longer 
syncing their CGM or activity tracker data, outbound call or text messaging efforts will be made to reach 
the patient. If after three weeks there has been no data received and no communication with the 
patient, a voicemail will be left asking patients to reply within three days or they will be considered 
dropped from the study. No response to these voicemails will result in the shipment to these patients of 
a postage-paid box and a letter. The letter will inform patients that they are considered as non-
participating and need to return the CGM devices, activity tracker, and smartphone. 
During the course of the program, should any participant report medical issues that may affect that 
patient’s ability to participate in the program, the patient will be directed to consult with his/her 
physician. 
8. Treatment of Subjects  
This program will provide dedicated resources to assure informed consent.  
Patients will be instructed to continue to follow the advice of their physicians, including taking 
prescribed medications. 
Patients will sign and date an IRB-approved consent form that indicates that if they are injured from 
applying or wearing the CGM system or activity tracker in the course of the program that they will 
receive treatment and that their insurance may be billed. Copays and costs related to injuries from 
applying or wearing the CGM devices and activity tracker which are not paid for by patient’s insurance 
will be covered by Savvysherpa (Sponsor). Charges for medical care will be based on insurance 
contracted rates and not mastercharge sheet prices. 
Patients with medical concerns related to the study devices will be instructed to contact the study 
doctor and/or his staff for evaluation. Patients with any other health concerns will be encouraged to see 
their health providers, or if needed, seek emergency assistance as part of their normal standard of care. 
Patients and study staff will be provided with the device manufacturers’ technical assistance telephone 
numbers to report any device-related problems or concerns. 
Patients will be provided with a program phone number to call and report other problems or concerns. 
Patients who need assistance with the application and use of the CGM system can call their coach or be 
scheduled for an educational class. 
9. Assessment of Safety 
While the proposed program is essentially educational in nature, every effort will be made to ensure 
that patients are using their devices properly. Should any concerns about patient safety arise, patients 
will be directed to see the study doctor or his staff, and if necessary, seek emergency medical assistance.  
The Dexcom Continuous Glucose Monitoring System described in this protocol is considered by the 
Sponsor to be of non-significant risk as it does not meet the definition of a significant risk device per 21 
CFR 812.3(m), in that CGM  

17 
 
(1) Is not intended as an implant and presents a potential for serious risk to the health, safety, or 
welfare of a subject; 
(2)  Is not purported or represented to be for a use in supporting or sustaining human life and 
presents a potential for serious risk to the health, safety, or welfare of a subject; 
(3)  Is not for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or 
otherwise preventing impairment of human health and presents a potential for serious risk to the 
health, safety, or welfare of a subject; or 
(4)  Otherwise does not present a potential for serious risk to the health, safety, or welfare of a 
subject. 
Additionally, the system is being used in a manner not entailing significant risk, in that it is being used 
for educational purposes and as an adjunct to normal care. 
The following information supports a non-significant risk determination for the device that will be used 
in this protocol: 
•  Chesapeake IRB has previously designated this CGM investigational device as a Non-
Signficant Risk device for our research protocol Pro00021722; 
• 
FDA-approved Dexcom CGM Systems have been considered a non-significant risk 
device; 
•        The CGM devices used in this study are being used on-label in the intended population; 
•        The Medtronic-Minimed Guardian RT® CGMS, an FDA-approved device using similar 
technology, has been considered a non-significant risk device; 
•        The FreeStyle Navigator® CGMS, an FDA-approved device using similar technology, has 
been considered a non-significant risk device; 
•        The insertion needle thickness used in the device is not significantly thicker than the 
needles used in syringes for insulin injection and the potential needle insertion depth is 
less than 0.6 inches; 
•        None of the expected device-related adverse events as defined in the protocol and 
associated documents would be life-threatening or would result in any permanent 
impairment of a body function or permanent damage to a body structure; 
•        There are no expected electrical safety risks as the device has passed the electrical 
safety tests as per EN45502-1 and EN60601; 
•        If the subject feels any discomfort during the course of the study, he/she will be able to 
remove the device immediately (the device is not permanent); 
•        The device is being used to complement, not replace, self-monitoring of blood glucose 
meter information, and readings are not intended to be used alone to make diabetes 
self-management decisions. As with the currently approved device and per intended 
use of similar technologies, subjects in the study will be instructed not to use the device 
for diabetes therapy or management; 

18 
 
•        Subjects will be instructed to monitor their blood glucose levels as per their usual 
practice. 
Adverse events (AE) associated with the use of the device include pruritus (severe itchiness present 48 
hours after removal), erythema (reddening of the skin present 48 hours after removal), and 
inflammation (swelling and pain, defined as 8 or greater on a 10 point scale 48 hours after removal) 
where the adhesive touches the skin; local infection at insertion site; and shooting pain located at the 
site of the sensor (defined as 8 or greater on a 10 point scale). Rarely, the sensor wire will fracture when 
the sensor is being inserted, worn, or removed. If a sensor breaks and no portion of it is visible above 
the skin, the participant will be instructed to not remove it and seek medical care from the study doctor 
and/or his staff. 
No serious adverse events (SAE) or Unanticipated Problems (UP) are expected as a result of participation 
in this minimal risk study. However, AE, SAE and UP will be monitored in the following ways: 
• 
Participants in the study will be instructed to call the study doctor’s clinical research coordinator 
to report all AE, SAE and UP related to the use of the CGM devices. The study doctor and/or his 
staff will assess the severity of any health problems associated with the device, and if needed, 
see the patient at the study clinic to assure appropriate care. 
• 
Study coaches will listen for any reports of AE or SAE or UP in the course of their 
communications with participants, and will connect reporting patients with the study doctor’s 
clinical research coordinator so events can be assessed and documented and patients can 
receive care, if needed. 
• 
Any reports of AE or SAE or UP received by Dexcom’s Technical Support representatives will be 
documented and reported to the Sponsor. Coaches will then promptly notify the study doctor’s 
clinical research coordinator of these reports so that the coordinator can then follow up with 
the patient to assess event severity and relatedness, and schedule the patient for care, if 
needed. 
The Sponsor-Investigator will receive CGM-related AE and SAE and UP information from Dexcom 
through secure data transfers. AE and SAE and UP information from the study doctor will also be stored 
and transferred securely. Any other records pertaining to AE and SAE from patient conversations with 
program staff will be recorded and documented using call-management software and the patient’s Case 
Report Form. 
The Sponsor-Investigator will ensure proper reporting of AE and SAE and UP to Chesapeake IRB, the 
CGM manufacturer, the FDA, and any other regulatory bodies according to regulations and standard 
operating procedures. (See Appendix C for a chart illustrating the reporting process, and Appendix B for 
AE assessment guidance for coaches.) 
Patients will be provided with a summary printout of their recorded CGM data at the end of their 
participation with CGM. Patients can request a summary printout anytime during the trial. Patients can 
share their CGM data with their providers. 
The Standard of Care guidelines associated with the program direct patients to seek medical care when 
needed. Guidance exists within the guidelines to seek medical advice when glucose values are extremely 
high over long periods of time, fluctuate rapidly from high levels to low levels and vica versa, or a 

19 
 
pattern of low glucose values is present. Coaches will remind patients of these guidelines but will not 
give medical advice. Coaches can send summary CGM data to patients upon patient request. 
Because the CGM data is an adjunct to patients’ diabetes care, the investigator and research staff will 
NOT constantly monitor patients’ realtime CGM data nor will research staff and coaches contact 
patients’ medical providers on behalf of patients when low or high CGM values are observed. Patients 
will be responsible for using the blood glucose meter to manage their diabetes and to seek medical 
attention when needed.  
Episodes of hyperglycemia or hypoglycemia that require patients to seek medical attention will be 
considered an AE or SAE depending upon the situation.  
10. Data Collection and Statistical Analysis 
This study is a formative evaluation to assess the implementation of a program that uses state-of-the-art 
tools and techniques (e.g. streamlined patient set-up, multi-channel education through coaching, and 
high-quality, patient-friendly devices) to engage patients in an educational program for CGM-based 
diabetes management. To do this, we will collect data to measure the degree to which each of the three 
program elements has been effective. 
As an evaluation study, the study is not hypothesis-driven, and involves no statistical analysis plan for 
hypothesis-testing. Further, as participation will be based on self-selection with no group assignment; 
there is no sample size calculation. Rather, this study is exploratory in nature. 
In this study we anticipate enrolling 500 patients with T2D. Since our primary aim is to perform a 
formative evaluation of a new program, we plan to collect measures relevant to enrollment and device 
distribution processes, telephone and secure text messaging with study participants, and any challenges 
encountered (by both study participants and administrators) in the implementation of the program. We 
view these measures as benchmarks that will inform future program iterations and quality improvement 
efforts. We will also investigate whether the program may be more effective for certain subgroups; for 
example, whether observed differences in program adoption, persistence, behavior change, or changes 
in diabetes management markers (e.g., estimated glucose values and hemoglobin A1C measurements), 
vary according to such factors as age, familiarity with technology, educational attainment, or disease 
progression. 
Data Collection 
Since our program achieves its efficacy through education, self-discovery, and the behavior change that 
results from that education, we will collect data about our ability to connect with and engage 
participants in the program.  Specifically, we will collect data on recruitment efforts (e.g., recruitment 
rate; patient preferences in setting up their devices (i.e., via self-start, home visit, or in-class); 
information related to study enrollment (e.g., method and date of enrollment, pre-program survey); and 
program engagement metrics (e.g., device calibrations, use of companion mobile application, CGM 
component completion rates). By enrolling in the study, participants consent to the acquisition, review, 
and analysis of data from their medical records. We will also collect the following data, which will allow 
us to both evaluate the program as delivered, and to help us tailor future versions of the program to 
better serve the participants that we enroll:  

20 
 
• 
Reasons for declining to participate, as given to program personnel at different contact points 
• 
Recordings of coaching calls and introductory training sessions 
• 
Observations from coaches about the most effective calling procedures, behavioral strategies, 
talking points, and online facilitation techniques 
• 
Time dedicated to device preparation, and to each aspect of the introductory training session 
• 
Total letters sent, and the number returned due to bad addresses 
• 
Recruitment strategies to which each potential participant was exposed 
• 
Total coaching calls attempted and completed per participant, and the durations of those calls 
• 
Suggestions made during coaching calls and during the exit interview about how to improve the 
program  
• 
Demographic information such as age, education, and social support 
• 
Survey results to assess familiarity with technology such as computers and smartphones, 
knowledge about nutrition and self-care, and self-efficacy in disease management. 
 
A secondary goal is to evaluate the effectiveness of the program as implemented in this study. On all 
patients we will collect interstitial glucose levels from the CGM device, activity and other available data 
from the activity tracking device, any changes in prescription medication use during the normal course 
of participants’ medical care outside of the study, routine lab measures, any changes in mental health 
(specifically depression), and total costs of medical care before, during, and after the study. Patients will 
be asked to share information contained in their medical records and claims through December 31, 
2027, even if patients stop early from participating in the study. 
The following measurements will be collected from study participants:  
 
 
Data Collection Time 
Data Elements from Participants 
Source 
Study 
Enrollment 
During 
course of 
study 
CGM 
Completion 
(10 weeks) 
Post-Program 
through 
12/31/27 
Age 
Medical Record1 
X 
 
 
 
Time since diabetes diagnosis 
Enrollment 
Survey2 
X 
 
 
 
Race/Ethnicity 
Enrollment 
Survey2 
X 
 
 
 
Hemoglobin A1C 
Medical Record 
X 
 
X 
X 
Diabetes Distress Questionnaire 
Enrollment 
Survey2 
X 
 
 
 
Cancer Indicator 
Medical Record1 
X 
 
 
 
Heart Failure Indicator 
Medical Record1 
X 
 
 
 
 
 
 
 
 
 
Diabetes medication indicator 
Medical Record1 
X 
 
X 
X 
Metformin indicator 
Medical Record1 
X 
 
X 
X 
Glipzide indicator 
Medical Record1 
X 
 
X 
X 
Pioglitazone indicator 
Medical Record1 
X 
 
X 
X 
Rosiglitazone indicator 
Medical Record1 
X 
 
X 
X 
Sitagliptin indicator 
Medical Record1 
X 
 
X 
X 
Linagliptin indicator 
Medical Record1 
X 
 
X 
X 
Saxagliptin indicator 
Medical Record1 
X 
 
X 
X 
Exenatide indicator 
Medical Record1 
X 
 
X 
X 
Liraglutide indicator 
Medical Record1 
X 
 
X 
X 
Glyburide indicator 
Medical Record1 
X 
 
X 
X 
Basal insulin indicator 
Medical Record1 
X 
 
X 
X 
Bolus insulin indicator 
Medical Record1 
X 
 
X 
X 
Other prescription drug use 
Medical Record1 
X 
 
X 
X 
Interstitial glucose levels 
CGM device3 
 
X 
X 
 

21 
 
Contacts with program coaches 
Coaching 
platform4 
 
X 
X 
X 
Interactions with secure texting 
Digital app5 
 
X 
 
X 
Accelerometer data, including daily steps, 
distance walked, calories burned, active 
minutes, hourly activity, walking goal 
achievement, stationary time; heart rate; 
sleep stages, duration, and consistency; and 
any other metrics as available. 
Activity tracking 
device6 
 
X 
 
X 
Total cost of medical care during program 
Medical Record7 
 
 
 
X 
WHO-5 Well-Being Index (depression 
screen) 
Pre/post study 
surveys 
X 
 
 
X 
Exit Interview Questionnaire 
Post-study 
survey8 
 
 
 
X 
1These items will be abstracted from the patient’s medical record or administrative claims by Savvysherpa research staff  
2This survey will be mailed to participants or delivered over the phone by a coach or call agents.  
3Dexcom will securely transfer CGM-based EGV measurements to Savvysherpa. 
4”Coaching platform” refers to any interactions with human coaches via phone or secure text message.  
5Savvysherpa will collect patients’ use of text messaging.  
6Savvysherpa will data from activity trackers via participants syncing their activity tracking devices.  
7Savvysherpa researchers will identify this from participants’ administrative medical claims.  
8This survey will be mailed to participants or delivered over the phone by a coach or call agents. 
 
Statistical Analysis 
Formative evaluation 
During and after the study, we will conduct a qualitative assessment to evaluate the implementation of 
the proposed diabetes self-management program. Qualitative information to be analyzed will include 
coaches notes, descriptions of requests for technical support, observations of home visits, and 
information provided through participant surveys. The purpose of this study is to generate insights that 
will inform a future, larger study evaluating the effectiveness of the program across a larger study 
population. While we will measure many of the same outcomes in that future study, the design and 
implementation will evolve based on the results of the current study. We intend to conduct multivariate 
analyses to evaluate program implementation performance in various subgroups; for example, we will 
evaluate enrollment rates, program completion rates, and other participation metrics against participant 
demographics and disease progression measures. This analysis will be carried out using intent-to-treat 
analysis principles. 
Program effectiveness  
While it is not the primary aim of this study, the data we collect will be used to evaluate the program’s 
effectiveness in maintaining participants’ glycemic control. We will evaluate changes in participants’ A1C 
measurements over time, as well as summary statistics of interstitial glucose measurements obtained 
from CGM devices, similar to those examined by Lind et al. (Lind, 2017). Endpoints of interest to this 
analysis include but are not limited to average measured glucose levels over the course of the study, 
glucose variability, and frequency and nature of medical care utilization throughout the study 
timeframe. This analysis will provide insight into patients’ ability to self-manage their glucose levels 
using the program, as well as help refine the program and inform the design of a future, larger study of 
its effectiveness.  
All eligible participants will be included in the analysis.  

22 
 
11. Direct Access to Source Data/Documents 
The Sponsor-Investigator, Dexcom, and the study doctor will permit any program-related monitoring, 
audits, IRB/IEC review, and regulatory inspection(s), deemed necessary by the IRB, and will provide 
direct access to relevant source data/documents as may be required. 
12. Risks 
This is a minimal risk study. Program participants are being asked to wear a Fitbit activity tracker and a 
Dexcom CGM system. 
Risks of the Activity Tracker Device 
The Fitbit has a wrist band. Skin irritation from these devices is a remote possibility (there are very few 
reports in the online literature regarding this occurrence with similar devices). Study participants who 
experience skin irritation will be instructed to remove the activity tracker during sleep, and/or to 
alternate wearing it on the opposite wrist. There is also a slight risk that the privacy of the activity 
tracker data could be exposed if an unauthorized source hacks into the activity tracker’s data system. 
Due to security and authorization that Savvysherpa has in place this risk is minimal.  
Risks of CGM 
When the wire-like sensor is deployed by the applicator, participants can expect a sensation similar to a 
needle insertion for a blood draw. Risks of CGM use include discomfort during sensor insertion, along 
with pain, inflammation, redness, swelling, minor bleeding and minor infection at the sensor insertion 
site. Participants might also experience these symptoms as a result of contact between the adhesive pad 
of the sensor and the skin. In rare cases, an infection can spread to other parts of the body.  
Allergic reactions can develop in response to the sensor, the adhesive, and other parts of the CGM. If 
these symptoms occur, participants have the ability to remove the CGM at will and can anticipate that 
their symptoms will clear up within one week. 
The sensor and/or applicator may fracture during use. If a sensor remains in the skin, there is minimal 
risk to the patient as long as a physician confirms there are no symptoms of infection or inflammation. 
Patients will be advised that the investigational sensor, transmitter, and smartphone must be removed 
before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. 
The device is MR Unsafe. Participants should not bring any portion of the device into the MRI 
environment. The Dexcom IUO CGM System has not been tested during MRI or CT scans or with 
diathermy treatment. The magnetic fields and heat could damage the device, causing it to stop 
displaying glucose readings, display inaccurate glucose readings, or prevent alerts.  
Patients will also be advised of CGM system warnings that may affect the proper operation of the device 
and/or the patient’s safety. These warnings will be described in the informed consent and authorization 
form, and in the informational materials provided to patients when they receive their systems. 
Patients will be provided with a phone number for Dexcom’s Technical Support. Staff for this line will be 
well-qualified to address any potential questions and risks associated with the investigational device. 
Significant or serious health risks with CGM are not anticipated.  

23 
 
The same precautions have been taken to code and/or encrypt the investigational system’s electronic 
data as have been taken with the commercial Dexcom devices. Regardless, throughout the program, 
patients will be advised not to rely on the device to make any treatment decisions, and to measure their 
blood glucose in order to confirm any symptoms of hypoglycemia. 
Risks of Glucose Meter 
Finger-stick blood samples will be taken during this study. This may cause some discomfort, pain, 
bruising, and/or soreness afterwards. Rarely, an infection may occur. Routine finger-stick sampling for 
use with a blood glucose meter is already standard-of-care for T2D patients. 
Risks of Medical Record Review and Data Collection 
This project involves extracting Protected Health Information (PHI) from patients’ medical records. PHI 
will also be extracted from Dexcom patient databases. Activity tracker data will be synced via https from 
the trackers to the secure servers of Fitbit. Data collected from the activity trackers will then be sent via 
https to Savvysherpa’s secure servers. Personally Identifiable Information (PII) will be collected from 
health providers, Dexcom, and/or Fitbit, as well as through survey responses, coach-patient texts, call 
recordings, online program engagement, and/or in-person group participation at educational classes. 
The combined dataset will be de-identified by removing personal identifiers from each system and 
replacing them with a unique study identifier. 
The combined data set will be stored in Savvysherpa’s HITRUST-certified secure server environment that 
can only be accessed by authorized personnel via a physically secured room. Any links between personal 
identifiers from the source systems and study identifier will be deleted ten years after study completion. 
Recordings of educational classes, coaching sessions, and coach-patient texts will also be deleted ten 
years after study completion. PII associated with these recordings may be visible to program staff and 
Dexcom in the course of quality improvement efforts and the development of training, but the identities 
and privacy of participants will otherwise be maintained.  
There is a risk that the information could be inadvertently disclosed to another entity although the risk is 
very small given the data security measures in place. 
Risks of Unsecured Communication 
Participants will be contacted via phone and secure text messaging. Phone communication will not be 
secured putting the participants at risk of having PII inadvertently disclosed. Secure text messaging is 
subject to hacking. 
13. Benefits 
Participants in the study may develop a greater personal understanding of how their lifestyle habits (e.g. 
physical activity, diet) affect their glucose levels (e.g. average glucose, PPG, GV, and NG). What they 
learn will help them understand better how to self-manage their glucose and be healthier. Information 
gained from this program will be used to further refine the program so that it can benefit more people. 
14. Compensation 
During the study, participants will use a free Fitbit Charge 2 activity tracker and a Dexcom CGM system 
for 10 weeks. Study participants will also have access to their personal CGM data (up to 24 hours) via the 
Dexcom CGM system app while using the CGM system and in a summary report after they have finished 

24 
 
using the system. During the 10 weeks of CGM use, participants will receive free over-the-phone and 
secure text messaging communication with coaches related to CGM and diabetes self-management. 
 
To compensate participants for the time it will take to get set-up and use their devices (e.g. receive a 
home visit/attend a class/attend an in-clinic meeting, or seek other assistance; study and understand 
program materials; maintain device function via calibrations and charging, return study devices, etc.), 
patients will be compensated up to a total of $250 according to the following schedule: 
 
Study task 
Compensation 
Wearing a Dexcom® CGM sensor for the first 10 days and 
wearing Fitbit Charge 2™ for 7 out of those 10 days 
$190 
Wearing a CGM sensor for each additional 10 days and 
wearing Fitbit Charge 2 for 7 out of those 10 days 
$10 (total not to exceed $60) 
 
Patients need not wear their 10-day sensors continuously, nor will they need to wear the same sensor 
for 10 days in order to qualify. Compensation will be provided in the form of a gift card after the 
participant has completed the program, or upon withdrawl from the study, whichever comes first. 
 
Participants may be invited to continue to wear and upload data from their activity trackers (defined as 
syncing at least every three weeks through August 31, 2018).  Patients will return the smartphone and 
activity tracker to the Sponsor at the end of the study.  
Patients who received a glucometer ($40) may keep it. 
Study participants will also continue to have access to their personal physical activity dashboard after 
the study ends. 
15. Quality Control and Quality Assurance 
All study staff interacting with patients will receive training in the fundamentals of the ethical treatment 
and safety of human subjects. The Principle Investigator will be responsible for assuring that program 
staff receive this training and that the entire research team adheres to the protocol. The Principle 
Investigator will also ensure that the principles of Good Clinical Practice are being followed.  
In addition, the research team participating in this study represent individuals whose qualifications and 
experience have equipped them to collect and analyze confidential patient data. The study’s medical 
advisors (Co-Investigators) will meet with the Principle Investigator to review progress and offer any 
direction that may be needed with regard to patient safety. The HITRUST-certified environment in which 
data will be stored will provide a high level of protection for all data collected (see below).  
16. Ethics 
The proposed program will involve patients with a medical condition. The program recruitment 
strategies assure that prospective patients have access to a staff member with whom they can discuss 
and ask questions about the program before signing an informed consent form and then while 
participating in the program. Patients who receive study materials in the mail will have a minimum of 
two days to review study materials and ask questions of research staff before signing and dating the 
informed consent form. Patients who meet with study staff (e.g. at a home visit, educational class, or in-

25 
 
clinic meeting) will be given ample time to read the consent form and as much time as needed to talk 
with a program representative about the study. There is no limit to the number of times patients may 
speak with program staff before making a decision about whether to participate.  
As some participants may not want their condition to be known to others, they will have the option and 
resources to start using the CGM system without having to attend a class. The program will serve as an 
adjunct to normal medical care. 
Patients will have the freedom to use the CGM system and activity tracker at times of their choosing. 
They will be participating at-will, may withdraw from the study any time, and will face no adverse 
consequences from the program or their providers if they withdraw from the study or choose not to 
participate at all. 
We want this study to be minimal risk. As such not all patients with T2D will be eligible. The 
inclusion/exclusion criteria preclude certain patient populations with T2D that would benefit from 
participating in the study. However, resource constraints and the management of risk do not allow for 
all patients with T2D to participate at this time.  
17. Data Handling and Record Keeping 
Data will be collected by these entities: 
• 
Savvysherpa will collect medical record data and claims cost data from from participants’ 
medical records. 
• 
Dexcom will collect interstitial glucose data and data related to device use (such as calibration 
timestamps) from participants in the CGM program.  
• 
Savvysherpa will collect program data from the participants directly and from the program. 
Program data will include survey responses, call recordings, coach-patient secure texts, and/or 
in-person group participation at educational classes.  
• 
Fitbit will collect data from activity trackers. 
Dexcom, Fitbit, and provider data will be shared with Savvysherpa. Savvysherpa will have access to 
versions of the data that include personally identifiable information (PII) and protected health 
information (PHI) from all of these entities. 
PHI will be extracted from the following sources and brought into Savvysherpa’s study infrastructure—a 
HITRUST-certified secure server environment. 
• 
Savvysherpa will work with providers to assure secure data transfer of medical record and 
claims cost data.  
• 
Claim records and medical records stored in a physically secured room will be accessed by an 
authorized party, extracted from the room using documented procedures, and loaded into the 
study infrastructure. 
• 
Dexcom CGM patient readings will be sent from Dexcom secure servers over a secure, 
encrypted connection to the secure, encrypted study cloud infrastructure.  
• 
Data from the activity trackers will be synced via Bluetooth to the client’s application. From the 
application, the data will be sent via https to the client’s secure servers. From the client’s secure 
servers, the data will be sent to Savvysherpa via https. 

26 
 
• 
Authorized program advisors will communicate with patients via phone call, and also by secure 
text messaging to smartphones issued to each patient. Messages will be delivered to an app 
utilizing patient’s credentials over an encrypted connection to the messaging server. Data, 
notes, and recordings related to these transactions will be stored within the study 
infrastructure. 
Within the study infrastructure, communication between servers and data stored on servers will be 
encrypted and accessed via login by authorized personnel for the purpose of assisting and advising 
patients in the program, and for conducting related analysis and program optimization. 
The combined dataset will be de-identified by removing personal identifiers from each system and 
replacing them with a unique study identifier. A list connecting personal identifiers and the unique 
identifier will be maintained and stored by Savvysherpa in a separate password-protected database. Any 
links between personal identifiers from the source systems and study identifier will be deleted 10 years 
after the completion of the study. Recordings of coaching sessions and group participation activity will 
also be deleted 10 years after the completion of the study. 
Over the course of the program Savvysherpa will have the PII necessary to allow for patient contact as 
outlined in the protocol.  This will be described in the informed consent document.   
18. Financing and Insurance 
The Sponsor of the study is Savvysherpa, Inc. Some or all funding for this program will be provided by 
Savvysherpa and/or its affiliates.  
19. Publication Policy 
The investigators intend to publish on the proposed implementation activities or results. 
20. References 
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36 (4): 1033–46. doi:10.2337/dc12-2625. 
Armstrong, Carrie. 2017. “ADA Updates Standards of Medical Care for Patients with Diabetes Mellitus.” 
American Family Physician 95 (1): 40–43.Chacko, Elsamma. 2016. “Exercising Tactically for Taming 
Postmeal Glucose Surges.” Scientifica 2016: 4045717. doi:10.1155/2016/4045717. 
Cox, Daniel J., Ann Gill Taylor, Elizabeth S. Dunning, Mary C. Winston, Ingrid L. Luk Van, Anthony McCall, 
Harsimran Singh, and William S. Yancy. 2013. “Impact of Behavioral Interventions in the Management of 
Adults with Type 2 Diabetes Mellitus.” Current Diabetes Reports 13 (6): 860–68. doi:10.1007/s11892-
013-0423-7. 
Cox, Daniel J., Ann G. Taylor, Matthew Moncrief, Anne Diamond, William S. Yancy, Shefali Hegde, and 
Anthony L. McCall. 2016. “Continuous Glucose Monitoring in the Self-Management of Type 2 Diabetes: A 
Paradigm Shift.” Diabetes Care 39 (5): e71-73. doi:10.2337/dc15-2836. 
LeFevre, Michael L., and U.S. Preventive Services Task Force. 2014. “Behavioral Counseling to Promote a 
Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults with Cardiovascular 

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Risk Factors: U.S. Preventive Services Task Force Recommendation Statement.” Annals of Internal 
Medicine 161 (8): 587–93. doi:10.7326/M14-1796. 
Lind, Marcus, William Polonsky, Irl B. Hirsch, Tim Heise, Jan Bolinder, Sofia Dahlqvist, Erik Schwarz, et al. 
2017. “Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With 
Type 1 Diabetes Treated With Multiple Daily Insulin Injections: The GOLD Randomized Clinical Trial.” 
JAMA 317 (4): 379–87. doi:10.1001/jama.2016.19976. 
Lipska, Kasia J., Xiaoxi Yao, Jeph Herrin, Rozalina G. McCoy, Joseph S. Ross, Michael A. Steinman, Silvio E. 
Inzucchi, Thomas M. Gill, Harlan M. Krumholz, and Nilay D. Shah. 2017. “Trends in Drug Utilization, 
Glycemic Control, and Rates of Severe Hypoglycemia, 2006-2013.” Diabetes Care 40 (4): 468–75. 
doi:10.2337/dc16-0985. 
McMillan, Kathryn Anne, Alison Kirk, Allan Hewitt, and Sandra MacRury. 2017. “A Systematic and 
Integrated Review of Mobile-Based Technology to Promote Active Lifestyles in People With Type 2 
Diabetes.” Journal of Diabetes Science and Technology 11 (2): 299–307. 
doi:10.1177/1932296816656018. 
Philis-Tsimikas, Athena, and Linda C. Gallo. 2014. “Implementing Community-Based Diabetes Programs: 
The Scripps Whittier Diabetes Institute Experience.” Current Diabetes Reports 14 (2): 462. 
doi:10.1007/s11892-013-0462-0. 
Polonsky, William H., and Lawrence Fisher. 2015. “When Does Personalized Feedback Make a 
Difference? A Narrative Review of Recent Findings and Their Implications for Promoting Better Diabetes 
Self-Care.” Current Diabetes Reports 15 (8): 50. doi:10.1007/s11892-015-0620-7. 
Polonsky, William H., Lawrence Fisher, Charles H. Schikman, Deborah A. Hinnen, Christopher G. Parkin, 
Zhihong Jelsovsky, Bettina Petersen, Matthias Schweitzer, and Robin S. Wagner. 2011. “Structured Self-
Monitoring of Blood Glucose Significantly Reduces A1C Levels in Poorly Controlled, Noninsulin-Treated 
Type 2 Diabetes: Results from the Structured Testing Program Study.” Diabetes Care 34 (2): 262–67. 
doi:10.2337/dc10-1732. 
Polonsky, William H., and Robert R. Henry. 2016. “Poor Medication Adherence in Type 2 Diabetes: 
Recognizing the Scope of the Problem and Its Key Contributors.” Patient Preference and Adherence 10: 
1299–1307. doi:10.2147/PPA.S106821. 
Priou, Pascaline, Marc Le Vaillant, Nicole Meslier, Sylvaine Chollet, Thierry Pigeanne, Philippe Masson, 
Acya Bizieux-Thaminy, et al. 2015. “Association between Obstructive Sleep Apnea Severity and Glucose 
Control in Patients with Untreated versus Treated Diabetes.” Journal of Sleep Research 24 (4): 425–31. 
doi:10.1111/jsr.12278. 
Quinn, Charlene C., Michelle D. Shardell, Michael L. Terrin, Erik A. Barr, Shoshana H. Ballew, and Ann L. 
Gruber-Baldini. 2011. “Cluster-Randomized Trial of a Mobile Phone Personalized Behavioral Intervention 
for Blood Glucose Control.” Diabetes Care 34 (9): 1934–42. doi:10.2337/dc11-0366. 
Ralston, James D., Irl B. Hirsch, James Hoath, Mary Mullen, Allen Cheadle, and Harold I. Goldberg. 2009. 
“Web-Based Collaborative Care for Type 2 Diabetes: A Pilot Randomized Trial.” Diabetes Care 32 (2): 
234–39. doi:10.2337/dc08-1220. 

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Ramsey, S. D., K. Newton, D. Blough, D. K. McCulloch, N. Sandhu, and E. H. Wagner. 1999. “Patient-Level 
Estimates of the Cost of Complications in Diabetes in a Managed-Care Population.” PharmacoEconomics 
16 (3): 285–95. 
Ratner, Robert, Ronald Goldberg, Steven Haffner, Santica Marcovina, Trevor Orchard, Sarah Fowler, 
Marinella Temprosa, and Diabetes Prevention Program Research Group. 2005. “Impact of Intensive 
Lifestyle and Metformin Therapy on Cardiovascular Disease Risk Factors in the Diabetes Prevention 
Program.” Diabetes Care 28 (4): 888–94. 
Siminerio, Linda M. 2010. “The Role of Technology and the Chronic Care Model.” Journal of Diabetes 
Science and Technology 4 (2): 470–75. doi:10.1177/193229681000400229. 
Skyler, J. S. 2000. “The Economic Burden of Diabetes and the Benefits of Improved Glycemic Control: 
The Potential Role of a Continuous Glucose Monitoring System.” Diabetes Technology & Therapeutics 2 
Suppl 1: S7-12. 
Stratton, I. M., A. I. Adler, H. A. Neil, D. R. Matthews, S. E. Manley, C. A. Cull, D. Hadden, R. C. Turner, and 
R. R. Holman. 2000. “Association of Glycaemia with Macrovascular and Microvascular Complications of 
Type 2 Diabetes (UKPDS 35): Prospective Observational Study.” BMJ (Clinical Research Ed.) 321 (7258): 
405–12. 
Takao, Toshiko, Takehiko Ide, Hiroyuki Yanagisawa, Masatoshi Kikuchi, Shoji Kawazu, and Yutaka 
Matsuyama. 2011. “The Effects of Fasting Plasma Glucose Variability and Time-Dependent Glycemic 
Control on the Long-Term Risk of Retinopathy in Type 2 Diabetic Patients.” Diabetes Research and 
Clinical Practice 91 (2): e40-42. doi:10.1016/j.diabres.2010.10.009. 
Temelkova-Kurktschiev, T. S., C. Koehler, E. Henkel, W. Leonhardt, K. Fuecker, and M. Hanefeld. 2000. 
“Postchallenge Plasma Glucose and Glycemic Spikes Are More Strongly Associated with Atherosclerosis 
than Fasting Glucose or HbA1c Level.” Diabetes Care 23 (12): 1830–34. 
Vigersky, Robert A., Stephanie J. Fonda, Mary Chellappa, M. Susan Walker, and Nicole M. Ehrhardt. 
2012. “Short- and Long-Term Effects of Real-Time Continuous Glucose Monitoring in Patients with Type 
2 Diabetes.” Diabetes Care 35 (1): 32–38. doi:10.2337/dc11-1438. 
Yoo, H. J., H. G. An, S. Y. Park, O. H. Ryu, H. Y. Kim, J. A. Seo, E. G. Hong, et al. 2008. “Use of a Real Time 
Continuous Glucose Monitoring System as a Motivational Device for Poorly Controlled Type 2 Diabetes.” 
Diabetes Research and Clinical Practice 82 (1): 73–79. doi:10.1016/j.diabres.2008.06.015. 
Zhuo, Xiaohui, Ping Zhang, Lawrence Barker, Ann Albright, Theodore J. Thompson, and Edward Gregg. 
2014. “The Lifetime Cost of Diabetes and Its Implications for Diabetes Prevention.” Diabetes Care 37 (9): 
2557–64. doi:10.2337/dc13-2484. 
 
21. Supplementary Materials (uploaded) 
The  Investigator’s Brochure for Dexcom’s investigational CGM system will be uploaded as part of our 
argument that this is a Non-Significant Risk device.

29 
 
 
22. Appendix A 
 

30 
 
23. Appendix B 
Adverse Events Severity and Relatedness Questions 
May 2017 
 
 
When patients share a complaint, program coaches will identify the complaint in the Anticipated 
Complaints Guidebook. Based on the complaint type, coaches will then ask questions to determine: 
1. Severity of the complaint (e.g., Mild, Moderate, or Severe), and 
2. Relatedness of the complaint to the use of program devices (e.g., Not Related, Probably Not 
Related, Possibly Related, and Probably Related)  
Coaches will document answers in the templates provided, including the Adverse Event document. 
 
If the complaint falls in any of the severity categories highlighted in red, the coach will make a “warm 
transfer” to the study doctor and/or his staff so that the patient can be scheduled for an ancillary 
appointment.  
 
If the complaint is an emergency, patients will be instructed to call 911.  
 
If a patient has a complaint that is not listed in the Anticipated Complaints Guidebook, the coach can 
“warm transfer” the patient to the study clinic for guidance. The coach will document as much as 
possible in Adverse Event document. Follow up with the clinic will determine severity and relatedness.  
 
Coaches will contact the PI when situations arise that are not covered in the Anticipated Complaints 
Guidebook. 
 
 
 
Skin Redness or Rash – Severity Category 
1. On a scale of 1 to 10, where 1 is very little, and 10 is severe, how would you rate the redness of 
your skin or rash?  
o If 1-5, do not record as AE, unless itchiness and/or pain are moderate 
o If 6-7, Mild AE 
o If 8-9, Moderate AE 
o If 10, Severe AE 
2. Are you experiencing pain or itchiness where your skin is red or where you have a rash? 
o If no, stop. 
o If yes, on a scale of 1 to 10 where 1 is very little, and 10 is severe, how would you rate 
the itchiness? 
• If 1-5, do not record as AE 
• If 6-7, Mild AE 
• If 8-9, Moderate AE 
• If 10, Severe AE 

31 
 
o If yes, on a scale of 1 to 10 where 1 is very little, and 10 is severe, how would you rate 
the pain? 
• If 1-2, do not record as AE 
• If 3-5, Mild AE 
• If 6-8, Moderate AE 
• If 9-10, Severe AE 
 
Skin Redness or Rash – Relatedness Category 
1. Where is the location of the redness or rash? 
o If in the same location as the sensor on your skin, then Probably Related 
o If in a location where a sensor was within 2 days, then Possibly Related 
o If in a location where a sensor was 2+ days in the past, then Probably Not Related 
o If in a location where a sensor was never placed, then Not Related 
 
 
Skin Itchiness – Severity Category 
1. On a scale of 1 to 10, where 1 is very little, and 10 is severe, how would you rate your skin 
itchiness? 
o If 1-5, do not record as AE 
o If 6-7, Mild AE 
o If 8-9, Moderate AE 
o If 10, Severe AE 
 
Skin Itchiness – Relatedness Category 
1. Where is the location of the itchiness? 
o If in the same location as the sensor on your skin, then Probably Related 
o If in a location where a sensor was within 2 days, then Possibly Related 
o If in a location where a sensor was 2+ days in the past, then Probably Not Related 
o If in a location where a sensor was never placed, then Not Related 
 
Insertion Site Pain or Discomfort – Severity Category 
1. On a scale of 1 to 10, where 1 is very little, and 10 is severe, how much does your pain or 
discomfort affect your ability to do your daily activities? 
o If 1-2, do not record as AE 
o If 3-5, Mild AE 
o If 6-8, Moderate AE 
o If 9-10, Severe AE 
 
Insertion Site Pain or Discomfort – Relatedness Category 
1. Where is the location of the pain or discomfort? 
o If in the same location as the sensor on your skin, then Probably Related 
o If in a location where a sensor was within 2 days, then Possibly Related 
o If in a location where a sensor was 2+ days in the past, then Probably Not Related 
o If in a location where a sensor was never placed, then Not Related 

32 
 
 
 
Insertion Site Swelling – Severity Category 
1. On a scale of 1 to 10, where 1 is very little, and 10 is severe, how would you rate the amount of 
swelling? 
o If 1-5, do not record as AE 
o If 6-7, Mild AE 
o If 8-9, Moderate AE 
o If 10, Severe AE 
 
Insertion Site Swelling – Relatedness Category 
1. Where is the location of the swelling? 
o If in the same location as the sensor on your skin, then Probably Related 
o If in a location where a sensor was within 2 days, then Possibly Related 
o If in a location where a sensor was 2+ days in the past, then Probably Not Related 
o If in a location where a sensor was never placed, then Not Related 
 
Insertion Site Bruising – Severity Category 
1. On a scale of 1 to 10, where 1 is very little, and 10 is severe, how much bruising do you have? 
o If 1-5, do not record as AE, unless the bruise is getting bigger, see question 2 
o If 6-7, Mild AE 
o If 8-9, Moderate AE 
o If 10, Severe AE 
 
2. Is the bruise or bump getting bigger? 
o If no, stop 
o If yes, Moderate AE 
o If yes and bruise is significantly getting bigger, Severe AE 
 
Insertion Site Bruising – Relatedness Category 
1. Where is the location of the pain or discomfort? 
o If in the same location as the sensor on your skin, then Probably Related 
o If in a location where a sensor was within 2 days, then Possibly Related 
o If in a location where a sensor was 2+ days in the past, then Probably Not Related 
o If in a location where a sensor was never placed, then Not Related 
 
Insertion Site Bleeding – Severity Category 
1. Has the bleeding stopped? 
o If no, then: “Is the spot of blood greater than the size of a nickel?” 
• If no, then stop. 
• If yes, then Severe AE 
o If yes, then: “Is the spot of blood greater than the size of a nickel?” 
• If no, then stop. 
• If yes, then Severe AE 

33 
 
 
Insertion Site Bleeding – Relatedness Category 
1. Where is the location of the bleeding? 
o If in the same location as the sensor, then Probably Related 
o If in a location where a sensor was within 2 days, then Possibly Related 
o If in a location where a sensor was 2+ days in the past, then Probably Not Related 
o If in a location where a sensor was never placed, then Not Related 
 
Insertion Site Infection – Severity Category 
1. Do you notice signs of infection that include inflammation, drainage, pus discharge and pain? 
a. If no, then stop 
b. If yes, on a scale of 1 to 10, where 1 is very little and 10 is severe, how much 
inflammation, drainage, pus discharge and pain do you have? 
• If 1 – 8, Moderate AE 
• If 9 – 10, Severe AE 
 
Insertion Site Infection– Relatedness Category 
1. Where is the location of the infection? 
o If in the same location as the sensor on your skin, then Probably Related 
o If in a location where a sensor was within 2 days, then Possibly Related 
o If in a location where a sensor was 2+ days in the past, then Probably Not Related 
o If in a location where a sensor was never placed, then Not Related 
 
Detached/Broken Sensor Wire – Severity Category 
1. Do you see the sensor wire sticking out of your skin? 
o If no, then stop 
o If yes, then ask: On a scale of 1 to 10,  where 1 is very little, and 10 is severe, how would 
you rate your pain or discomfort 
• If 1 – 7, then Mild AE 
• If 8 – 9, then Moderate AE 
• If 10, then Severe AE 
 
Detached/Broken Sensor Wire – Relatedness Category 
1. Where is the location of the broken sensor wire? 
o If in the same location as the sensor, then Probably Related (no other logical choice) 
 
 
 

34 
 
24. Appendix C