Accu-Chek® CONNECT at School (CATS) Pediatric Study
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Sponsor: Hoffmann-La Roche



 
 
 
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SUMMARY OF REVISION HISTORY 
 
Version  
Date of issue  
Reason for change 
1.0
 25-Aug-2015
 
New
 
version
 
 
 
 
 

 
 
 
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Coordinating Investigator: 
 
 MD MRCP MHA 
 
 
 
  
 
Responsibilities of the Coordinating Investigator: 
The Coordinating Investigator supports the Sponsor (Roche Diabetes Care, Inc.) with the design of 
the study, finalization of the study protocol and all relevant study training materials. 
During the conduct of the clinical study, the Coordinating Investigator will provide scientific advice 
and support the Sponsor in writing study publications. 
In addition, the Sponsor might request that the Coordinating Investigator coordinate the work in this 
study and support the submission process to the Institutional Review Board (IRB) and/or Regulatory 
Authorities.  
The Sponsor shall maintain an updated list of Principal Investigators, study sites, and institutions. This 
list can be kept separately from the protocol and provided to Principal Investigators.  The definitive 
list shall be provided with the clinical study report. 
 
 
Steering Committee 
The Steering Committee is composed of sponsor representatives and external consultants. The 
Committee will provide scientific and strategic directions for the trial and will have overall 
responsibility for the design, execution, and publication of the observational study. The Steering 
Committee will convene regularly during the trial (teleconferences or face-to-face meetings) to 
discuss and report on the study progress. External members include: 
• 
, PhD, CDE 
• 
, M.D. MRCP MHA, pediatric endocrinologist 
• 
 
• 
, RN, CDE 
• 
, RN, CDE, school staff 

 
 
 
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SIGNATURE SHEET FOR INVESTIGATORS 
Study Protocol RD002489 
ACCU-CHEK® CONNECT AT SCHOOL (CATS) PEDIATRIC STUDY 
I have thoroughly read and reviewed the above study protocol, and I agree that it contains all 
necessary details for carrying out this study. 
I agree to conduct the study as specified in this study protocol and in accordance with the principles 
of the Guidelines of the International Conference on Harmonisation (ICH) on Good Clinical Practice 
(GCP) where it can be applied to medical devices, with the Declaration of Helsinki, and FDA 21 CFR 
Parts 11, 50, 54, 56, 803, 812, 814 and 820.30; as applicable, with all local laws and regulations and 
with the regulatory requirements for source data verification. 
I fully understand that any changes instituted by the Investigator(s) without previous discussion with 
the appropriate sponsor personnel would constitute a violation of the protocol, including any ancillary 
studies or procedures performed on study subjects (other than those procedures necessary for the 
well–being of the subjects). 
I will discuss this material with subjects to ensure they are fully informed regarding the 
investigational device and the conduct of the study.  I will use only the Informed Consent Form 
approved by the Sponsor and will fulfill all responsibilities for submitting pertinent information to the 
Institutional Review Board (IRB) responsible for this study. 
I agree to ensure that the confidential information contained in this document will not be used for 
any purpose other than the evaluation or conduct of the clinical study without the prior written 
consent of Roche Diabetes Care, Inc. 
I agree that the Study Monitor/Clinical Research Associate (CRA), and/or other Sponsor 
representatives shall have access to any source data from which case report form information may 
have been generated. 
To be signed by the Principal Investigator and Sub- or Co-Investigator (as appropriate). 
Please sign and date next to your printed name: 
If more space is needed, please use a second copy of this page. 
 
 
 
 
 
Principal Investigator 
 
City 
  
Country 
PRINTED NAME 
  Signature 
  Date (dd-mmm-yyyy) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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Protocol Outline 
For comprehensive details, please refer to the respective sections. 
Study Title: 
ACCU-CHEK® CONNECT AT SCHOOL (CATS) PEDIATRIC STUDY 
Short Name  
AC Connect School Study  
Investigational 
Devices: 
ACCU-CHEK® Connect Diabetes Management System (DMS) 
Comparative  
Devices: 
The Control Group will continue to use their current diabetes management devices. 
Working 
Hypothesis: 
Use of ACCU-CHEK® Connect DMS over a period of 6 months will reduce diabetes-related 
distress in parents/caregivers of school-age children and adolescents with type 1 diabetes 
on multiple daily injections (MDI) therapy.    
Primary 
Objective: 
The primary objective of this study is to assess change in diabetes-related distress among 
parents/caregivers of school-age children on MDI therapy (PAID- C & T Parent 
Questionnaire) after 6 months utilization of the ACCU-CHEK® Connect DMS compared 
with usual care.  
Secondary 
Objectives: 
The secondary objectives of this study are to assess the changes in the following measures 
after 3 and 6 months utilization of the ACCU-CHEK® Connect DMS compared with usual 
care: 
• Change in diabetes-related distress among parent/caregiver. (PAID C & T Parent 
Questionnaires) at 3 months compared to Baseline 
• Change in diabetes-related distress among school-age children and adolescents with 
diabetes. (PAID-C & T Child Questionnaires) at 3 and 6 months 
• Change in perceived family conflict among school-age children with diabetes and 
parent/caregiver. (DFCS-parent and DFCS-youth Questionnaire) at 3 and 6 months 
• Change in affect toward blood glucose monitoring (BGM) among school-age children 
with diabetes and parent/caregiver. (BGMC-parent and BGMC-youth Questionnaire) at 
3 and 6 months changes in glycemic control: (HbA1c, Percentage in Glucose Target 
Range, Glycemic Variability, Hypoglycemia)  
Intervention Group Only at 6 Months: 
• Use of, Preference, Satisfaction with the ACCU-CHEK Connect DMS (All) 
Indication
 Type
 
1
 
diabetes
 
 
Target Population School-age children/adolescents with type 1 diabetes on MDI therapy and their 
parents/caregivers  
Number of 
Subjects 
Between 150 and 200 subjects   
Number of Sites  8 to 13 Pediatric Endocrinology Practices  
Study Design: 
Prospective, interventional, multi-center, post-market, 6-months, cluster randomized study, 
conducted in the US,;  
Study groups  
• Interventional Group: ACCU-CHEK® Connect Diabetes Management System  
• Control Group:  Usual care: Continued use of subjects´ current diabetes devices   
Study Duration:  
6 months treatment phase 

 
 
 
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Inclusion Criteria Child/adolescent and 18 year oldwith diabetes
• Diagnosis of type 1 diabetes for ≥ 3 months 
• Currently managed with multiple daily insulin injections (MDI); 
• 6-18 years of age inclusive at enrollment (Visit 1)  
• Attending full day school schedule (K-12 grades) 
• Able to provide SMBG data minimum of one month prior to study start 
• Currently using a Smartphone with ability to download the ACCU-CHEK Connect 
System App accordingly OR ability to use Smartphone provided for use in study 
 
Child/adolescent with Diabetes and Parent(s)/Caregiver(s): 
• Parents/Caregivers & Adolescent (18 years) provide written informed consent 
• Child (7-17 years) with diabetes provide age appropriate child assent  
• Parent/caregiver currently using a Smartphone and able to receive SMS/MMS 
messages Able to read and write in English language  
• Willing and able to comply with study procedures 
Exclusion Criteria Child/adolescent with diabetes 
• CSII therapy or known planned MDI to CSII transition within the study period 
• CGM use during the course of the study (both home and/or professional CGM) 
• Remote data sharing system/device use during the course of the study (i.e. NightScout, 
DexCom Share, Medtronic Connect) 
• Pregnancy  
• Diagnosed with any clinically significant condition (e.g. major organ system disease, 
infections, psychosis or cognitive impairment);  
• Subject requires chronic steroid in adrenal suppressive doses, other immuno-
modulatory medication or chemotherapy;  
Child/adolescent with diabetes and Parent(s)/Caregiver(s) 
• Visual impairment preventing the complete use of ACCU-CHEK® Connect system;  
• Parent/Caregiver is investigator or sub-investigator, general practitioner, practice staff, 
pharmacist, research assistant or other staff or relative of those directly involved in the 
conduct of the study and design of the protocol. 
Study Visits   
Visit 1  Baseline:   Office Visit – Study Start 
Visit 2  (Week 1):                 Phone Call 
Visit 3  (Month 3):     
  Office Visit 
Visit 4  (Month 6):   
  Office Visit – Study End 
Visit 5  (2-5 days after V4)   – only if ongoing Adverse Event at Visit 4 
Sample Size 
Calculation 
Change from baseline in PAID-C & T parent: Powering at 80% power to detect a treatment 
effect of 0.460 with 75 patients per group and a significance level of 0.05. Given 
assumptions of SD of 5 to 16, the sample size would be able to detect treatment group 
differences of 2.3 (SD=5) to 7.4 (SD=16.0). 100 subjects per group will be enrolled to 
accommodate attrition. 
Statistical 
Methods 
The primary analysis method for the primary objective will be where the dependent 
variable will be the change from baseline to 6 months in the PAID, with treatment group as 
the independent variable, and baseline PAID, child demographic and diabetes history 
characteristics as covariates. ANCOVA methods will also be used to analyze the secondary 
variables. Descriptive statistics will be provided for all outcomes over time by treatment 
group. The usability, satisfaction and preference questions for the intervention group will 

 
 
 
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be summarized by question descriptively by the scale value of each question (mean, 
standard deviation, range, 95% CI), and the distribution of responses within the group (n 
and percent of subjects at each level of response). 

 
 
 
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Schedule of Assessments 
 
Visit 1 
Baseline
Visit 2 
 
Visit 3 
Month 3 
Visit 4 
Month 6 
Visit 5 -
 
Day 1 
Week 1
± 2 days
Week 12 
± 2 weeks 
Week 24 
± 2 weeks 
2-5 d > 
V 4 
 In
 Office
 
Phone 
Call  
In Office  
In Office 
Phone 
Call 
Informed consent/assent 
X  
 
 
  
 
Check Eligibility and Smartphone compatibility 
X  
 
 
 
Pregnancy test, if applicable 
X  
 
 
 
Demographic data and other Baseline data  
X  
 
 
Diabetes Background, Devices, History & Medications 
X  
 
 
 
Record number of days diabetes related missed from 
Work (parent/caregiver) /school (child) in previous  3 months
X
 
  X
  X
 
Collect height and weight 
X  
  
X  
X 
HbA1c (Central Lab) 
X  
  
X  
X 
Administer Questionnaires  
X  
  
X  
X  
 
Record brand of current BG meter & serial number.  
X
 
 
 
 
 
Download SMBG data using existing site process 
X  
  
X2 
X2 
 
Review and discuss SMBG data with patient/parents and 
agree on modification of SMBG regimen, if needed. 
X
 
 X1 2 
X1 2 
 
Download current BG meter data using Diasend for eCRF  
X  
  
X2 
X2 
 
Dispense to interventional group 
• ACCU-CHEK® Connect DMS devices 
o Record BG meter serial number(s) 
• ACCU-CHEK® Call Center Cards  
• Smartphone, if applicable 
X3 
X3 
X3 
X3 
 
 
 
 
 
Perform Training and Set up ACCU-CHEK® 
Connect DMS 
(connectivity, portals and invitations) 
X3 
 
 
 
 
 
 
 
Record Malfunction of /complaints about any device, if any  
X  
X  
X 
X  
 
Record AE / SAE, if any 
X  
X  
X 
X  
 
Schedule new appointment(s) 
X  
  
X 
  
 
Follow-up call 2-5 days after Last Visit (only if ongoing AE(s)) 
  
 
 
  
X 
Update electronic CRF 
X  
X  
X 
X  
X 
1 Intervention group review data captured in ACCU-CHEK Connect DMS 
2 Control Group review usual care SMBG data with current diabetes management devices 
3 Intervention group only 

 
 
 
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Abbreviations 
AC® Connect DMS  
ACCU-CHEK® Connect Diabetes Management System 
AE
 Adverse
 
Event(s)
BGM
 Blood
 
Glucose
 
Monitoring
BGMC 
Blood Glucose Monitoring Communication
C
 Child
 
CFR 
Code of Federal Regulations
CGM
 Continuous
 
Glucose
 
Monitoring
CI
 Confidence
 
Interval
 
CIP 
Clinical Investigation Plan; synonym for protocol
CRA 
Clinical Research Associate
CSII 
Continuous Subcutaneous Insulin Infusion
CSR
 Clinical
 
Study
 
Report
DFCS 
Diabetes Family Conflict Scale
DKA
 Diabetic
 
Ketoacidosis
DMS
 Diabetes
 
Management
 
System
eCRF
 electronic
 
Case
 
Report
 
Form
FAS
 Full
 
Analysis
 
Set
FDA 
Food and Drug Administration
GCP 
Good Clinical Practice
HCP
 Healthcare
 
Professional
ICH 
International Conference on Harmonisation
IDE 
Investigational Device Exemption
IRB 
Institutional Review Board 
ISO
 International
 
Organization
 
for
 
Standardization
ITT
 Intent-to-Treat
 
(population)
MedDRA 
Medical Dictionary for Regulatory Activities
MDI 
Multiple Daily Injections
PAID 
Problem Areas in Diabetes (PRO) in various versions: PR, T and C 
PP
 Per
 
Protocol
PRO
 Patient
 
Related
 
Outcome
Protocol
 Synonym
 
for
 
CIP
SAE
 Serious
 
Adverse
 
Event
SAP 
Statistical Analysis Plan
SD
 Standard
 
Deviation
SDV
 Source
 
DataVerification
T
 Teen
 
T1DM
 Type
 
1
 
Diabetes
 
Mellitus
V
 Visit
 
 
 
 

 
 
 
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Contents 
PROTOCOL OUTLINE ......................................................................................................................................................5
 
SCHEDULE OF ASSESSMENTS 
..................................................................................................................................8 
ABBREVIATIONS
 ..............................................................................................................................................................9 
1 
INTRODUCTION
 ..........................................................................................................................................
 13 
1.1 
Introduction and Background 
................................................................................................................
 13 
1.2 
Study Rationale 
............................................................................................................................................
 15
 
2 
STUDY DESIGN AND DURATION 
........................................................................................................
 16 
2.1 
Study Design Overview 
.............................................................................................................................
 16 
2.2 
Rationale for the Study Design 
..............................................................................................................
 17 
3 
STUDY DEVICE(S) 
......................................................................................................................................
 18 
3.1 
Identification and Description of the Investigational Device: 
.................................................... 18 
Status of Documentation of Study Devices(s) 
...................................................................................................
 21 
Comparative Devices 
...................................................................................................................................................
 21
 
3.2 
Data Download Devices at study sites 
...............................................................................................
 21 
4 
STUDY OBJECTIVES 
..................................................................................................................................
 22 
4.1 
Primary Objective 
........................................................................................................................................
 22 
4.2 
Secondary Objectives 
................................................................................................................................
 22 
5 
SELECTION OF SUBJECTS AND INVESTIGATORS 
........................................................................ 23 
6 
STUDY POPULATION 
................................................................................................................................
 24 
6.1 
Inclusion Criteria 
.........................................................................................................................................
 24
 
6.2 
Exclusion Criteria 
........................................................................................................................................
 25 
6.3 
Point of Enrollment and Withdrawal 
....................................................................................................
 25 
6.4 
Replacements
 .....................................................................................................................................
..........
 26 
7 
VISIT SCHEDULE, STUDY PROCEDURES, TRAINING & DATA COLLECTION 
.................... 27 
7.1 
Visit Schedule 
...............................................................................................................................................
 27
 
7.2 
Visit 1 - Baseline (Day 1) 
.........................................................................................................................
 27 
7.3 
Visit 2 – Phone Call one week after Visit 1 
.......................................................................................
 29 
7.4 
Visit 3 - 12 weeks after Visit 1 
...............................................................................................................
 29 
7.5 
Visit 4 - Final Visit - 24 weeks after Visit 1 ........................................................................................
 29
 

 
 
 
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7.6 
Visit 5 - Follow-up Call 
.............................................................................................................................
 30 
7.7 
Unscheduled Study Visits or Phone Calls 
.........................................................................................
 31 
7.8 
Training of Subjects 
...................................................................................................................................
 31 
7.9 
Questionnaires
 .............................................................................................................................................
 32
 
7.10 
Central Laboratories 
..................................................................................................................................
 34 
7.11 
Data Collection 
............................................................................................................................................
 34
 
7.12 
Medical Care after Study Participation...............................................................................................
 36 
8 
RISK/BENEFIT ANALYSIS OF THE INVESTIGATIONAL DEVICE AND CLINICAL 
INVESTIGATION
 ..........................................................................................................................................
 37 
8.1 
Potential Risks 
..............................................................................................................................................
 37
 
8.2 
Minimization of Risks 
................................................................................................................................
 37 
8.3 
Potential Benefits 
........................................................................................................................................
 37 
9 
ADVERSE EVENTS RECORDING AND REPORTING 
...................................................................... 38 
9.1 
Definitions of Adverse Events 
................................................................................................................
 38 
9.1.1 
Adverse Event ...............................................................................................................................
................
 38 
9.1.2 
Serious Adverse Event 
..............................................................................................................................
 38 
9.2 
Definition of Hypoglycemia, Hyperglycemia Episodes and Diabetic Ketoacidosis 
........... 39 
9.2.1 
Asymptomatic Hypoglycemia Episode 
................................................................................................
 39 
9.2.2 
Symptomatic Hypoglycemia Episode 
..................................................................................................
 39 
9.2.3 
Severe Hypoglycemia Episode 
...............................................................................................................
 39 
9.2.4 
Hyperglycemia Episode 
............................................................................................................................
 39 
9.2.5 
Diabetic Ketoacidosis 
................................................................................................................................
 40 
9.3 
Expectedness Classification of Adverse Events 
.............................................................................. 40 
9.3.1 
Expected Adverse Events 
.........................................................................................................................
 41 
9.3.2 
Unexpected Adverse Events 
...................................................................................................................
 42 
9.4 
Assessment of Causality in Relationship to Device 
....................................................................... 42 
9.4.1 
Related
 ............................................................................................................................................................
 42
 
9.4.2 
Possibly Related 
..........................................................................................................................................
 42 
9.4.3 
Unrelated
 .......................................................................................................................................................
 43
 
9.4.4 
Not Assessable 
............................................................................................................................................
 43 
9.5 
Period of Observation 
................................................................................................................................
 43 
9.6 
Investigators’ Responsibility to Report Serious Adverse Events 
............................................... 43 
9.7 
Sponsor’s Responsibility to Report Serious Adverse Events/Serious Adverse 
Device Effects 
...............................................................................................................................................
 43
 
10 
MALFUNCTION/COMPLAINT REPORTING PROCESS 
................................................................. 45 
10.1 
Definitions ...............................................................................................................................
.......................
 45 
10.1.1 Definition of Malfunction 
.........................................................................................................................
 45 

 
 
 
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10.1.2 Definition of Complaint .............................................................................................................................
 45 
11 
STATISTICAL CONSIDERATIONS AND DATA ANALYSIS 
.......................................................... 46 
11.1 
Null Hypothesis and Sample Size Calculation 
................................................................................. 46 
11.2 
Populations for Analysis 
...........................................................................................................................
 46 
11.3 
Subject Demographics and Baseline Characteristics 
................................................................... 46 
11.4 
Primary Objective Analysis 
......................................................................................................................
 47 
11.5 
Secondary Objective(s) Analysis ...........................................................................................................
 47
 
11.6 
Safety Analysis 
.............................................................................................................................................
 48
 
11.7 
Interim Analysis 
...........................................................................................................................................
 49
 
12 
ETHICAL AND LEGAL CONSIDERATIONS 
....................................................................................... 50 
12.1 
Statement of Compliance 
........................................................................................................................
 50 
12.2 
Subject Informed Consent
 ......................................................................................................
.................
 50 
12.3 
Confidentiality of Study Documents and Subject Records 
......................................................... 50 
12.4 
Data Protection 
............................................................................................................................................
 51
 
12.5 
Institutional Review Board (IRB) 
...........................................................................................................
 51 
12.6 
Regulatory Authorities 
..............................................................................................................................
 51
 
12.7 
Amendments to the Clinical Study Protocol 
..................................................................................... 51
 
12.8 
Suspension or Premature Termination of the Clinical Study 
..................................................... 52 
12.9 
Record Retention 
........................................................................................................................................
 52
 
12.10 Reimbursement, Indemnity and Insurance 
....................................................................................... 52 
12.11 Publication of Data and Protection of Trade Secrets 
.................................................................... 52 
13 
CLINICAL CONDUCT, STUDY MATERIAL AND ACCOUNTABILITY 
...................................... 53 
13.1 
Material and Procedures 
.........................................................................................................................
 53 
13.1.1 Numbering of Subjects 
.............................................................................................................................
 53 
13.1.2 Supply of Study Material to Study Sites
 .......................................................................................
......
 53 
13.1.3 Dispensing of Study Devices 
..................................................................................................................
 53 
13.1.4 Return of Study Devices 
...........................................................................................................................
 53 
13.1.5 Destruction of Study Devices 
.................................................................................................................
 54 
13.2 
Site Selection 
................................................................................................................................................
 54
 
13.3 
Responsibilities of the Site Principal Investigator(s) 
..................................................................... 54 
13.4 
Study Monitoring and Auditing 
.............................................................................................................
 55 
13.5 
Clinical Site Visit Schedule 
......................................................................................................................
 55 
13.6 
Training of Investigators and Study Site Staff 
..................................................................................
 56 
14 
REPORTING OF PROTOCOL VIOLATIONS AND DEVIATIONS 
................................................. 57 
15 
REFERENCES
 ................................................................................................................................................
 58 
 

 
 
 
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1 Introduction 
1.1 Introduction and Background  
Approximately 1 out of 400 children and adolescents in the United States have type 1 diabetes 
mellitus (T1DM). (1) During 2008–2009, an estimated 18,436 people younger than 20 years in the 
United States were newly diagnosed with type 1 diabetes annually. (1) 
The daily self-management of children and adolescents with T1D is complex and dynamic, requiring 
frequent self-monitoring of blood glucose (SMBG), insulin injections, and individual meal plans. (2-4) 
Living with diabetes can feel overwhelming for parents and children, because constant vigilance is 
required for proper care.  
  
Children with diabetes experience higher rates of depression and other emotional problems than the 
general population. (5) Although less prevalent than depressive and distress symptoms, there is 
evidence that children with diabetes are also at elevated risk of anxiety symptoms and have rates 
estimated between 13-17%. (6) Anxiety can negatively impact children and their families in various 
ways. Fears of specific diabetes events such as hypoglycemic episodes among children and their 
parents/caregivers can contribute to heightened levels of stress and general anxiety overall. For the 
person living with diabetes, any level of increased anxiety is negatively related to the quality of 
glycaemic control, making diabetes self-management more difficult. (6) Constantly worrying can 
weigh on children and lead to feeling helpless and being unable to manage diabetes. (6) 
Children with T1DM often need support to adequately manage their illness at school; (7) however, 
the majority of school personnel have an inadequate understanding of diabetes. (8) This can impact 
both academic performance (9) and quality of life. Previous studies have revealed problems 
commonly experienced by children and adolescents with diabetes and their parents with regard to 
restroom privileges, performing SMBG, eating snacks, or administering insulin when needed. (10-12) 
Children are often asked to leave the classroom to do these self-care functions or to go to the school 
nurse’s office, which can be a long distance from the classroom. (11) It is concerning that children 
often go unassisted to the nurse’s office, which takes them out of the classroom for long periods of 
time and increases their risk in the event of a diabetes emergency. (11) It is also difficult for children 
with diabetes to go on field trips and participate in sporting activities or to be given modified school 
meals. (8, 14)  
Concerns about diabetes care at school can be a major stressor for parents of children and 
adolescents with T1DM. (15,16) Children who reported greater sadness at having diabetes and who 
believed it was less fair that they had diabetes had higher HbA1c at 6-months. (17) The burden of 
responsibility that is laid upon the parents could provoke depressive symptoms and may have 
significant consequences for the care of their child. (8,19) Fears of specific diabetes events such as 
hypoglycemic episodes among children and their parents/caregivers can contribute to heightened 
levels of stress and general anxiety overall. For the person living with diabetes, any level of increased 

 
 
 
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anxiety is negatively related to the quality of glycaemic control, making diabetes self-management 
more difficult. (3) Constantly worrying can weigh on children and lead to feeling helpless and being 
unable to manage diabetes. (3) 
When given adequate support at schools and the flexibility to performing diabetes care tasks at 
school, school children generally achieve better diabetes control than children who report less 
flexibility. (17,20) Moreover, children who can conveniently check their blood glucose levels at school 
are more likely to participate in all school activities, and their parents are more likely to be satisfied 
with their child’s diabetes care at school. (21)  
The American Diabetes Association recently published recommendations for the management of 
children with diabetes in the school and day care setting. (22) Relevant recommendations include: 
• 
Provide permission for self-sufficient and capable students to carry equipment, supplies, 
medication, and snacks; to perform diabetes management tasks; and to have cell phone access 
to reach parent/ guardian and health care provider.  
• 
Allow children and youth should be allowed to provide their own diabetes care at school to the 
extent that is appropriate based on the student’s development and his or her experience with 
diabetes. 
• 
Encourage independence in older children to make his or her decisions about his or her own 
care.”  
The Accu-Chek® Connect Diabetes Management System (DMS) has the potential to address issues 
and concerns related to safe diabetes management at school. The system automatically uploads 
blood glucose meter to a smart phone application that then transfers the data to a “cloud” storage 
platform, which could be accessed and shared between patients, patient caregivers and their 
healthcare providers in real time. This capability would likely alleviate much of the anxiety and 
emotional burden associated with diabetes management among pediatric/adolescent patients and 
their parents and other caregivers. Moreover, the seamless and wireless transfer of patient data in 
formats that facilitates accurate and efficient identification of glucose patterns will likely enhance the 
ability of children/adolescents, parents/caregivers and healthcare professionals to utilize the data in 
meaningful ways, leading to improved clinical and quality of life outcomes.  
 
 
 
 
 
 

 
 
 
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1.2 Study Rationale 
Management of children with type 1 diabetes mellitus (T1DM) requires adult supervision of the child 
both at home and while away from parents. As children may spend up to one-third of each day away 
from parents, it is essential that children with T1DM have access to appropriate diabetes care at all 
times, as well as all adults responsible for managing their care have adequate access to the 
children’s diabetes-related data. The ACCU-CHEK® Connect system may provide a platform by which 
all adults responsible for the management of a child with T1DM have real-time access to that child’s 
diabetes-related data, no matter their location. 
Numerous studies have demonstrated the negative impact of inadequate support and failure to 
adhere to guidelines/federal regulations; however, studies assessing the use of telemedicine 
technologies with this population are few.  
A positive psychosocial impact of ACCU-CHEK® Connect DMS use in and around children withT1DM 
on their parents/caregivers and the children themselves would significantly add to the body of 
evidence. 
Two other studies with the ACCU-CHEK® Connect DMS will be initiated in the US during 2015. These 
will address other elements of management of diabetes by means of the new ACCU-CHEK® Connect 
Diabetes Management System. 
In addition to the above, data from this study will be used to support internal development projects 
including but not limited to development of future ACCU-CHEK
® devices. Teaching cases may be 
developed from the data to teach health care professionals techniques.  

 
 
 
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2 Study Design and Duration 
2.1 Study Design Overview 
This is a prospective, interventional, multi-center, post-market, 6-months, cluster randomized study, 
conducted in the US. In order to maintain a true control group for comparison, the investigational 
sites will be randomly assigned to one of the following treatments: 
• Interventional Group ACCU-CHEK® Connect Diabetes Management System  
• Control Group  
Usual care: Continued use of subjects´ current diabetes devices   
 
Figure 1  
Study Design 
 
Between 150 - 200 children with diabetes will be included in the clinical study and the duration of 
participation is 6 months for each subject. A cluster of 10-20 children is expected to enroll at each 
investigational site. 
All subjects recruited by an Interventional Site will be provided with an ACCU-CHEK
® Connect DMS 
(and up to one additional meter to keep at school), trained in the system’s use, and asked to use this 
system for the following 6 months.  
All subjects recruited by the Control site will continue to use their current diabetes management 
system.  
All parents/caregivers independently of the age of their child are also part of the study, and will 
complete questionnaires about diabetes related stress, system use and other aspects of diabetes. 
Furthermore, the health care providers (investigators and study staff) as well as school staff will also 
be asked to assess their preference in comparison to previously used systems. In order to obtain data 
prior to study start self-monitored blood glucose (SMBG) data from all subjects will be downloaded 
at Baseline using Diasend – for the data transfer to the eCRF 
  
During the study the Control sites will continue to download data using Diasend whereas data 
download at Interventional sites will be managed by ACCU-CHEK® Connect DMS. 

 
 
 
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Control sites will continue to use data analysis methods according to their current practice for 
making therapy decision throughout the study.  No change in behavior should be introduced by the 
study in this group and therefore they will not use data downloads via Diasend for therapy decisions, 
if this is not currently their practice, but they might need to perform downloads via Diasend for eCRF 
transfer only. 
 
2.2 Rationale for the Study Design 
In the light of the increasing Smartphone technology and the launch of several apps to manage 
health situations other than diabetes, the suite of ACCU-CHEK® -devices has been extended with the 
ACCU-CHEK® Connect Diabetes Management System. 
Recently, the system has been approved by the FDA.  
In order to accompany the launch in the United States, it was decided to conduct a post-market 
study in school-children with diabetes type 1. The children´s parents, the children with diabetes 
themselves, the investigator and study staff as well as any school staff will be asked assess the 
ACCU-CHEK® Connect Diabetes Management System and any systems in the control group – from 
several points of view. 
In order for all individuals to really get to know the system, and to experience the advantages, we 
decided to follow each child with diabetes for a total of 6 months. 
In order to enable assessment of this user experience with the ACCU-CHEK
® Connect DMS, a 
combination of validated patient reported outcome (PRO) - scales and usability/preference questions 
will be used.  
The system is developed for the use in parallel to MDI therapy. Thus, children on pump therapy will 
be excluded. 
Furthermore, we decided to include children and adolescents with diabetes in K-12 grades in full day 
school setting, aged 6-18 years. 
The children and their parents/caregivers will be asked to complete questionnaires to assess 
diabetes-related distress, family conflict, and affect toward blood glucose monitoring at baseline, 3 
month, and 6 month visit.  
In addition, the intervention group will complete a questionnaire regarding use, preference, and 
satisfaction with the ACCU-CHEK
® Connect DMS at the 6 month visit. 
The Sponsor company and their experts are aware that a time away from the usual home setting has 
an impact on the management of diabetes, and thus, we decided to include a control group in order 
to enable comparison under same conditions.  
 

 
 
 
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3 Study Device(s)  
3.1 Identification and Description of the Investigational Device: 
 
The ACCU-CHEK® Connect Diabetes Management System contains three primary components:  
• 
ACCU-CHEK® Aviva Connect Blood Glucose Monitoring System 
• 
ACCU-CHEK® Connect Diabetes Management App 
• 
ACCU-CHEK® Connect Online Diabetes Management System 
                        
 
Figure 2  
The main components of ACCU-CHEK
® Connect Diabetes Management System 
 
ACCU-CHEK® Aviva Connect Blood Glucose Monitoring System 
The ACCU-CHEK® Aviva Connect Blood Glucose Monitoring System is intended to be used for the 
quantitative measurement of glucose (sugar) in fresh capillary whole blood drawn from the fingertip.  
The ACCU-CHEK® Aviva Connect Blood Glucose Monitoring System is intended to be used by a 
single person and should not be shared. 
The ACCU-CHEK® Aviva Connect Blood Glucose Monitoring System is intended for self-testing 
outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the 
effectiveness of diabetes control. The ACCU-CHEK® Aviva Connect Blood Glucose Monitoring System 
should not be used for the diagnosis of or screening of diabetes or for neonatal use. 
The ACCU-CHEK® Aviva Plus Test Strips are for use with the ACCU-CHEK
® Aviva Connect Blood 
Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples 
drawn from the fingertips. This system is intended to be used by a single person and should not be 
shared.  The ACCU-CHEK
® Aviva Connect blood glucose monitoring system includes: 
• 
Meter:     
  
ACCU-CHEK® Aviva Connect BG Meter with batteries 
• 
Test Strip:   
  
ACCU-CHEK® Aviva Plus Test Strips 
• 
Controls:   
  
ACCU-CHEK® Aviva Control Solutions 

 
 
 
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• 
Lancing Device:  ACCU-CHEK® FastClix Lancing Device with lancet drums 
 
Figure 3  ACCU-CHEK® Aviva Connect BG meter  
 
 
 
 

 
 
 
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ACCU-CHEK® Connect Diabetes Management App 
The ACCU-CHEK® Connect Diabetes Management App is designed to help: 
• 
Transfer data from your ACCU-CHEK® Connect blood glucose meter. 
• 
Transfer data to your ACCU-CHEK® Connect online diabetes management system account 
(online account) and optionally share this data with healthcare providers (HCP) or caregivers. 
• 
Receive insulin bolus advice (for those using meal-dosed insulin). 
• 
Perform structured testing. 
• 
Assist in general diabetes management through logging of contextual data. 
 
Note: Each mobile device is different.  If the mobile device does not conform to these instructions, 
consult the mobile device user
's manual. 
Figure 4  The ACCU-CHEK
® Connect Diabetes Management App 
 
 
ACCU-CHEK® Connect Online Diabetes Management System 
This web-based software supports effective diabetes management for both the healthcare 
professional and for the person with diabetes. Benefits of the ACCU-CHEK® Connect online diabetes 
management system include:  
• 
Quick overview of key diabetes therapy indicators  
• 
User-friendly tools for problem identification and data visualization  
• 
Simple upload to online accounts from compatible ACCU-CHEK® blood glucose meters and 
insulin pumps  
• 
Works in conjunction with the ACCU-CHEK® Connect diabetes management app for mobile 
devices which includes the ACCU-CHEK® Bolus Advisor and ACCU-CHEK® Connect blood 
glucose meter (not available in all countries)  
• 
Sharing data from personal accounts to healthcare professional office accounts when both 
parties have online accounts  
• 
The 3-Day Profile is a tool that guides the person with diabetes through three days of 
structured testing. This is completed on the app using built-in reminders and viewed in the 
online accounts. It is clinically proven1 to reduce HbA1c when used in collaboration with a 
healthcare professional.  
 

 
 
 
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The ACCU-CHEK Connect online diabetes management system includes two types of online 
accounts:  
• 
A Personal Account for the person with diabetes  
• 
An Office Account for the healthcare professional  
 
 
Figure 5  
ACCU-CHEK® Connect online diabetes management system 
Consumables  
The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEK Aviva Connect Blood 
Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples 
drawn from the fingertips. 
The ACCU-CHEK FastClix Lancing Device uses a lancet to obtain a drop of blood from a fingertip. It 
is designed to make obtaining a drop of blood as comfortable as possible.  The lancing device is 
loaded with a drum containing 6 sterile lancets. 
The ACCU-CHEK Aviva Control Solutions contains a known amount of glucose that 
acts like blood when you apply it to the test strip.  Performing a control test lets the user know that 
the meter and test strips are working properly. 
Status of Documentation of Study Devices(s) 
The investigational devices used in this study have received clearance/approval by the FDA. 
Comparative Devices  
The subjects randomized to the Control Group will be asked to continue to use their current 
devices/systems.  
3.2  Data Download Devices at study sites 
At Baseline all sites (both groups) will download SMBG data (from all subjects) in two ways: 
• 
using the existing site process for therapeutic decision 
• 
using Diasend – for the data transfer to the eCRF 
 
During the study the Control sites will continue to download data in these two ways whereas 
Interventional sites will only use the ACCU-CHEK
® Connect DMS. 

 
 
 
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4 Study Objectives 
4.1 Primary Objective 
The primary objective of this study is to assess change in diabetes-related distress among 
parent/caregiver of school-age children with diabetes (PAID C & T Parent- Questionnaire) after 6 
months utilization of the ACCU-CHEK® Connect DMS compared with usual care. 
4.2 Secondary Objectives 
The secondary objectives of this study are to assess the changes in the following measures after 3 and 
6 months utilization of the ACCU-CHEK® Connect DMS compared with usual care: 
• 
Change in diabetes-related distress among parent/caregiver. (PAID-C & T Parent Questionnaires) 
at 3 months compared to Baseline 
• 
Change in diabetes-related distress among school-age children with diabetes. (PAID-C & T Child 
Questionnaires) at 3 and 6 months 
• 
Change in perceived family conflict among school-age children with diabetes and 
parent/caregiver. (DFCS-parent and DFCS-youth Questionnaire) at 3 and 6 months 
• 
Change in affect toward blood glucose monitoring (BGM) among school-age children with 
diabetes and parent/caregiver. (BGMC-parent and BGMC-youth Questionnaire) at 3 and 6 
months 
• 
Changes in glycemic control: 
o HbA1c 
o Percentage in Glucose Target Range  
o Glycemic Variability 
o Hypoglycemia  
 
Intervention Group Only at 6 months: 
• 
Use of, Preference, Satisfaction with the ACCU-CHEK Connect DMS 
o Parent/caregiver(s) 
o children/adolescents with diabetes 
o School staff 
o Healthcare Provider (investigator and study staff) 
 

 
 
 
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5 Selection of Subjects and Investigators 
Investigational sites will be recruited from pediatric endocrinology practices in the US. When the 
complete cohort of sites have been selected to participate, a random assignment of each site to 
intervention or control treatment groups will be performed and communicated to the primary 
investigators.  
Subjects will be identified and recruited from the Investigator’s (pediatric endocrinology practices) 
established subject population or from respective group practices using the inclusion criteria; see 
Section 6. 
If a subject and his/her parents/caregivers agree to consider participation in the study, the 
parents/caregivers will be informed verbally and in writing by means of review of the Informed 
Consent Form. Time for the possibility to ask questions to authorized study staff will be provided prior 
to obtaining signatures.   
If a subject and his/her parents/caregivers decide to participate, the parents/caregivers shall sign the 
current IRB approved informed consent form before any study-related procedures;  
Children with diabetes will be informed in language according to their age, and asked to sign the 
assent form before any study-related procedures. 
Please refer to Section 12.2. 
 
 
 
 

 
 
 
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6 Study Population 
The targeted study population is school-aged children, age 6-18 years, with type 1 diabetes currently 
managed by MDI therapy.  
All parents/caregivers are also part of the study independently of the age of the child and will be 
asked to fill out questionnaires. 
Recruitment will take place over three months at the site. Subjects will be recruited based on their 
own/their parents/caregivers´ interest to participate in this study as well as verification of subject and 
parent eligibility through inclusion/exclusion criteria; see below. 
Smartphones 
The child/adolescent must currently be using a Smartphone with ability to download the ACCU-
CHEK Connect System App accordingly OR able to use a Smartphone provided by the study sponsor 
exclusively for use in the study.   
Specific device compatibility is determined via QR code on the AC Connect meter packaging. When 
scanned it either takes user to appropriate app-store (compatible device): Google play (Android) or 
Apple App Store (iOS) or to page that lists the compatible mobile devices. 
Compatible phones and devices are continually changing: a compatibility list will be kept.  
Number of subjects to be enrolled is between 150 and 200.    
Health care providers (investigators and study staff) as well as school staff will also be asked to 
assess their preference in comparison to previously used systems.   
6.1 Inclusion Criteria 
To be eligible to participate in this clinical study, subjects and their parents/caregivers must meet 
ALL of the respective criteria:  
Child/adolescent with diabetes 
• 
Diagnosis of type 1 diabetes for ≥ 3 months 
• 
Currently managed with multiple daily insulin injections (MDI); 
• 
6-18 years of age inclusive at enrollment (Visit 1) 
• 
Attending full day school schedule (K-12 grades) 
• 
Able to provide SMBG data minimum of one month prior to study start 
• 
Currently using a compatible Smartphone (see above) with ability to download the ACCU-
CHEK Connect System App accordingly OR ability to utilize Smartphone and ACCU-CHEK 
Connect System App as provided for use in study (Intervention group only) 
 
Child/adolescent with Diabetes and Parent(s)/Caregiver(s): 
• 
Informed Consent: 
o Parents/Caregivers provide written informed consent  
o Adolescents (18 years) with diabetes provide written informed consent 
o Child (7-17 years) with diabetes provide age appropriate child assent  

 
 
 
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o Child (6 years) with diabetes does not provide any assent  
• 
Parent/caregiver currently using a compatible Smartphone with ability to receive SMS/MMS 
messages 
• 
Able to read and write in English language  
• 
Willing and able to comply with study procedures 
6.2 Exclusion Criteria 
Subjects may not participate in this clinical study if they and/or their parents/caregivers meet ANY of 
the respective criteria: 
Child/adolescent with Diabetes: 
• 
On CSII or intending to transition from MDI to CSII during study period 
• 
CGM use during the course of the study (both home and/or professional CGM) 
• 
Remote data sharing system/device use during the course of the study (i.e. NightScout, 
DexCom Share, Medtronic Connect) 
• 
Pregnancy 
• 
Diagnosed with any clinically significant condition (e.g. anemia, major organ system disease, 
infections, psychosis or cognitive impairment);  
• 
Chronic use of steroids in adrenal suppressive doses, other immuno-modulatory medication or 
chemotherapy  
Parents/Caregivers and child with Diabetes 
• 
Visual impairment; preventing the complete use of Connect system 
• 
Parent/caregiver is the investigator or any sub-investigator, general practitioner, practice staff, 
pharmacist, research assistant or other staff or relative of those directly involved in the conduct 
of the study and design of the protocol. 
6.3 Point of Enrollment and Withdrawal  
A subject is considered enrolled in the study as soon as  
• 
His/her parents/caregivers have signed the Informed Consent and  
• 
18 year old with diabetes has signed the Informed Consent (NOTE: parental consent is not 
required if 18 years of age at time of study entry) 
• 
Child with diabetes has signed age-appropriate child assent 
• 
Child/adolescent with diabetes has been deemed eligible according to above 
inclusion/exclusion criteria. 
A subject is considered withdrawn if he/she was first enrolled, and thereafter one or more of the 
following occurs: 
• 
Screening failure (any reason). 
• 
Withdrawal of consent to participate in the study. 

 
 
 
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• 
Non-compliance with the protocol procedures  
• 
Subject begins CSII therapy during the course of study participation 
• 
Subject begins CGM during the course of study participation 
• 
Subject begins remote data sharing system/device during the course of study participation 
• 
Subject becomes pregnant (self-reported) 
• 
Investigator determines it is not in the best interest of the subject to continue participation in 
the study. 
If any of the above occurs, the Investigator will: 
• 
Ensure subject presents at site accompanied by parents/caregivers in order to ensure complete 
documentation (Study Completion Form in the eCRF including the date of and reason for early 
discontinuation and questionnaire), and to return all study materials. 
6.4 Replacements 
Subjects who drop-out will not be replaced.  

 
 
 
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7 
Visit Schedule, Study Procedures, Training & Data Collection 
7.1 Visit Schedule 
 The study consists of the following visits: 
• Visit 1 – Baseline  
In office 
• Visit 2 – Week 1  
Phone Call 
• Visit 3 – 12 weeks  
In office 
• Visit 4 – 24 weeks   
In office  Final Visit  
• Visit 5 - 2-5 days after Final Visit   Phone Call in case of ongoing AEs at Visit 4, only 
Please refer to the overall Schedule of Assessments and the below details for each study visit. 
7.2 Visit 1 - Baseline (Day 1) 
Study procedures include the following assessments: 
• 
Obtain written informed consent 
o Parents/caregivers will sign the Informed Consent  
o 18 year old child with diabetes will sign informed consent 
o Children with diabetes will sign age-appropriate assent form 
• 
Check eligibility of Inclusion and Exclusion criteria 
• 
Child/adolescents with diabetes: Perform urine pregnancy test (menstruating females) 
• 
Child/adolescent with diabetes and parents/caregivers: Smartphones; see section 6 
• 
Collect/document the following parameters: 
Information on the child/adolescent with type 1 diabetes 
o Demographics (age/gender/race/ethnicity)  
o Obtain and record Diabetes Background and History including insulin therapy, use of CGM, 
current diabetes devices, use of diabetes management software and Apps, SMBG habits 
and frequency 
o Obtain and record Diabetes Medication, total daily basal dose and average number of 
boluses per day, sensitivity factors, insulin-to-carb-ratio and target point/range. 
o Identify Diabetes Management responsibility (parent/caregiver primarily managing, child 
self-managing, or child currently transitioning to self-management 
o Communication regarding diabetes parents/caregiver when at school 
• Method: (phone/email/text) 
• Frequency: (multiple times/day, daily, weekly, as needed for problem resolution only). 
Information on parent(s)/caregiver(s)´  
o Demographics (age/gender/race/ethnicity/education/job- and marital status) 

 
 
 
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o Any software, devices or Apps used to monitor child with diabetes remotely 
o Communication regarding diabetes with child when at school 
• Method: (phone/email/text) 
• Frequency: (multiple times/day, daily, weekly, as needed for problem resolution only) 
o Communication regarding diabetes with school staff  
• Method: (phone/email/text) 
• Primary Contact: (school nurse, teacher, or other school staff) 
• Frequency: (multiple times/day, daily, weekly, as needed for problem resolution only) 
• 
Collect height and weight 
• 
Obtain capillary (finger-stick) blood sample for determination of HbA1c (at central laboratory) 
• 
Administer Questionnaires  
o Intervention Sites:   prior to training in the use of ACCU-CHEK® Connect DMS 
o Control Site(s):  
prior to general study instructions 
• 
Record brand of current BG meter and serial number 
• 
Download SMBG data using existing site process and discuss SMBG download with patient 
and parent/caregivers and collaboratively agree on therapy changes (pharmacologic and/or 
behavioral) and modify SMBG regimen, if needed. 
• 
Download current BG meter using Diasend for eCRF data 
• 
Schedule appointment for week one phone call (Visit 2) and 3 months (Visit 3) 
• 
Record number of days missed from work (parent/caregiver)/school (child with diabetes) that 
are diabetes related in previous 3 months and indicate reason (doctor appointments, illness or 
other. 
• 
Discuss and record current prescribed therapy (pharmacologic and/or behavioral) and 
prescribed SMBG regimen. 
• 
Record any adverse events (AEs) since last visit if not done immediately 
• 
Record all relevant data in the eCRF  
 
Intervention Sites, only  
• 
Dispense ACCU-CHEK® Connect DMS and record serial number of BG meter(s) 
• 
Dispense Smartphone to child/adolescent (if applicable) 
• 
Set up  ACCU-CHEK® Connect DMS for connectivity, portals & invitations 
• 
Provide training in the use of the system 
• 
register current operating system of smart phone with version number 
• 
Dispense Call Center Card and instruct in reporting of malfunctions/complaints with ACCU-
CHEK® devices  
 

 
 
 
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7.3 Visit 2 – Phone Call one week after Visit 1 
Study procedures include the following assessments: 
• 
Record any adverse events (AEs) since last visit, if this has not been done immediately 
• 
Record malfunctions/complaints of any device, if any 
• 
Intervention group: Follow-up with parents/caregivers and child with diabetes to identify 
issues/obstacles associated with system in use 
• 
Record all relevant data in the eCRF  
7.4 Visit 3 - 12 weeks after Visit 1 
Study procedures include the following assessments: 
• 
Record any malfunctions/complaints, of device as applicable 
• 
Assess and record any new AE, if this has not been done immediately and/or changes to 
ongoing AE/SAEs since the previous visit.  
• 
Download child´s BG data and review 
o Intervention Sites:   review ACCU-CHEK Connect Diabetes Management data 
o Control Site(s)  
review usual care SMBG data 
• 
Discuss SMBG download with patient and parent/caregivers and collaboratively agree on 
therapy changes (pharmacologic and/or behavioral) and modify SMBG regimen, if needed. 
• 
Discuss any change in software, devices, or apps used to manage diabetes or monitor child 
w/diabetes remotely 
• 
Collect height and weight 
• 
Record number of (diabetes related) days parents/caregivers missed from work and child with 
diabetes missed from school since last visit; indicate reason (doctor appointments, illness or 
other) 
• 
Obtain capillary (finger-stick) blood sample for determination of HbA1c (at central laboratory) 
• 
Intervention Group: Follow-up with parents/caregivers and child with diabetes to identify 
issues/obstacles associated with system in use 
• 
Control Group: Download current BG meter using Diasend for eCRF data 
• 
Have child and his/her parents complete Questionnaires  
• 
Make appointment for the last Visit, Visit 4 – 6 months after Visit 1  
• 
Record all relevant data in the eCRF  
7.5 Visit 4 - Final Visit - 24 weeks after Visit 1  
Study procedures include the following assessments: 
• 
Record any malfunctions/complaints, of any device as applicable 

 
 
 
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• 
Assess and record any new AE/SAEs and/or changes to ongoing AE/SAEs since the previous 
visit.  
• 
If ongoing AE/SAE; schedule appointment for a Follow-up call in 2-5 days 
• 
Download child´s BG data and review 
o Intervention Sites:   review ACCU-CHEK Connect Diabetes Management data 
o Control Site(s)  
review usual care SMBG data 
• 
Discuss and record any therapy changes (pharmacologic and/or behavioral) and modify SMBG 
regimen, if needed. 
• 
Discuss any change in software, devices, or apps used to manage diabetes or monitor child 
w/diabetes remotely 
• 
Collect height and weight 
• 
Record number of (diabetes related) days parents/caregivers missed from work and child with 
diabetes missed from school since last visit; indicate reason (doctor appointments, illness or 
other) 
• 
Obtain capillary (finger-stick) blood sample for determination of HbA1c (at central laboratory) 
• 
Intervention Group: Follow-up with parents/caregivers and child with diabetes to identify 
issues/obstacles associated with system in use 
• 
Control Group: Download current BG meter using Diasend for eCRF data 
• 
Have child and his/her parents complete Questionnaires  
• 
Have child/parents/caregivers return smartphones, if these had been provided at the beginning 
of the study  
• 
Record all relevant data in the eCRF 
7.6 Visit 5 - Follow-up Call 
This follow-up phone call takes place 2-5 days after the study end. Study procedures include the 
following: 
• 
Assess and record any changes to AE/SAEs which were ongoing at Visit 4 (Final Visit). 
• 
Record all relevant data in the eCRF  
 
 
 

 
 
 
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7.7 Unscheduled Study Visits or Phone Calls 
During the course of the study, subjects may require additional (unscheduled) visits with their 
physicians (Investigators) for any number of reasons including, but not limited to the following: 
• 
Diabetes medication/therapy adjustments  
• 
Assess whether ACCU-CHEK® Connect data provided by the patient was sufficient to make 
informed decisions regarding patient therapy adjustment.   
• 
Adverse Events such as, but not limited to: 
o Common respiratory infections including colds and flu. 
o Urinary tract infections. 
o Gastrointestinal disturbances. 
o Depression. 
o Minor injuries. 
For tracking purposes and future analysis of the potential cost effectiveness, any additional study 
visits will be documented as Unscheduled Visits in the electronic case report form (eCRF). 
Any conditions like above should be documented under Adverse Events. 
Any changes to medication should be documented, as follow: 
• Insulin (any changes in doses or parameters) under Diabetes Medication 
Full documentation of the visit including any assessments or examinations performed should be 
maintained in the source documents; including: 
• 
Person requesting unscheduled visit 
• 
Reason for unscheduled visit 
• 
If visit is remote or in-office 
• 
Type of remote visit (i.e. telephone, email, text, video chat, etc.) 
• 
Action taken during consult 
• 
Source of data utilized for consult (i.e. electronically sent reports, web portal, verbal, etc.) 
• 
Therapy/device/SMBG changes made as a result of remote visit 
• 
Any change in software, devices, or apps used to manage diabetes or monitor child w/diabetes 
remotely 
7.8 Training of Subjects 
In order to prepare subjects as well as their parents/caregivers for the study procedures, they will be 
trained at the Baseline Visit (Visit 1) in the following: 
Intervention Group: 
The children with diabetes as well as their parents/caregivers will be trained in the following: 

 
 
 
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• 
use and functionalities of the ACCU-CHEK® Connect DMS. 
• 
reporting of malfunctions/complaints via the Call Center 
• 
general study procedures 
 
Control Group:  
The children with diabetes as well as their parents/caregivers in this group will only be trained in 
general study procedures, as the children continue to use their previous diabetes management 
system. 
 
 
7.9 Questionnaires  
Children with diabetes and their parents/caregivers will be asked to complete the following 
Questionnaires: 
• 
Visit 1 (Intervention group to complete prior to receiving training for ACCU-CHEK® Connect 
DMS): 
o Parents/Caregivers (independently of age of the child) 
 PAID - Parent to Child or Teen - dependent on age of child with diabetes 
 BGMC - parent 
 DFCS - parent 
 
o Adolescent/Teen with diabetes (12-18y) 
 PAID - Teen  
 DFCS - youth 
 BGMC – youth 
 
o Child with diabetes (8-11y) 
 PAID - Child  
 DFCS - youth 
 BGMC - youth 
 
 
• 
Visit 3:  
o Parents/Caregivers (independently of age of the child) 
 PAID - Parent to Child or Teen - dependent on age of child with diabetes 
 BGMC - parent 
 DFCS - parent 
 
o Adolescent/Teen with diabetes (12-18y) 
 PAID-Teen  
 DFCS - youth 
 BGMC – youth 

 
 
 
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o Child with diabetes (8-11y) 
 PAID - Child  
 DFCS - youth 
 BGMC - youth 
 
 
• Visit 4:  
o Parents/Caregivers (independently of age of the child) 
 PAID - Parent to Child or Teen –(dependent on age of child with diabetes) 
 BGMC - parent 
 DFCS – parent 
 Questionnaire about Use, Preference, Satisfaction (Intervention Group Only) 
 
o Child/Adolescent/Teen with diabetes (12-18y) 
 PAID - Teen DFCS - youth 
 BGMC – youth 
 Questionnaire about Use, Preference, Satisfaction (Intervention Group Only) 
 
o Child with diabetes (8-11y) 
 PAID - Child  
 DFCS - youth 
 BGMC – youth 
 Questionnaire about Use, Preference, Satisfaction (Intervention Group Only) 
 
Healthcare Providers, School Staff of the intervention group will be asked to complete the 
Questionnaires about Use, preference, Satisfaction  
All Questionnaires will be completed through the eCRF set-up in the Marvin-system; see section 7.11.  
 
 

 
 
 
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7.10 Central Laboratories 
Central lab will be utilized for the determination of: 
• 
HbA1c at Visit 1, 3 and 4. 
 
For details regarding tubes, labeling, packaging, dispatch to central laboratory, please refer to the 
Central Laboratory Handbook. 
 
 
 
 USA 
 
 
7.11 Data Collection 
A Subject Screening and Enrolment Log will be completed for all subjects whose 
parents/caregivers have provided their informed consent i.e., signed the Informed Consent Form - 
with the reasons for non-eligibility, if applicable. 
eCRF 
An eCRF has been set up in the Marvin system, provided by 
 Germany. 
For each subject who has signed the Subject Informed Consent Form, the Investigator must allocate 
a subject ID number via the eCRF-system of two digits for the site and three digits for the subject: 
SS-XXX. 
For each enrolled subject, an eCRF must be completed (throughout the study) and electronically 
signed by the Principal Investigator or Sub-/ Co-Investigator (at the end of the subject’s participation 
in the study). 
Upon training, Investigators and authorized study staff will enter subject data during or shortly after 
the respective visits. 
Data Discrepancy Management 
Subsequently, the entered data will be systematically checked: 
• 
by means of pre-defined computerized validation checks (as outlined in the Data Management 
Plan) 
• 
by data review by the Sponsor including but not limited to the Data Manager, Monitor and 
Study Manager. 
All data discrepancies will result in data queries within the eCRF-system, which must be addressed 
(data confirmed or changed) by the study site staff and closed by the originator. 

 
 
 
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In addition, protocol violations and deviations must be recorded in the eCRF throughout the study, 
and documented further via the query-system, as applicable (see Section 14). 
If a subject withdraws from the study, the reason must be recorded on the eCRF. 
Subject and Parent/Caregiver Questionnaire 
Subjects and their parents/caregivers will be asked to complete a questionnaire at Visits 1, 3 and 4, 
see Section 7.9. These questionnaires will be presented via the site’s provided study laptop. 
At the first login, the subject is asked to define and enter a new password.  
As soon as the subject has completed the questionnaire(s), he/she should close the entry screen by 
clicking the red “Log-out” button at the upper right corner. 
For the sake of confidentiality, neither the Investigator nor other stud
y staff will be able to read the 
subject’s entries. 
 
HCP and School Nurse Staff Questionnaires 
For Intervention Group sites only, the HCP (Site Investigator and School Nurse/staff (if available)) will 
be asked to complete to complete a Questionnaire.   
 
Measures arising from sources other than questionnaires 
Glycemic Control: HbA1c levels - at Baseline, visit 3 and 4 – analyzed by central lab 
 
• 
Data from ACCU-CHEK® Connect BG-meters: 
o Change in SMBG habits and frequency (Baseline and Visit 4)  
o Percentage in Glucose Target Range, above and below Glucose Target Range 
o Glycemic Variability 
o Hypoglycemia  
 
• 
Data from ACCU-CHEK® Connect DMS and eCRF entries: 
o Assessment by HCP whether Accu-Chek Connect data provided by the patient was 
sufficient to make informed decisions regarding patient therapy adjustment.   
 
SMBG data and other diabetes-related data from ACCU-CHEK® Connect system is planned to be 
uploaded into the eCRF during the study and after study completion. The mapping of these device 
data to the correct subject with diabetes will be an automated de-identification process for saving 
the device data with the subject data. 
 
 
Database Closure 
Quality control of the database will be made throughout the study conduct in order to prepare the 
database closure. After the database has been declared clean (i.e. complete and accurate), the 
database will be locked. 

 
 
 
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Any changes to the database after that time can only be made by joint written agreement between 
the Study Manager and the Statistician. 
7.12 Medical Care after Study Participation 
Upon the subject´s termination (premature or planned) in the clinical study, it is up to the subject 
him/herself and the parents/caregivers, preferably in agreement with the treating physician, to 
determine their future treatment needs from the following options: 
 
• 
return to the device used prior to the study  or 
• 
start/continue with ACCU-CHEK® Connect DMS  
• 
use any other suitable device available on the market  

 
 
 
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8 Risk/Benefit Analysis of the Investigational Device and Clinical Investigation 
8.1 Potential Risks 
During participation in this clinical study, subjects may encounter the following known potential risks 
of diabetes management therapy: 
• 
Possible hypoglycaemia. 
• 
Possible hyperglycaemia which might progress to ketosis and diabetic ketoacidosis (DKA). 
• 
Mild discomfort and soreness, risk of infection from multiple finger sticks 
• 
Anxiety over recording SMBG values that maybe out of the expected target ranges. 
The above risks are an integral part of diabetes therapy and applied in daily practice. It has to be 
underlined that subjects face the same risks as listed during their routine therapy. The likelihood of 
serious events occurring is considered uncommon. 
8.2 Minimization of Risks 
The Sponsor has minimized the potential of the above risks to occur by: 
• 
Selection of qualified Investigators consulting study subjects during the scheduled visits. 
• 
Selection of subjects, parents/caregivers experienced in diabetes management therapy  
• 
Subjects are advised not to change their current MDI diabetes therapy without consulting their 
physician (Investigator). 
8.3 Potential Benefits 
The study subjects and their families may experience the following potential benefits while 
participating in this study: 
• 
Subjects and their families may be motivated to learn more about diabetes and to have better 
discussions of potential issues with their health care providers. 
• 
Subjects and their families may gain personal satisfaction and decreased diabetes distress 
from participating in this study.  
• 
Subjects may reduce their HbA1c from participating in this study 
• 
The following will be provided during the study at no charge to subjects and their families: 
o ACCU-CHEK® Connect Diabetes Management App 
o ACCU-CHEK® Aviva Connect BG Meter and consumables 
o Smartphones, if applicable 
• 
At study completion, subjects and families in the intervention group may elect to keep and use 
the investigational device; except the study provided Smartphone, if applicable. Regardless of 
group assignment each family will receive a   gift card for the completion of Visit 1, 3 and 4 
(total
 
 
 if
 all
 visits
 completed).

 
 
 
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9 Adverse Events Recording and Reporting 
9.1 Definitions of Adverse Events 
The definitions are based on ISO 14155:2011(E) and respective sections CFR Title 21 for Medical 
Device Studies. 
9.1.1 
Adverse Event 
An Adverse Event (AE) 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. 
In addition, this definition includes events related to the procedures involved. For users or other 
persons, this definition is restricted to events related to investigational medical devices. 
9.1.2 
Serious Adverse Event 
A Serious Adverse Event (SAE) is any AE that fulfils at least one of the following criteria: 
• 
Led to death. 
• 
Led to a serious deterioration in the health of a subject  resulting in: 
o A life-threatening illness or injury, or 
o A permanent impairment of a body structure or a body function, or 
o An in-patient or prolonged hospitalization, or 
o A medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function. 
• 
Foetal distress, foetal death or a congenital abnormality or birth defect. 
A planned hospitalization for a pre-existing condition, or a procedure required by the study 
procedure, without serious deterioration in health, is not considered an SAE. 
 
 
 

 
 
 
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9.2 Definition of Hypoglycemia, Hyperglycemia Episodes and Diabetic 
Ketoacidosis 
Hypoglycemia and hyperglycemia can be symptomatic or asymptomatic and are subset of AEs 
occurring within Diabetes studies. 
Any hypoglycemia or hyperglycemia episode which occurs during the course of the study will be 
documented by the subject him-/herself in his/her individual Subject Diary, if applicable, or will be 
defined specifically by the study procedure e.g. in the visit description of this study protocol. 
9.2.1 
Asymptomatic Hypoglycemia Episode 
An asymptomatic hypoglycemic episode is defined as a low blood glucose reading below 70 mg/dL 
(3.9 mmol/L) without symptoms and is considered as a non-captured expected AE described in 
Section 9.3.1.2. 
9.2.2 
Symptomatic Hypoglycemia Episode 
A symptomatic hypoglycemia episode is defined as an AE with symptoms consistent with 
hypoglycemia and may be confirmed by blood glucose readings below 70 mg/dL (3.9 mmol/L). 
Symptoms might include but are not limited to: sweating, dizziness, light-headedness, tremors, 
nervousness, hunger, headaches, weakness or tiredness.  
Symptomatic hypoglycemia is considered an expected and captured AE, as described in Section 
9.3.1.1. 
9.2.3 
Severe Hypoglycemia Episode 
A severe hypoglycemia episode is defined as symptoms in loss of consciousness and/or seizures 
resolving upon administration of glucose or glucagon by another person (only third party assistance). 
A blood glucose value below 36 mg/dL (2.0 mmol/L) might be available, but is not mandatory (if no 
assistance, then not considered Severe Hypoglycemia). 
Such episodes are defined as SAEs and, thus, they must follow the SAE reporting pathway via the 
eCRF (or be faxed). 
9.2.4 
Hyperglycemia Episode 
Hyperglycemia is defined as high blood glucose readings, a recommended threshold to intervene 
could be defined as values above 240 mg/dL (13.3 mmol/L). However, investigators should consider 
the condition of the individual subject. 
Only hyperglycemia episodes in combination with medical intervention or additional diagnostic 
procedures have to be documented as AE in the eCRF, as described in Section 9.3.1.1. 

 
 
 
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9.2.5 
Diabetic Ketoacidosis 
Diabetic Ketoacidosis is defined as any symptoms such as polydipsia, polyphagia, polyuria, nausea, or 
vomiting; and presence of serum ketones, or moderate or large urinary ketones; and either arterial 
blood pH <7.3 or serum bicarbonate <15 mg/L and treated as directed by the subject’s physician. 
Such episodes are also defined as SAEs and, thus, they must follow the SAE reporting pathway via 
the eCRF (or be faxed). 
 
9.3 Expectedness Classification of Adverse Events 
An AE will be classified as either expected or unexpected (see Figure 6). 
For the purpose of this study, expected AEs will be divided into non-captured and captured AEs. 
These distinctions were made based on the frequency of occurrence, severity of event, and risk to 
subject. All captured AEs will be documented in the eCRF. 
 

 
 
 
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Figure 6  
Expectedness Classification of Adverse Events 
Abbreviations:  
AE = adverse event; eCRF = electronic Case Report Form. 
9.3.1 
Expected Adverse Events 
9.3.1.1 
Captured Expected Adverse Events 
The following expected AEs may occur at any time in the course of managing diabetes. Immediate or 
short term risks to subjects from some of these expected AEs are higher than those identified under 
Non-Captured Expected AEs. 
Therefore, for the purposes of this study, the following expected AEs will be considered captured 
expected AEs and the AE Form in the eCRF needs to be completed: 
• 
Symptomatic hypoglycemia episodes (see Section 9.2.2). 
• 
Hyperglycemia in combination with medical intervention.. 
• 
Ketosis and ketoacidosis. 
These captured expected AEs will be handled as follows: 
Subjects will be instructed to follow their personal physicians’ instructions for management of low 
and high blood glucose values or otherwise as instructed by the Investigator. 
9.3.1.2 
Non-Captured Expected Adverse Events 
Non-Captured expected AEs may occur at any time in the normal course of managing diabetes. For 
the purpose of this study, they will be considered as non-captured expected AEs and will not be 
documented in the eCRF, these include: 
AEs 
Non-Captured 
AEs 
Unexpected AEs 
Captured AEs 
Captured AEs 
AE Form in eCRF 
Expected AEs 

 
 
 
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• 
Asymptomatic hypoglycemia episode (see Section 9.2.1). 
• 
Hyperglycemia without medical intervention. 
• 
In the event of a sore finger, subjects will be advised to avoid taking self-monitoring blood 
glucose samples from that finger. 
• 
In the event of a mild infection at a lancing site, the study subject will be reminded to wash 
hands before all blood tests and encouraged to consult their nurse or physician on the 
management of an infection. 
 
Since these non-captured expected Adverse Events identified above are common as well as expected 
and pose minimal immediate risk to the subjects, they will not be tracked and logged as AEs during 
the course of the study. Investigators may log reports of these non-captured expected AEs as is 
customary within their practice. 
These non-captured expected AEs will be handled as follows: 
Subjects will be instructed to follow their personal physicians’ instructions for management of low 
and high blood glucose values as well as for minor skin damage, minor bleeding and mild discomfort. 
9.3.2 
Unexpected Adverse Events 
All AEs which do not meet the criteria mentioned under expected AEs (Section 9.3.1) are considered 
as unexpected AEs and will be documented in an AE Form in the eCRF. 
9.4 Assessment of Causality in Relationship to Device 
9.4.1 
Related 
An AE is deemed related with a device if ALL of the following criteria apply: 
• 
There is a reasonable temporal sequence between AE and use of the device. 
• 
It follows a known or expected response pattern of the device. 
• 
It cannot be reasonably explained by the known characteristics of subject
's clinical state. 
 
Adverse events resulting from insufficiencies and/or inadequacies in the instructions for use or the 
deployment of the device will be classified as related. 
Adverse events resulting from a user error will be classified as related. 
9.4.2 
Possibly Related 
An AE is deemed possibly related if: 
• 
There is a reasonable temporal relationship between the AE and use of the device; and 
• 
It follows a known or expected response pattern of the device but could have been easily 
produced by a number of other aetiologies. 

 
 
 
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9.4.3 
Unrelated 
When there is no reasonable temporal association between the device and the AE or the event was 
related to the subject’s clinical state or concomitant treatment(s). 
9.4.4 
Not Assessable 
When there is not sufficient information to assess a relationship. 
9.5 Period of Observation 
All AEs ongoing at the time of study termination - irrespective their severity - should be followed up – 
via telephone - for a maximum of 5 days after the subject’s last visit to the site. A medical statement 
should be included in the AE Form in the eCRF for all ongoing AEs after the Period of Observation. 
9.6 Investigators’ Responsibility to Report Serious Adverse Events 
Investigators must immediately report all SAEs on the SAE Report Form which has been integrated in 
the eCRF - irrespective of expectedness or relationship to study procedures or study devices. 
For reported deaths, the Investigator should provide any additional information, as requested and 
required, such as autopsy reports or terminal medical reports. 
The Investigator should complete and (electronically) sign the form, and send it (electronically, within 
the eCRF system) to: 
Study Safety Officer:  
  
 
In case, the eCRF system is not functioning, a paper version of the form should be completed by 
hand, signed and sent as described above (faxed or e-mailed). 
If SAE/SADE information is unsatisfactory and essential data is missing, the Investigator is requested 
to conduct the necessary follow-up actions and/or to provide additional information as soon as 
possible. 
9.7 Sponsor’s Responsibility to Report Serious Adverse Events/Serious Adverse 
Device Effects 
The below Study Safety Officer is responsible for all safety related topics of the study: 
Name: 
 
Email:  
 
Phone: 
 
Fax: 
 
 
 

 
 
 
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Upon receipt of an SAE Report Form, the Study Safety Officer will: 
• 
Review the SAE Report Form for completeness and make a medical assessment. 
• 
Ensure that additional (initially, follow-up and final) information is obtained and communicated, 
as applicable. 
 
After Safety Assessment the SAE is reported, as applicable, via the following internal lines: 
Roche Q-Function is responsible for reporting of initial, follow-up and final SAE reports to: 
• 
Regulatory Authorities. 
 
Study Manager or designee is responsible for reporting to: 
• 
Institutional Review Boards (IRB) 
• 
Other Investigators. 

 
 
 
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10 Malfunction/Complaint Reporting Process 
The FDA cleared medical device (ACCU-CHEK® Connect Diabetes Management System) observed 
in this study is used within the Intended Use. This is also valid for possible ACCU-CHEK® BG meters 
used by the Control group during the first 3 months of the study. 
Accu-Chek® Customer Care - Call Center Cards 
Roche Diabetes Care, Inc. will provide the Investigator, including the study site staff, with a template 
of the Accu-Chek® Call Center Card containing the Accu-Chek® Customer Care Service Center 
phone number, study name and Roche Diabetes Care, Inc. internal study number. 
The study staff will distribute the Call Center Card when the Roche product is dispensed to study 
participants.  Study subject(s) and parents/caregivers should be instructed to use this card when 
contacting the Accu-Chek® Customer Care Service Center to identify that they are participating in a 
Clinical Study using Roche products.  The information requested by the Accu-Chek® Customer Care 
Service Center will enable Roche Diabetes Care, Inc. to meet its reporting obligations. 
Subjects and parents/caregivers will be instructed to report any malfunctions/complaints to the 
Accu-Chek® Customer Care Service Center as described above, for the Roche product. Subjects may 
also have the option to report malfunctions/complaints to their Investigator during a study visit, 
whereby the Investigator and subject contact the Roche Diabetes Care, Inc. Accu-Chek® Customer 
Care Service Center together, to identify the subject is participating in a Clinical Study using Roche 
products.  Contact details will be noted on subject´s identification card.  
10.1 Definitions 
10.1.1 
Definition of Malfunction 
A "malfunction" is a failure of the device to meet its performance specifications or otherwise perform 
as intended. Performance specifications include all claims made in the labeling for the device. 
10.1.2 
Definition of Complaint  
Complaint means any written, electronic or oral communication that alleges deficiencies related to 
the identity, quality, durability, reliability, safety, effectiveness or performance of a device after it is 
released for distribution.  21CFR 820.3(b) 
 

 
 
 
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11 Statistical Considerations and Data Analysis 
The primary and secondary analysis 
as defined in this study protocol will be described in the 
Statistical Analysis Plan (SAP) and summarized in the final Clinical Study Report (CSR). All 
additional exploratory analyses  required  for  publications or requested for different needs will be 
included in a separate Appendix e.g. Publication Analysis Plan (PAP). This might 
include any ad-hoc 
additional analyses not defined in the final version of the study protocol/amendment and the SAP. 
11.1 Null Hypothesis and Sample Size Calculation 
The primary outcome variable is change from baseline in PAID-C & T Parents at 6 months. A sample 
size of 75 patients per group will have 80% power (α=0.05, 2-sided) to detect a treatment effect size 
of 0.460. Given assumptions of common SD from 5-16, this sample size would be able to detect 
treatment group differences of 2.3 to 7.4, respectively. In order to account for possible drop-out prior 
to the 6 month endpoint, 100 subjects per group will be enrolled. 
 
11.2 Populations for Analysis 
The intent-to-treat (ITT) population will consist of all families that have completed at least one 
questionnaire at both baseline and end of study. 
The full analysis set (FAS) will consist of all families that have completed the parent/caregiver PAID-
PR questionnaire at both baseline and end of study. 
The safety population will consist of all subjects. 
11.3 Subject Demographics and Baseline Characteristics 
Child/Adolescent with diabetes 
• 
Demographics (age/gender/race/ethnicity)  
• 
Collect and record most recent HbA1c including date of measurement. 
• 
Obtain and record Diabetes Background and History including insulin therapy, previous 
personal CGM, SMBG habits and frequency and diabetes complications 
• 
Obtain and record Diabetes Medication including but not limited to brand name(s) of insulin 
used, total daily dose, total basal and bolus doses, sensitivity factors, etc.  
• 
Identify Diabetes Management responsibility (parent/caregiver primarily managing, child self-
managing, or child currently transitioning to self-management 
• 
Communication regarding diabetes parents/caregiver when at school 
o Method: (phone/email/text) 
o Frequency: (multiple times/day, daily, weekly, as needed for problem resolution only). 
• 
Number of missed school days in past 3 months (diabetes-related) 

 
 
 
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Parent / caregiver 
• 
Demographics (age/gender/race/ethnicity/education/job- and marital status) 
• 
Communication regarding diabetes with school staff  
o Method: (phone/email) 
o Primary Contact: (school nurse, teacher, or other school staff) 
o Frequency: (Multiple times/day, daily, weekly, as needed for problem resolution only) 
• 
Number of missed work days in past 3 months (diabetes-related) 
 
All subject characteristic variables will be summarized descriptively. Continuous variables will be 
summarized in terms of descriptive statistics including the number of subjects (N) without missing 
values, mean, standard deviation (SD), and range  
Categorical variables will be summarized in terms of absolute frequencies and percentages. In 
general, the denominator for the percentage calculation will be based upon the total number of 
subjects in the study population, unless otherwise specified. 
11.4 Primary Objective Analysis 
Change in diabetes-related distress in parents/caregivers of children who utilize the ACCU-CHEK® 
Connect Diabetes Management system compared to the change observed in the Control Group.  
Diabetes related distress will be measured via the PAID- C & T parent questionnaires which will be 
administered Pre and Post Study Participation.  
A change in the total PAID-C & T parent score between pre and post study will be calculated and 
compared between groups utilizing with treatment group as the independent variable, and covariates 
such as baseline PAID, and child demographic and diabetes history variables.   
Descriptive statistics for observed and change from baseline scores, and  2-sample t-tests will be 
presented at both 3 and 6 month visits. This analysis will be performed on the Full Analysis Set 
population.  
11.5 Secondary Objective(s) Analysis 
The following secondary objectives will be analyzed by comparing the Pre-Post changes in 
questionnaire scores from subjects utilizing the ACCU-CHEK® Connect Diabetes Management 
system with changes from those subjects in the Control Group.  Pre, Post, and Change scores will be 
calculated for each group and summarized by descriptive statistics. The change scores will be 
compared between groups utilizing both ANCOVA methods described above, and with 2-sample t-
tests. These analyses will be performed on both the FAS and the ITT populations.  
• 
Change from baseline in PAID- C & T parent at 3 months in parents/caregivers. 
• 
Change from baseline in diabetes-related family conflict in parents/caregivers as measured by 
DFCS questionnaires at 3 and 6 months 

 
 
 
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• 
Change from baseline in attitudes toward blood glucose monitoring in parents/caregivers as 
measured by BGMC-parent questionnaire at 3 and 6 months. 
• 
Change from baseline in diabetes-related distress among school-age children as measured by 
the PAID- C & T child questionnaires at 3 and 6 months. 
• 
Change from baseline in perceived family conflict among school-age children measured by the 
DFCS-youth questionnaire at 3 and 6 months. 
• 
Change from baseline in affect toward blood glucose monitoring (BGM) among school-age 
children as measured by the BGMC-youth questionnaire at 3 and 6 months. 
• 
Change from baseline in perceived family conflict in parent/caregiver as measured by DFCS- 
parent questionnaire at 3 and 6 months. 
• 
Changes from baseline in glycemic control at 3 and 6 months defined as: 
o HbA1c 
o Percentage in Glucose Target Range  
o Glycemic Variability 
o Hypoglycemia  
 
• 
The secondary objectives of ease of use, satisfaction, and preference for using the ACCU-
CHEK® Connect Diabetes Management System compared with previous systems will be 
analyzed by summarizing the end of study outcomes from the following participant groups 
within the intervention group: 
o Parent 
o Children 
o School staff 
o Healthcare Provider (s) 
Each question from this Post Questionnaire will be summarized separately utilizing descriptive 
statistics of the numerical scale value of the question (mean, standard deviation, range and 95% CI), 
and the distribution of values (number and percent of respondents at each level of response). These 
analyses will be performed on both the FAS and the ITT populations 
11.6 Safety Analysis 
All AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). Only AEs 
occurring after the start of the ACCU-CHEK ® Connect Online Diabetes Management System will be 
included in the AEs tables. 
Summaries of incidence rates (frequencies and percentages) of individual AEs by MedDRA System 
Organ Class and Preferred Term will be prepared. Such summaries will be displayed for all AEs, AEs 
by maximum severity, AEs by strongest causality to study device (and any associated pump devices), 
and AEs leading to withdrawal of study device. 
Deaths, other SAEs and AEs leading to withdrawal will be listed separately. 
Episodes (numbers) of the following AEs will be summarized: 
• 
Symptomatic hypoglycaemia 
• 
Severe hypoglycaemia (SAEs) 

 
 
 
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• 
Diabetic Ketoacidosis (SAEs) 
 
11.7 Interim Analysis 
No interim analysis will be conducted on the primary objective. Nevertheless a “data pull” analysis 
will be conducted at a suitable timepoint.  
 

 
 
 
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12 Ethical and Legal Considerations 
12.1 Statement of Compliance   
The study will be performed in accordance with the principles stated in the current version of World 
Medical Association’s Declaration of Helsinki “Recommendations Guiding Physicians in Biomedical 
Research Involving Human Subjects”, that are consistent with the principles outlined in the ICH 
Guideline on GCP where it applies to medical devices and the applicable national regulations for 
medical device law and applicable ordinances, FDA 21 CFR Parts 11, 50, 54, 56, 803, 812, 814 and 
820.30, as applicable in each participating country. 
12.2 Subject Informed Consent 
It is the responsibility of the Investigator, or a person designated by the Investigator (if acceptable by 
local regulations), to obtain written Subject informed consent – before any study procedures - from 
each subject considering participation in this study, after adequate explanation of the aims, methods, 
anticipated benefits, and potential hazards of the study – orally as well as presented in the written 
Subject Informed Consent. 
The Investigator or designee (if applicable) must also explain that the subject is completely free to 
refuse to enter the study or to withdraw from the study at any time, for any reason and could return 
to standard care. 
The Investigator or authorized staff must document the date of each subject´s informed consent in 
the respective eCRF. 
If any new safety information results in significant changes in the risk/benefit assessment, the 
Informed Consent Form should be reviewed, updated and re-submitted to the IRB for approval. 
Subjects already participating in the study should be informed of the new information, and asked to 
give their written inform consent to continue in the study. 
New subjects shall only receive the updated documents. 
All subjects will be given a copy of the signed Subject Informed Consent Form(s). 
 
12.3 Confidentiality of Study Documents and Subject Records 
The Investigator must assure that subjects’ anonymity will be maintained and that their identities are 
protected from unauthorized parties. On the eCRFs or other documents submitted to the Sponsor, 
subjects should not be identified by their names, but by a unique study identification code, i.e. 
Subject ID (Number). 
The Investigator will keep a Subject Screening and Enrolment Log linking study identification 
codes, and subject contact information. The Investigator will maintain these study documents e.g. 
subjects’ written inform consent forms, in strict confidence and as part of the Investigator’s Site File. 

 
 
 
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Any data obtained from subjects participating in the study may be used to build case studies for 
educational purposes and all identifying data will be completely removed or blacked-out for these 
purposes. 
12.4 Data Protection 
The subject and their parent/caregivers will be informed of their right of access, objection and 
correction of the data recorded during this study, and that this right may be exercised at any time 
through his/her physician. 
Information relating to participating physicians will be declared and the physicians will be informed – 
within the framework of their agreement – of their right to access, object to and correct this 
information. 
12.5 Institutional Review Board (IRB) 
This protocol and any accompanying material provided to the subject (such as subject information 
sheets or descriptions of the study used to obtain informed consent) as well as any advertising used 
or compensation given to the subject, will be submitted by the Investigator to an IRB. Approval from 
the committee must be obtained before starting the study, and should be documented in a letter to 
the Investigator specifying the date on which the committee met and granted the approval. Any 
modifications made to the protocol after receipt of the IRB approval must be re-submitted by the 
Investigator to the Committee in accordance with local procedures and regulatory requirements.  
12.6 Regulatory Authorities 
Submissions and/or notification to Regulatory Authorities will be performed as required by local 
legislation in each participating country for this type of study. 
12.7 Amendments to the Clinical Study Protocol 
Study protocol modifications to ongoing studies must be made only after consultation between an 
appropriate representative of the Sponsor and the Investigator. These modifications must be 
prepared by a representative of the Sponsor and initially reviewed and approved by the appropriate 
representatives of the Sponsor and Statistician. 
All study protocol modifications must be submitted to the appropriate IRB for approval in accordance 
with local procedures, and Competent/Regulatory Authorities as required. Approval must be granted 
in writing before any changes can be implemented, except for those changes necessary to eliminate 
an immediate hazard to the subjects, or when the change(s) involve only logistical or administrative 
aspects of the study (e.g. change in Monitor, change of telephone number). Note: these changes will 
be re-submitted for IRB review and approval as soon as possible. 
 

 
 
 
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12.8 Suspension or Premature Termination of the Clinical Study 
Both the Sponsor and the Investigator reserve the right to terminate the clinical study at any time. 
Should this be necessary, the parties will arrange the procedures on an individual basis after review 
and consultation. The only reason for early termination of the study by the Sponsor would be the 
occurrence of unexpected safety or ethical consideration for the protection of the subject’s interests. 
In terminating the study, the Sponsor and the Investigator will assure that adequate consideration is 
given to the protection of the subject’s interests. 
12.9 Record Retention 
In order to comply with Roche Diabetes Care requirements, Investigators must maintain all required 
essential documents – in the Investigator Site File - at the site for at least 15 years after the study 
ends.  
Essential study documents are those documents which individually and collectively permit evaluation 
of the conduct of the trial and the quality of the data produced – stored before during and after the 
study conduct in the Investigator´s Site File. They include but are not limited to, those pertaining to 
subject files and other source data (e.g. hospital files, consultation records, laboratory reports, etc). 
The Investigator should ensure that the Investigator Site File is stored in a secure location and should 
take measures to prevent accidental or premature destruction of  any documents. 
The Investigator must contact the Sponsor for approval prior to discarding any study-related 
documents, even if retention requirements have been met. 
If the Investigator leaves the clinical site at which the study has been conducted, he/she or current 
representative must contact the Sponsor to make suitable arrangements to ensure that the study 
records, including a copy of the Screening and Enrollment Log are retained as specified above 
and to provide for the continuing access to the records by Sponsor representatives and Regulatory 
Authorities. 
12.10 Reimbursement, Indemnity and Insurance 
Subjects will receive a   gift card for the completion of every in clinic visit (Visit 1, 3 and 4) 
Reimbursement, indemnity and insurance shall be addressed in a separate agreement agreed upon 
by the parties. 
12.11 Publication of Data and Protection of Trade Secrets 
The results of this study may be published or presented at scientific meetings. If this is foreseen, the 
Investigator agrees to submit all manuscripts or abstracts to Roche Diabetes Care prior to 
submission. This allows the Sponsor to protect proprietary information and to provide comments 
based on information from other studies that may not yet be available to the Investigator. 
Any formal publication of the study in which input of Roche Diabetes Care personnel exceeds that of 
conventional monitoring will be considered as a joint publication by the Investigator and the 
appropriate Roche Diabetes Care personnel. Authorship will be determined by mutual agreement. 

 
 
 
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13 Clinical Conduct, Study Material and Accountability 
13.1 Material and Procedures 
13.1.1 
Numbering of Subjects 
As soon as a subject has signed the Informed Consent Form, the Investigator or authorized study 
staff will allocate a subject ID number via the eCRF-system.  
The subject ID number consists of 2 digits for the site and 3 digits for the subject: SS-XXX. 
 
13.1.2 
Supply of Study Material to Study Sites 
The Investigator will receive all of the materials needed to initiate and conduct the clinical study. The 
materials include, but are not limited to: 
• 
Study protocol, final approved version. 
• 
Electronic CRF, available on-line. 
• 
Investigator Site File including all relevant documents. 
• 
Study devices (intervention group only): 
o ACCU-CHEK® Connect Diabetes Management System (DMS) and consumables 
o Smartphones, if applicable. 
• 
Sponsor - provided study laptop 
o Subjects Questionnaires. 
o HCP and School Nurse Questionnaires 
• 
Packaging material for return of study devices (interventional group only) 
• 
Central lab kits, (for HbA1c and urine pregnancy) manual and shipping labels and supplies 
13.1.3 
Dispensing of Study Devices 
The site will be responsible for maintaining a supply inventory log recording receipt and disposition 
of all the devices with serial or batch numbers and supply materials, if applicable. 
For this purpose, a study-specific Supplies Dispense & Return Form shall be completed for each 
subject. 
13.1.4 
Return of Study Devices 
Subjects will be permitted to keep the dispensed ACCU-CHEK® Aviva Connect Blood Glucose 
Monitoring System at the end of the study. 
Subjects who received a sponsor-provided Smartphone for use during the study must return it at the 
end of the study.  

 
 
 
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For this purpose, a study-specific Supplies Dispense & Return Form shall be completed for each 
subject. 
Sites will be asked to return the study provided laptop 
 
13.1.5 Destruction of Study Devices 
It will be decided if the study devices will be returned to the Sponsor for after-use-inspection. 
If devices are not to be returned to the Sponsor, destruction (of used and used devices including 
comparative devices) is only allowed upon written permission from the Sponsor. 
13.2 Site Selection 
Sites will be selected for participation in this clinical study by the Sponsor. These sites must have 
qualified personnel and must be equipped with the appropriate medical facilities to fulfill the study 
requirements. The clinical sites must be associated with and under the guidance of an Ethics 
Committee which satisfies all Regulatory Authority requirements and conducts meetings on a regular 
basis. These sites must also have an adequate subject population to meet the study requirements. 
Sites will include pediatric endocrinologist as well as pediatric diabetes specialists who focus on the 
management of pediatric type 1 diabetes. All sites will be familiar with diabetes data management 
software to review patient generated data. 
 
Sites will be approved for participation by the Study Manager. 
13.3 Responsibilities of the Site Principal Investigator(s) 
The site Principal Investigator(s) shall be responsible for the day-to-day conduct of the clinical study 
as well as for the safety and well-being of the study subjects. 
The site Principal Investigator(s) must satisfy the following requirements: 
• 
Have adequate knowledge and experience in diabetes care management as documented in the 
Investigator
's Curriculum Vitae. 
• 
Have the resources and time to comply with the requirements of this clinical study. 
• 
Have access to an appropriate medical facility and equipment necessary for the conduct of this 
clinical study. 
• 
Have primary responsibility for the accuracy, legibility and security of all study data. 
• 
Have an adequate subject population to meet the requirements of the study. 
• 
Observe confidentiality at all times throughout the study. 
• 
Ensure only eligible subjects, per the approved study protocol, are enrolled into the study and 
that written informed consent is obtained from each subject. 
• 
Follow protocol procedures and provide accurate data in a timely manner. 

 
 
 
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13.4 Study Monitoring and Auditing 
It is understood that the responsible Roche Diabetes CareMonitor (or designee) will contact and visit 
the Investigator regularly and will be allowed, on request, to inspect the various records of the study 
(eCRFs and other pertinent data) provided that subject confidentiality is maintained in accord with 
local requirements. It will be the Monitor
's responsibility to review the eCRFs at regular intervals 
throughout the study, to verify protocol compliance and the completeness, consistency and accuracy 
of the data being entered. The Monitor should have access to the laboratory test reports and other 
subject records to verify the entries on the eCRFs. The Investigator (or designee) agrees to cooperate 
with the Monitor to ensure that any problems detected in the course of these Monitoring Visits are 
reviewed and resolved. 
The Investigator shall supply the Sponsor on request with any required background data from the 
study documentation or clinic records. This is particularly important when errors in data transcription 
are suspected. In case of special problems and/or governmental queries or requests for audit 
inspections, it is also necessary to have access to the complete study records, provided that subject 
confidentiality is protected. 
Details about requirements for Source Data Verification (SDV) and other aspects of Monitoring will 
be described in the Study Handbook. 
13.5 Clinical Site Visit Schedule 
A Pre-Study Qualification Visit will be conducted prior to the start of the study to ensure that: 
• 
Study sites and their facilities meet the requirements of the study. 
 
A Site Initiation Visit will be conducted prior to the start of the study to ensure: 
• 
Investigator understands and accepts his/her obligations in conducting the clinical study 
according to the protocol. 
• 
Investigator and study staff have reviewed and understood the study protocol. 
• 
Training regarding study devices and study procedures. 
 
Regular Monitoring Visits will take place during the course of the study to ensure: 
• 
Continued acceptability of facilities and oversight of the study by the EC. 
• 
Adherence to protocol and applicable regulation. 
• 
Maintenance of adequate subject records. 
• 
All SAEs/AEs are reported to Sponsor and to responsible authority, as required. 
• 
Verification of source data to eCRFs. 
 
At the study termination, study staff will collect all applicable materials and supplies and return them 
to the Sponsor. After all study data has been collected and verified and the study database has been 
locked, a Close-Out Visit will occur to: 

 
 
 
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• 
Ensure all supplies have been accounted for and documented according to the study protocol 
and the remaining materials either returned to the Sponsor or distributed to the subjects as 
outlined in the study protocol. 
• 
Complete all monitoring at the study site and close-out any open data discrepancies. 
• 
Ensure all regulatory documents are on file at the clinical site. 
• 
Review the Investigator
's responsibilities after the termination activities have been completed. 
13.6 Training of Investigators and Study Site Staff 
All Investigators and study staff, authorized to perform study procedures, will receive training on the 
following aspects of the study: 
• 
Clinical study protocol including: 
o Principles ICH & GCP, Declaration of Helsinki and FDA 21 CFR Parts 11, 50, 54, 56, 803, 812, 
814 and 820.30; as applicable, with all local laws and regulations and with the regulatory 
requirements for source data verification 
o Protocol and study procedures. 
o SAE Reporting procedures including completion of SAE Report Form (eCRF) and/or 
Malfunction /complaint Reporting procedures 
o Monitoring and Audits. 
o As necessary for compliant study conduct. 
• 
Study devices: 
o ACCU-CHEK® Connect Diabetes Management System (DMS) and consumables 
o Smartphones, if applicable. 
• 
Completion of eCRF: 
o Passwords, Data Entry, Corrections, Query process, and Sign-off. 
o Completion of SAE Report Form and sending to the Sponsor. 
o Documentation of protocol violations and deviations. 
o Device data upload procedures if applicable 
• 
Completion of Subject Questionnaire – electronically by means of provided study laptop (at 
site) into the study eCRF web based system.. 
• 
Completion of HCP Questionnaire – electronically by means of the provided study laptop into 
the study eCRF web based system . 
• 
Procedures for Central Lab (Handbook etc.) 

 
 
 
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14 Reporting of Protocol Violations and Deviations 
For the purpose of this study, the following definitions will be used: 
Protocol Violation: a violation that may impact subject safety, affect the integrity of study data 
and/or affect subject’s willingness to participate in the study. 
Protocol Deviation: a violation that does not impact subject safety, compromise the integrity of 
study data and/or affect subject’s willingness to participate in the study. 
Protocol violations and deviations will be recorded in the eCRF throughout the study, and 
documented further via the query-system, as applicable. 
The Investigator must notify the Sponsor and the reviewing EC of any protocol violations to protect 
the life or physical well-being of a subject in an emergency as soon as possible but no later than 5 
working days after the emergency occurred. 
For protocol deviation, only the Sponsor also needs to be notified. 
In this study, visit time windows deviations are not considered as protocol deviations. 

 
 
 
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15 References 
1.  Centers for Disease Control and Prevention. 2014 National Diabetes Fact Sheet: national estimates 
and general information on diabetes and prediabetes in the United States. Accessed April 3, 2015 
from http://www.cdc.gov/diabetes/pubs/factsheet11.htm.  
2.  Weissberg-Benchell J, Glasgow AM, Tynan WD, Wirtz P, Turek J, Ward J: Adolescent diabetes 
management and mismanagement. Diabetes Care 1995;18:77–82, 1995 
3.  Faro B: Students with diabetes: implications of the Diabetes Control and Complications Trial for 
the school setting. J Sch Nurs 1995;11:16–21. 
4.  Faro B, Ingersoll G, Fiore H, Ippolito KS:Improving students’ diabetes management through school-
based diabetes care. J Pediatr Health Care 2005;19:301–308. 
5. Hood KK, Naranjo D, Barnard K. Measuring depression in children and young people. In: Lloyd CE, 
Pouwer F, Hermanns N, editors. Screening for Depression and Other Psychological Problems in 
Diabetes: A Practical Guide. New York: Springer Press; 2012: 119-38. 
6. Herzer M, Hood KK. Anxiety symptoms in adolescents with type 1 diabetes: association with blood 
glucose monitoring and glycemic control. J Pediatr Psychol 2010; 35: 415-25. 
7.  Wysocki T, Meinhold P, Cox DJ, Clarke WL. Survey of diabetes professionals regarding 
developmental changes in diabetes self-care. Diabetes Care 1990;13:65–68. 
8.  Lindsay R, Jarrett L, Hillam K. Elementary schoolteachers’ understanding of diabetes. Diabetes 
Educ 1987;13: 312–314.