Digital Self-Management and Health Coaching for Type 2 Diabetes - Impact on Diabetes Clinical and Wellness Indicators
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Sponsor: LabStyle Innovations Ltd.

 
 
Digital Self-Management and Health Coaching for Type 2 Diabetes 
- Impact on Diabetes clinical and wellness indicators 
 
STUDY PROTOCOL 
 
Protocol ID 
CP-0010 
Revision 
A 
Date 
Mar 2018 
Sponsor: 
LabStyle Innovation (LSI) 
Contact: Yifat Hershcovitz 
Phone: 972.52.529.6979 
E-mail: yifat@mydario.com  
 
 
 

 
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List of Abbreviations 
 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
App 
Software Application on smart mobile device 
BGMS 
BP 
Blood Glucose Monitoring System 
Blood Pressure 
CDE 
CRF 
Certified Diabetes Expert 
Case Report Form  
HCT 
Hematocrit  
EC 
Ethics Committee 
GCP 
Good Clinical Practice 
FDA 
Food and Drug Administration 
IDE 
Investigational Device Exemption 
IRB 
Institutional Review Board 
PI 
Principal Investigator 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SMD 
Smart Mobile Device 
SSF 
Study Site File 
USADE 
Unanticipated Serious Adverse Device Effect 
LSI 
LabStyle Innovation Ltd.  
 
 
 

 
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Protocol Synopsis 
 
Protocol Title: 
Digital Self-Management and Health Coaching for Type 2 Diabetes - Impact 
on Diabetes clinical and wellbeing indicators 
Protocol ID: 
CP-0010 
Principal 
Investigator: 
Dr. Alan Schorr 
380 Middletown Blvd 
Ste 710 
Langhorne, PA 19047 
Phone:  (215) 750-1691 
Email: Alan Schorr <abs@sugardoc.com> 
Sponsor: 
LabStyle Innovation (LSI) 
8 Hatokhen St. 
North Industrial Park  
Caesarea 3088900, Israel 
Sponsor 
Representative: 
Yifat Hershcovitz 
Phone: 972.52.529.6979 
E-mail: yifat@mydario.com 
Product to be 
Evaluated: 
Dario Blood Glucose Monitoring System (BGMS) and connected cloud 
platform 
Research Center: 
Diabetes and Endocrinology Consultants of Pennsylvania, LLC (Decpa LLC) 
380 Middletown Blvd 
Suite 710, Oxford Square 
Langhorne, PA 19047-1845  
Research Center 
Representative: 
 
Dr. Alan Schorr 
 
Data Management 
& Statistics: 
 
LabStyle Innovation (LSI) 
 
Study Objectives: 
To evaluate the impact of the Dario digital self-monitoring platform 
provided with diabetes management coaching on: 
1. Individual’s Quality of Life for 
2. Clinical parameters (HbA1C, weight, lipids profile, etc.) 
For people with Type 2 Diabetes at end of study vs. baseline. 
Study Design: 
single-arm  
Study Type 
Interventional, Behavioral 

 
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Study Specimen: 
Lab test Venous blood - Blood glucose level and HbA1C  
Self-test Capillary whole blood   - Blood glucose level 
Study Procedures: 
Each subject enrolled in the study will be requested to complete an intake 
questionnaire including diabetes quality of life questions. The subject will 
use Dario Blood glucose monitoring system and will be contacted by a 
Certified Diabetes Educator (CDE) two to three times a month as well as 
have a direct communication using other communication channels such as 
mail, chat and text messaging (SMS) for lifestyle and diabetes 
management coaching for a total duration of three months. In the end of 
study, the subject will complete a diabetes quality of life questionnaire and 
have a blood test to evaluate its clinical parameters. 
Study Population: 
Males and females with type 2 Diabetes, ages above 35 recruited through 
clinic, physician offices, and similar sources having HbA1c level of 8.5% or 
more, verified by last lab test  performed  during the last 60 days  
Number of Visits 
2 visits only 
Sample Size: 
25 subjects  
Data to be 
Collected: 
• QoL questions 
• Demographic (age, gender, ethnicity, education, etc.) 
• Diabetes profile: type, time since diagnosis and insulin treatment 
• Concomitant medications 
• Medical history 
• Dario measurement details (test strip lot #, smart mobile device type, 
Dario meter #) 
• Capillary whole blood Glucose levels 
• Venous blood test: HbA1C, Lipid profile, HCT results 
• 
Blood Pressure (BP) 
Inclusion / 
Exclusion Criteria 
Inclusion Criteria 
1. 
Adults 35 years of age or older 
2. 
Diagnosed type 2 Diabetes 
3. 
HbA1C test taken less than 2 months ago and is equal to or above 
8.5% 
4. 
Able to read, write and understand English 
5. 
Have supported smartphone (see appendix C for the full 
smartphone list) with internet package for their service provider 
6. 
The subject is able and agrees to sign the informed consent form  
 
Exclusion Criteria 
1. 
Adults with impaired cognition 

 
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2. 
Cohabiting with a participant in the study 
3. 
Have an underlying medical condition (such as kidney disease, 
hemoglobin variants, anemia) that may provide misleading A1C 
levels 
4. 
Subject is critically ill  
5. 
Subject has an impairment that prevents him/her from following 
the study procedures 
6. 
Subject is not using medication that may interfere with the blood 
glucose measurement 
7. 
HCT level which are outside Dario BGMS declared range (20%-
60%) 
Analyses & 
Reports: 
Complete analysis and final report after enrolling up to 25 subjects and 
aiming to have 20 people running the full three months program (after 
withdrawal) to complete the coaching program that meet the 
inclusion/exclusion criteria 

 
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TABLE OF CONTENTS 
Digital Self-Management and Health Coaching for Type 2 Diabetes - Impact on Diabetes 
clinical and wellness indicators ........................................................................................................ 1 
Protocol Signature Page ................................................................................................................... 2 
List of Abbreviations ........................................................................................................................ 3 
Protocol Synopsis .............................................................................................................................. 4 
INCLUSION CRITERIA ....................................................................................................... 5 
EXCLUSION CRITERIA ...................................................................................................... 5 
1.0 Introduction .............................................................................................................................. 9 
2.0 Device Information .................................................................................................................. 9 
2.1 
DEVICE NAME ...................................................................................................... 9 
2.2 
BGMS INTENDED USE .......................................................................................... 9 
2.3 
DEVICE DESCRIPTION ......................................................................................... 10 
2.4 
DEVICE AS PROVIDED FOR STUDY ...................................................................... 11 
2.5 
DEVICE LABELING .............................................................................................. 12 
2.6 
DARIO DIGITAL PLATFORM ................................................................................ 12 
3.0 Study Objectives ..................................................................................................................... 12 
4.0 Study Design and Procedure ................................................................................................. 13 
4.1 
STUDY DESCRIPTION .......................................................................................... 13 
4.2 
STUDY OUTCOME MEASURES .............................................................................. 13 
4.3 
STUDY FLOW ...................................................................................................... 13 
5.0 Study Population .................................................................................................................... 16 
5.1 
INCLUSION CRITERIA .......................................................................................... 16 
5.2 
EXCLUSION CRITERIA ......................................................................................... 16 
5.3 
RECRUITMENT .................................................................................................... 16 
6.0 Consent process ...................................................................................................................... 17 
6.1 
SCREENING QUESTIONNAIRE .............................................................................. 17 
6.2 
INFORMED CONSENT ........................................................................................... 17 
6.3 
MEDICAL INFORMATION ..................................................................................... 17 
7.0 Study Conduct ........................................................................................................................ 17 
7.1 
STUDY CATEGORY .............................................................................................. 17 
7.2 
DURATION OF STUDY .......................................................................................... 18 
7.3 
DEVICE ACCOUNTABILITY .................................................................................. 18 
7.4 
PROTOCOL DEVIATION ....................................................................................... 18 
7.5 
PROTOCOL MODIFICATION ................................................................................. 18 
7.6 
CONFIDENTIALITY .............................................................................................. 19 
7.7 
RECORD RETENTION ........................................................................................... 19 

 
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7.8 
CASE REPORT FORMS ......................................................................................... 19 
7.9 
STUDY FUNDING ................................................................................................. 19 
8.0 Adverse Events ....................................................................................................................... 19 
8.1 
DEFINITIONS ....................................................................................................... 20 
8.2 
REPORTING REQUIREMENTS ............................................................................... 20 
8.3 
ANTICIPATED ADVERSE EVENTS ........................................................................ 21 
8.4 
ADVERSE EVENT RECORDING ............................................................................. 21 
8.5 
EXPEDITED REPORTING OF SAE ......................................................................... 21 
9.0 Statistical Analysis ................................................................................................................. 21 
9.1 
SAMPLE SIZE....................................................................................................... 21 
9.2 
DATA ANALYSES ................................................................................................ 22 
10.0 Study Monitoring, Auditing, and Inspecting ....................................................................... 22 
10.1 STUDY MONITORING .......................................................................................... 22 
10.2 STUDY AUDITING AND INSPECTING .................................................................... 22 
10.3 DATA RECORDING METHOD ................................................................................ 22 
11.0 Ethical Considerations ........................................................................................................... 23 
12.0 Publication Policy ................................................................................................................... 23 
13.0 Appendices .............................................................................................................................. 24 
Appendix A – Case Report Form .................................................................................................. 24 
Appendix B – Coaching Session Summary ................................................................................... 25 
Appendix C – Supported smart mobile devices ........................................................................... 26 
 
 
 

 
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1.0 Introduction 
Diabetes is one of the prevailing epidemics of the century. The increasing global 
prevalence of diabetes is challenging traditional approaches towards diabetes 
management.  Novel self-management tools, which aim to engage patients in daily 
diabetes care and optimize the role of health care professionals, may facilitate a more 
robust, scalable, and effective approach to the management of diabetes.  
Self-monitoring of blood glucose is a valuable tool for helping patients achieve and 
maintain target blood glucose levels to reduce the risk of diabetes-related complications. 
Particularly, frequent self-monitoring of blood glucose is an essential requirement to 
adequately manage diabetes mellitus type 1 or type 2. When performed and utilized 
properly, blood glucose meters for self-measurement of blood glucose allow diabetic 
patients to determine their blood glucose level and to use the information as part of their 
treatment program.  
Health coaching is defined as health education, promotion and support by a medical 
professional to enhance the well-being of individuals and facilitate the achievement of 
their health-related goals. Diabetes health coaching is provided by certified diabetes 
educator (CDE) giving overall guidance related to all aspects of diabetes to increase 
subject’s knowledge and skills about the disease and to promote self-care behaviors for 
effective self-management and glycemic control.  
A connected BGMS with a digital platform that enables real-time accessibility by the 
health coach to the patient’s clinical data, provides an effective way to intervene on real 
clinical information. Intervention in close proximity to recorded clinical events (e.g. 
hyperglycemic events, continuous out of range (OOR), etc.) on easy to remember 
occurrences may lead to more effective life change activities by the patient. 
The aim of this study is to evaluate the effect of digital self-monitoring blood glucose and 
diabetes health coaching, in adults with Type 2 Diabetes and its impact on diabetes 
clinical and wellness indicators over a period of 3 months.  
 
2.0 Device Information 
2.1 
Device Name 
Dario Blood Glucose Monitoring System (BGMS) with Dario digital platform providing 
access to patient’s clinical information and logged behavior captured in the BGMS 
Application (app). 
 
2.2 
BGMS Intended Use  
The Dario Blood Glucose Monitoring System consists of the Dario Blood Glucose Meter, 

 
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Dario Glucose Test Strips, Dario Glucose Control Solutions and the Dario App as the 
display component of the Dario Blood Glucose Monitoring System. The Dario Blood 
Glucose Monitoring System is intended for the quantitative measurement of glucose 
(sugar) in fresh capillary whole blood samples drawn from the fingertip. The Dario Blood 
Glucose Monitoring System is intended to be used by a single person and should not be 
shared.  
 
The Dario Blood Glucose Monitoring System is intended for self-testing outside the body 
(in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of 
diabetes control. The Dario Blood Glucose Monitoring System should not be used for the 
diagnosis of or screening of diabetes or for neonatal use.   
 
The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to 
quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from 
the fingertip.  
 
The Dario Control Solutions are for use with the Dario Blood Glucose Meter and the Dario 
Blood Glucose Test Strips to check that the meter and test strips are working together 
properly and that the test is performing correctly. 
 
2.3 
Device Description 
The Dario Blood Glucose Monitoring System (BGMS) by LabStyle Innovation (LSI) is used 
for measuring blood glucose levels from fresh capillary whole blood samples taken from 
the fingertip. It consists of a blood glucose meter (dongle), which is connected to a smart 
mobile device for usage with a dedicated application, disposable test strips stored in a 
cartridge, a lancing device and lancets.  
 
The Dario™ BGMS has a unique all-in-one feature allowing the holding of all relevant 
items for glucose self-testing in one small, easy to carry, simple to use lancing device 
enclosure, while enabling blood glucose measurement as is customary in other smart and 
non-smart mobile device-based blood glucose meter products on the market. 
 
The Dario BGMS comprises the following components:  
• Blood Glucose Meter (BGM) (attaches to a smart mobile) 
• Smart Mobile Device Application Software (available on iTunes (Apple)/Google 
Play (Android)) 
• Disposable Glucose Test Strips (25 per cartridge) 
• Disposable mobile device cover 

 
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• Control Solutions (Level 1 and Level 2) 
• Lancing Device and Lancets. The Lancing Device provides storage enclosures for 
the Dario™ Blood Glucose Meter and for the Test Strip cartridge. 
 
 
 
Figure 1: Dario Device 
 
 
Figure 2: Dario Device Components 
 
2.4 
Device as Provided for Study 
The below list of device and components will be provided by LSI for usage in the study. 
 

 
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• Dario BGMS Welcome Kits which include: 
o Dario Blood Glucose Meter (BGM) that attaches to a smart mobile device  
o Dario Lancing Device 
o Dario Lancets 
o Disposable mobile device cover 
• Dario Blood Glucose Test Strip Cartridge packs 
• Dario lancets 
• Dario Control Solution 
 
The subject will be handed with the following equipment and supplies: 
• One Dario BGMS Welcome Kit 
• Blood Glucose Test Strip Cartridge packs – total of 300 test strips 
• 
100 Lancets 
• 
Control solutions  
Subject will use their own smartphone. Only subjects with supported smartphones will 
participate in the study. 
2.5 
Device Labeling 
The following labeling items are provided when the user receives the Dario: 
• Dario™ Blood Glucose Monitoring System User Guide  
• 
Dario™ Blood Glucose Monitoring System Quick Guide with Instructions for Use  
All pieces of device labeling will be provided in English.   
2.6 
Dario Digital Platform 
Dario digital platform (Dario Engage) provides visibility and reports on patient blood 
measurement and in the context of the measurement additional user inserted data, such 
as physical activity, mood, carbs counting, diabetes type, Insulin type etc.  The system 
facilitates 100% data capture with near real-time data synchronization. All cloud stored 
information enables ubiquitous access of the coach to the system. The coach or any other 
healthcare provider can then intervene and follow-up the patient’s diabetes monitoring 
to enhance patient motivation and compliance. 
 
3.0 Study Objectives  
 
To evaluate the impact of the digital self-monitoring platform provided with diabetes 
management coaching on: 
1. Individual’s Quality of life  
2. Clinical parameters (HbA1C, weight, lipids profile, etc.) 

 
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For adults with Type 2 Diabetes at end of study vs. baseline  
 
4.0 Study Design and Procedure 
4.1 
Study Description 
This study is designed to assess the effect of digital self-monitoring platform used with 
the remote support of a Health coach on clinical outcomes and Diabetes quality of life.  
Study design will be an open-label randomized trial of adults with Type 2. Patients are 
recruited through the Diabetes and Endocrinology Consultants center setting. Upon 
randomization to the intervention group, study participants will receive three months 
diabetes health coaching comprising of:  
1. Two scheduled phone sessions with a Diabetes health coach a month;  
2. Ongoing dual communication with the coach using digital communication 
channels such as chat, SMS and emails 
3. Diabetes education, behavior modification, goal setting and reinforcement.  
The Dario App will record participant’s glucose measurements and additional information 
captured by the patient such as medication intake, food and physical activity results.  
The coach will get access to the patients’ App captured information and will intervene ad 
necessary in the context of the clinical information. 
4.2 
Study Outcome measures 
The following outcomes will be evaluated on subjects that completed the three month 
coaching program at the end of study vs. baseline. 
1. Wellness 
a. Quality of Life evaluation by questionnaires  
2. Clinical outcome 
a. HbA1C taken in blood test  
b. Capillary Blood Glucose 
c. Weight and BMI 
d. Cardiovascular risk parameters, Lipid panel: Total Cholesterol, Triglyceride, 
LDL and HDL levels – Blood test 
e. Blood Pressure 
4.3 
Study Flow  
• Upon arrival at the study site, potential candidate will be required to complete a 
CRF (Case Report Form) to verify subject eligibility.  If found eligible, the subject 

 
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will be provided information about the study and consented to participate in the 
study.  
• Subject will be provided with Dario BGMS Welcome Kit, Dario Test Strip 
Cartridges, lancets and Control Solutions. 
• Subject will download the App and register and will conduct the first Dario 
measurement in the clinic 
• Subject will be handed with Coach communication channels page (including coach 
name, phone number and email address_  
• At this stage the subject has completed the first clinic visit of the study and can 
start the coaching program. 
• The Diabetes health coach will be provided subject’s information and will set up 
the first  phone call coaching session with the subject.   
• Before the first session the coach will receive a subset of the CRF with the subjects 
relevant information.  
• During the first session, the Diabete health coach will complete an intake session 
which includes aspects in Diabetes quality of. The questions express the 
satisfaction of the patient with managing and controlling diabetes. The items were 
added according to specific quality of life module (”Development of diabetes-specific 
quality of life module to be in conjunction with the World Health Organization quality of 
life scale brief version (WHOQOL-BREF)” Lin et al. Health and Quality of Life Outcomes 
(2017) 15:167).  The Diabetes health coach will set up phone calls with the subject 
on a basis of two times per month for a period of three months. 
• During the entire coaching period of three months the Diabetes health coach will 
have two coaching sessions a months (a total of six session throughout the 
program) and also will communicate via various communication channels: chat, 
SMS, email and phone and will drive the coaching based on the data captured by 
Dario Application including: blood glucose measurements, physical activity, carbs 
etc. Each coaching session will be recorded in a dedicated coaching summary form 
as provided in appendix B. 
• Following the three months coaching the coach will have a closing session with 
the subject which will include progress, satisfaction and quality of life questions. 
• On day 91 to day 100 the subject will be required to arrive at  the Name of Clinic 
for a venous blood sample administered by a nurse/technician for testing: 
o HbA1C 

 
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o Lipid panel: Total Cholesterol, Triglyceride, LDL and HDL levels 
o HCT 
The nurse will measure weigh  Body Mass Index and Blood Pressure.  
• 
The subject is then released from the study.  
• 
The flowchart below illustrates the study flow: 
                     
 
 
 

 
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5.0 Study Population  
5.1 
Inclusion Criteria 
To be eligible to participate in this study, a subject must meet all the following criteria: 
7. 
Adults 35 years of age or older 
8. 
Diagnosed type 2 Diabetes 
9. 
HbA1C test taken less than 2 months ago and is equal to or above 8.5% 
10. Able to read, write and understand English 
11. Have supported smartphone (see appendix C for the full smartphone list) with 
internet package for their service provider 
12. The subject is able and agrees to sign the informed consent form  
5.2 
Exclusion Criteria 
A potential subject who meets any of the following criteria will be excluded from 
participation in this study: 
8. 
Adults with impaired cognition 
9. 
Cohabiting with a participant in the study 
10. Have an underlying medical condition (such as kidney disease, hemoglobin 
variants, anemia) that may provide misleading A1C levels 
11. Subject is critically ill  
12. Subject has an impairment that prevents him/her from following the study 
procedures 
13. Subject is not using medication that may interfere with the blood glucose 
measurement 
14. HCT level which are outside Dario BGMS declared range (20%-60%) 
5.3 
Recruitment  
The study is aimed to recruit a total of 25 male and female subjects having Type 2 
Diabetes between ages 35 years or older. The recruitment will be performed through the 
Diabetes and Endocrinology Consultants of Pennsylvania, LLC (Decpa LLC) center.  The 
clinic will identify patients that have done HbA1C test during the last 60 days and has 
HbA1C level as indicated in the inclusion criteria. These subjects will be approached by 
the clinic to participate in the study.  
Each subject completes the study in 2 visits to the diabetes and endocrinology 
consultants center. The subject will receive a Diabetes health coaching which will include 
2 monthly coaching sessions for a period of three months. The total study duration 
depends on the ability to enroll 25 subjects and is planned for three to four months. 
 

 
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6.0  Consent process 
6.1 
Screening Questionnaire 
Potential candidate arriving at the study site will complete a screening questionnaire to 
verify his/her eligibility to be included in the study and to collect basic information 
including but not limited to: type of diabetes, age, gender, ethnicity, level of education, 
previous experience using smart mobile device, previous experience using BGMS, etc.  
 
The screening questionnaire is provided in the CRF in Appendix A. 
6.2 
Informed Consent   
Candidates found eligible for the study will receive an explanation by the investigator or 
delegate regarding the research nature of the study, the scope and aims of the study, the 
procedures to be followed and any discomfort that he/she may experience.  The 
candidate will then be asked to read the informed consent form, ask any questions 
he/she may have and sign the form to indicate consent to participate in the study.  
Written informed consent must be obtained from each study candidate. The form should 
be signed and dated by both the subject and the investigator or delegate. One copy of 
the signed consent will be given to the subject and the original will be retained by the 
site.  
Subjects may withdraw their consent to participate in the study at any time without 
prejudice. The investigator may withdraw a subject if, in his clinical judgment, it is in the 
best interest of the subject or if the subject cannot comply with the protocol. Any 
withdrawal case should be fully documented in the CRF.   
6.3 
Medical Information 
Demographic and medical information acquired verbally from the subject and through 
the screening questionnaire – including (but not limited to) age, gender, relevant medical 
information, concomitant medications, etc. – will be recorded in the CRF for all subjects 
participating in this study. 
 
7.0 Study Conduct  
7.1 
Study Category 
This clinical study is exempt from most provisions of the IDE regulation because it fits the 
category provided in 21 CFR 812.2(c)(3): 
 

 
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The Dario™ BGMS –  
• is properly labeled in accordance with 21 CFR 809.10(c);  
• is noninvasive1;  
• does not require an invasive sampling procedure that presents significant risk1;  
• does not by design or intention introduce energy into a subject;  
and 
• 
is not used as a diagnostic procedure without confirmation of the diagnosis by 
another, medically established diagnostic product or procedure.  
7.2 
Duration of Study  
Each subject completes the study in 2 visits to the diabetes and endocrinology 
consultants center.  
 
The total study duration depends on the ability to enroll up to 25 subjects and is planned 
for three to four months. 
7.3 
Device Accountability  
Complete traceability records of all devices and accessories will be kept throughout the 
study.  
Dario meter serial number and strip lot numbers, will be documented in subject’s CRF. 
Additional material used during the study will also be recorded. 
Subject will use their own smartphone. Only subjects with supported smartphones will 
participate in the study. 
7.4 
Protocol Deviation 
Any deviation from the study protocol should be notified to the sponsor and fully 
documented on study deviation forms. Situations where the investigator anticipates, 
contemplates or makes a conscious decision to deviate from the protocol must be 
approved by the sponsor prior to deviation.  Situations where unforeseen circumstances 
are beyond the control of the investigator’s control (product failure, patient illness, etc.) 
and/or where the investigator needs to protect the subject’s life or physical well-being in 
an emergency do not require prior sponsor approval. 
7.5 
Protocol Modification 
An amendment to the protocol may be proposed to the sponsor by the clinical site staff. 
The amendment will be prepared and approved by the sponsor. The amendment must be 
                                                 
1 According to 21 CFR 812.3(k), blood sampling that involves simple venipuncture is considered 
noninvasive. 

 
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submitted to the IRB. When applicable, the amendment’s implementation will take place 
only once approved by the IRB. 
7.6 
Confidentiality   
Each subject will be identified by his/ her initials and a unique subject identification 
number. Source data will be stored with source documents. The Study Site File (SSF) will 
be held in a secure area. The subject’s name and personal data will remain confidential 
and will not be published in any way. However, the sponsor’s representative and 
regulatory representatives, auditors and inspectors may have access to medical files in 
order to verify authenticity of the collected data. 
7.7 
Record Retention 
It is the investigator’s responsibility to retain study essential documents for at least 5 
(five) years after the clinical study.    
7.8 
Case Report Forms 
The study case report form (CRF) is the primary data collection instrument for the study.  
All data requested on the CRF must be recorded.  All entries in the CRF should be printed 
legibly using ballpoint pen (no pencil). If any entry error has been made, such an error 
should be corrected by drawing a single straight line through the incorrect entry and 
entering the correct data above it.  All such changes must be initialed and dated by the 
person making the change. Erasing or whiting-out errors is prohibited. 
 
The following abbreviations should be used: 
• If the answer to a question is unknown, write ‘UNK’ (Unknown) 
• If a question is not applicable, write ‘N/A’ (Not Applicable) 
• If a requested task has not been done, write ’ND’ (Not Done) 
 
Completed CRF must be signed and dated by Investigator confirming the accuracy and 
completeness of data entries. 
7.9 
Study Funding  
The study is funded by LabStyle Innovation Ltd.  
 
8.0 Adverse Events  
All adverse events (AE) occurring during the study will be recorded on the appropriate 
case report form page by the nurse/technician.  The nature, severity and relation of the 

 
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adverse event to the study device will be documented. The PI will sign the adverse event 
form. 
8.1 
Definitions  
Adverse Event (AE) means any undesirable experiences (sign, symptom, illness, or other 
medical event) occurring to a subject, whether or not associated with the investigational 
product or related procedures. 
 
Serious Adverse Event (SAE) means any adverse event experience that results in any of 
the following outcomes: death, a life-threatening adverse experience, inpatient 
hospitalization or prolongation of an existing hospitalization, a persistent or significant 
disability/incapacity, permanent impairment of a body function or permanent damage to 
a body structure, or necessitated medical or surgical intervention to preclude permanent 
impairment of a body function or permanent damage to a body structure. 
 
Unanticipated Adverse Device Effect (UADE) means 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.2 
8.2 
Reporting Requirements 
According to the study category (see Error! Reference source not found.), the reporting 
requirements appropriate for this study are provided in 21 CFR 812.150(b) (1): 
“Unanticipated adverse device effects. A sponsor who conducts an evaluation of an 
unanticipated adverse device effect under § 812.46(b) shall report the results of such 
evaluation to FDA and to all reviewing IRB’s and participating investigators within 10 
working days after the sponsor first receives notice of the effect.  Thereafter the sponsor 
shall submit such additional reports concerning the effect as FDA requests.” 
Additionally, the clinical site staff is required to report all possible device malfunctions or 
failures observed during the study. These incidents will be documented in the relevant 
page of the CRF. 
 
                                                 
2  21 CFR § 812.3(s) 

 
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8.3 
Anticipated Adverse Events 
Anticipated adverse events for the Dario™ BGMS include those that are reasonably 
expected to occur in association with any other type of commercially available BGMS 
intended for home use, which includes local pain at the finger prick site. Due to the fact 
that the device will be used only at the site and its results will not serve for treatment 
decisions, there are no other anticipated adverse events.   
 
Additional anticipated adverse events that may occur in the study are these associated 
with obtaining capillary blood sample e.g., local pain at needle insertion site, small 
hematoma, etc. 
8.4 
Adverse Event Recording 
All adverse events occurring during the study must be recorded by the investigator or 
delegate on the appropriate AE form in the subject’s CRF within a reasonable time (up to 
5 calendar days from being aware of the event).  
8.5 
Expedited Reporting of SAE 
In the unlikely occurrence of a serious adverse event, such event must be reported to the 
sponsor within 24 hours of investigator’s/delegate's knowledge of the event by calling or 
emailing the information to: 
 
 
If applicable, the investigator should also inform the representative of the IRB within 24 
hours of becoming aware of the event. A copy of the report cover letter should be filed in 
the SSF.  
  
The sponsor is responsible for the ongoing safety evaluation of the device and, if 
applicable, communicating the information with the FDA.  
 
9.0 Statistical Analysis  
9.1 
Sample Size  
This study will include up to 25 subjects. 
 
Yifat Hershcovitz 
Phone: 972-525296979 
E-mail: yifat@mydario.com  

 
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9.2 
Data Analyses 
Data will be analyzed comparing the quality of life and clinical outcome before and after 
the program.  
 
To assess the outcome of the study, the effect of intervention along with digital self-
monitoring will be evaluated. Paired group tests will be applied for comparing the results 
gathered on the same subjects after three months to the baseline values.  
 
 
10.0 Study Monitoring, Auditing, and Inspecting 
10.1 Study Monitoring 
This study will be monitored by the sponsor’s representatives. The investigator will 
allocate adequate time to accommodate such monitoring activities.  The investigator will 
also ensure that the monitor or other compliance or quality assurance reviewer is given 
access to all study-related documents and study related facilities (e.g., clinic, laboratory, 
etc.). 
 
The sponsor will monitor the study as follows: 
- 
In the first week of the study 
- 
Six weeks into the study 
- 
In the end of the study 
10.2 Study Auditing and Inspecting 
The investigator will permit study-related monitoring, audits, and inspections by the IRB, 
the sponsor, and government regulatory bodies of all study related documents (e.g. CRF).  
The investigator will ensure the capability for inspections of applicable study-related 
facilities (e.g., clinic, laboratory, etc.). 
 
Participation as an investigator in this study implies acceptance of potential inspection by 
government regulatory authorities and applicable compliance and quality assurance 
officers on behalf of the sponsor. 
 
10.3 Data recording method 
The CRF data will be inserted into an excel spreadsheets for analysis.  
 

 
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A double insertion method will be performed on the outcome data by the clinic personal 
(the before and after QoL and clinical data) to assure correctness. 
 
11.0  Ethical Considerations  
This study is to be conducted according to US and international standards of Good Clinical 
Practice (FDA Title 21 part 812 and ICH guidelines), applicable government regulations 
and institutional research policies and procedures. 
 
This protocol and any amendments will be submitted to a properly constituted 
Institutional Review Board (IRB) for formal approval of the study conduct.  The decision of 
the IRB concerning the conduct of the study will be made in writing to the investigator 
and a copy of this decision will be provided to the sponsor before commencement of this 
study.   
 
All subjects for this study will be provided a consent form describing this study and 
providing sufficient information for subjects to make an informed decision about their 
participation in this study.  This consent form will be submitted with the protocol for 
review and approval by the IRB for the study.  The formal consent of a subject, using the 
IRB-approved consent form, must be obtained before that subject is enrolled in the 
study.  
 
Any changes in the study protocol and/or informed consent form that affect the safety 
and/or welfare of the subject must be re-approved by the IRB and the approval 
documented.  
 
12.0 Publication Policy 
All information concerning this study that was not previously published is considered 
confidential information. This confidential information shall remain the sole property of 
LabStyle Innovation; it shall not be disclosed to others without written consent from 
LabStyle Innovation and shall not be used except in the performance of this study. 
 
Any investigator involved with this study is obligated to provide the Sponsor with all data 
derived from the study.  
The investigator will be aloud, providing a written approval from the sponsor, to publish 
the study data and outcome.  
 
 
 

 
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13.0 Appendices 
Appendix A – Case Report Form 
Appendix A - 
Coaching Pilot Case 
 
 

 
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Appendix B – Coaching Session Summary 
 
Coach Initials
 
 
 
 Subject ID 
 
 
 
Date: _____________ 
 
 
Session number: 1 / 2 / 3 / 4 / 5 / 6 / __ 
 
Session main discussion points: 
 
 
 
 
 
 
 
Set goals: 
 
 
 
 
 
 
 
Session additional comments: 
 
 
 
 
 
 
 
 
General satisfaction: 
 
(very unhappy)   1  /   2   /   3   /   4    /  5   (very happy) 
 
 
 
 
 
 
 
 

 
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Appendix C – Supported smart mobile devices 
 
• 
iPhone 4S, 5, 5S, SE, 6, 6 Plus, 6S, 6S Plus 
• 
LG G3, G4, G5, G6 
• 
Samsung Galaxy S4, S5, S6, S6 Edge, S7, S7 Edge, S8, S8+ 
• 
Galaxy Note 4, 5, 8 
 
Most up-to-date list can be found under https://mydario.com/support/getting-started/