US ONYX 2.0 Study: A Clinical Study of the Onyx 2.0 System for Blood Glucose Monitoring in Patients With Diabetes
Phase: NA
Conditions: Diabetes Mellitus
Sponsor: Ascensia Diabetes Care

Protocol GCA-PRO-2016-001-01 ver Aug 25, 2016                                 
    Ascensia Diabetes Care  
 
                                                                                       CONFIDENTIAL 
 
 
 
US ONYX 2.0 Study: A Clinical Study of the Onyx 2.0 System for 
Blood Glucose Monitoring in Patients with Diabetes 
 
I have read this protocol and agree to conduct the study as outlined.  I also agree that prior to 
seeking approval from an Institutional Review Board (IRB), the Ascensia Diabetes Care study 
manager must approve any changes to the protocol 
 
Study Site 06 
Principal Investigator: 
Dr. Timothy Bailey   
 
 
 
 
Phone: 760 466-1520 
625 West Citracado Parkway Suite 112  
Escondido, CA   92025 
e-mail address: tbailey@amcrinstitute.com  
 
Signature:_____________________________ 
 
 
 
 
 
Printed Name:    ______________________________ 
 
Date:      ______________________________ 
 
 
This protocol and the evaluation data obtained from the study are confidential and may not be disclosed without 
prior written consent of Ascensia Diabetes Care.  
 
 

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Table of Contents 
1.0 BACKGROUND/INTRODUCTION ............................................................................ 4 
2.0 OBJECTIVES ........................................................................................................... 5 
3.0 STUDY DESIGN ....................................................................................................... 6 
4.0 SUBJECT INCLUSION AND EXCLUSION .............................................................. 8 
5.0 MATERIALS AND METHODS .................................................................................. 9 
6.0 RISK/ BENEFIT ASSESSMENT ............................................................................. 13 
7.0 REPORTING OF ADVERSE EVENTS ................................................................... 15 
8.0  STUDY TERMINATION CRITERIA ....................................................................... 17 
9.0  REGULATORY ...................................................................................................... 18 
10.0  DATA COLLECTION AND MANAGEMENT ....................................................... 19 
11.0    STATISTICAL METHODS AND ANALYSIS ..................................................... 20 
12.0   ADMINISTRATION ............................................................................................. 21 
APPENDIX A – CONTOUR DIABETES APP 2.0 QUESTIONNAIRE .......................... 23 
APPENDIX B - INSTRUCTIONS FOR CLEANING AND DISINFECTING METERS ... 33 
APPENDIX C – SCHEDULE OF EVENTS ................................................................... 34 
 
 

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Abbreviations 
AE  
 
Adverse Event   
App 
A downloadable application for use on a “smart device”.  In this study – 
Contour® Diabetes App 2.0 
BG 
 
Blood Glucose 
BGMS  
Blood Glucose Monitoring System 
BLE 
 
Bluetooth Low Energy 
CRF   
Case Report Form 
CV 
 
Curriculum Vitae 
DC  
 
Diabetes Care 
DMS  
Diabetes Management Software 
EC  
 
Ethics Committee 
EDC  
Electronic Data Collection 
HCP 
 
Health Care Provider  (also called clinician) 
IC 
 
Informed Consent 
IDE  
 
Investigational Device Exemption 
IRB 
  
Institutional Review Board 
MDI 
 
Multiple Daily Injections 
PI 
 
Principal Investigator 
QRG   
Quick Reference Guide  
RF 
 
Radiofrequency 
SAE 
 
Serious Adverse Event 
SMBG  
Self-Monitoring of Blood Glucose 
SSD 
 
Structured Source Documents 
UG 
 
User Guide 
USB 
 
Universal Serial Bus 

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1.0 BACKGROUND/INTRODUCTION 
Self-monitoring of blood glucose (SMBG) is an important technique for assessing glycemic control 
in people with diabetes and can be useful for guiding therapy as it allows people with diabetes to 
evaluate their individual response to treatment. Emerging technologies, such as mobile apps, are 
helping people to manage their diabetes by providing personalized, real-time, data-driven support. 
Currently, there are many apps available to directly assist with diabetes management, plus others 
that help track additional relevant information such as exercise, stress, diet, and medications. Many 
available diabetes apps involve manual logging of blood glucose and insulin data, which may be 
inconvenient for users and prone to errors.  It is important that results obtained from SMBG are 
accurate because they are used to make critical decisions about diabetes management, and 
inaccurate results could lead to nutritional and drug dosing errors. 
Until recently, automatic wireless transmission of blood glucose data using smartphone technology 
was not available to people with diabetes.  A new blood glucose monitoring system (BGMS), the 
Contour® Next ONE has been developed (development name ONYX) for use with currently 
available Contour® Next test strips.  The new BGMS features a wireless-enabled, blood glucose 
meter that links to a smart mobile device via Bluetooth® connectivity.  The system is designed to 
sync with the Contour Diabetes App that was developed for Android or iOS operating systems and 
can be used on a smartphone or tablet.  The app provides multiple functions intended for a simple-
yet-comprehensive user experience. 
Contour Diabetes App 1.0  
The initial release of the App provides users with features that allow them and their health care 
provider (HCP) to assess their diabetes control with features such as sequential day views, modal 
day views, glucose pattern detection with notifications, and smart test plans. The Contour Diabetes 
App retrieves BG readings from the meter, and allows users to view the readings and edit their 
attributes (meal marking, notes, etc.) as well as edit their meter settings. It combines readings with 
contextual data like food and medication to educate and motivate people with diabetes to take action 
to improve the state of their disease.   
Contour Diabetes App 1.0 includes notifications of “Critical High” and “Critical Low” blood 
glucose patterns if recognized in the patient data. Smart test plans (also called Smart Reminders) 
can help the user manage personal diabetes care regimens by providing pre-set test and appointment 
reminders. Basic testing plans are included in App 1.0.  The App includes a Cloud Services 
Platform which offers online remote storage of user data and account information.  User data is 
synchronized with the Cloud and with other customer owned devices. 
Contour Diabetes App 1.0 was tested in the hands of people with diabetes in a study conducted at 
one clinical site in the US1.  This study enrolled 45 persons with diabetes (type 1 or type 2 diabetes 
on insulin therapy) who used the Contour Next One meter and Contour Diabetes App as part of 
their routine diabetes management at home for 3 weeks.   At the end of the study, subjects 
completed a questionnaire about their experiences using the system.  In summary 95% of subjects 
reported they were able to successfully sync their blood results on the meter with the App, as well 
as access and interpret the blood glucose displays in the App. 
 
                                                          
1 Bailey T, Davis T, Wallace J, Pardo S, Morin R, Usability of a New Blood Glucose Monitoring System (BGMS) With A 
Mobile App, poster presented at the 76th Annual American Association of Diabetes Meeting, June 12, 2016, New 
Orleans, LA 

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In addition, the accuracy of the Contour Next One system was demonstrated in laboratory and 
clinical settings.  In a clinical user evaluation study, with 329 patients with diabetes, 99.4% of the 
Contour Next One results were within ±15mg/dL/15% of the laboratory reference results.2 These 
results met the International Standard ISO 15197:2013(E).  
The Contour Next One BGMS with Contour Diabetes App 1.0 has received CE mark and has been 
commercially launched in Europe.  Note that this study will test the next release version of the 
Contour Diabetes App 2.0. 
Contour Diabetes App 2.0 
The Contour Diabetes App 2.0 is an updated version of the CE marked Contour Diabetes App 1.0.   
This feature set includes sequential day views (My Readings view), modal day view (Expanded 
Graph view), glucose pattern detection with notifications, and smart test plans. The glucose pattern 
notifications provide messages to the user that are informational, not prescriptive, using the 
paradigm “Information, Motivation, and Behavior (IMB)”.  These messages are based on 
algorithmic recognition of patterns in the users’ glucose results and are intended to help guide the 
user through a series of educational screens to identify the data which triggered the pattern and 
explore options for addressing the situation. Smart test plans (also called Smart Reminders) can help 
remind the user to perform certain tasks to improve the quality of information gathered in 
relationship to a specific event or circumstance (i.e. preparing for a visit with a healthcare 
professional or if an individual does not like to test).  
In summary, Contour Diabetes App 2.0 which is the investigational mobile application under test in 
this study contains the following updates to App 1.0: 
 Detects an additional 19 patterns to the original two (Critical High and Critical Low) 
 Expanded smart testing reminder plans  
To optimize the functionality of the system, it is imperative that persons with diabetes provide 
feedback regarding the effectiveness of the Contour Next One system in routine diabetes 
management, with a focus on the new features in Contour Diabetes App 2.0.  This protocol 
describes a clinical study where people with diabetes will evaluate the Contour Next One blood 
glucose monitoring system in conjunction with an investigational Contour Diabetes App 2.0.   
 
2.0 OBJECTIVES  
Primary Objective: 
The purpose of this study is to assess the utility of the Contour Diabetes App 2.0 when used with 
the Contour Next One meter (the Onyx system) in the hands of subjects with type 1 diabetes or 
insulin-using subjects with type 2 diabetes.  It is designed to determine the subjects’ self-reported 
success in utilizing the features of the system. Each feature will be evaluated independently, by 
including a series of statements about each feature set for which a numerical score or rating will be 
provided by subjects. The evaluation includes:   
 
Obtain a synced blood glucose reading 
                                                          
2 Christiansen M, Greene C, Pardo S, Warchal-Windham ME, Harrison B, Morin R, Bailey T, Accuracy and User 
Performance Evaluation of a New Blood Glucose Monitoring System in Development For Use With CONTOUR Next 
Test Strips, Poster presented at the 15th Annual Diabetes Technology Meeting (DTS), Oct 22, 2015, Bethesda, MD  
 

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 
Recognize  and use  “Smart Reminders”  
 
Access and interpret glucose displays such as Expanded Graph and My Readings views 
 
Recognize glucose pattern notifications (as applicable since all subjects may not receive 
pattern messages) 
Goal: For the following features, at least eighty five percent (85%) of potential users should be able 
to report that they were able to successfully utilize the feature.    A rating of 1, 2, or 3 for each 
feature (1=strongly agree, 2=agree, 3=neither agree nor disagree, 4=disagree, 5=strongly disagree) 
indicates that the subject was able to successfully utilize the feature.  These include: 
 
Obtain a synced blood glucose reading 
 
Recognize  and use  “Smart Reminders” 
 
Access and interpret glucose displays such as Expanded Graph and My Readings views. 
Other Objectives: 
1. Ease of Use: Determine ease of use of the Contour Diabetes App 2.0 when used with the 
Contour Next One meter via subjects’ self-assessment. 
2. Hypoglycemia Frequency: Report severe hypoglycemia events 
3. Glycemic Control:  Measure changes in hemoglobin A1C and fructosamine levels  
4. Total daily insulin dose: Evaluate changes in self-reported insulin doses throughout the 
study. Both bolus and basal insulin doses are reported and, if insulin varies from day to day, 
average units will be reported.  
5. Clarity of User Instructions: Obtain the subjects’ ratings on the clarity and utility of the 
instructions.  
6. Subject Feedback: Obtain the subjects’ opinions about their experiences using the Contour 
Diabetes App 2.0 in conjunction with the Contour Next One meter system. 
7. Overall experience with the system Hardware/Software: Obtain data on hardware/software 
failures and unexpected events using the App.   
8. Weight/BMI:  Measure changes in weight and BMI 
9. Feature Utilization rates (from cloud data) 
 
3.0 STUDY DESIGN  
This study will test the investigational Contour Diabetes App 2.0 with the investigational Contour 
Next One system in the hands of users managing their diabetes at home. The study conducted under 
this protocol will be conducted at one site in the US.  The study will follow federal regulations (US) 
for conducting a study using investigational devices in routine diabetes management.  
Approximately 48 subjects with diabetes will come to the study sites  and receive the investigational 
Contour Next One meter, the Contour Diabetes App 2.0 and the following commercially available 
products:   Contour Next test strips, Contour Next control solution, lancing devices and lancets.  
Subjects will be assisted in loading the Contour Diabetes App 2.0 onto their personal mobile device 
after enrollment.  They will then use the BGMS system in conjunction with the downloaded App to 
manage their diabetes at home for six weeks – two weeks run-in to initiate the pattern manager, and 
four weeks in-life.  They will be notified that certain aspects of the app will not take effect until a 
full two weeks of glucose data has been entered.  They will return to the clinic after approximately 
six weeks and complete a questionnaire regarding the usability of the devices and their experience 
with the devices in their daily diabetes management routine.  (See Appendix C Schedule of Events 
for details).  Forty (40) subjects must complete the study.  

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Office Visit 1 – Study enrollment, including demographics and diabetes history information.  
Receive meter, strips, and instructions, and download the App:  Approximately one hour. Blood 
drawn for HbA1c and fructosamine, weight and height measured, total (may be an average if insulin 
varies) daily insulin dose recorded.    
Follow-up phone calls to subjects:  At least 2 scheduled phone calls to each subject during the study 
– the first at approximately week two, the second at approximately week four.  Subjects will be 
reminded to NOT update their mobile devices to Android 7 versions. 
Office Visit 2 – approximately six weeks later:  1 hour to complete questionnaires and be 
interviewed by staff.  Blood to be drawn for HbA1c and fructosamine, weight measured, total (may 
be an average if insulin varies) daily insulin dose reported. 
Safety and Efficacy Endpoints: 
Primary Endpoints 
Questionnaire outcome – Subjects will complete a questionnaire at the end of the study at Visit 2 
that will assess the usability of the App 2.0 with the meter and their experience using the Contour 
Diabetes App 2.0 system in their daily diabetes management routine.  The App features will be 
evaluated independently by asking a series of questions about each. The features evaluated may 
include:   
 
Obtain a synced blood glucose reading 
 
Recognize  and use  “Smart Reminders” 
 
Access and interpret glucose displays such as Expanded Graph and My Readings views. 
 
Recognize glucose pattern notifications (as applicable since all subjects may not receive 
pattern messages) 
Goal: For the following features, at least eighty five percent (85%) of potential users should be able 
to report that they were able to successfully utilize the feature.    A rating of 1, 2, or 3 for each 
feature (1=strongly agree, 2=agree, 3=neither agree nor disagree, 4=disagree, 5=strongly disagree) 
indicates that the subject was able to successfully utilize the feature.  These include: 
 
Obtain a synced blood glucose reading 
 
Recognize  and use  “Smart Reminders” 
 
Access and interpret glucose displays such as Expanded Graph and My Readings views. 
Statements such as 1, 8, 9, and 42 in Appendix A correspond to statements subject to the 85% 
criterion. These statements are shaded. 
Secondary Endpoints 
 A change from baseline to completion of: 
o HbA1c 
o Fructosamine  
o Weight 
o BMI 
o Total Daily Insulin  (self-reported bolus and basal doses) 
 Feature Utilization rates 
Safety 
The following are to be captured: 

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 Adverse events 
 Severe Hypoglycemic episodes 
 Hospitalizations 
4.0 SUBJECT INCLUSION AND EXCLUSION   
Approximately forty eight (48) subjects with diabetes will be enrolled. 
Inclusion Criteria 
The subject must:  
 Be aged 18-75 years, male or female 
 Read and understand English  
 Have diagnosis of type 1 (goal is 40%  to 70%) or insulin-using type 2 diabetes for at least 6 
months  
 Be taking multiple daily insulin injections (MDI) of at least two pre-meal bolus insulin 
injections daily or using an insulin pump (Goal is not more than 30% of subjects using 
insulin pump therapy) 
 Performing self-monitoring of blood glucose at home at least twice daily 
 Have an iOS mobile device or Android mobile device with Bluetooth capability  
o iOS device: iPod, iPad, or iPhone 5 or later version with iOS 9.x or 10.x software  
o Android: smart phone, software version 5.x or 6.x.  
o Bluetooth: software version 4.0 or higher 
 Agree NOT to update the software on their mobile device until after the study is concluded, 
as follows: 
o No updates of Android device to upcoming Android version 7 (Nougat) 
 Be willing to utilize the Contour Next One meter and the Contour Diabetes App 2.0 on 
personal mobile device which communicates to meter to manage diabetes and be willing to 
keep a study diary 
Exclusion Criteria  
 Known Hemophilia or any other bleeding disorder 
 Pregnancy (reported by subject; no pregnancy test required) 
 Current user of Contour Next One BGMS including Contour Diabetes App.  
 Physical, visual or neurological impairments that would make the person unable to 
perform testing with the Contour Next One BGMS or to use the Contour Diabetes 
App  
 Working for a competitive medical device company, or having an immediate family 
member or someone who is not a family member but is living within the household of 
someone who works for such a company.   
o Immediate family members are the subject’s parents, spouse, children, and siblings, 
including the parent’s spouse; step children and adopted children and their spouses.   

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o A competitive medical device company is a company that provides a medical device 
or components of a device that is related to diabetes.  For example, people who are 
not eligible are those who work for companies that create or manufacture the 
following (or a company that is in a partnership with a company that provides such 
devices): lancing devices, blood glucose monitoring systems, continuous glucose 
monitoring systems, insulin pens, or systems related to the measurement of HbA1c.  
People who are eligible are those who work for companies associated with products 
such as wound dressings, medications or dietary products. 
 A condition, which in the opinion of the investigator or designee, would put the person or 
study conduct at risk (reason for exclusion will be clearly documented by investigator or 
designee on the subject disposition form). 
 
5.0 MATERIALS AND METHODS 
5.1 Study Details 
5.1.1 General 
a) This study will evaluate the Contour Diabetes App 2.0 system at one site where study staff  
have been trained on the Contour Diabetes App and Contour Next One system. 
b) At least forty (40) subjects must complete the study 
c) All subjects will complete the informed consent (IC) process.  
d) Inclusion/exclusion information will be collected. Subjects must meet these criteria to be 
enrolled in the study. 
e) A unique study number will be assigned to each subject. 
f) The study staff will document subject demographics (including both screen failed and 
enrolled subjects), diabetes history and management. Subject’s responses to demographic 
and medical history questions will be self-reported. Medical record verification is not 
required.  
g) Original study data reported at the clinic will be collected on paper structured source 
documents (SSDs).  Study staff will complete all SSDs.  Laboratory reports for A1C and 
fructosamine will serve as their own source docs. Electronic data collection (EDC) will be 
used for permanent data storage and will be entered by site staff.   
h) The subject will be informed that, if during the course of participating in this trial, he/she 
would need to perform a personal diabetes management procedure, verification of blood 
glucose measurements should be performed with the user’s typical pre-study procedures.  
5.1.2 Visit 1: BGM Training and Testing  
a) The subject will be provided with a Contour Next ONE meter, Contour Next test strips, 
Contour Next control solution, Contour Next ONE User Guide (UG) and Quick Reference 
Guide (QRG) and Study Diary. In addition, each subject will be provided a lancing device 
system and lancets.  
b) The lancing system, any remaining Contour Next strips and control solution may be kept by 
the subject after the study.  The meter, QRG and UG must be returned after the study is 
completed. 

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c) For orientation/instruction, the subject will be directed to read specific sections of the 
instructional materials.  The study staff will then review these materials with the subject and 
provide an overview of the system.   
d) The subject will perform a control test with their study meter to assure the meter is working 
properly.  
e) The subject will perform a fingertip blood test with the Contour Next One system and 
following the App download, verify in the presence of the study staff that the reading is 
syncing with the App.  
5.1.3 Visit 1: Contour Diabetes App 2.0 Setup  
a) In the presence of the subject, a de-identified email account will be created by the study staff 
for each subject. Ascensia Diabetes Care will provide the format of these email account 
names and the study staff will direct this setup.  An example of the email address format is:  
ADC6001@xxxxx.com where 6001 is the subject ID.   
b) The App will be downloaded onto the subjects’ personal phone with the assistance of the 
study staff, and Ascensia Diabetes Care technical support staff, as needed.   
c) The initial setup of the App will be overseen with the assistance of the study staff. All steps 
in the Profile setup must be entered. Personal identifiable information will not be entered 
into the App. 
d) The subject will be trained on the use of the App using the instructional materials provided. 
The study staff will answer questions to ensure they know how to perform a blood glucose 
test, review results, enter attributes such as meal marking, notes, medications, exercise, etc.  
e) The staff will verify along with the subject that the App is properly loaded onto the personal 
mobile device, the meter is successfully paired to the App and the meter reading is properly 
synched to the App. 
f) The users will be informed that some pattern notifications will be enabled only after two 
weeks of glucose data have been entered.  
g) After initial setup the study staff will inform Ascensia Diabetes Care of the subject’s 
enrollment, the subject’s de-identified email address and user ID.  The Ascensia Diabetes 
Care administrator will verify that the profile was correctly set up via the Cloud.  
5.1.4  Home study  
a) Subjects will be expected to use the App at home for six weeks for their routine diabetes 
management.  They will be expected to:  
 Synch the meter readings with the App 
 Recognize glucose pattern notifications (as applicable since all subjects may not receive 
pattern messages) 
 Recognize and use “Smart Reminders” 
 Access and interpret glucose displays such as expanded graph (modal day) and My 
Readings (sequential logbook). 
b) Throughout the study at home, subjects can use the Study Diary to record 

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 Any notations about the use of the system 
 Confusing features or problems they encountered 
 Other feedback they would like to recall for the final visit questionnaire and comments.   
The diary should be brought to the final study visit and will be reviewed by the study staff.  
It can be used by the subjects to refresh their memories during the questionnaire phase.   
This diary will be a source document, to be placed in the study file but not entered into the 
Electronic Data Capture system (EDC). 
c) Ascensia Diabetes Care technical support staff will be available for providing technical 
support as needed throughout the study via telephone.   
 
5.1.5  Scheduled Telephone Contacts 
a) At approximately 2 and 4 weeks after each subject’s Visit 1, the site staff will contact the 
subject (e.g., via telephone) for an update on their experience with the Contour Next One  
system including the following: 
 Safety update including any severe hypoglycemic events or hospitalizations which 
are both considered Adverse events 
 Total Daily Insulin (basal and bolus insulin) 
 User feedback about the usability of the system including unexpected, confusing 
events or problems with the system    
 Friendly reminder not to upgrade the software on their mobile device (to Android 7 
versions) until after the study is concluded.  
5.1.6  Site Visit 2 
a) Each subject will return to the clinic after approximately six weeks, bringing with them the 
meter, UG, QRG, mobile device and study diary. 
b) Subjects will complete a questionnaire regarding the utility of the device and their 
experience with the device in their daily diabetes management routine, and get a blood draw 
for the final A1C and fructosamine test.  See Appendix C for schedule of procedures. 
c) During the questionnaire phase, subjects will be provided with printed screen shots of the 
App which identify App features mentioned in the questionnaire. 
d) Staff will interview the subject for an update on their experience with the Contour Diabetes 
App 2.0 when used with the Contour Next One meter including the following: 
 Safety update including any severe hypoglycemic events or hospitalizations which 
are both considered Adverse events 
 Total Daily Insulin (bolus and basal) 
 User feedback about their experience using the system including unexpected, 
confusing events or any problems they encountered. 
5.1.7  Post Study 
a) After the subject has completed the study, the de-identified App data which has been sent to 
the cloud will be retrieved by the Ascensia Diabetes Care system administrator.   
b) After all data is successfully retrieved from the cloud, the subject’s App will be de-activated 
and the subjects’ study email accounts will be deleted.   

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c) All used study meters will be cleaned and disinfected following the instructions in the User 
Guide.  All study meters will be returned to Ascensia Diabetes Care. 
 
5.2 
Staff Training for Subject Visits 
The site study staff will participate in a training session conducted by the Ascensia Diabetes 
Care Study Manager or designee.   A Smart device (both Android and iOS) will be provided by 
Ascensia Diabetes Care to demonstrate the App to the study staff. Ascensia Diabetes Care study 
manager (or designee), study monitor, and Ascensia Diabetes Care technical support staff may 
all be present for the training.    
 
5.3 
Resources Supplied by Ascensia Diabetes Care 
Staffing 
 Ascensia Diabetes Care Study Manager 
 Study Monitor 
 Ascensia Diabetes Care technical support personnel as needed 
 
Materials 
 Protocol  
 Structured source documents, worksheets and study diary 
 Electronic data capture system  
 Draft of Informed Consent document 
 Contour Next One meters 
 Contour Next test strips (300 strips for each subject) 
 Contour Next control solution 
 Lancing device system and lancets (300 lancets for each subject) 
 Access to Contour Diabetes App 2.0 for download 
 App instructional materials 
 Contour Next One UGs and QRGs 
 Subject Study Diary 
 Android smart device for training purposes 
 iOS smart device for training purposes 
 
5.4 
Resources Supplied by the Clinical Site 
Staffing 
 Principal Investigator and Sub-Investigators, as needed 

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 Study Coordinator 
 Study staff members as needed including phlebotomist  
 A data entry person for EDC data entry (Requires Medidata RAVE training) 
 
Other 
 Final informed consent documents, and other necessary supporting documents, as appropriate 
 IRB submission of protocol and informed consent documents, and other necessary supporting 
documents, as appropriate 
 Computer with internet connection for site access to EDC system 
 Wireless internet access 
 Facility with adequate space for conducting all testing.   
 Approximately 48 subjects who meet enrollment criteria  
 Appropriate care/supplies for treating  hypoglycemic events if necessary (e.g. nutritional 
supplements or fast acting glucose tablets/gel) 
 Venipuncture supplies 
 Measurement of  hemoglobin A1c and fructosamine  (or send the blood to Central laboratory 
for these tests) 
 
5.5 
Subject Compensation 
Subjects will receive nominal compensation for their time and inconvenience as specified in the 
informed consent form. 
 
6.0 RISK/ BENEFIT ASSESSMENT 
Risks Associated with the App 
Risks associated with the use of diabetes Apps, which may include some confusion with 
interpreting the messages shown on the App and inappropriate use of information, could lead to 
improper management of diabetes. 
The App used in this clinical study will not provide any prescriptive advice for diabetes therapy 
which could be a cause for error in diabetes management. Patients are instructed how to use the 
information provided by the App appropriate for their diabetes management.  
The Contour Diabetes App 2.0 used in this study is an investigational device. But the forerunning 
Contour Diabetes App 1.0 is CE-marked and has been launched commercially outside the US. The 
risk management analysis of the Contour Diabetes App 2.0 focuses on any risks related to the 
additional recognized glucose patterns and smart testing plans implemented in the updated version.    
While conflicting patterns may be displayed to the user possibly causing confusion in interpretation 
of the messages, an extensive pattern management algorithm has been incorporated in the system to 
mitigate this risk and decrease any confusion.  Furthermore, the additional smart testing plans 
included in this update do not add any risks to the device.  
 

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Other Known Risks with BGM Use 
Risks associated with this study include those associated with obtaining blood from finger and 
venipuncture.   
The following risks are anticipated and will not be reported as Adverse Events (see section 7.0 for 
further details): 
1) Bleeding: Mild bleeding similar to being stuck with a pin 
2) Swelling (Edema): A mild swelling similar to a mosquito bite 
3) Bruising: Less than one inch across (fingerstick) or 2 inches across (venipuncture) 
4) Redness (Erythema): Mild reddening or darkening of the skin in the immediate area 
around the puncture site 
5) Soreness: Mild discomfort at the puncture site resolving (going away) within one to two 
days (fingerstick) or within hours (venipuncture) 
The following risks are unlikely but possible and will be reported as anticipated Adverse Events: 
1) Bleeding: Continued bleeding requiring changing a bandage 
2) Bruising: A worsening bruise that is firm to the touch 
3) Redness (Erythema): Bright redness or skin darkening spreading across the area 
(fingerstick) or across the arm (venipuncture) 
4) Soreness: Worsening pain and/or pain that interferes with activity 
5) Infection: Bright redness or skin darkening spreading across the area with warmness 
and/or swelling, and/or red streaking 
6) Nerve injury: Numbness or shooting pain in the forearm 
7) Fainting: Dizziness including in extreme cases fainting  
8) Numbness in the area of the puncture wound  
9) Subjects should be instructed to report such events to the investigator or designee.  
Expected Benefits 
This study allows persons with diabetes the opportunity to participate in a study designed to 
evaluate a new product for use in their home diabetes management. But subjects have no further 
personal individual benefit from study participation regarding their diabetes therapy. Subjects have 
the opportunity to gain experience with an app-based diabetes data management under the 
supervision of an investigator.  
Risk-Benefit Evaluation 
In this clinical study, subjects will not be administered additional drugs and individual diabetes 
treatment will not be changed due to the study procedures. 
Potential risks for the subjects caused by the use of the investigational Contour Diabetes App 2.0 
have been evaluated in a systematic risk assessment procedure. The identified risks (“anticipated 
adverse events”) were classified to be in the non-critical range and do not exceed the risks described 
in this chapter. 
The risks and burden associated with the participation in this clinical study do not exceed the risk 
and burden associated with the subjects’ regular diabetes treatment. The subjects have no personal 
benefit from participating in the study, but will be paid compensation. 

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The insights obtained in this study will help to understand patients’ experiences and needs using 
app-based diabetes management systems which might eventually help patients with diabetes 
mellitus to better accomplish their treatment goals. 
This study allows persons with diabetes the opportunity to participate in a study designed to 
evaluate a new product for use in his/her home diabetes management program.    
 
7.0 REPORTING OF ADVERSE EVENTS  
The procedures to be conducted under this protocol are considered low risk. 
7.1 
Description and Classification 
7.1.1. An adverse event (AE) during a clinical evaluation is “any untoward medical occurrence, 
unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in 
subjects, users or other persons, whether or not related to the investigational medical device.”  It is 
not dependent on whether the event is considered to be related to the investigational product or the 
study.  An adverse event includes events not seen at the beginning of the study, or worsened if 
present at the beginning. Adverse events can be classified as presented in Table 1. 
7.1.2. The next classification to consider is whether or not the AE is Anticipated or Unanticipated.  
In order for an AE to be considered ‘anticipated’ it must be listed in the protocol and ICF prior to 
any occurrence. 
7.1.3. For studies on products that have not yet been cleared for market, it is important that all 
AE’s be documented and included in the study file. 
7.1.4. An unanticipated serious adverse device effect (USADE) is:   Any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with a device, if 
that effect, problem or death was not previously identified in nature, severity or degree of incidence 
in the investigational plan or application (including a supplementary plan or application), or any 
other unanticipated serious problem associated with a device that relates to the rights, safety or 
welfare of subjects [MEDDEV 2.7.3 ].  
7.2 
Hypoglycemia is defined as having a measured fingerstick (SMBG) or venous glucose result 
of ≤ 80 mg/dL [3.9 mmol/L] and can be a common occurrence with persons who have diabetes. 
Hypoglycemic events categorized as severe hypoglycemia will be reported in this trial and will be 
considered adverse events.  Severe hypoglycemia has occurred if the answer is yes to any of the 
following 3 questions: 
1. Did the patient have an episode of suspected hypoglycemia treated with any form of carbohydrate 
or with glucagon that required the assistance of others to treat?  
Note “patient requires the assistance of others to treat” means that neurologic impairment was 
severe enough to prevent self-treatment in the opinion of those providing assistance to treat.  
 Assisting a patient out of kindness, when assistance is not required should not be considered as 
“requiring the assistance of other to treat.” 
OR 
2. Did the patient lose consciousness during the episode? 
OR 
3. Did the patient have a seizure during the episode?   

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 If the subject experiences a severe hypoglycemic event it will be considered to be an anticipated 
AE and will be recorded on the Adverse Event Form by the study staff.   
 
7.3 
Procedure for Reporting an Adverse Event  
7.3.1 All adverse events will be documented during this study by completing the Adverse Event 
Form.  The nature of each event and date of onset, outcome, course, maximum intensity and action 
taken with respect to treatment should be established.  Details of any corrective treatment should be 
recorded on the AE Form.  Investigators should follow-up on the status of subjects experiencing an 
ongoing adverse event until the event has been resolved, or until the condition has stabilized.   
 
 
Table 1: Classification of Adverse Event 
Serious* 
Non-Serious 
An adverse event that leads to:  
a) death;  
b)  a serious deterioration in health of the subject that,  
1) 
resulted in a life-threatening illness or injury,  
2) 
 resulted in a permanent impairment of a body 
structure or a body function,  
3) 
required 
in-patient 
hospitalization 
or 
prolongation of existing hospitalization,  
4) 
resulted in medical or surgical intervention to 
prevent permanent impairment to body structure 
or a body function;  
c) To fetal distress or a congenital abnormality or birth 
defect.  
May be anticipated or unanticipated. 
*EN ISO 14155.  Clinical investigation of medical devices 
for human subjects – Good Clinical Practice 
All adverse events not reported as serious.  At each visit, all adverse events 
observed by the investigator/designate or reported by subject must be 
evaluated and recorded on an adverse event form.   
A non-serious adverse event is further classified with respect to severity and 
relationship to the trial product.  A non-serious adverse event may be 
anticipated or unanticipated. 
Further classification with regard to severity 
 
Mild: Transient symptoms, easily tolerated, no interference with subjects 
daily activities. 
 
Moderate: 
Marked symptoms, moderate interference with subjects 
daily activities, and tolerable. 
 
Severe:  Considerable interference with subject’s daily activities, not 
tolerable. 
Relationship to trial product: 
• 
Definitely Related: Causal relationship has been established and documented 
• 
Probably Related: Good reasons and sufficient documentation to assume causal relationship have been established 
• 
Possibly Related: Causal relationship is likely and cannot be excluded  
• 
Probably Not Related: Good reasons and sufficient documentation not established to assume causal relationship  
• 
Not Related: The event is most likely related to an etiology other than the trial treatment 
 
7.3.2 Reporting of Adverse Events in the US: 
1. The Investigator or designee will notify the Study Manager or Monitor within 24 hours of any 
Serious Adverse Event that occurred during the study.  The sponsor will promptly review all 
information relevant to the safety of the investigational device.  The information must be 
provided by phone or fax to: 

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Jane F. Wallace 
Ascensia Diabetes Care  
Global Clinical Affairs 
Mishawaka, IN    USA 
Phone: 574-257-3063  
Cell: 574-850-1467 
Fax: 574-257-3029 
Email:  jane.wallace@ascensia.com 
 
2. The investigator or designee must notify the sponsor and reviewing IRB by phone or fax of 
Unanticipated Serious Device-Related Adverse Events within 24 hours of learning of the event, 
followed by a written a report within 10 working days after learning of the event.  
3. Upon receipt of a report of an UADE by the Ascensia Diabetes Care Study Manager or Monitor, 
the report will be immediately forwarded to the Ascensia Diabetes Care Medical Director, 
Robert Morin, MD (phone 914 325 8109; email address: robert.morin@ascensia.com). 
4. The sponsor (Ascensia Diabetes Care) must report Unanticipated Adverse Device Effects 
(UADE) to the FDA, all participating investigators, and reviewing IRBs within 10 working days 
after the sponsor first receives notice of the event. 
5. Regardless of the above definitions, any additional adverse experience that the investigator 
considers serious, and/or of concern in relationship to the study must be documented and 
reported to the Study Manager or Monitor within 24 hours.  
6. All non-serious adverse events will be reported to the IRB in the study closeout correspondence 
to the IRB. 
7.4 
Medical Device Reporting (MDR) 
If an adverse event occurs that is directly caused by a marketed product used in the study, the 
adverse event should be reported immediately, but in any case within 24 hours, to the Customer 
Service Department at 1-800-348-8100. Also contact the Ascensia Diabetes Care representative 
listed in Section 12.0.   
 
8.0  STUDY TERMINATION CRITERIA 
Criteria to Withdraw Subject from Study  
Subjects may be withdrawn from the study at their own request for any reason at any time. 
Subjects may be withdrawn at the discretion of the Investigator for one of the following reasons: 
 Adverse Event  
 Subject non-compliance with protocol requirements 

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 Other, at the discretion of the investigator 
Data collected from withdrawn subjects will be analyzed as appropriate and results retained for 
safety assessments.  
Data will not be retained in analyses related to the primary objective of the study if there is a valid 
reason to believe that the data may be biased, incorrect or confounded.   
 
9.0  REGULATORY  
Regulatory Status of the System 
The Contour Next One meter and Contour Diabetes App 1.0 (which is a simpler version of this 
App) have CE-mark, but may still be investigational in the US.  The Contour Diabetes App 2.0 
which is the focus of this study will be investigational at the time of the study.   In addition to the 
regulations outlined in the Ascensia Diabetes Care Global Clinical Affairs standard operating 
procedures, this protocol also complies with the clinical trial regulations of British Standard BS EN 
13612:2002, and “Performance evaluation of in vitro diagnostic medical devices”, GCP ISO 14155.  
Institutional Review Board Approval  
An Institutional Review Board (IRB) must approve this protocol, the Informed Consent (IC) 
document and any other supporting study documents which impact subject safety, prior to study 
initiation.  The investigational site may not begin the study until the IRB has given its written and 
dated approval via a letter that identifies the version/date of the protocol and Informed Consent 
Form (ICF).  A copy of the approval letter and the approved ICF must be provided to the 
Investigator and to Ascensia Diabetes Care prior to the Study Initiation Visit.   
Informed Consent Requirement 
Each subject must provide informed consent before she/he can participate in the study. The 
informed consent process fully apprises the subjects of the risks and benefits to them and to society 
for participating in the study. The ICF will clearly state that designated study personnel will be able 
to view the subject’s medical information.  The ICF will also state that Ascensia Diabetes Care 
representatives may observe some subjects as part of study staff training, study monitoring or for 
troubleshooting problems with the investigational devices.  If the subject understands and agrees to 
participate in the study, he/she will sign the ICF and then it will be signed by the person conducting 
the informed consent process. All subjects will be given a copy of the ICF. If a subject has a 
question about his/her rights, he/she may contact a member of the IRB at any time during or after 
study participation. 
Study Documentation and Procedures 
The investigator will keep study records for a minimum of three years. If the investigator is unable 
to store the documents for the required time, other arrangements may be made with Ascensia 
Diabetes Care.  
Investigational Devices  
The investigational Contour Diabetes App 2.0 will be un-installed from the subjects’ mobile device 
at Visit 2, after the subject has completed the study.   The Contour Next One meters, UGs and 
QRGs are for investigational use only and must be accounted for and returned to Ascensia.  Jane 
Wallace, Study Manager, is responsible for oversight of tracking of investigational materials.  All 

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meters should be disinfected per Appendix B prior to shipping back to Ascensia Diabetes Care. 
Study Monitoring 
The study will be monitored by Ascensia Diabetes Care personnel or designee(s).  A monitoring 
plan will be completed by the Study Manager/Study Monitor prior to the study.   The study monitor 
or designee will conduct a study initiation visit, at least 1 monitoring visit, and a close out visit.  
(Note:  the latter two visits may occur within a continuous timeframe). 
Ascensia Diabetes Care representatives or a designee may observe some subject visits as part of 
study staff training, study monitoring or for troubleshooting problems with the investigational 
devices. Ascensia Diabetes Care representatives will maintain subject confidentiality and will not 
interfere with the rights of human subjects or with their safety or bias study conduct. 
Site staff will correspond with Study Manager daily during the enrollment phase, reporting the 
status of subject enrollment, by providing subject ID and subject study email address (de-identified) 
so the Ascensia Diabetes Care administrator can verify the setup profile was initiated successfully.  
Investigator’s Report of Study Closure 
The Ascensia Diabetes Care Study Manager or designee will send a letter to the site informing them 
that the study is closed.  The study will be considered closed when the data has been locked for data 
analysis. 
The Investigator or designee will submit a report summarizing subject disposition and other study 
details, as appropriate, to the Ascensia Diabetes Care Study Manager and the reviewing IRB/EC.  
This report will be completed within 3 months of the study closure date. 
In addition, the Ascensia Diabetes Care Study Manager or designee will report the completion of 
the study to the IRB within 6 months of study closure. 
Registration of Trial  
The trial will be registered with clinicaltrials.gov as required.  
 
10.0  DATA COLLECTION AND MANAGEMENT 
A unique number will identify each subject. The unique number will be the only identifying 
information entered. A master list of subject names, with their subject IDs, will be kept by the 
Investigator at the study site. The Investigator will retain all signed IC documents. 
Study data will be recorded on paper forms that will serve as source documents.  These data will be 
entered by the site staff (or designee) into an Electronic Data Capture (EDC) system provided by 
Ascensia Diabetes Care. In addition to data collection, the EDC system will be used for data 
cleaning as well as monitoring operations. Site and sponsor users will be trained on the system prior 
to the study start at their site, and their access to EDC system will be contingent upon successful 
completion of training requirements. Study personnel will complete and sign all appropriate source 
document forms in compliance with Good Clinical Practice (GCP). Source documents (Forms) 
should be completed legibly, in black or blue ink. If it is necessary to make corrections, a single line 
should be drawn through the original entry, the new entry written in, and the correction initialed and 
dated by the individual making the correction. 
The original forms will be retained by the Investigator for a minimum of three years.  
The Investigator or designee will sign and date an Adverse Event Form for each Adverse Event 
experienced by any subject. 

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Data Downloaded from the Cloud 
Additionally, apart from the data collected, then entered into EDC, de-identified data collected in 
the Contour Diabetes App will be uploaded to the Cloud throughout the study into a US server (US 
site data). At the end of the study the cloud data will be downloaded to an Ascensia Diabetes Care 
database.  This downloaded cloud data will be able to be accessed by Ascensia Diabetes Care 
engineering group and Ascensia Diabetes Care Global Medical/Clinical Affairs personnel. 
Summaries of the cloud data will be included in the Final Clinical Study Report and Statistics 
Reports. The downloaded data will include the following information, all of which are anonymous, 
de-identified subject data: 
 Subject study email address 
 Meter serial number 
 Meter and manually entered blood glucose readings with associated dates, times and 
meal markers 
 Settings: target ranges, low, high, and critical lows and highs 
 Entries such as notes, exercise (type and duration), food 
 Smart Reminders – record of reminders set by the subject  
 Record of pattern notifications including pattern type, dates, times, and pattern status 
indicators.  
The following will not be saved and included in the study database:  subject emergency contact 
name, phone number or any other identifying information.  
11.0    STATISTICAL METHODS AND ANALYSIS   
An n = 40 responses yields approximately a 93.3% chance of “passing” the primary objective 
criteria if there is an 85% probability that a randomly selected person could perform the critical 
tasks successfully. 
Performance Criteria for subject’s success at utilizing system features:   
There is at least an 85% probability that any user would be able to utilize the App features with 
success. A hypothesis test will be performed to test the hypotheses for each feature individually: 
%
85
}
Pr{
:
0

ly
successful
task
basic
given
a
perform
can
user
H
 
against: 
%
85
}
Pr{
:
1

ly
successful
task
basic
given
a
perform
can
user
H
 
With n = 40 responses, we must observe at least 31 responses with a 1, 2, or 3 score on a critical 
questionnaire statement (statements 1, 8, 9, and 42 as shown in Appendix A) to reject the null 
hypothesis, H0. This criterion yields the following risk characteristics:  
There is approximately a 93.3% chance (power) of obtaining at least 31 “successes” out of n = 40 
responses IF the actual probability of success is 85%. Conversely, there is approximately a 90% 
chance of failing to obtain at least 31 successes out of n = 40 responses IF the actual probability of 
success is only about 66.8%. 
It is likely that the actual sample size will not be exactly 40, but in fact may be slightly higher or 
lower.  Responses of “no opinion” will not be counted for any hypothesis test.  The critical values 
for hypothesis tests will be adjusted for sample size, to maintain approximately the same power 
characteristics, i.e., the probability of rejecting the null if the success probability is 85% will be kept 
to be no greater than 95%. 

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The results accessing each feature will be evaluated independently.  Statements 1, 8, 9, and 
42 in Appendix A correspond to the primary endpoint and the 85% criterion.  
Cluster Analyses and Other Associated Analyses 
Ordinal-scaled variables from ease of use and diabetes management attitude surveys will be 
used in a k-means cluster analysis, to assess the possibility of unknown groupings (clusters) 
of subjects within the study sample.  Other variables, such as diabetes type, age, gender, and 
frequency of blood glucose testing will be used to potentially further characterize the 
groupings.  Inasmuch as there is no a priori expectation for the numbers of clusters, nor is 
there any expectation or hypotheses that any variables will have associations with clusters, 
these analyses should be considered exploratory. 
A condition of hardware/software failure that cause or contribute to a subject’s inability to access or 
utilize any given feature will be considered an un-evaluable observation. (i.e., will not be included 
in the numerator/denominator for calculating percentage of user success.)  
Frequency distributions of scores will be provided for the other variables, i.e., subjects’ ratings on 
ease of use and subjects’ ratings on clarity/utility of user instructions, subjects’ opinions about their 
use of the Contour Diabetes App 2.0 system.  Correlation coefficient, and associated 95% two-sided 
confidence interval, will be computed for laboratory HbA1c versus average glucose.  Average 
glucose will be computed from cloud data. 
Histograms for the change in HbA1c, fructosamine, weight, and total daily insulin (as reported by 
subjects) from visit 1 to visit 2 will be constructed.  ANOVA (or equivalent method) will be used to 
determine whether change in HbA1c, Fructosamine, weight, and total daily insulin are significantly 
different from zero.  P-values less than or equal to 0.05 will be considered significant.  Confidence 
intervals (95%, two-sided) for the average change in HbA1c, fructosamine, weight, and total daily 
insulin dose will be computed.   
Average daily utilization rates for selected App features will be computed, together with 95% (non-
simultaneous) confidence intervals.  Frequency tables for discrete demographic variables will be 
constructed.  Descriptive statistics, such as mean, standard deviation, median, minimum, maximum 
will be computed for continuously-valued demographic variables (e.g., subject age). 
 
12.0   ADMINISTRATION  
All investigator and site staff communications regarding the study should be directed to the 
Ascensia Diabetes Care Study Manager. If at any time questions or problems arise concerning the 
evaluation, please contact the Ascensia Diabetes Care Study Manager at the telephone number 
listed below: 
Ascensia Diabetes 
Care Study Manager: 
Jane F. Wallace 
Ascensia Diabetes Care 
Global Clinical Affairs 
Mishawaka IN   USA 
 
Phone: 574-257-3063   
Cell: 574-850-1467 
Fax: 574-257-3029 
e-mail: jane.wallace@ascensia.com 
 

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Documents to be collected prior to the start of the study include, but are not limited to: 
 
CV(s) of Investigator(s) and Sub-Investigators  
 
Signature(s) of PI on protocol 
 
Letter of IRB approval  
 
IRB  approved ICF 
 
Financial Disclosures for PI and Sub-Investigators   
 
Ascensia Diabetes Care Clinical Trial Agreement 
 
Investigator’s Agreements for Sub-Investigators   
 
Staff GCP training documentation – this will be requested at study initiation visit. 
Data / documents to be collected during or after completion of the study: 
 
EDC database  
 
Progress Notes 
 
Signature and Delegation Log (for all study staff) 
 
Investigator’s Report of Study Closure and IRB acknowledgement 
 
Study related-training documentation 
 

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Appendix A – Contour Diabetes App 2.0 Questionnaire  
Obtain a synced blood glucose reading 
1. Overall, I was able to successfully sync my blood glucose value on the meter with the App. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
2. Overall, I am satisfied with how easily my blood glucose value on the meter syncs with the App. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
3. The syncing of my blood glucose value from the meter to the App is reliable. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
4. The syncing of my blood glucose value from the meter to the App is accurate. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
5. Did you change time zones during the study?    Yes or No 
 
6. If Yes, did the App adjust to the time zone change as expected or did you experience any 
problems?  Please comment below. 
(open text field) 
 
7. Do you have any comments about syncing of the meter with the App? 
(open text field) 

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Access and interpret glucose displays such as expanded graph and sequential views. 
8. Overall, I was able to successfully access glucose displays such as Expanded Graph view and 
My Readings view in the App. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
9.  Overall, I was able to successfully interpret glucose displays such as Expanded Graph view 
and My Readings view in the App.     
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
10.   Accessing the Expanded Graph view was: 
1= Very Simple  
2= Simple  
3= Neither Simple nor Difficult  
4= Difficult  
5= Very Difficult 
No opinion 
11.  Using the Expanded Graph view was: 
1= Very Simple  
2= Simple  
3= Neither Simple nor Difficult  
4= Difficult  
5= Very Difficult 
No opinion 
12.  Expanded Graph View in the App was understandable and easy to interpret. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 

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13.  Expanded Graph View in the App was helpful for me in managing my diabetes. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
14.  Accessing the My Readings view was: 
1= Very Simple  
2= Simple  
3= Neither Simple nor Difficult  
4= Difficult  
5= Very Difficult 
No opinion 
15.  Using the My Readings view was: 
1= Very Simple  
2= Simple  
3= Neither Simple nor Difficult  
4= Difficult  
5= Very Difficult 
No opinion 
16.  My Readings View in the App was understandable and easy to interpret. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
17.  My Readings View in the App was helpful for me in managing my diabetes. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
 
 
 

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18.  I was able to successfully access the Edit view in the App. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
 
19.  Using the Edit view was: 
1= Very Simple  
2= Simple  
3= Neither Simple nor Difficult  
4= Difficult  
5= Very Difficult 
No opinion 
 
20.  I think using the Edit view became easier to use after multiple uses.  
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
 
21.  Using the Meal Marker selection screen was: 
1= Very Simple  
2= Simple  
3= Neither Simple nor Difficult  
4= Difficult  
5= Very Difficult 
No opinion 
22.  Meal Marking in the App was helpful for me in managing my diabetes. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 

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23.  I think Meal Marking became easier to use after multiple uses of the App.  
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
 
24.  I found that Meal Marking in the App was useful and I would be likely to use in the future.  
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
25.  I used the Manual Blood Glucose Entry Screen in the App. 
Yes  or   No 
If ‘No’ go to Question 27. 
 
26.  Using the Manual Blood Glucose Entry screen was: 
1= Very Simple  
2= Simple  
3= Neither Simple nor Difficult  
4= Difficult  
5= Very Difficult 
No opinion 
27.  Do you have any comments about the glucose displays, meal marking or using the Edit View in 
the App? 
(open text field) 
Clarity Of User Instructions 
28.  The instructions in the short videos and informational screen shots of the App are 
understandable. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 

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29.  The short videos and informational screen shots were helpful to me in using the App. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
30.  The Help section found in the App was helpful to me in using the App. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
31.  Do you have any comments about the instructional materials provided with the system? 
(open text field) 
Recognition of glucose pattern messages 
32.  The App notified me of some identified blood glucose patterns.    
        Yes         No  
If Yes continue to Question 33.  If No, skip to Question 42.  
 
33.  The information I learned through my blood glucose pattern messages in the App was 
understandable and I was able to interpret them. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
34.  The information I learned through my blood glucose pattern messages was useful / helpful for 
me in managing my diabetes. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
 

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35.  I found the ability to adjust the frequency of the pattern messages helpful. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
36.  I think the App showed me too many pattern messages. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
37.  I think the App showed me just the right number of pattern messages. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
38.  I was able to successfully access Pattern Manager view in the App.. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
39.  The Pattern Manager view was helpful to me in managing my diabetes.  
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
 
 
 

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40.  I would be likely to use Pattern Manager in the App in the future.  
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
41.  Do you have any comments about the glucose pattern messages or the pattern manager in the 
App?     (open text field) 
 Use of “Smart Reminders” 
42.  I was able to successfully access and use the “Smart Reminders” feature in the App.  
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
43.  Accessing the Smart Reminders feature was: 
1= Very Simple  
2= Simple  
3= Neither Simple nor Difficult  
4= Difficult  
5= Very Difficult 
No opinion 
44.  Using the Smart Reminders feature was: 
1= Very Simple  
2= Simple  
3= Neither Simple nor Difficult  
4= Difficult  
5= Very Difficult 
No opinion 
45.  I found Smart Reminders test plans that were helpful to me. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 

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46.  I followed the Smart Reminders test plans.  
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
47.  Smart Reminders in the App were useful / helpful for me in managing my diabetes.    
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
48.  I would be likely to use the Smart Reminders feature in the App in the future.    
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
49.  Do you have any comments about the Smart Reminders feature in the App?  
 (open text field) 
Other Questions   
50.  When using health apps, privacy is a very important concern for me. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
51.  My blood glucose value appearing on my smart phone is not a privacy concern for me. (For 
example, someone else viewing my BG results on my smart phone is not a concern for me.) 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 

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52.  Do you have any comments about privacy when using health apps?   
 (open text field) 
 
53.  This BGM/App System will provide me with a better understanding of my disease. 
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
54.  This BGM/App System helped me feel more engaged with my diabetes management program.   
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
55.  Using this BGM/App System, I felt more motivated to adhere to my health care provider’s 
therapy and testing recommendations.   
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
56.  Using this BGM/App System, I found myself testing more frequently throughout the day.   
1= Strongly Agree  
2= Agree  
3= Neither Agree nor Disagree  
4= Disagree  
5= Strongly Disagree 
No opinion 
57.  What could make you want to use the Contour Next One system and App more frequently?  
Please comment (open text field) 
58.  Is there anything in the Contour Next One system and App which causes you to not want to use 
the system?  Please comment. (open text field) 
59.  Do you have any other comments about the BGMs/ App system?(open text field) 
 
 

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Appendix B - Instructions for Cleaning and Disinfecting Meters   
Single use items, such as test strips, test strip vials or lancing devices, shall not be used with 
multiple subjects.  Blood glucose meters and similar devices shall be cleaned and disinfected using 
an EPA-registered disinfectant that is suitable for use on hard, non-porous surfaces.  See 
http://oaspub.epa.gov/pestlabl/ppls.home for a list of EPA-registered disinfectants, or search 
http://ppis.ceris.purdue.edu.  The list includes products such as the following. 
EPA Registration 
Manufacturer 
Product Name 
Active Ingredient 
67619-12 
Clorox Professional 
Products Company 
Clorox 
Germicidal 
Wipes 
0.55% 
sodium 
hypochlorite 
9480-6 
Professional 
Disposables 
International 
PDI 
Sani-Cloth 
PLUS 
0.25% 
quaternary 
ammonium chlorides 
14.85% isopropanol 
67619-25 
Clorox Professional 
Products Company 
Hydrogen 
Peroxide 
Cleaner Disinfectant 
Wipes 
1.4% 
hydrogen 
peroxide 
56392-7 
Caltech 
Dispatch 
Hospital 
Cleaner Disinfectant 
0.55% 
sodium 
hypochlorite 
1. Follow the manufacturer’s directions printed on the container.  Wear gloves.  
2. If the meter is soiled, clean before disinfecting. 
3. Disinfect by wiping the meter until wet.  Take care to prevent solution from running into the 
test strip port or around the buttons.   
4. Allow the meter to remain wet for the contact time indicated on the disinfectant product 
label. 
5. After the indicated contact time has elapsed, wipe dry with a clean paper towel. 
6. Allow the meters to air dry for at least 2 hours before using the meter again. 
7. Dispose of all materials used in the cleaning and disinfecting procedure according to current 
lab biohazard procedures. 
References 
 
CLSI.  Protection of laboratory workers from occupationally acquired infections; approved 
guideline – third edition.  CLSI document M29-A3.  ISBN1-56238-567-4. 
 
Rutala W, Weber D, Healthcare Infection Control Practices Advisory Committee.  Guideline 
for disinfection and sterilization in healthcare facilities, 2008.  CDC. 
FDA, Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods 
and Labeling, May 2, 2011. 

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Appendix C – Schedule of Events 
 
Event 
Screen 
App Use Run-In 
Patterns Activated (Auto) 
 
Visit 1 
Day 0 
(Visit 1) 
Approx 
Day 14 
Day 15 
Approx 
Day 28 
Approx Day 
42 (Visit 2) 
Procedural 
 
 
 
 
 
 
Informed Consent 
X 
 
 
 
 
 
Medical History*  
X 
 
 
 
 
 
Determine Eligibility 
X 
 
 
 
 
 
Body Weight/Height 
 
X 
 
 
 
X 
Office Visit 
X 
X 
 
 
 
X 
Notify personal health care provider of study 
participation  
 
X 
 
 
 
 
Receive study supplies 
 
X 
 
 
 
 
Download App to Smart Device, pair with 
meter, setup app profile  
 
X 
 
 
 
 
Perform BG test, upload meter results, sync 
with Cloud  
 
X 
 
 
 
 
Telephone Contact 
 
 
X 
 
X 
 
Return with meter, UG, mobile device.  
 
Assure meter is synced to the App. 
 
Verify and record mobile device 
software 
 
 
 
 
 
X 
Safety 
 
 
 
 
 
 
Capture Adverse Events 
 
 
X 
 
X 
X 
Severe Hypoglycemic Episode History 
 
 
X 
 
X 
X 
Hospitalization History** 
 
 
X 
 
X 
X 
Determine Total daily insulin dose (self 
reported) 
 
X 
X 
 
X 
X 
Endpoints 
 
 
 
 
 
 
HbA1c 
 
X 
 
 
 
X 
Fructosamine 
 
X 
 
 
 
X 
User Questionnaire 
 
 
 
 
 
X 

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Feature Utilization Rate*** 
 
 
 
 
 
X 
User Feedback on Failures/Unexpected 
events 
 
 
X 
 
X 
X 
Uninstall App from mobile device 
 
 
 
 
 
X 
* Medical History Screen applies to Inclusion Exclusion criteria only for purposes of eligibility 
** History of hospitalization from last telephone contact or office visit to include main reason for admission. 
*** Feature Utilization Rate will be computed from cloud downloaded data post-study