Evaluation of the Performance of Contour Next® and Contour Plus Elite® Blood Glucose Monitoring Systems (BGMS) in Arterial Blood Samples From Hospitalized Adults
Conditions: Diabetes Mellitus
Sponsor: Ascensia Diabetes Care

Protocol /CIP: GCA-PRO-2021-004-01 
 
 
 
 
 
Ascensia Diabetes Care 
Project 00096 – Final version: 09AUG2022 
 
 
 
 
 
CONFIDENTIAL 
 
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Evaluation of the Performance of Contour Next® and Contour Plus 
Elite® Blood Glucose Monitoring Systems in Arterial Blood Samples 
from Hospitalized Adults 
 
  Protocol/CIP:    GCA-PRO-2021-004-01 
 
Sponsor:            Ascensia Diabetes Care Australia Pty Ltd 
                             L3 SE6 25 SOLENT CCT 
                             Baulkham Hills, NSW 2153, Australia 
 
 
 
 
Rosanna Cirio, MA 
Manager, Clinical Affairs 
Date 
Andrew Humeniuk, BS, DC, MBA 
Clinical Study Lead  
Date 
Wendy Mak 
Medical Affairs Manager APAC 
Date 
James Venosky, NPDP 
Sr. Program Manager  
Lightning &  Thunder Project  
  
Date 
Rimma Shaginian, MD, MPH  
Medical Lead – Emerging 
Markets, Medical 
 
Date 
Shahrir Alam 
Regulatory Affairs Product 
Manager 
Date 
 
 
Scott Pardo, PhD, PStat® 
Deputy Director,  Statistics and 
Data Management 
 
Date 

Protocol /CIP: GCA-PRO-2021-004-01 
 
 
 
 
 
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CONFIDENTIAL 
 
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Investigator Statement I have read this protocol and agree to ensure  the conduct of the clinical 
performance study in accordance to the protocol as outlined  I understand and agree  that before 
seeking approval from an Ethics Review Committee, the Ascensia Diabetes Care study manager 
must approve any changes to the protocol.  I also agree to protect the rights, safety, dignity and 
well-being of the participants .  
 
 
Principal Investigator:             Mark Plummer, MD 
Site:                                         Royal Adelaide Hospital , ICU Research Unit 
Address:                          
 
 
_____________________________                  ___________________                         ____________________ 
           PI Signature :                                      Printed Name:                                    Date: 
 
 
 
 
 
This protocol and the data obtained from the study are confidential and may not be disclosed 
without the prior written consent of Ascensia Diabetes Care (ADC). 
 
 
 

Protocol /CIP: GCA-PRO-2021-004-01 
 
 
 
 
 
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Table of Contents  
 
Table of Contents .......................................................................................................................... 3 
Abbreviations................................................................................................................................ 5 
1.0 Identification of the Protocol/ Clinical Investigation Plan (CIP) ............................................... 6 
2.0 Contact Information ............................................................................................................. 6 
3.0 Synopsis of the Clinical Study ................................................................................................ 7 
4.0 Identification and description of the investigational device ................................................... 8 
5.0 Background .......................................................................................................................... 9 
6.0 Justifiation for Design of the Clinical Study ........................................................................... 10 
7.0 Risks and benefits of the investigational device and clinical investigation ............................. 10 
8.0 Objectives and Hypotheses .................................................................................................. 11 
9.0 Clinical Study Design ............................................................................................................ 12 
10.0 
Investigational device(s) and comparator(s) ...................................................................... 12 
11.0 
Participants ...................................................................................................................... 14 
12.0 
Procedures ....................................................................................................................... 15 
13.0 
Monitoring Plan ............................................................................................................... 19 
14.0 
Statistical Plan.................................................................................................................. 19 
15.0 
Data Management ........................................................................................................... 22 

Protocol /CIP: GCA-PRO-2021-004-01 
 
 
 
 
 
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16.0 
Amendments to the Protocol............................................................................................ 23 
17.0 
Deviations from the clinical protocol ................................................................................ 25 
18.0 
Device Accountability ....................................................................................................... 25 
19.0 
Regulatory ....................................................................................................................... 26 
20.0 
Statements of compliance ................................................................................................ 27 
21.0 
Informed Consent Process ................................................................................................ 27 
22.0 
Adverse events and adverse device effects ....................................................................... 29 
23.0 
Handling and Reporting of Device Deficiencies .................................................................. 31 
24.0 
Vulnerable population ...................................................................................................... 31 
25.0 
Suspension/Premature termination and Participant Withdrawal Criteria .......................... 32 
26.0 
Results Handling .............................................................................................................. 32 
27.0 
Publication policy ............................................................................................................. 32 
28.0 
Administration ................................................................................................................. 33 
29.0 
Bibliography ..................................................................................................................... 33 
Appendix A-  Instructions for Cleaning and Disinfecting  Meters .................................................... 36 
Appendix B - Instructions for Processing Blood for Laboratory Analyzer Analysis ........................... 37 
Appendix C - Instructions for Tracking Accuracy and Precision of Laboratory Analyzer ................... 38 
Attachment 1 -   Contour Next User Guide .................................................................................... 40 
Attachment 2 – Contour Plus Elite User Guide ............................................................................... 42 

Protocol /CIP: GCA-PRO-2021-004-01 
 
 
 
 
 
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CONFIDENTIAL 
 
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Abbreviations 
 
 
ADC                           Ascensia Diabetes Care 
AE 
Adverse Event 
ADE 
Adverse Device Effect 
BG 
Blood Glucose 
BGMS 
Blood Glucose  Monitoring System 
CIP 
Clinical Investigation Plan (Protocol) 
CRF 
Case Report Form 
EC 
Ethics Committee 
EDC 
Electronic Data Capture 
GCP 
Good Clinical Practice 
HCP 
Health Care Professional 
ICU 
Intensive Care Unit 
ICF 
Informed Consent Form 
LAR 
Legally Authorized Representative 
PI 
Principal Investigator  
POC 
Point Of Care 
SAE 
Serious Adverse Event 
SADE 
Serious Adverse Device Effect 
SIV 
Site Initiation Visit 
          

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1.0 Identification of the Protocol/ Clinical Investigation Plan (CIP) 
1.1 
Title of the clinical investigation:  Evaluation of the Performance of Contour Next® and 
Contour Plus Elite® Blood Glucose Monitoring Systems in Arterial Blood Samples from 
Hospitalized Adults 
1.2 
Protocol Number:  GCA-PRO-2021-004-01 
1.3 
Date:  August 09, 2022 
1.4 
Revision Status 
 
Date 
Revision History 
Initial Release 
 
1.  
 
2.0 Contact Information  
2.1 
Sponsor:     Ascensia Diabetes Care Australia Pty Ltd 
                              L3 SE6 25 SOLENT CCT 
 
Baulkham Hills, NSW 2153, Australia 
 
 
CRO:          Project Manager : 
 
Gladys Williams 
 
Labcorp Development Pty Ltd.  
 
gladys.williams3@labcorp.com 
       Phone: +61 499 511 781 
2.2 
PI / coordinating investigator:   
First Name: Mark 
 
Last Name:  
Plummer, MD 
Institution/Practice/Clinic 
Name:  
Royal Adelaide Hospital , ICU Research Unit 
Address:  
Port Road 
Town/City:  
Adelaide 
State/Province/Region:  
SA 
Country:  
Australia 
Zip/Postal Code:  
5000 
Office Phone Number:  
0491708399 
 
 
PI Direct Office Phone Number  0419708399 
Office Email Address:  
Mark.plummer@sa.gov.au 

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2.3 
Professional position, roles, responsibilities and qualifications: ICU Medical Doctor. 
2.4 
Name(s) and address(es) of other institutions involved:   
 
Labcorp Development Pty Ltd. (Labcorp) 
ABN 99 003 613 134, Suite 3.02 
97 Waterloo Road, Macquarie Park, NSW 2113, Australia 
2.5 
Description of study financing and the agreement between the sponsor/site. 
         Clinical Trial Research Agreement between Investigational Site and LabCorp.   
3.0 Synopsis of the Clinical Study  
Design Type:   
Open Label, prospective, single arm study  
Investigational 
Devices:  
Contour Next ® Blood Glucose Monitoring System  
Contour Plus Elite® Blood Glucose Monitoring System 
Trial objective 
The purpose of the study is to extend the intended use of two BGMSs to 
include testing of arterial blood by Health Care Professionals (HCP) in a 
clinical setting.  
This trial will evaluate the performance of both Contour Next BGMS 
and Contour Plus Elite BGMS using arterial blood from adult patients 
hospitalized in a Critical Care Unit (medical and surgical Intensive Care 
Units (ICUs)). The investigational BGMS will be tested  by a Point of 
Care (POC) operator in a clinical setting using residual arterial blood 
samples from adults who  underwent prescribed arterial blood tests that 
were deemed necessary due to their medical conditions. 
Reference Analyzer 
Cobas c 702; Roche Diagnostics 
Sample size: 
A total of at least 120 blood samples tested in duplicate with at least 
N=240 evaluable results are required for this study. Up to 150 
participants may be enrolled to obtain the required number of samples. 
Inclusion and 
Exclusion 
criteria: 
Inclusion Criteria 
• Patients who are at least 18 years old. 
• Residual Arterial blood samples collected from adult patients hospitalized 
in a Critical Care Unit (medical and surgical intensive care units (ICUs)).  
• Sample blood volume must be sufficient to complete investigational 
testing in addition to prescribed clinical laboratory testing. 
 

Protocol /CIP: GCA-PRO-2021-004-01 
 
 
 
 
 
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Exclusion Criteria 
●    Residual arterial blood samples collected from participants previously 
      enrolled and evaluated for this study.  
  
Objectives and 
Endpoints: 
The primary objective of the study is to evaluate the performance of Contour 
Next and Contour Plus Elite BGMSs with residual arterial blood samples. The 
performance of the BGMSs will be analyzed according to the following 
objectives:  
Primary Objective:  
• At least 95% of all blood glucose results shall fall within ±12.5% of reference 
values (laboratory method) for glucose concentration ≥100 mg/dL (5.55 
mmol/L) and within ±12 mg/dL(±0.67 mmol/L) at glucose concentrations 
<100 mg/dL (5.55 mmol/L). 
• At least 98% of values should be within ±20% of reference values (laboratory 
method) for glucose concentration ≥75 mg/dL (4.16 mmol/L) and within ±15 
mg/dL (±0.83 mmol/L) at glucose concentrations < 75 mg/dL (4.16 mmol/L).  
Number of study sites 
1  
Proposed Start Date: 
September 2022 
Study Duration 
Total expected duration of the clinical investigation is  ~24 weeks. The 
residual blood sample from the participant will be tested per study 
procedures on the day of sample collection. 
4.0 Identification and description of the investigational device  
4.1 
Name of the investigational device: 
• Contour Next blood glucose monitoring system (Meter, Contour Next Test Strips, 
Control solutions)   
• Contour Plus Elite blood glucose monitoring system (Meter, Contour Plus  Test Strips, 
Control solutions)   
4.2 
Intended purpose of Investigational Device  
4.2.1 The Contour Next and Contour Plus Elite blood glucose monitoring systems 
(BGMS), comprised of the blood glucose meter, the compatible test strips, and 
control 
solutions, 
are 
automated 
systems 
intended 
for 
the 
quantitative  measurement of glucose in fresh capillary whole blood drawn from 
the fingertip or palm and venous blood.  Its use in this clinical trial is for the 
quantitative measurement of  glucose in arterial blood.  

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4.2.2 The system is intended to be used for self-testing  by lay persons with diabetes  and 
for near-patient testing by health care professionals (HCP) to monitor  the 
effectiveness of diabetes  control.  
4.2.3 The BGMS can only be used for monitoring blood glucose levels and is not for 
diagnosis or screening of diabetes. The system is intended for in vitro diagnostic 
use only. 
4.3 
Manufacturer of the device is Ascensia Diabetes Care. 
4.4 
Traceability of the devices are achieved by serial numbers on the meters and lot numbers 
of the test strips and controls. 
4.5 
The population for which the device is intended in this study is critically ill patients in a 
hospital setting.  
4.6 
No contact between the devices and the patients is required since all testing will be 
performed on residual blood sampled from a tube.  
4.7 
The technical and functional features of the Investigational devices, Contour Next and 
Contour Plus Elite Blood Glucose Monitoring Systems, can be found in the User Guides 
(Attachment 1 and Attachment 2).  
4.8 
The instructions for use for the devices are provided in the User Guides (Attachment 1 and 
Attachment 2).  
4.9 
Training and experience required for use of the device is GCP training and laboratory 
experience. The study staff will be provided specific device training as part of the Site 
Initiation Visit (SIV) by the sponsor.  
5.0 Background 
Diabetes and stress hyperglycemia is very common in hospital settings and are associated with 
increases in hospital complications, length of stay and mortality. It is noteworthy that 
hypoglycaemia in hospitalized patients is also associated with poor in-patient outcomes and health-
care costs. Published meta-analysis, including results of the NICE-SUGAR study, showed that 
intensive insulin therapy (target blood-glucose control, 80 to 110 mg/dl) was not beneficial and 
increased the risk of severe hypoglycemia in critically ill patients. Therefore it is important that 
hyperglycemia and hypoglycaemia should be avoided in hospitalized patients. 
Different methods of blood glucose measurement in critically ill patients are used in daily practice, 
ranging from point-of-care (POC) glucose measurements with capillary or arterial blood, arterial 
whole blood in blood gas analyzers and to plasma or serum from venous or arterial blood measured 
in the central lab. Blood glucose measurements in plasma in remote central laboratory facilities of 
the hospital may be impractical, inefficient and unsafe to implement  tight glycemic control due to 
the inevitable time delay between sampling and availability of the blood glucose result to the 
clinical staff. Methodologies for blood glucose measurements at the patient’s bedside or in the ICU 
itself are therefore preferred from a logistical point-of-view.  

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In critically ill patients, having severe hemodynamics disturbance, decreased microcirculation, 
hypoxia for example, the only reliable source to assess vital parameters including blood glucose is 
arterial blood. Tight glycemic control and avoiding hypoglycemia as well as hyperglycemia in 
these severe patients is pivotal. It is noteworthy that a majority of these patients have complex 
comorbidities and are very often being treated by multiple agents (polypharmacy); therefore the 
performance of BGMS in their patients may be significantly different than when they are used for 
self-management of diabetes. Several studies have described variability in measurements made by 
different POC BGMSs or between these instruments and central laboratory analyzers, mainly due 
to the lower accuracy in the low blood glucose range and lower specificity of the enzymes used 
such as glucose oxidase, which make them susceptible to interference. That is why the more 
stringent accuracy assessment criteria for hospital-based blood glucose monitoring have been 
proposed by many international organizations, including the International Standardization 
Organization (ISO), and the Clinical Laboratory and Standards Institute (CLSI) and FDA.  
6.0 Justifiation for Design of the Clinical Study 
The Contour Next and Contour Plus Elite are investigational blood glucose monitoring systems 
(BGMS), comprised of the blood glucose meter, the compatible test strips, and control solutions. 
They are automated systems intended for the quantitative measurement of glucose  in arterial 
blood, venous blood, fresh capillary whole blood drawn from the fingertip or palm. The system 
is intended to be used for self-testing by lay persons with diabetes  and for near-patient testing by 
health care professionals to monitor  the effectiveness of diabetes control. Alternative site testing 
(palm) should be done only during steady state times (when glucose is not changing rapidly). 
The system is intended for in vitro diagnostic use only. Its investigative use is for the quantitative 
measurement of glucose in arterial blood by Health Care Professionals (HCP) in a clinical 
setting. 
This investigational clinical trial will evaluate the performance of two BGMS (Contour Next 
BGMS and Contour Plus Elite BGMS) using arterial blood from adult patients hospitalized in a 
Critical Care Unit (medical and surgical intensive care units (ICUs)). The BGMS will be used by 
a POC operator in a clinical setting using residual arterial blood samples from adults who 
underwent prescribed arterial blood tests that were deemed necessary due to their medical 
conditions. Only  residual blood, no longer needed for clinical purposes, will be used for this study.  
7.0 Risks and benefits of the investigational device and clinical investigation 
Risks 
This is a low risk study. Residual blood samples will ONLY be collected and tested for the study 
if the participant is having blood tests as prescribed by their physician and the blood is no longer 
needed for the patient’s medical care. Therefore, there will be no additional blood samples 
withdrawn for this study. All testing procedures with the investigational device will be performed 

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by the study staff in a laboratory setting and at no point will the patient come in contact with the 
Investigational device or any other study related material. There is no discomfort to the patient as 
only residual blood will be collected.  
There are no risks to patients associated with this study except for the potential for loss of 
confidentiality. Measures will be taken to minimize this risk by de-identifying study samples. 
Study samples will be assigned a number and only the participant’s age and gender will be recorded. 
The participants initials or any other identifiable information will not be captured. 
Without the identification list that is exclusively stored at the site, connection between personal 
data and study data is not possible.   
Results of this investigational study are not intended for diagnostic purposes of the individual and 
are not significant for the participant’s welfare. The results of the study are only intended to assess 
the performance of two BGM’s when tested with arterial blood.  
Benefits 
There are no direct benefits to the participant for donation of residual blood samples for this study  
except to contribute to a study that provides information on the performance of two blood glucose 
monitoring systems when measuring glucose in arterial blood by healthcare professionals within 
a clinical setting.  
Participants will not receive compensation for the donation of blood samples. 
There are no anticipated adverse device effects.  
8.0 Objectives and Hypotheses  
The primary objective of the study is to evaluate the performance of Contour Next and Contour 
Plus Elite BGMSs with residual arterial blood samples. The performance of the BGMS will be 
analyzed according to the following objectives:  
8.1 
Primary Objective: The accuracy criteria below are taken from the CLSI. Point-of-Care 
Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline – Third 
Edition. CLSI document POCT12-A3. Wayne, PA: Clinical and Laboratory Standards 
Institute; 2013).  
8.1.1 At least 95% of all blood glucose results shall fall within ±12.5% of reference 
values (laboratory method) for glucose concentration ≥100 mg/dL (5.55 mmol/L) 
and within ±12 mg/dL (±0.67 mmol/L) at glucose concentrations <100 mg/dL (5.55 
mmol/L). 
Note: Satisfying Criterion 8.1.1 would also satisfy the ISO 15917:2013 criteria of 
obtaining the ±15% of reference values (laboratory method) for glucose 

Protocol /CIP: GCA-PRO-2021-004-01 
 
 
 
 
 
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concentration ≥100 mg/dL (5.55 mmol/L )and within ±15 mg/dL (±0.83 mmol/L)  
at glucose concentrations <100 mg/dL (5.55 mmol/L). 
8.1.2 At least 98% of values shall be within ±20% of reference values (laboratory method) 
for glucose concentration ≥75 mg/dL (4.16 mmol/L) and within ±15 mg/dL (±0.83 
mmol/L) at glucose concentrations < 75 mg/dL (4.16 mmol/L). 
8.2 
Other Objectives: 
Compute differences between BGMS and laboratory blood glucose measurements and plot them 
against hematocrit results. 
9.0 Clinical Study Design  
9.1 
This is an open label, prospective, single arm study. The results of the study devices will be 
compared to the laboratory analyzer results from the same blood sample. 
9.2 
For each BGMS, at least 120 evaluable samples and at least (N=240) evaluable results due 
to duplicate testing are required. Up to 150 participants may be enrolled to obtain the 
required number of samples. 
9.3 
Randomization: 
9.3.1 Since two BGM systems will be tested in the study, the order of testing the study 
devices will be randomized.  
9.3.2 Three strip lots (per BGMS) will be tested, with each sample tested with one lot.  
The strip lots will be randomized. 
9.4 
 The results from these two BGMS systems will not be compared to each other. 
9.5 
The study design follows  CLSI-POCT12-A3:2013; and ISO 20916:2019 (E)  to ensure it 
is scientifically robust and valid. 
9.6 
Participants with non-evaluable data will be replaced as needed to obtain at least N=120 
samples, and at least N=240 results (duplicate results) for each BGMS. 
10.0 Investigational device(s) and comparator(s)  
10.1 Materials and  Methods 
10.1.1 Resources Supplied by Investigator - Staffing 
• Principal Investigator / and Sub-Investigators 
• Healthcare professional to collect blood samples  
• Site Study Staff  to perform meter testing and hematocrit, and Laboratory 
professionals to perform laboratory analyzer testing 

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10.1.2 Resources Supplied by Investigator - Other 
• Hospital Ethics Committee approval of the protocol 
• Facility with adequate laboratory resources for conducting all tests (blood 
glucose laboratory analyzer, hematocrit measurement instrument) 
• Facility with adequate participant  population for up to 150 study-appropriate 
samples within the desired course of the trial 
• Laboratory Analyzer, approved by the sponsor, to measure glucose in plasma. 
(Cobas c 702, Roche Diagnostics)) 
• Thermometer/hygrometers for measuring environmental conditions at the meter 
testing location as needed 
• Print-outs of the glucose analyzer results for Quality Control (QC) checks 
during study days 
10.1.3 Resources Supplied by Ascensia - Materials 
• Protocol and sample case report forms 
• Serum controls for the laboratory glucose analyzer  
• CONTOUR  NEXT® meters  
• CONTOUR  PLUS ELITE® meters  
• CONTOUR  NEXT®  User Guide 
• CONTOUR  PLUS ELITE® User Guide 
• CONTOUR NEXT® strips (3 lots) with inserts 
• CONTOUR PLUS® strips (3 lots) with inserts 
• CONTOUR NEXT® and CONTOUR PLUS® Low, Normal, and High 
(Levels) Control solutions with inserts 
• Thermometer/hygrometers for measuring environmental conditions at 
the meter testing location if needed. The site may use its calibrated 
measuring devices with approval of Ascensia 
10.2 Note that the participants will not be exposed to the study devices since residual blood 
samples will be collected in a tube and used for all study procedures.  
10.3 All meters will have Bluetooth® ON. 
10.4 The meters, test strips, and CONTOUR NEXT and PLUS control solutions must be stored 
at 9-30C. See Appendix C for serum control storage. 

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11.0 Participants  
11.1 Recruitment and Enrollment   
11.1.1 A minimum of 120 participants will be recruited for enrollment. Additional 
participants may be recruited to obtain a total of 240 evaluable results. Up to 150 
participants may be enrolled to obtain the required number of samples. See section 
13.8 for  definition of evaluability.  
11.1.2 The participant population will consist of adults who are hospitalized in a Critical 
Care Unit, (medical and surgical intensive care units (ICUs)) at the Investigational 
site.  
11.1.3 Participants will be recruited from the hospitals Electronic Medical Records upon 
admission by the study staff. 
11.1.4 If consent is required, the participant or the Legally Authorized Representative 
(LAR) of the Participant signs the Informed Consent Form. 
11.1.5 The study staff will document participant demographics including age and gender. 
11.1.6 If a participant withdraws before study start or is excluded by the Investigator, 
another participant could be recruited so that the validity of the study results will 
not be compromised. 
11.1.7 Unused residual samples will be discarded according to hospital standard 
operational procedures. 
11.2 Inclusion Criteria 
11.2.1 Patients who are at least 18 years old. 
11.2.2 Residual Arterial blood samples collected from participants hospitalized in a 
Critical Care Unit (medical and surgical intensive care units (ICUs)). 
11.2.3 Sample blood volume must be sufficient to complete investigational testing 
procedures clinical laboratory testing. 
11.3 Exclusion Criteria 
11.3.1 Residual arterial blood samples collected from participants previously enrolled. and 
evaluated for this study.  
11.4 Study Duration  
11.4.1 Total expected duration to complete  the clinical investigation is 24 weeks 
11.4.2 The expected duration of each participant's participation is not applicable since 
there is no direct participant participation. Only residual blood samples from 

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participants will be tested per the study procedures only on the day of sample 
collection. 
12.0 Procedures  
12.1 Summary 
Laboratory professionals will test the blood glucose concentration of residual arterial blood 
samples, collected (into a tube with anticoagulant) from participants using the Contour Next and 
Contour Plus Elite BGMSs. For participant’s safety reasons, only residual arterial blood will be 
used which had been collected as prescribed for clinical testing and is no longer needed for clinical 
purposes.  
A minimum of 120 residual arterial blood samples will be tested with both BGMSs in duplicate. 
Approximately 2mL of whole blood will be removed from the participant's sample tube and will 
be used for completing a total of 4 tests using both BGMSs (two tests with Contour Next BGMS 
and two tests with Contour Plus Elite BGMS), a hematocrit measurement, and duplicate laboratory 
glucose measurements. Each participant sample will be tested using both BGMS as per the 
randomization schedule. After completion of the BGMS testing, each meter will be cleaned and 
disinfected as per the procedures in Appendix A.    
 
The site staff will use their Laboratory Analyzer (approved by the Sponsor) for the laboratory 
assessment of blood glucose samples tested in duplicate (laboratory duplicate results will be 
averaged).  
During the study, a minimum of 10 test strip vials (50 test strips in each vial) that cover a minimum 
of 3 test strip lots will be used for each BGMS. The test strip lots will be  randomly coded as green, 
blue, or red to easily identify the bottles during the study. See Table 1 for the description of test 
strip distribution during the study (note: the 3 test strip lots are arbitrarily designated as Red, Green, 
or Blue). 
Blood samples will be assigned to one of three test strip lots. The assignment will be made in a 
rotating order following the random order in which samples are received. 
The order of testing for both BGMSs will also be randomized for each sample. 
Table 1 - Strip Lot Assignments Per Meter Type 
Meter System &  
Test Strips 
Green Lot 
Red Lot 
Blue Lot 
CONTOUR NEXT Meter 
(CONTOUR NEXT Test Strips) 
~40  Samples  
~80 tests  
~40 Samples 
~80 tests  
~40 Samples 
~80 tests  
CONTOUR PLUS ELITE Meter 
(CONTOUR PLUS Test Strips) 
~40 Samples 
~80 tests  
~40 Samples    
~80 tests  
~40 Samples 
~80 tests  
 

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12.2 Study Staff Training  
The site study staff will participate in a training session conducted by the Ascensia Study 
team or designee.  The training will be documented and the following will be reviewed: 
12.2.1 Protocol & case report forms 
12.2.2 Review of the instructions for use (UG) 
12.2.3 Review of meter control solution testing 
12.2.4 Error messages and troubleshooting 
12.2.5 Good Clinical Practice  
12.2.6 Training and practice using the Contour Next ® and Contour Plus Elite® BGMS  
12.2.7 Practice preparing and reading hematocrit samples if using Ascensia hematocrit 
instrument 
12.3 Meter Control Solution Testing   
Control testing on study BGMS will occur after the meters arrive at the site and before trial 
starts. 
12.3.1 The site staff will equally distribute the strip lots for control testing before the 
start of the trial. 
12.3.2 The site staff will perform 3 (one each of  low, normal and high) control tests on 
each of the CONTOUR NEXT® and CONTOUR PLUS ELITE® BGMS assigned 
for the study. 
12.3.3 Results will be recorded and compared to the ranges for the control are listed on 
the test strip bottle.  
12.3.4 If results are out of range, troubleshooting will be performed (see meter UGs) and 
the test will be repeated for a total of up to 3 attempts.  
12.3.5 If the meter tests are out of range after troubleshooting is complete, the meter will be 
removed from the study, and Ascensia Study Manager will be notified.  Additionally, 
this will be documented on the ‘Device Deficiency Reporting Form’. 
12.4 Blood  Glucose Testing 
12.4.1 
Blood samples used for the study, approximately ~2mL, will be obtained from 
residual arterial blood that is drawn for prescribed testing. No blood will be 
taken from study participants solely for this study. 
12.4.2 
Samples will be collected according to hospital standards and procedures and will 
be collected into a tube containing anticoagulants (lithium/heparin). 

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12.4.3 
All samples will be transported to the laboratory per standard practice and 
submitted for prescribed clinical testing. 
12.4.4 
Arterial blood samples will be inspected to verify if the volume drawn was 
sufficient to complete both prescribed clinical and investigational testing by 
laboratory personnel. 
12.4.5 
Samples that do not have sufficient volume to complete the required 
investigational testing will not be used for the clinical trial. 
12.4.6 
The collected samples will be used within a maximum of 5 h of sample 
collection time, and will be kept at room temperature (23 ± 5 °C) before 
evaluation. 
12.4.7 
If sufficient volume is available, no more than the agreed amount for each site  
of arterial whole blood will be removed from the original sample to perform 
blood glucose testing on two investigational BGMSs, laboratory analyzer, and 
hematocrit measurement. 
12.4.8 
Each blood sample will be assigned an ID that is not traceable to the identity of 
the participant. The first digit will indicate the site ID followed by three digits 
indicating the sample ID as follows: X-001, X-002, X-003, and so on. 
12.4.9 
Strip lot (color code) will be determined via a randomization schedule provided by 
the Sponsor.  
12.4.10 The testing order of the meter will also be based on a randomization schedule. Note 
that one Contour Next and one Contour Plus Elite BGMS per participant will be 
used and the meters will be disinfected after use as per procedures listed in 
Appendix A. 
12.4.11 For each participant, a CONTOUR NEXT® BGMS, and a CONTOUR PLUS 
ELITE® BGMS will be brought to the testing area. A test strip (as assigned for the 
given BGMS) will be inserted into each of the 2 meters (same color code strip lot 
for both meters).  
12.4.12 A drop of blood will be placed on a piece of Parafilm (or other non-absorbent 
material) and immediately tested with the first and second meter. 
12.4.13 The test strips in the two meters will then be replaced, to prepare the meters for 
duplicate testing. 
12.4.14 A new drop of blood will be placed on the Parafilm and immediately tested with 
the first and second meter for duplicate testing .  
12.4.15 A hematocrit measurement (%) will also be performed on the sample per site 
hematocrit analyzer procedures.  
12.4.16 An aliquot of blood (from the same sample as used in meter testing) will be 
centrifuged within 10 minutes of BG testing for separation into plasma. (See 
Appendix B)  
12.4.17 The start time of centrifugation will be recorded. Centrifugation must be performed 
within 10 minutes of the first-meter assay.  

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12.4.18 The plasma will be tested in duplicate with the laboratory analyzer within 60 
minutes of the meter test. If greater than 60 minutes of the meter test, plasma 
samples may be refrigerated or frozen. (See Appendix B) 
 
12.5 Errors 
12.5.1 If the meter reports an error code during blood glucose testing, the instructions 
shown in the UG should be followed. Re-testing is recommended (per the UG).  
The reason for the repeated test will be documented in the comments section of the 
form. No more than a total of 3 attempts are allowed. 
12.5.2 The study staff will record all meter error codes as appropriate for the meter tests 
as it occurs. 
12.6 Testing Schematic 
Table 2 – Sample Testing Schematic 
Step 
Test type 
Description 
1 
Sample prep 
 Ensure collection of  residual Arterial sample in collection tube containing anticoagulant 
(lithium/heparin). 
 Confirm sufficient blood volume to perform all testing procedures.  
 If so,  then aliquot ~2mL into microtube and cover. 
2 
Testing prep 
Assign one  CONTOUR NEXT meter and one  CONTOUR PLUS  ELITE meter to the patient 
sample.  
 Follow the strip lot randomization (red, green, blue) and get the test strip bottle for the 
respective meter. 
 Get a piece of parafilm.  
 For steps 3 and 4, follow meter test order per randomized schedule.  
3 
 Meter Test 1 
 Put a test strip into each meter. 
 Immediately place 1 drop of blood on the parafilm and test with both meters and record results.  
 In case of error, may repeat 2 more times with a new blood drop. 
 Record time of successful meter test.  
4 
Meter Test 2 
 Replace test strips , place new drop of blood  on parafilm and repeat Step 3 for duplicate 
testing.  
5 
Hematocrit 
 Using the blood from the same collection tube, perform hematocrit measurement in accordance 
with site procedures. 
 Record result. 
6 
Centrifugation  Centrifuge blood, and record start time. (Should be within 10 min of meter tests). 
7 
Laboratory 
tests 
 Perform blood glucose testing of plasma on laboratory analyzer in duplicate.   
 Record results. 
 
12.7 Accuracy and Precision of Laboratory Analyzer  
• Performance of the Analyzer instruments to be used for this study will be tracked 
with 2 methods. The primary method will be the analyzer quality control QC check 
procedure regularly applied by the clinical site. In addition, serum controls will be 

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provided by Ascensia for internal research purposes only, and will not impact the 
study data or data collection. See Appendix C for further details. 
12.8 Temperature and Humidity Logs  
• The study staff will measure the temperature and humidity in the meter testing area 
once during the day that meter testing occurs and record the results on the appropriate 
log form. 
• Study staff will maintain temperature log for the storage of investigational materials 
including the meters, test strips, meter controls, and serum controls. 
13.0 Monitoring Plan  
13.1 A monitoring plan will be completed by the Study Manager/designee prior to the study. 
13.2 The study manager or designee will conduct a study initiation visit. The frequency of the 
number of monitoring visits by sponsor personnel or designee(s) will be based on the 
monitoring plan and will include at least 1-3 monitoring visits and a close-out visit.  
13.3 Sponsor representatives may observe some study testing as part of study monitoring. This 
will be done under supervision of the Investigator. 
13.4 Sponsor representatives will maintain participant confidentiality and will not interfere with 
the rights of human participants, safety, or bias study conduct. 
14.0 Statistical Plan  
14.1 Sample Size 
14.1.1 The sample size requirement is based on the primary objective, section 8.0. 
14.1.2 There will be a minimum of  N = 120 study samples  entered into the study.  The 
meter results will be taken in duplicate, so that the total sample size of meter results 
will be 2*120 = 240. 
14.1.3 With a sample size of n = 240 results, there is approximately a 95% chance that at 
least 228 of those results (95% of 240) will be "accurate" (errors within either ±12 
mg/dL (±0.67 mmol/L) when the comparator result is < 100 mg/dL (5.55 mmol/L), 
or ±12.5% when the comparator result is ≥ 100 mg/dL (5.55 mmol/L) if the 
evaluation (meter) system has a 96.77% chance of yielding an "accurate" result. 
14.1.4 Conversely, there is about a 95% chance of obtaining fewer than 228 "accurate" 
results if the system only has an approximately 92.03% chance of yielding an 
accurate result. 

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14.1.5 Note that each glucose result obtained with the evaluation devices will be 
considered either 'accurate' or 'not accurate, where accuracy depends on the 
particular test criterion as described in section 7.0 of this protocol. 
14.2 Blood  Glucose Measurements 
Data analysis follows analyses and presentations described in the CLSI. Point-of-Care 
Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline – Third 
Edition. CLSI document POCT12-A3. Wayne, PA: Clinical and Laboratory Standards 
Institute; 2013. 
14.3 Bland-Altman  Plots 
Modified Bland-Altman plots (the difference between each evaluation device results and 
reference results plotted against reference results) will be constructed. 
14.4 Weighted Least Squares Regression 
Weighted least squares regressions of meter results against comparator results will be performed.  
If M represents the meter result, and C the comparator result, the linear model can be expressed as: 
𝑴𝑴=  𝜷𝜷𝟎𝟎+ 𝜷𝜷𝟏𝟏𝑪𝑪+ 𝜺𝜺 
𝜺𝜺~𝑵𝑵(𝟎𝟎, 𝒄𝒄𝒄𝒄∗𝑪𝑪) 
The parameter cv is the coefficient of variation, which is assumed to be constant across the glucose 
range. The weighting function will be: 
𝒘𝒘= 𝑪𝑪−𝟐𝟐 
This weighting function is used to account for the constant cv nature of glucose measurement 
(Draper and Smith, 1998).0F1 
14.5 Accuracy Analyses 
14.5.1 Two sets of metrics will be calculated: 
• 
Relative (Percent) Difference (RD) for reference result  ≥ threshold 
glucose : 
𝑹𝑹𝑹𝑹= 𝑴𝑴−𝑪𝑪
𝑪𝑪
𝟏𝟏𝟏𝟏𝟏𝟏% 
 
1 Draper, N.R., Smith, H., (1998) Applied Regression Analysis, 3rd Ed., John Wiley and Sons, 
New York 
 

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where: M = strip/meter result and C = comparator or reference method result. 
Difference (D) for reference result < threshold  glucose: 
𝑫𝑫= 𝑴𝑴−𝑪𝑪 
14.5.2 Primary objective: The threshold glucose value is 100 mg/dL(5.55 mmol/L).  
Accuracy will be assessed using the Clinical and Laboratory Standards Institute 
(CLSI) – Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; 
Draft Guideline-Third Edition (POCT12 (Draft 4) Vol.0 No.0 Replaces C30-A2 
Vol.22 No.17).  
i.e.,  D within ±12 mg/dL ( ±0.67 mmol/L ) for comparator result < 100 mg/dL 
(5.55 mmol/L)  and RD within ±12.5% for comparator result ≥ 100  mg/dL (5.55 
mmol/L). 
For RD, the percent of results within  ±5%,  ±10%,  ±12.5%,  ±15% and  ±20% will 
be computed. 
For D, the percent less than or equal to ±5 mg/dL (±0.28mmol/L), ±10 mg/dL 
(±0.56 mmol/L), ±12.0 mg/dL (±0.67 mmol/L), ±15 mg/dL, (±0.83 mmol/L), and 
±20 mg/dL(±1.11 mmol/L)will be computed. 
The RD and D distribution tables will be constructed using a threshold of 100 
mg/dL (5.55 mmol/L).  
As discussed in section 14.1 (Sample Size), with n =240, the critical number 
(minimum) of accurate results is 228, which yields approximately 95% chance of 
satisfying the criterion if the actual probability that any result will be accurate is at 
least 96.77%. Symbolically, this criterion is equivalent to testing the hypothesis: 
 
H0 : Prob{accurate}<96.77% versus  the alternative: 
H1  :  Prob{accurate } ≥   96.77% 
This test has a power of about 95%, with n = 240, to reject H0 if the actual 
probability of obtaining an accurate result is 96.77%. Conversely, there is about a 
95% chance that the null will NOT be rejected if the actual probability that a result 
with the evaluation device would satisfy this definition of accuracy is only about 
92.03%.  It is possible that the sample size after the study is completed may not be 
exactly 240. The critical values will be approximately 95% or 98% of results (first 
and second parts of primary objective, respectively), and the associated hypotheses 
will be adjusted to reflect the change while maintaining no more than a 95% chance 
of rejecting the null hypotheses. 
14.5.3 The second part of the primary objective states that at least 98% of the n = 240 
results must fall within ±15 mg/dL(±0.83 mmol/L) of the comparator result 

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(comparator < 75 mg/dL/4.16 mmol/L)) or ±20% of the comparator result 
(comparator ≥ 75 mg/dL/4.16 mmol/L ).  Thus, with n = 240, there must be at least 
236 BGMS results satisfying this requirement.  This is equivalent to testing the 
hypotheses: 
H0: Prob{accurate}<98.33% versus  the alternative: 
H1:  Prob{accurate } ≥   98.33% 
There is approximately a 95% chance of rejecting H0 in favor of H1 if the actual probability 
that a meter measurement would satisfy the ±15mg/dL (±0.83 mmol/L) or 20% is 98.33%.  
Conversely, there is about a 95% chance that the null will NOT be rejected if the actual 
probability that a result with the evaluation device would satisfy this definition of accuracy 
is only about 96.23%. 
14.6 Hematocrit Analysis – Other Objectives 
14.6.1 Hematocrit will be measured for each participant. Mean, median, minimum, 
maximum, and standard deviation, will be computed for hematocrit 
determinations. 
14.6.2 The effect of hematocrit on meter results will be presented via regression of 
differences between the meter and laboratory BG measurements against 
hematocrit. 
14.7 Data Evaluability  
Blood glucose data will be considered not evaluable for the following reasons: 
14.7.1 Samples with no associated hematocrit value.  
14.7.2 Samples with no associated (Cobas c 702)} value.  
14.7.3 Failure to begin to separate the plasma from the red cells (Cobas c 702) analysis) 
within 10 minutes of obtaining the first meter test. 
14.7.4 The collected samples are not used within a maximum of 5 h of sample 
withdrawal time. 
14.7.5 Plasma samples that have been frozen for more than 84 days. 
14.7.6 For a given sample, the meter is missing a replicate. 
14.7.7 Results of the Glucose analyzer blood sample  are not within ±4% of each other, 
100* (Rep2-Rep1)/Rep1, or ±0.22mmol/L of each other (Rep2 – Rep1) if the 
average falls below 5.55mmol/L. 
14.8 Means and SDs for the serum control data will be computed. 
15.0 Data Management  
15.1 A unique number will identify each participant/sample. The unique number will be entered 
on the CRFs. The site will create a procedure to de-identify participants from samples so 

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that the staff members documenting participant names will not have access to sample results 
and the staff members testing the samples will not have access to participant names. A 
master list of participant names,  with their participant IDs, will be kept by the Investigator 
at the study site until the study has been closed. 
15.2 Study personnel will complete and sign all appropriate forms in compliance with Good  
Clinical Practice (GCP). Case report forms should be completed legibly, in black or blue 
ink. If it is necessary to make corrections,  a single line should be drawn through the original 
entry, the new entry is written in, and the correction initialed and dated by the individual 
correcting the CRF. 
15.3 Study data will be primarily collected through an electronic data capture (EDC) system 
used by Ascensia. The data will be recorded on forms by designated study staff that will 
serve as source documents and entered into the  EDC system. All source forms will be 
retained by the site.  
15.4 In addition to data collection, the EDC system will be used for data cleaning as well as 
monitoring operations. Site users will be trained on this system before the start of the study 
and their access to EDC system will be contingent upon successful completion of training 
requirements.   
15.5 The investigator/study site shall archive study documents. The investigator\/study site 
should take measures to prevent accidental or premature destruction of these documents. 
After the study has been completed, all data and documents have to be retained a minimum 
of three years or according to the relevant country/region regulations. Under no 
circumstances shall the investigator/study site relocate or dispose any study documents 
before having obtained written approval of the sponsor. This also applies when the 
archiving period expires. 
 
16.0 Amendments to the Protocol  
16.1 Any change to this protocol requires a protocol amendment (or revision) unless the IRB/EC 
agrees to an administrative change (for minor changes).  
16.2 Determine the justification(s) for the protocol revision, impact of the changes on participant 
safety, the clinical or statistical significance of the data, impact of changes on the clinical 
investigators and their staff, and impact on timely completion of the clinical trial. 
16.3 Determine if the revision meets the criteria of a Substantial Amendment.  
16.4 Substantial Amendments  

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16.4.1 Substantial amendments to the conduct of the clinical trial may arise from changes 
to the protocol or from new information relating to the scientific documents in 
support of the trial. Substantial changes require notification to the overseeing 
Member State Competent Authority before implementation. For any questions on 
whether a change would be considered substantial, consult with the respective 
Member State.  
16.4.2 Amendments to the trial are regarded as “substantial” where they are likely to have 
a significant impact on the: 
• 
Safety, health or rights or physical or mental integrity of the 
participants, 
• 
Scientific value of the trial including robustness or reliability of the 
data generated by the study, 
• 
Conduct or management of the trial, 
• 
Quality or safety of any investigational product used in the trial. 
16.4.3 An amendment is only to be regarded as “substantial” when one or more of the 
above criteria are met but each Member State may have additional requirements 
that shall be considered. 
16.4.4 Examples of substantial amendments may include (but are not limited to): 
• 
New tests 
• 
Increase in the number of visits due to safety issues associated with 
the ongoing trial 
• 
Change of inclusion/exclusion criteria 
• 
Change in the number of participants 
• 
Updated PI / ICF 
• 
Updated investigator brochure with relevant safety information 
• 
Change in the management of the study 
• 
Temporary halt to the study or restart of the trial after a temporary 
halt 
16.5 Once justified, the protocol changes can be drafted and the changes documented in the 
Revision History. The changes are to be incorporated directly into the body of the protocol 
document itself (revised protocol). 
16.6 Once the drafted revision is approved internally and by the PI, it will be submitted to the 
EC / IRB, where required. All subsequent, IRB/EC approved, revised protocols would be 
numbered sequentially. 

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16.7 The amended protocol will be approved by the original approvers, including the sponsor 
representatives or designee and the Principal Investigator(s). 
16.8 The sponsor must assure that each investigator (and his/her staff) is following the most 
recent IRB/EC approved amendment or revised protocol as the study proceeds. The sponsor 
must ensure that the study monitors, investigator(s) and study staff have been trained with 
respect to any recent protocol amendments and revisions prior to implementation. 
17.0 Deviations from the clinical protocol  
17.1 A protocol deviation is any alteration or modification to the procedures described in the 
protocol.  
17.2 The investigator is not allowed to deviate from the protocol. The only exceptions to this are: 
17.2.1 The deviation is necessary to protect the participant's rights, safety and well-being, 
or the scientific integrity of the clinical investigation without prior approval of the 
sponsor and EC. 
17.2.2 Prospective deviations that broaden the scope of the protocol (waivers of the 
protocol) are prohibited.  Under emergency circumstances, these instances can 
proceed. 
17.3 Procedures for recording, reporting and analyzing protocol deviations will include 
recording the deviation on a Protocol Deviation log form to be supplied by the Sponsor. 
18.0 Device Accountability  
18.1 Description of the procedures for the accountability of investigational devices as follows: 
18.1.1 Access to investigational devices shall be controlled and the investigational devices 
shall be used only in the clinical investigation and according to the protocol. 
18.1.2 The sponsor shall keep records to document the physical location of all 
investigational devices from shipment of investigational devices to the 
investigation sites until return or disposal. 
18.1.3 Accountability: The principal investigator or a delegate shall keep records 
documenting the receipt, use, return and disposal of the investigational devices, 
(including unused, expired or malfunctioning devices) which shall include: 
• 
Date of receipt 
• 
Identification of each device (serial number of meter or strip lot) 
• 
The expiry date, if applicable 
• 
Date(s) of use 

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• 
Participant number 
• 
Date of return of unused, expired or malfunctioning investigational 
devices, if applicable 
All materials for this study must be stored according to the stated storage conditions and 
with limited access to individuals authorized by the investigator.  
At the end of the clinical study, all remaining study material must be returned to the sponsor 
or destroyed with sponsor approval. After study completion, shipped, consumed and 
remaining investigational medical devices will be reconciled. 
19.0 Regulatory 
19.1 Ethics Committee Approval 
19.1.1 Before study initiation, an Ethics Committee (EC) must review this protocol,  
Informed consent form (ICF) and any other supporting study documents which 
impact participant safety. The EC will  determine if the Informed Consent is 
required according to local regulations and requirements or if a waiver will be 
obtained1F2.  
19.1.2 The investigational site may not begin the study until the EC has given its written 
and dated approval via a letter that identifies the version/date of the protocol and 
ICF if applicable.   
19.1.3 A copy of the EC approval letter must be provided to the Investigator and to sponsor 
prior to the Study Initiation Visit. 
19.2 Study Documentation Procedures 
19.2.1 The investigator will keep study records for a minimum of three years. 
Alternatively, other arrangements may be made with Ascensia for study document 
storage. 
19.2.2 Study Investigational Devices will be labeled "For Performance Evaluation Only" 
for this study. 
19.2.3 After the study, all BGMS will be disinfected before they are returned to Ascensia. 
A decontamination log will be completed for the used meters. The meters, unused 
strip vials, control solutions, and meter User Guideswill be accounted for at the site 
and returned to the Ascensia Study Manager upon completion of the trial. 
19.3 Investigator's Report of Study Closure 
19.3.1 Sponsor representatives will notify the site that the study is closed.  The study will 
be considered closed when the data has been locked for data analysis.  
 
2 In vitro diagnostic medical devices — Clinical performance studies using specimens from human 
participants —Good study practice: ISO 20916:2019(E). 

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19.3.2 The Investigator or designee will submit a report summarizing participant 
disposition and other study details, as appropriate, to the Study Manager and the 
reviewing EC. This report will be completed within 3 months of the study closure 
date.   
19.3.3 In addition, the Study Manager, or designee, will report the completion of the study 
to the EC within 6 months of study closure.  
20.0 Statements of compliance  
20.1 This clinical investigation will be conducted in compliance with applicable requirements: 
20.1.1 Protection of Human Participants regulations in 21 CFR part 50. 
20.1.2 Institutional Review Boards (IRB) regulations in 21 CFR part 56. 
20.1.3 CLSI. Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; 
Approved Guideline – Third Edition. CLSI document POCT12-A3. Wayne, PA: 
Clinical and Laboratory Standards Institute; 2013. 
20.1.4 International Standards: ISO 20916:2019(E) – In vitro diagnostic medical devices 
– Clinical performance studies using specimens from human participants – Good 
Study Practice and In Vitro Diagnostic Regulation 2017/746 Annex XIII, Part 2. 
20.1.5 Declaration  of Helsinki, ICH-GCP: 2013. 
20.1.6 Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Device) 2002. 
20.1.7 National Statement on Ethical Conduct in Human Research 2007 (Updated 2018). 
The National Health and Medical Research Council, the Australian Research 
Council and Universities Australia. Commonwealth of Australia, Canberra British 
Standard: EN ISO 14155:20110 - Clinical investigation of medical devices for 
human participants – Good Clinical Practice. 
20.1.8 British Standard BS EN 13612:2002, “Performance evaluation of in vitro 
diagnostic medical devices. 
20.2 The clinical study shall not begin until the required approval from the EC or regulatory 
authority have been obtained. 
20.3 Clinical trial insurance shall be provided as appropriate. 
21.0 Informed Consent Process  
21.1 The EC will determine if the Informed Consent is required according to local regulations 
and requirements for use of residual blood samples for this study. 
21.1.1 Informed Consent may be waived according to requirements under the National        
Health and Medical Research Statement on Ethical Conduct in Human Research 
(2007; incorporating all updates)if the study meets all requirement for waiver as 
follows: 

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a. 
Involvement in the research carries no more than low risk to participants.   
There is no intervention in this study. Only residual blood from routine clinical  
care blood assessments will be used for analysis.  It involves a minimal volume 
of residual blood for analysis (approx. 2 mls). With appropriate measures in place 
to preserve participant privacy and confidentiality, collection of residual blood is 
a neglible/ low risk procedure. Care of participants medical condition is 
unaffected by the study. 
b. 
The benefits from the research justify any risks of harm associated with not 
seeking consent. 
This study is a low risk study due to fact that only the patient’s residual blood 
samples are used and there is no intervention. Although there is no direct benefit 
to the participant research has the potential to benefit health care by providing 
additional information regarding a blood glucose monitoring device. 
c. 
It is impracticable to obtain consent from participants who are considered 
“critically ill” and for the donation of residual blood. 
The majority of participants in ICU are sedated and mechanically ventilated and 
it’s not possible  to request consent from them. Given this is only collection of 
residual blood sample and no intervention, with only gender and age collected, it 
would be onus, given what is required, to request next of kin of the participant, to 
provide consent. Additionally, it is truly not feasible for the researchers to conduct 
over 120 consents for this negligible risk study. 
d. 
There are no known or likely reasons for thinking that participants would not have 
consented if they had been asked. 
Given there is no intervention, and only residual blood (which would otherwise 
be thrown away) will be used, with minimal data  (gender and age only)  collected, 
there is no reason to believe that patients would not have consented if asked.  
e. 
There is sufficient protection of their privacy. 
Anonymised data only will be collected, specifically gender and age only. 
Additionally, participants will not be identifiable from any presentations or 
publications arising from the research.    
   
f. 
There is an adequate plan to protect the confidentiality of data. 
There are no risks to patients associated with this study except for the potential 
for loss of confidentiality. Measures will be taken to minimize this risk by 
anonymising study samples. Study samples will be assigned a number and only 
the participant’s age and gender will be recorded. The participants initials or any 
other identifiable information will not be captured. 
g. 
The results have no significance for the participants’ welfare and information 
arising from the research will be available to them on  regulatory databases 
including Clinicaltrials.gov. and EUDAMED. 

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The results of the residual blood analysis will not impact on the care of 
participants, standard of care blood assessments (such as glucose) will be taken in 
addition to the residual blood samples (which will be used for study’s analysis). 
The study will be added to Clinicaltrials.gov website. 
h. 
There is no possibility of commercial exploitation of derivatives of the data and 
will not deprive the participants of any financial benefits to which they would be 
entitled. 
There is no financial benefit to be derived from participating in this study. The 
study is being conducted for research purposes only. 
i. 
The waiver is not prohibited by State, federal, or international law. 
21.2 A waiver of consent is not prohibited in South Australia. 
 
22.0 Adverse events and adverse device effects  
22.1 The procedures to be performed under this protocol are considered to be of low risk 
since the glucose testing procedures will use residual samples which are remnants of 
arterial blood collected as part of routine practice and after all standard analysis has 
been performed. 
22.2 Due to the nature of this study, no adverse events are expected as per the following: 
22.3 This study only includes ‘left-over samples’ of blood collected by standard, approved 
technique for prescribed tests. 
22.4 Participants will not be exposed to any of the BGMS  at any point; all study activities will 
be conducted in the institution’s lab.   
22.5 Regardless of the above, any experience that the investigator considers to be an Adverse 
Event will be documented and reported immediately to Ascensia. 
22.6 Definition of Adverse Events  
22.6.1 Adverse Event (AE): Adverse event refers to any untoward medical occurrence, 
inappropriate patient management decision, unintended disease or injury, or 
untoward clinical signs in participants, users, or other persons, with any connection 
to study related activities, whether or not related to IVD medical device under 
investigation.  
22.6.2 Adverse Device Effect (ADE or Adverse Effect): Any adverse event resulting from 
insufficient or inadequate instructions for use, installation, operation, or any 
malfunction of the IVD medical Device under investigation. Includes any adverse 
event resulting from use error or from unintentional misuse of the device.  
22.6.3 Serious Adverse Device Effect (SADE): Adverse device effect that has resulted in 
any of the consequences characteristic of a serious adverse event. 

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22.6.4 Serious Adverse Event (SAE): Refers to an event that led to any of the following: 
• 
death, 
• 
serious deterioration in the health of the participant, users or other persons as defined 
by one or more of the following: 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function including chronic 
diseases, or 
3) in-patient or prolonged hospitalisation, or 
4) medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function 
• fetal distress, fetal death or a congenital abnormality or birth defect including physical 
or mental impairment. 
 
22.7 Adverse Event Classification  
Table 3: Categories of Adverse Events (ISO 20916: 2019)  
Adverse 
Events 
Non -device related 
Device related  
 
Applies to: 
• 
Interventional Studies 
• 
Sampling procedure causes 
direct harm to the participant 
Applies to: 
• 
Interventional Studies: inaccurate test result leads to 
indirect harm to the participant 
• 
Sampling procedure causes direct harm to the 
participant 
Non-Serious 
Adverse event (includes all 
categories) 
Adverse device effect  
Serious 
Serious Adverse event (includes 
all categories that are serious) 
Serious adverse device effect 
Anticipated 
Unanticipated 
Anticipated Serious 
adverse device effect 
Unanticipated Serious 
adverse device effect 
 
22.8 Adverse Event Reporting  
22.8.1 Adverse events will be documented during this study by completing the AE Form.  
The Investigator or designee will sign and date an AE Form for each AE that is 
observed.   
22.8.2 AEs will be evaluated by a member of the study staff and the PI.  The nature of 
each event and date of onset, outcome, course, maximum intensity and action taken 
for treatment should be established. Details of any corrective treatment should be 
recorded on the AE Form. 

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22.8.3 Investigators should follow up on the status of participants experiencing an ongoing 
AE until the event has been resolved, or until the condition has stabilized.  
22.8.4 The Investigator or designee will notify the Study Manager or  Study Monitor 
within 24 hours of any Serious Adverse Event that occurred during the study.  
Ascensia will promptly review all information relevant to the safety of the 
investigational device. 
22.8.5 Upon the receipt of a report of an SAE by the Ascensia Study Manager or 
Monitor, the report will be immediately forwarded to:  
Rimma Shaginian, MD, MPH 
Medical Director, Emerging Markets 
Global Medical Affairs, Ascensia Diabetes Care 
Email: rimma.shaginian@ascensia.com 
23.0 Handling and Reporting of Device Deficiencies 
23.1 Any functional problems with the investigational BGMS will be considered a device 
deficiency and will be documented by the study staff and timely reported to Ascensia.   
23.2 The study staff should be specific about describing the problem and the sequence of events 
that led to it. All information will be documented on the Data Deficiency Form, including 
the meter type, serial number, and test strip lot.   
23.3 Malfunctioning BGMs will be replaced and this will be documented for device tracking. 
23.4 All device deficiencies related to the identity, quality, durability, reliability, safety or 
performance of an investigational medical device shall be documented throughout the 
clinical investigation and appropriately managed by the sponsor. 
23.5 Device deficiencies that did not lead to an adverse event but could have led to a medical 
occurrence shall be reported to the sponsor without delay.  
23.6 All device deficiencies are to be reviewed and documented in writing whether they could 
have led to a SADE. 
24.0 Vulnerable population 
24.1 While the samples will be taken from critically ill patients who are considered to be in the 
vulnerable population category, the procedure does not involve additional risk since the 
samples are residual with no additional sampling required.  
24.2 If EC determines consent is required and the participants are unable to provide consent, 
then proxy consent by an LAR shall be provided to protect the rights of the participant.   

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25.0 Suspension/Premature termination and Participant Withdrawal Criteria 
25.1 In the event the study is prematurely suspended or terminated, the sponsor shall be notified 
as well as the Ethics Committee. 
25.2 The participant’s sample may be withdrawn from the study at the discretion of the 
Investigator.  
26.0 Results Handling 
26.1 There is no plan for treating or following up with participants based on the investigational 
results from this study.  
27.0 Publication policy  
27.1 The results will be published in regulatory databases, Clinicaltrials.gov. and EUDAMED. 
 
27.2  In general, for publication of data, the principles of Good Clinical Practice and Good 
Scientific Practice are respected. All manuscripts, abstracts or other modes of presentation 
arising from the results of the study must be reviewed and approved in writing by the 
sponsor in advance of submission. The sponsor’s intention is neither to influence nor to 
prevent the publication of the study results to the medical and scientific community. The 
review is exclusively aimed at protecting the sponsor's proprietary information existing 
either at the date of commencement of the study or generated during the study. Details of 
the publication policy and related sponsor and principal investigator responsibilities are 
included in the clinical investigation agreement. 

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28.0 Administration 
All investigator and site staff communications regarding the study should be directed to the 
Labcorp  Study Manager. If at any time questions or problems arise concerning the evaluation, 
please contact the Labcorp  Study Manager or the Ascensia Study Manager at the telephone 
number listed below. 
 
 
Andrew Humeniuk  
Ascensia Cllnical Study Lead 
Email: andrew.humeniuk@ascensia.com 
Office Phone: +1-914-236-1838   
Direct (Cell): +1-862-260-5783 
 
29.0 Bibliography   
• Boucai L, Southern WN, Zonszein J. Hypoglycemia-associated mortality is not drug-
associated but linked to comorbidities. Am J Med 2011; 124: 1028–35. 
• CLSI. Point-of-care blood glucose testing in acute and chronic care facilities; approved 
guideline. CLSI document POCT 12–A3. Wayne, PA: Clinical and Laboratory Standards 
Institute; 2013. 
• Dhatariya K, Mustafa OG, Rayman G. Safe care for people with diabetes in hospital. Clin 
Med (Lond) 2020; 20: 21–27.  
• Erbach M, Freckmann G, Hinzmann R, et al. Interferences and limitations in blood glucose 
self-testing: an overview of the current knowledge. J Diabetes Sci Technol. 2016;10:1161-
1168. 
• Finfer S, Wernerman J, Preiser JC, et al. Clinical review: consensus recommendations on 
measurement of blood glucose and reporting glycemic control in critically ill adults. Crit 
Care. 2013;17(3):229. 
• Friedrich JO, Chant C, Adhikari NK: Does intensive insulin therapy really reduce mortality 
in critically ill surgical patients? A reanalysis of metaanalytic data. Crit Care 2010, 14:324. 
Barbara Pinho 
Clinical Trial Lead 
Email: barbara.pinho@covance.com 
Phone Number: +351 256 848 254 

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• Griesdale DE, de Souza RJ, van Dam RM, Heyland DK, Cook DJ, Malhotra A, Dhaliwal 
R, Henderson WR, Chittock DR, Finfer S, Talmor D: Intensive insulin therapy and 
mortality among critically ill patients: a metaanalysis including NICE-SUGAR study data. 
CMAJ 2009, 180:821-827. 
• ISO 15197:2013. In vitro diagnostic test systems-requirements for blood glucose 
monitoring systems for self-testing in managing diabetes mellitus. Reference number ISO: 
2013(E), Geneva: International Organization for Standardization; 2013. 
• ISO 20916: 2019. In vitro diagnostic medical devices—clinical performance studies using 
specimens from human participants—Good Study Practice. Geneva: International 
Organization for Standardization (ISO); 2019. 
• ISO 22870: 2016. Point-of-care testing (POCT)—requirements for quality and competence. 
Geneva: International Organization for Standardization (ISO); 2016. 
• Lonjaret L, Claverie V, Berard E, et al. Relative accuracy of arterial and capillary glucose 
meter measurements in critically ill patients. Diabetes Metab. 2012;38(3):230-235. 
• Marik PE, Preiser JC: Toward understanding tight glycemic control in the ICU: a 
systematic review and metaanalysis. Chest 2010, 137:544-551. 
• Maruo K, Oota T, Tsurugi M, et al. Noninvasive near-infrared blood glucose monitoring 
using a calibration model built by a numerical simulation method: trial application to 
patients in an intensive care unit. Appl Spectrosc. 2006;60(12):1423-1431. 
• Moghissi ES, Korytkowski MT, DiNardo M, et al. American Association of Clinical 
Endocrinologists and American Diabetes Association consensus statement on inpatient 
glycemic control. Diabetes Care 2009; 32: 1119–31.  
• National Statement on Ethical Conduct in Human Research 2007 (Updated 2018). The 
National Health and Medical Research Council, the Australian Research Council and 
Universities Australia. Commonwealth of Australia, Canberra British Standard: EN ISO 
14155:2011 - Clinical investigation of medical devices for human participants – Good 
Clinical Practice. 
• NICE-SUGAR Study Investigators, Finfer S, Chittock DR, Su SY, Blair D, Foster D, 
Dhingra V, Bellomo R, Cook D, Dodek P, Henderson WR, Hébert PC, Heritier S, Heyland 
DK, McArthur C, McDonald E, Mitchell I, Myburgh JA, Norton R, Potter J, Robinson BG, 
Ronco JJ: Intensive versus conventional glucose control in critically ill patients. N Engl J 
Med 2009, 360:1283-1297. 
• Petersen JR, Graves DF, Tacker DH, Okorodudu AO, Mohammad AA, Cardenas VJ Jr. 
Comparison of POCT and central laboratory blood glucose results using arterial, capillary, 

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and venous samples from MICU patients on a tight glycemic protocol. Clin Chim Acta. 
2008;396(1-2):10-13. 
• Pleus,S, Freckmann,G, Baumstart,A, Huag, C: Stability of Glucose Concentrations In 
Frozen Plasma. J Diabetes Science and Technol.2020 Oct 9:1932296820963657. doi: 
10.1177/1932296820963657. 
• Schleis TG. Interference of maltose, icodextrin, galactose, or xylose with some blood 
glucose monitoring systems. Pharmacotherapy. 2007;27:1313-1321. 
• Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Device) 2002. 
• Umpierrez GE, Hellman R, Korytkowski MT, et al. Management of hyperglycemia in 
hospitalized patients in non-critical care setting: an Endocrine Society clinical practice 
guideline. J Clin Endocrinol Metab 2012; 97: 16–38. 
• Vlasselaers D, Herpe TV, Milants I, et al. Blood glucose measurements in arterial blood of 
intensive care unit patients submitted to tight glycemic control: agreement between bedside 
tests. J Diabetes Sci Technol. 2008;2(6):932-938. 
 
 
 

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Appendix A-  Instructions for Cleaning and Disinfecting  Meters 
 
Study staff will clean and disinfect meters according to the User Guide instructions for Health Care 
Professional.  
 
Health Care Professionals 
Health care professionals or persons using this system on multiple patients should follow the 
infection control procedure and the recommendations for prevention of blood-borne 
transmissible diseases approved by their facility. 
 
The following disinfection solutions are recommended; 70% isopropyl alcohol, 6.0% sodium 
hypochlorite (full bleach), 0.6% sodium hypochlorite (diluted bleach), 
didecyldimethylammonium chloride (DDAC). 
 
NOTE: Using cleaning and disinfecting solutions other than those recommended by the 
manufacturer could result in damage to system components.  The cleaning and disinfecting 
directions provided should not cause any damage or degradation to the external case, buttons, or 
display. 
 
CAUTION: Do not allow any solution to run into the meter through open areas, such as around 
the buttons or the meters test strip or data ports, such as USB port.  
Blood glucose meters must be cleaned and disinfected by study staff before returning to Ascensia. 
 
 
 
 
References 
Protection of laboratory workers from occupationally acquired infections; approved guideline – 
third edition.  CLSI document M29-A3.  ISBN1-56238-567-4. 
Rutala W, Weber D, Healthcare Infection Control Practices Advisory Committee.  Guideline for 
disinfection and sterilization in healthcare facilities, 2008.  CDC. 

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Appendix B - Instructions for Processing Blood for Laboratory Analyzer 
Analysis 
 
1. Whole blood taken via a blood gas syringe. After the arterial blood gas is processed the residual 
blood is transferred to a tube with anticoaguant for processing. 
 
2. Once the residual blood tube is collected, process it as follows within 5 hours of collection:   
a. Label all tubes with the participant number using a Sharpie marker. 
b. Gently invert the blood tube several times to mix the anticoagulant.  
c. Perform the meter testing as per protocol.  
d. Within 10 minutes of first successful meter test, centrifuge the whole blood to separate 
the plasma from the red blood cells.  Timing of all meter testing/centrifugation will be 
recorded on the appropriate CRF.   
e. As soon as possible after centrifugation, transfer plasma from the centrifugation tube 
to a micro/dispo tube or similar container.  Ensure the container is labeled and the cap 
is secured. 
 
3. The plasma may be refrigerated for up to 24 hours or frozen at ≤−20°C in a tightly sealed 
container until assayed.   
 
4. For refrigerated plasma samples:  
a.  Assays should be performed no later than 24 hours if refrigerated.  
b.  Bring to room temperature (ambient) and invert the sample several times to ensure 
     proper mixing. 
c.  Test the sample in duplicate on the laboratory analyzer.   
 
5. For frozen plasma samples:  
a.  The plasma samples are stable frozen at ≤−20°C for up to 12 weeks and may be batch 
     tested.  
b.  Thaw at room temperature (ambient) and invert the sample several times to ensure 
     proper mixing. 
c.  If needed, thawed samples may refrigerated for up to 24 hours before testing. 
d.  Test the sample in duplicate on the laboratory analyzer.   
 
 
 
 

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Appendix C - Instructions for Tracking Accuracy and Precision of 
Laboratory Analyzer  
 
Procedure for Tracking Accuracy and Precision of Site Laboratory Analyzer  
Performance of the Laboratory Analyzer will be assessed to ensure accuracy of the site’s laboratory 
analyzer. Analyzer performance will be tracked by two methods: testing of the Laboratory 
Analyzer quality control (QC) procedure regularly applied by the clinical site for their own 
instrument control check process and serum controls provided by Ascensia. 
The following are the procedures required for each method: 
I. 
Laboratory Analyzer QC Procedure  
The Laboratory Analyzer will be maintained and operated according to the instructions 
in the manufacturer’s operating manual by site’s lab specifications/SOP previously 
reviewed by ADC. Before the study begins, the analyzer will be set up and the 
appropriate maintenance will be performed.  
The site will perform glucose analyzer control tests in accordance with the site’s quality 
control check procedures and requirements. Site staff will keep a log for the analyzer, 
including daily operational checks and maintenance. 
II. Ascensia Serum Controls 
A set of four serum control levels will be provided to the investigator to document the 
performance of the (Cobas c 702, Roche Diagnostics) at each BG level. These serum 
controls have been assayed by a method traceable to one proposed for use as a national 
glucose reference method.  
Serum Control Testing Schedule: 
• Pre-study: The controls will be assayed (singlet readings) on the Laboratory 
Analyzer for at least three runs prior to the assay of participant samples. The runs 
will occur over at least three days, if possible.  The data will be sent to the Ascensia 
Study Manager, or designee, for review before the study begins. 
• Once the study begins, serum control testing should be completed on each Analyzer 
on a day prior and within the same week of testing plasma samples.  
• Record all data on the CRF. One reading will be recorded for each control level (for 
a total of 4 readings per run).   
 

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Proper Handling of Ascensia Serum Controls 
• Ascensia completed the characterization of serum controls purchased from Bio-Techne® 
(formerly Bionostics). During the characterization, staff observed that sample stratification 
during thawing can occur if the control vials are not handled judiciously. The 
recommended procedure is as follows. 
o Store the frozen controls in a -20C freezer upon arrival.  
o Thaw the frozen control amber glass vials at 2-8ºC for 2-3 days in the refrigerator.  
Each vial holds approximately 2.0 mL. 
o Before opening, mix the vials well by gently inverting them at least 10 times. 
o Prepare an aliquot of each level in capped microcentrifuge tubes.  Cap tightly.  We 
prefer Fisherbrand™ Microcentrifuge 0.5mL tubes (PN 02-681-333) with O-ring 
seal caps (PN 02-681-358). 
o Store any remaining control in the amber glass vials at 2-8ºC. 
o Before running a control sample on the laboratory analyzer, mix the aliquot tubes 
by gently inverting them. 
o At the beginning of each day, remix the amber glass vials and refill the aliquot tubes.  
When not in use, store the aliquots at 2-8ºC. 
o The thawed control use life is two weeks. Discard all thawed control—aliquot tubes 
and amber glass vials—after two weeks. 
o Since slow thawing for 2-3 days is recommended, it is advisable to keep an extra 
thawed set available for testing. 
 
 

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Attachment 1 -   Contour Next User Guide 
 
 
 
 

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Attachment 2 – Contour Plus Elite User Guide 
 
 
 
 
 

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