Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® Blood Glucose Monitoring Systems (BGMS) in Neonates Using Capillary Blood Samples
Conditions: Diabetes Mellitus
Sponsor: Ascensia Diabetes Care

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
   
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
Page 1 of 42 
 
Evaluation of the Performance of CONTOUR NEXT® and CONTOUR 
PLUS ELITE® Blood Glucose Monitoring Systems in Neonates using 
Capillary Blood Samples 
 
Protocol/Clinical Investigation Plan:   
GCA-PRO-2021-003-01  
 Amendment 1:  14 October 2022 
 
 
 
Sponsor:              Ascensia Diabetes Care 
                            100 Summit Lake Drive 
                            Valhalla, NY  10595 
 
 
Maria Teresa Viggiani, MS, CCRA 
Clinical Trial Manager, 
Clinical Affairs 
Date 
Scott Pardo, PhD, PStat® 
Deputy Director,  Statistics and 
Data Management 
Date 
Rosanna Cirio, MA 
Manager, Clinical Affairs 
Date 
James Venosky, NPDP 
Sr. Program Manager  
  
Date 
Rimma Shaginian, MD, MPH  
Medical Lead - Emerging Markets 
 
Date 
Shahrir Alam 
Regulatory Affairs Product 
Manager 
Date 
 
 
 
 
 
 

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
   
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
Page 2 of 42 
Investigator Statement 
 
I have read this protocol and agree to conduct the clinical performance study according to the protocol. 
I understand and agree that before seeking approval from an Institutional Review Board (IRB), 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 subjects. 
 
Principal Investigator (PI):     Dennis Dietzen, PhD 
Site:                                         St. Louis Children’s Hospital, Washington University 
Address:                                  1 Children’s Place 
                                                             St. Louis, MO  63110  
 
_________________________________    ________________________________     ____________________ 
                     PI Sgnature                                        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-2021-003-01 - Amendment 1  
 
 
   
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
Page 3 of 42 
Table of Contents  
 
Abbreviations................................................................................................................................ 5 
1.0 Identification of the Protocol/ Clinical Investigation Plan (CIP) ............................................... 6 
2.0 Contact Information ............................................................................................................. 7 
3.0 Synopsis of the Clinical Study ................................................................................................ 8 
4.0 Identification and description of the investigational device ................................................... 9 
5.0 Justification for the Design of the Clinical Study.................................................................... 10 
6.0 Risks and benefits of the investigational device and clinical investigation ............................. 11 
7.0 Objectives and Hypotheses .................................................................................................. 12 
8.0 Clinical Study Design ............................................................................................................ 12 
9.0 Investigational device(s) and comparator(s) ......................................................................... 13 
10.0 
Subjects ........................................................................................................................... 14 
11.0 
Procedures ....................................................................................................................... 15 
12.0 
Monitoring Plan ............................................................................................................... 20 
13.0 
Statistical Plan.................................................................................................................. 20 
14.0 
Data Management ........................................................................................................... 24 
15.0 
Amendments to the Protocol............................................................................................ 24 
16.0 
Deviations from the clinical protocol ................................................................................ 26 

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
   
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
Page 4 of 42 
17.0 
Device Accountability ....................................................................................................... 26 
18.0 
Regulatory ....................................................................................................................... 27 
19.0 
Statements of compliance ................................................................................................ 28 
20.0 
Informed Consent Process ................................................................................................ 28 
21.0 
Adverse events and adverse device effects ....................................................................... 29 
22.0 
Handling and Reporting of Device Deficiencies .................................................................. 31 
23.0 
Vulnerable population ...................................................................................................... 32 
24.0 
Suspension/Premature termination and Subject Withdrawal Criteria ................................ 32 
25.0 
Results Handling .............................................................................................................. 32 
26.0 
Publication policy ............................................................................................................. 32 
27.0 
Administration ................................................................................................................. 33 
28.0 
Bibliography ..................................................................................................................... 33 
Appendix A - Instructions for Cleaning and Disinfecting Meters ..................................................... 34 
Appendix B - Instructions for Processing of Blood for the glucose analyzer .................................... 35 
Appendix C - Instructions for Tracking Accuracy and Precision of the Laboratory Glucose Analyzer 36 
Appendix D - Instructions for Hematocrit Sample Preparation and Testing .................................... 38 
Attachment 1 - CONTOUR NEXT User Guide .................................................................................. 39 
Attachment 2 - CONTOUR PLUS ELITE User Guide ......................................................................... 41 
 

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
   
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
Page 5 of 42 
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 
EDC 
Electronic Data Capture 
GCP 
Good Clinical Practice 
HCP 
Health Care Professional 
ICF 
Informed Consent Form 
IRB 
Institutional Review Board 
LAR 
Legally Authorized Representative 
NICU 
Neonatal Intensive Care Unit 
PI 
Principal Investigator  
POC 
Point Of Care 
SAE 
Serious Adverse Event 
SADE 
Serious Adverse Device Effect 
SCN 
Special Care Nurseries 
SIV 
Site Initiation Visit 
UG 
User Guide 
          

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 6 of 42 
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 Neonates 
using Capillary Blood Samples 
1.2 
Protocol Number:  GCA-PRO-2021-003-01 
1.3 
Date:  October 14, 2022 
1.4 
Revision Status 
 
Date 
Revision History 
30Jun2022 
                  Initial Release version 
14Oct2022 
1. Amendment 1 
Sections 3.0, 8.2, and 10.1.1: Changed “up to 150 subjects may be enrolled to 
obtain the required number of samples” to “up to 200 subjects may be enrolled to 
obtain the required number of samples.”  
Section 13.1.2:  Changed “meter results will be 2*120 = 240” to “meter results 
will be at least 2*120 = 240.”  
Section 13.10: Added “or valid” to the following statements: “Samples with 
no associated or valid hematocrit value.”  “Samples with no associated or valid 
Cobas 6000 value.” 
Appendix D: Added “Ensure the tube setting on the HemataStat II™ is set to 
0.5 mm ID (inner diameter).” 
 
 
 
 
 
 

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 7 of 42 
2.0 Contact Information  
2.1 
Sponsor :   Ascensia Diabetes Care 
                                100 Summit Lake Drive 
 
Valhalla, NY, 10595 
 
Clinical Trial Manager contact: 
 
Maria Teresa Viggiani 
Phone (Office): 914-236-1836                
Direct: 914-417-9310 
E-mail: maria.viggiani@ascensia.com   
OR 
Rosanna Cirio 
Phone (Office): 862-225-3414 
Direct: 914-343-5736 
E-mail: rosanna.cirio@ascensia.com 
 
 
 
 
 
 
 
2.2 
Principal Investigator (PI):    
 
Dennis Dietzen, PhD 
2.2.1 Name, address, emergency contact details:  St. Louis Children’s Hospital 
  
 
 
 
1 Children’s Place 
  
 
 
 
St. Louis, MO  63110 
  
 
 
 
314-286-2857 
  
 
 
 
 
Dietzen_D@wustl.edu 
2.2.2 Professional position, roles, responsibilities and qualifications:  
             Professor of Pathology & Immunology, and Pediatrics, Washington University 
                         Medical Director, Laboratory Services, St. Louis Children’s Hospital 
                         Medical Director, Laboratory Services, Children’s Specialty Care Center, St. Louis 
                         PhD, Biochemistry and Molecular Biology, Indiana University School of Medicine 
 
2.3 
Name and address of the investigation site:  
Site address is the same as in 2.2.1. 
                        Business address of the site:  
Washington University 
 
 
 
 
 
One Brookings Drive 
 
 
 
 
 
Campus Box 1054 
 
 
 
 
 
St. Louis, MO  63130 
 
2.4 
Name(s) and address(es) of other institutions involved:   Not Applicable  
2.5 
Description of study financing and the agreement between the sponsor/site. 
Separate document: Clinical Trial Agreement between Ascensia Diabetes Care and Washington 
University, St. Louis.  

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 8 of 42 
3.0 Synopsis of the Clinical Study  
Design Type:   
Open Label, prospective, single arm study  
Investigational 
Devices:  
CONTOUR NEXT ® Blood Glucose Monitoring System (BGMS) 
CONTOUR PLUS ELITE® Blood Glucose Monitoring System 
Trial objective 
The purpose of this study is to extend the intended use of two BGMSs to 
include testing of neonatal blood by Health Care Professionals in a clinical 
setting for the quantitative measurement of glucose levels in neonates.  
This trial will evaluate the performance of both the CONTOUR NEXT 
BGMS and CONTOUR PLUS ELITE BGMS using blood from neonates 
within a hospital ward, e.g. routine/newborn nurseries, Special Care 
Nurseries, Neonatal Intensive Care Unit (NICU). The investigational 
BGMSs will be tested by a Point-of-Care operator using residual heel-stick 
capillary blood samples from neonates who underwent routine prescribed 
testing. 
Reference Analyzer 
Cobas® 6000 
Sample size: 
A total of 120 blood samples tested in duplicate with N=240 evaluable 
results are required for this study. Therefore, at least 120 subjects will be 
enrolled. Up to 200 subjects may be enrolled to obtain the required number 
of samples.  
A sub-group of at least 5 capillary whole blood samples will be tested 
in neonates who are less than 24 hours of age.   A sub-group of at least 
5 capillary whole blood samples will be tested in neonates from the 
NICU.  
Inclusion and 
Exclusion 
criteria: 
Inclusion Criteria 
• Residual capillary (heel-stick) blood samples collected from neonates (less 
than 28 days of age) after birth as part of prescribed testing. 
• Sample blood volume must be sufficient to complete investigational testing 
in addition to routine prescribed clinical laboratory testing. 
Exclusion Criteria 
• Samples from subjects who are ≥ 28 days of age. 
• Samples from subjects who have previously been enrolled into this study. 

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 9 of 42 
Objectives 
and 
Endpoints: 
The primary objective of the study is to evaluate the performance of CONTOUR 
NEXT and CONTOUR PLUS ELITE BGMSs with residual neonatal 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 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).  
Number of study sites 1 site 
Proposed start date 
July 2022 
Study Duration 
The study duration is expected to be approximately 4 months. The duration 
of each subject’s participation is not applicable because the study uses 
residual samples. 
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 devices 
4.2.1 The CONTOUR NEXT and CONTOUR PLUS ELITE blood glucose monitoring 
systems (BGMS) are investigational BGMSs 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 fresh capillary whole blood 
drawn from the fingertip or palm, arterial blood, and venous blood.  Its use in this 
trial is for the quantitative measurement of glucose levels in neonates from fresh 
capillary whole blood drawn from the heel. 

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 10 of 42 
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 
Ascensia Diabetes Care (ADC) is the manufacturer of the device. 
4.4 
Traceability of the devices is 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 residual blood sampled from 
neonates in a hospital setting.  
4.6 
No contact between the devices and the patients is required since all testing will be 
performed on blood sampled from a tube.  
4.7 
The technical and functional features of the investigational devices, CONTOUR NEXT and 
CONTOUR PLUS ELITE BGMSs, can be found in the User Guides (UG) in Attachments 
1 and 2.  
4.8 
The instructions for use for the devices are found in the UGs (Attachments 1 and 2).  
4.9 
Training and experience required for use of the device is Good Clinical Practice (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 Justification for the Design of the Clinical Study 
Hypoglycemia is the most common metabolic disturbance occurring in the neonatal period, which 
can lead to neonatal morbidity and developmental sequelae. Screening at-risk infants and the 
management of low blood glucose levels in the first hours to days of life is a frequent issue in the 
care of newborn infant. Transitional neonatal hypoglycemia usually resolves within 2 or 3 days of 
age. Severe prolonged neonatal hypoglycemia can cause seizures, brain damage, and 
neurodevelopmental impairment. Signs of neonatal hypoglycemia are non-specific, and babies 
with hypoglycemia are frequently asymptomatic. Therefore, it is common to screen babies 
considered at high risk for neonatal hypoglycemia with repeated blood glucose measurements. 
Usually, plasma or serum samples are used for routine blood glucose estimation in a hospital 
laboratory. However, such an approach using a laboratory-based testing method is not practical in 
acute situations due to the delayed turnaround time. Therefore, BGMS are frequently used for the 
bedside estimation of blood glucose levels. Rapid measurement time, smaller volume of required 
blood samples, and enhanced usability are the main benefits of using BGMS compared with 
laboratory-based testing. Most BGMS that are currently used are initially developed for monitoring 
blood glucose levels in adult patients with diabetes. Neonatal blood differs from adult blood in two 
major aspects—it has lower concentrations of blood glucose and a wider range of hematocrit levels 
(Adamkin 2011; BAPM 2017; Harris et al 2012; Lucas et al 1988; Movalia and Ogino 2006; 
Nuntnarumit et al 2011; Roth-Kleiner et al 2010; Rozance 2006).  

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 11 of 42 
The CONTOUR NEXT and CONTOUR PLUS ELITE BGMSs are investigational BGMSs 
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  neonatal 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 
HCPs to monitor the effectiveness of diabetes control. Its use in this trial is for the quantitative 
measurement of  glucose levels in neonates from fresh capillary whole blood drawn from the heel 
by HCPs in a clinical setting. 
This investigational clinical trial will evaluate the performance of two BGMSs, CONTOUR NEXT 
BGMS and CONTOUR PLUS ELITE BGMSs, in neonates within a hospital ward, e.g. 
routine/newborn nurseries, Special Care Nurseries (SCN), Neonatal Intensive Care Units (NICU). 
The BGMS will be used by a POC operator in a clinical setting using residual heel-stick capillary 
blood samples from neonates who underwent routine prescribed testing. The residual blood no 
longer needed for clinical purposes will be used for this study. 
6.0 Risks and benefits of the investigational device and clinical investigation 
Risks  
This is a low risk study.  Residual blood samples will ONLY be tested for the study if the neonate 
is having prescribed blood tests done as ordered by their physician. Therefore, there will be no 
additional blood samples collected for this study.  All testing procedures with the investigational 
device will be perfomed by the study staff in a laboratory setting and at no point will the neontate  
come in contact with the Investigational device or any other study-related material. There is no 
discomfort to the neonate 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. 
Without the identification list that is exclusively stored at the site, connection between personal 
data and study data is not possible. 
Benefits  
There are no direct benefits to the subject (neonate) for donation of residual blood samples for this 
study except to contribute to a study that provides information on the performance of two BGMSs 
when measuring glucose in capillary blood by HCPs within a clinical setting. Subjects will not 
receive compensation. 
There are no anticipated adverse device effects.  

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 12 of 42 
7.0 Objectives and Hypotheses  
The primary objective of the study is to evaluate the performance of CONTOUR NEXT and 
CONTOUR PLUS ELITE BGMSs with residual heel-stick capillary blood samples from neonates, 
i.e. babies who are less than 28 days old. The performance of the BGMS will be analyzed according 
to the following objectives:  
7.1 
Primary Objective: The accuracy criteria below are taken from 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.  
7.1.1 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 7.1.1 would also satisfy the ISO 15917:2013 criteria of 
obtaining the ±15% of reference values (laboratory method) for glucose 
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). 
7.1.2 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). 
7.2 
Other Objectives: 
• Evaluate the performance of both BGMSs for neonates who are <24 hours old. Compute 
differences between BGMS and laboratory blood glucose measurements and plot them against 
hematocrit results. 
• Evaluate the performance of both BGMSs with blood samples from babies in the NICU.  
• Compute differences between BGMS and laboratory blood glucose measurements and plot 
them against bilirubin results, for those subjects where bilirubin measurements were recorded 
(when available). 
8.0 Clinical Study Design  
8.1 
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. 
8.2 
For each BGMS, 120 evaluable samples (N=240 evaluable results due to duplicate testing) 
are required. Therefore at least 120 subjects will be enrolled. Up to 200 subjects may be 
enrolled to obtain the required number of samples. 

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 13 of 42 
8.3 
Randomization: 
8.3.1 Since two BGMSs will be tested in the study, the order of testing the study devices 
will be randomized.  
8.3.2 Three strip lots (per BGMS) will be tested, with each sample tested with one lot.  
The strip lots will be randomized. 
8.4 
The results from these two BGMSs will not be compared to each other. 
8.5 
The study design follows CLSI- POCT12-A3:2013 and ISO 20916:2019(E) to ensure it is 
scientifically robust and valid. 
8.6 
Subjects with non-evaluable data will be replaced as needed to obtain N=120 samples, and 
N= 240 results (duplicate results) for each BGMS. 
9.0 Investigational device(s) and comparator(s)  
9.1 
Materials and  Methods 
9.1.1 Resources Supplied by Investigator - Staffing 
• Principal Investigator / and, if applicable, Sub-Investigators 
• HCP to collect blood samples  
• Laboratory professionals to perform meter testing, hematocrit, and laboratory analyzer 
testing 
9.1.2 Resources Supplied by Investigator - Other 
• Hospital IRB and/or Central IRB approval of the protocol. 
• Facility with adequate laboratory resources for conducting all tests (including blood 
glucose laboratory analyzer, hematocrit measurement instrument). 
• Facility with adequate neonatal population for at least 120 study-appropriate samples 
within the desired course of the trial. 
• Cobas® 6000 (Roche Diagnostics Corp., Indianapolis, IN) Laboratory Analyzer, to 
measure glucose in plasma.  
• Print-outs of the Cobas 6000 results for Quality Control (QC) checks during study days. 
9.1.3 Resources Supplied by Ascensia - Materials 
• 
Protocol and sample Case Report Forms (CRF) 
• 
CONTOUR  NEXT® meters  
• 
CONTOUR  NEXT® strips (3 lots) with inserts 
• 
CONTOUR  NEXT® UGs  

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 14 of 42 
• 
CONTOUR  PLUS ELITE® meters  
• 
CONTOUR PLUS® strips (3 lots) with inserts 
• 
CONTOUR  PLUS ELITE® UGs  
• 
CONTOUR NEXT® and CONTOUR PLUS® Low ,  Normal and High  Control 
solutions with inserts 
• 
Hematocrit instrument and testing supplies 
• 
Thermometer/hygrometers for measuring environmental conditions at the 
meter testing location, if needed. The site may use its calibrated measuring 
devices with approval of ADC. 
• 
Disinfectant (see Appendix A for procedure and detail) 
• 
Serum controls for the laboratory glucose analyzer 
• 
Atomic clock(s) 
9.2 
Note that the subjects will not be exposed to the study devices since residual blood 
samples will be collected in a tube and used for all study procedures.  
9.3 
All meters will have Bluetooth® ON. 
9.4 
The meters, test strips, and CONTOUR NEXT and PLUS control solutions must be stored 
at 9-30C. See Appendix C for serum control storage. 
 
10.0 Subjects  
10.1 Recruitment and Enrollment   
10.1.1 A total of at least 120 blood samples with evaluable results (N=240) are required 
for this study. Up to 200 subjects may be enrolled into the study to obtain the 
required number of samples. See section 13.10 for the definition of evaluability.  
10.1.2 The subject population will consist of neonates from hospital wards (e.g. 
routine/newborn nurseries, SCN, NICU) of the clinical investigational site.  
10.1.3 There will be a sub-group of at least 5 samples collected from neonates who are 
less than 24 hours of age. 
10.1.4 There will be a sub-group of at least 5 samples collected from neonates from the 
NICU. 
10.1.5 The samples in these two sub-groups are permitted to overlap. 
10.1.6 The study staff will document subject demographics, including age and gender. 

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 15 of 42 
10.1.7 Unused residual blood samples collected for study testing procedures will be 
discarded according to hospital Laboratory Safety Guidance (Occupational 
Safety and Health Administration) procedures. 
10.2 Inclusion Criteria 
10.2.1 Residual capillary (heel-stick) blood samples from neonates (less than 28 days 
of age) after birth as part of prescribed testing. 
10.2.2 Sample blood volume must be sufficient to complete investigational testing in 
addition to routine prescribed clinical laboratory testing. 
10.3 Exclusion Criteria 
10.3.1 Samples from subjects who are ≥ 28 days of age. 
10.3.2 Samples from subjects who have previously been enrolled into this study.  
10.4 Study Duration  
10.4.1 The total expected duration to complete the clinical investigation is ~4 months. 
10.4.2 The expected duration of each subject's participation is not applicable since there 
is no direct subject participation.  Only  residual blood samples from subjects 
will be tested per the study procedures only on the day of sample collection. 
11.0 Procedures  
11.1 Summary 
Laboratory professionals will test the glucose concentration of residual capillary whole blood 
samples, collected (into a tube) from neonatal heel-sticks only, using the CONTOUR NEXT and 
CONTOUR PLUS ELITE BGMSs. The investigational site will enroll neonates from hospital 
wards (e,g, routine/newborn nurseries, SCN, NICU). For subject safety and ethical reasons, only 
those neonates already scheduled to have blood samples obtained for prescribed testing (by the 
hospital staff), will be enrolled into this study.  No neonate will have heel-stick blood collected 
solely for the purpose of this study. 
A minimum of 10 capillary whole  blood samples (from residual neonatal heel-stick) will be tested 
in duplicate on both BGMSs. A sub-group of at least 5 of these blood samples will be from neonates 
who are less than 24 hours of age. A sub-group of at least 5 blood samples will be from neonates 
in the NICU. These two sub-groups’ samples are permitted to overlap. 
Up to 50uL of whole blood will be removed from the subject'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), and a hematocrit measurement. Each subject 
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.    

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 16 of 42 
The site staff will use their Laboratory Glucose Analyzer (approved by the Sponsor) for the 
laboratory assessment of blood glucose samples tested in duplicate as part of prescribed testing of 
the same sample. The laboratory duplicate results will be averaged. In cases where the prescribed 
test for the sample is a bilirubin analysis, the results of this test will be recorded as part of the study 
data. 
During the study, three test strip lots will be used for each BGMS. The test strip lots will be 
arbitrarily designated 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. 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. For each sample, the order of testing each of the two 
BGMSs will also be randomized. 
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  
 
11.2 Study Staff Training  
The site study staff will be given copies of the protocol and meter instructional material (UG). 
They 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: 
11.2.1 Protocol & CRFs 
11.2.2 Meter Instructions for Use (UG) 
11.2.3 Meter control solution testing 
11.2.4 Error messages and troubleshooting 
11.2.5 GCP 
11.2.6 Practice using the CONTOUR NEXT and CONTOUR PLUS ELITE BGMSs 
11.2.7 Practice preparing and reading hematocrit samples  
 
11.3 Meter Control Solution Testing  
Control testing on the study BGMS will occur after they arrive at the site and before the trial 
starts.  

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 17 of 42 
11.3.1 The site staff will equally distribute (approximately) the strip lots for control 
testing. 
11.3.2 The site staff will perform 3 control tests (one each of low, normal, and high) on 
each BGMS assigned for the study.  
11.3.3 Results will be recorded and compared to the control ranges listed on the test 
strip bottle.  
11.3.4 If results are out of range, troubleshooting will be performed (see UG), and the test 
will be repeated for a total of up to 3 attempts.  
11.3.5 If the meter tests are out of range after troubleshooting is complete, the meter will be 
removed from the study, and the Ascensia Study Manager will be notified.  
Additionally, this will be documented on the ‘Device Deficiency Reporting Form’. 
11.4 Blood  Glucose Testing 
11.4.1 
No blood will be taken from study subjects solely for this study. Neonatal 
blood will be collected for prescribed testing and residual blood from the 
sample will be used for this study. Blood will be collected following HCP's 
orders by nursing/phlebotomy staff using standard heel puncture techniques. 
All samples will be transported to the laboratory per standard practice and 
submitted for prescribed clinical testing. Samples will be collected according 
to hospital standards and procedures and will be collected into a tube 
containing anticoagulants (lithium heparin). 
11.4.2 
Neonatal  blood samples will be inspected to verify if the volume drawn was 
sufficient to complete both prescribed clinical and investigational testing by 
laboratory personnel. Samples that do not have sufficient volume to complete 
the required investigational testing will not be used for the clinical trial.  
11.4.3 
If sufficient volume is available, this is the time of enrollment.  No more than 
the agreed amount (50 uL) of capillary whole blood will be removed from the 
original sample to perform blood glucose testing on two investigational 
BGMSsand a hematocrit measurement.  
11.4.4 
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. 
11.4.5 
Each blood sample for the study will be assigned an ID that is not traceable to 
the identity of the subject. 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. 
11.4.6 
Strip lot (color code) will be determined via a randomization schedule provided by 
the Sponsor. 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 subject will be used and the meters will be disinfected after use as per 
procedures listed in Appendix A. 

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 18 of 42 
11.4.7 
For each subject, 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).  
11.4.8 
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. 
11.4.9 
The test strips in the two meters will then be replaced, to prepare the meters for 
duplicate testing.  
11.4.10 A new drop of blood will be placed on the Parafilm and immediately tested with the 
first and second meter.  
11.4.11 A hematocrit measurement (%) will also be performed. (See Section 11.6.)  
11.4.12 The blood (from the same sample as used in meter testing) will be centrifuged within 
10 minutes of BG testing for separation into plasma.  
11.4.13 The start time of centrifugation will be recorded. Centrifugation must be performed 
within 10 minutes of the first-meter assay.  
11.4.14 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. 
11.5 Errors 
11.5.1 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. 
11.5.2 The study staff will record all meter error codes as appropriate for the meter tests as 
it occurs. 
11.6 Hematocrit 
11.6.1 At least one hematocrit tube, but preferably two, will be filled with the residual 
whole blood and then centrifuged.  
11.6.2 The hematocrit will be measured from only one tube; the second tube will be 
collected as a backup in case the first tube is not measurable (i.e., tube spun out, 
broken tube, clay seal compromised, etc.).  Additional details regarding hematocrit 
measurements are found in Appendix D.  

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 19 of 42 
11.7 Testing Schematic 
Table 2.  Sample Testing Schematic 
Step 
Test/action 
Description 
1 
Sample prep 
▪ Ensure collection of residual neonatal sample in collection tube containing 
anticogulant (lithium/heparin). 
▪ Confirm sufficient blood volume to perform all testing procedures.  
▪ If so, then aliquot up to 50 uL 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 randomization 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. Record results. 
▪ In case of error, may repeat 2 more times with a new blood drop. 
▪ Record time of successful meter tests.  
4 
Meter Test 2 
▪ Replace test strips, and place new blood drop on parafilm to repeat Step 3 
for duplicate testing.  
5 
Hematocrit 
▪ Using the blood from the same collection tube, fill up to 2 hematocrit tubes.  
▪ Perform hematocrit measurement, and record results. 
6 
Centrifugation ▪ Centrifuge blood, and record start time. (The centrifugation start time must 
be within 10 min of meter tests). 
7 
Laboratory 
tests* 
▪ Perform blood glucose testing of plasma sample on laboratory analyzer 
(Cobas) in duplicate.   
▪ Record results. 
* Pre-study and on-study serum control testing on Cobas: See 11.8 and Appendix C. 
11.8 Accuracy and Precision of Cobas 6000  
Performance of the Cobas 6000 will be tracked by two methods. The primary method will be the 
instrument QC check procedure regularly applied by the clinical site. In addition, serum controls 
will be provided by Ascensia for internal research purposes only, and will not impact the study 
data or data collection. See Appendix C for further details.  
 
11.9 Bilirubin Data  
Bilirubin data will be collected to assess potential interference with elevated bilirubin levels 
occurring in neonates. In cases where the prescribed test for the sample is a bilirubin analysis, the 
results of this test will be recorded as part of the study data from the hospital records. 
No bilirubin test will be performed on study samples just for the purpose of this study.  Thus, not 
all study samples may have bilirubin data.   

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 20 of 42 
 
11.10 Temperature and Humidity Logs  
• The study staff will measure the temperature/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 a temperature log for the storage of investigational materials 
including the meters, test strips, controls, and serum controls. 
12.0 Monitoring Plan  
12.1 A monitoring plan will be completed by the Study Manager/designee prior to the study. 
12.2 The study manager or designee will conduct the SIV. 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.  
12.3 Sponsor representatives may observe some study testing as part of study monitoring. This 
will be done under supervision of the Investigator. 
12.4 Sponsor representatives will maintain subject confidentiality, and will not interfere with the 
rights of human subjects or safety, or  bias study conduct. 
13.0 Statistical Plan  
13.1 Sample Size 
13.1.1 The sample size requirement is based on the primary objective, section 7.0. 
13.1.2 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 at least 2*120 = 240. 
13.1.3 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. 
13.1.4 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. 
13.1.5 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. 

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 21 of 42 
13.2 Blood Glucose Measurements 
Data analysis follows analyses and presentations described in 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. 
The unit conversion formula for blood glucose is the following: 
Xmmol/L = Ymg/dL / 18.016 
13.3 Bland-Altman  Plots 
Modified Bland-Altman plots (the difference between each evaluation device results and reference 
results plotted against reference results) will be constructed. 
13.4 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: 
𝑴=  𝜷𝟎+ 𝜷𝟏𝑪+ 𝜺 
𝜺~𝑵(𝟎, 𝒄𝒗∗𝑪) 
The parameter cv is the coefficient of variation, which is assumed to be constant across the glucose 
range.  The weighting function will be: 
𝒘= 𝑪−𝟐 
This weighting function is used to account for the constant cv nature of glucose measurement 
(Draper and Smith, 1998). 
13.5 Accuracy Analyses 
13.5.1 Two sets of metrics will be calculated: 
Relative (Percent) Difference (RD) for reference result  ≥ threshold glucose: 
𝑹𝑫= 𝑴−𝑪
𝑪
𝟏𝟎𝟎% 
where: M = strip/meter result and C = comparator or reference method result. 
 
Difference (D) for reference result < threshold  glucose: 
𝑫= 𝑴−𝑪 

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 22 of 42 
13.5.2 Primary objective:  
The threshold glucose value is 100 mg/dL (5.55 mmol/L).  Accuracy will be assessed using 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. 
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 13.1 (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%. 
13.5.3 The second part of the primary objective  
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 (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 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%.  It is possible 

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 23 of 42 
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. 
13.6 Neonates < 24 hrs. old and Neonates in NICU – Other Objectives 
In addition to the neonates less than 28 days of age, additional analyses of data from neonatal 
subjects ≤ 24 hrs. old  and neonates in NICU will be performed. 
13.6.1 Specifically, differences in BG results between BGMS and reference laboratory 
instrument will be plotted against the laboratory instrument results (modified Bland-
Altman plot). 
13.6.2 There must be at least 5 subjects <24 hrs. old and 5 subjects in NICU enrolled to 
perform this analysis. These groups may have any or all subjects in common.  
13.7 Hematocrit Analysis – Other Objectives 
13.7.1 Hematocrit will be measured for each subject. Mean, median, minimum, 
maximum, and standard deviation, will be computed for hematocrit 
determinations. 
13.7.2 The effect of hematocrit on meter results will be presented via regression of 
differences between the meter and laboratory BG measurements against 
hematocrit. 
13.8 Bilirubin Analysis – Other Objectives  
For neonates who would have bilirubin results, regression analysis will be used to assess the effects 
of bilirubin on the difference between meter and laboratory reference method blood glucose 
measurements.  
There must be at least 3 subjects enrolled with bilirubin recorded to perform this analysis.  If fewer 
than 3, then the results will be reported in a table. 
13.9 Temperature and Humidity 
Mean, median, standard deviation, minimum and maximum room temperature, and humidity will 
be computed. 
13.10 Data Evaluability  
Blood glucose data will be considered not evaluable for the following reasons: 
• 
Samples with no associated or valid hematocrit value.  
• 
Samples with no associated or valid Cobas 6000 value.  

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 24 of 42 
• 
Failure to begin to separate the plasma from the red cells within 10 minutes of 
obtaining the first meter test. 
• 
The collected samples exceed a maximum of 5 h of sample withdrawal time, and 
will be kept at room temperature (23 ± 5 °C) before evaluation. 
• 
For a given sample, the meter is missing a replicate. 
• 
Results of the glucose analyzer blood sample are not within ±4% of each other, 
100* (Rep2-Rep1)/Rep1, or ±4mg/dL (0.22mmol/L) of each other (Rep2-Rep1) 
if the average falls below 100mg/dL (5.5mmol/L). 
14.0 Data Management  
14.1 A unique number will identify each subject/sample. The unique number will be entered on 
the CRFs. The site will create a procedure to de-identify subjects from samples so that the 
staff members documenting subject names will not have access to sample results and the 
staff members testing the samples will not have access to subject names. A master list of 
subject names,  with their subject IDs, will be kept by the Investigator at the study site until 
the study has been closed. 
14.2 Study personnel will complete and sign all appropriate forms in compliance with GCP. 
CRFs 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. 
14.3 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.  
14.4 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.    
15.0 Amendments to the Protocol  
15.1 Any change to this protocol requires a protocol amendment (or revision) unless the IRB 
agrees to an administrative change (for minor changes).  
15.2 Determine the justification(s) for the protocol revision, impact of the changes on subject 
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. 
15.3 Determine if the revision meets the criteria of a Substantial Amendment.  

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 25 of 42 
15.4 Substantial Amendments  
15.4.1 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 IRB 
before implementation. For any questions on whether a change would be considered 
substantial, consult with the respective IRB.  
15.4.2 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 subjects, 
• 
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. 
15.4.3 An amendment is only to be regarded as “substantial” when one or more of the above 
criteria are met but the IRB may have additional requirements that shall be 
considered. 
15.4.4 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  
• 
Informed Consent Form (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 
15.5 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). 
15.6 Once the drafted revision is approved internally and by the PI, it will be submitted to the 
IRB, where required. All subsequent, IRB-approved, revised protocols would be numbered 
sequentially. 

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 26 of 42 
15.7 The amended protocol will be approved by the original approvers, including the sponsor 
representatives or designee and the PI. 
15.8 The sponsor must assure that each investigator (and his/her staff) is following the most 
recent IRB 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. 
16.0 Deviations from the clinical protocol  
16.1 A protocol deviation is any alteration or modification to the procedures described in the 
protocol. The investigator is not allowed to deviate from the protocol. The only exceptions 
to this are: 
16.1.1 The deviation is necessary to protect the subject's rights, safety and well-being, or 
the scientific integrity of the clinical investigation without prior approval of the 
sponsor and IRB. 
16.1.2 Prospective deviations that broaden the scope of the protocol (waivers of the 
protocol) are prohibited.  Under emergency circumstances, these instances can 
proceed. 
16.2 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. 
17.0 Device Accountability  
17.1 Description of the procedures for the accountability of investigational devices as follows: 
17.1.1 Access to investigational devices shall be controlled and the investigational devices 
shall be used only in the clinical investigation and according to the protocol. 
17.1.2 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. 
17.1.3 Accountability: The PI 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 
• 
Subject number 

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 27 of 42 
• 
Date of return of unused, expired or malfunctioning investigational 
devices, if applicable 
18.0 Regulatory 
Ascensia (sponsor) has determined that according to IDE requirements of 21 CFR 812.2(c), this 
IVD study meets all conditions for IDE exemption and therefore submission of an IDE application 
to FDA is not required.  Determination is based on the following: 
The Contour Next and Contour Plus Elite Glucose Monitoring Systems (IVDs); 
• are labeled in accordance with 21 CFR 809.10(c) 
• are non-invasive 
• do not require an invasive sampling procedure that presents significant risk 
• do not by design or intention introduce energy into a subject 
• are not used as a diagnostic procedure without confirmation of the diagnosis by another, 
medically established diagnostic product or procedure. 
 
18.1 IRB Approval 
18.1.1 Before study initiation, an IRB must review this protocol, the ICF, and any other 
supporting study documents which impact subject safety. The IRB will determine if 
the Informed Consent is required according to local regulations and requirements or 
if consent is not required (ISO 20916:2019(E)).  
18.1.2 The investigational site may not begin the study until the IRB has given its written 
and dated approval via a letter that identifies the version/date of the protocol and 
ICF, if applicable, or a notification that consent is not required.  
18.1.3 A copy of the IRB approval letter must be provided to the Investigator and to sponsor 
prior to the SIV. 
18.2 Study  Documentation Procedures 
18.2.1 The investigator will keep study records for a minimum of three years. Alternatively, 
other arrangements may be made with Ascensia for study document storage. 
18.2.2 Study Investigational Devices will be labeled "For Investigational Use only. The 
performance characteristics of this product have not been established" for this study. 
18.2.3 After study completion, all BGMSs 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 UGs will be accounted for at the site 
and returned to the Ascensia Study Manager upon completion of the trial. 

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 28 of 42 
18.3 Investigator's Report of Study Closure 
18.3.1 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.  
18.3.2 The Investigator or designee will submit a report summarizing subject disposition 
and other study details, as appropriate, to the Study Manager and the IRB.  This 
report will be completed within 3 months of the study closure date.   
18.3.3 In addition, the Study Manager, or designee, will report the completion of the study 
to the IRB within 6 months of study closure.  
19.0 Statements of compliance  
19.1 This clinical investigation will be conducted in compliance with applicable requirements: 
19.1.1 Protection of Human Subjects regulations in 21 CFR part 50. 
19.1.2 IRB regulations in 21 CFR part 56. 
19.1.3 Investigational Device Exemptions regulations in 21 CFR part 812. 
19.1.4 Declaration  of Helsinki. 
19.1.5 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. 
19.1.6 International Standards: ISO20916:2019(E) – In vitro diagnostic medical devices – 
Clinical performance studies using specimens from human subjects – Good Study 
Practice and In Vitro Diagnostic Regulation 2017/746 Annex XIII, Part 2. 
19.1.7 British Standard BS EN 13612:2002, “Performance evaluation of in vitro diagnostic 
medical devices.” 
19.2 The clinical study shall not begin until the required approval from the IRB or regulatory 
authority have been obtained. 
19.3 Clinical trial insurance shall be provided as appropriate. 
20.0 Informed Consent Process  
The IRB will  determine if the Informed Consent is required according to local regulations and 
requirements for use of residual blood samples for this study.   
 
The following will only apply if Informed Consent is required by the IRB.  If the IRB determines 
that consent is not required, this section will not apply. 
 

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 29 of 42 
20.1 Since the subject is a neonate, the subject’s parent/guardian - Legally Authorized 
Representative (LAR) - will complete the informed consent process before performing any 
study procedures.  
20.2 The LAR will be informed about the study objectives, investigational devices, study 
procedures, expected study duration, and risks of study participation. 
20.3 Study participation is voluntary. The information will be given in written form (ICF) as 
well as verbally by the investigator.  
20.4 The subject’s LAR will sign and date the ICF.  The ICF will then be dated and signed by 
the investigator. 
20.5 The investigator will retain the original of the documents.  The subject’s LAR will receive 
a copy of the ICF and if applicable, insurance terms and conditions.  
21.0 Adverse events and adverse device effects  
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 neonatal blood 
collected as part of routine prescribed practice. 
Due to the nature of this study, no adverse events (AE) are expected as per the following: 
21.1 This study only includes residual (‘left-over’) samples of blood collected by standard, 
approved technique for prescribed tests. 
21.2 No neonate will be exposed to any of the BGMS at any point; all study activities will be 
conducted in the institution’s lab. 
21.3 The samples will be de-identified in order to protect the confidentiality of the subjects. 
Confidentiality issues are mitigated due to the fact that the nursing staff overseeing the 
babies will not be informed of any study results, and samples will be de-identified prior to 
being given to the laboratory staff who perform study testing   
21.4 Regardless of the above, any experience that the investigator considers to be an AE will be 
documented and reported immediately to Ascensia. 
21.5 Definition of Adverse Events  
21.5.1 Adverse Event (AE): Adverse event refers to any untoward medical occurrence, 
inappropriate patient management decision, unintended disease or injury, or 
untoward clinical signs in subjects, users, or other persons, with any connection to 
to study related activities, whether or not related to the IVD medical device under 
investigation. 

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 30 of 42 
21.5.2 Adverse Device Effect (ADE or Adverse Effect): Any AE resulting from insufficient 
or inadequate instructions for use, installation, operation, or any malfunction of the 
IVD medical Device under investigation.  This includes any AE resulting from use 
error or from unintentional misuse of the device.  
21.5.3 Serious Adverse Event (SAE): Refers to an AE that led to any of the following:  
a) death, 
b) serious deterioration in the health of the subject, 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, 
c)   fetal distress, fetal death, or a congenital abnormality or birth defect, including 
physical or mental impairment. 
 
21.5.4 Serious Adverse Device Effect (SADE): Adverse device effect that has resulted in 
any of the consequences of an SAE.                           
 
21.6 Adverse Event Classification  
Table 3. Classification of Adverse Events (ISO 20916: 2019) 
Adverse Events 
Non -device related 
Device related  
 
Applies to : 
• 
Interventional Studies 
• 
Sampling procedure causes 
direct harm to the subject 
Applies to : 
• 
Interventional Studies: inaccurate test result leads 
to indirect harm to the subject. 
• 
Sampling procedure causes direct harm to the 
subject 
 
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 

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 31 of 42 
21.7 Adverse Event Reporting  
21.7.1 AEs 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.   
21.7.2 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. 
21.7.3 Investigators should follow up on the status of any AE until the event has been 
resolved, or until the condition has stabilized.  
21.7.4 The Investigator or designee will notify the Study Manager or  Study Monitor within 
24 hours of any SAE that occurred during the study.  Ascensia will promptly review 
all information relevant to the safety of the investigational device. 
21.7.5 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 Lead, Emerging Markets 
Global Medical Affairs, Ascensia Diabetes Care 
Email: rimma.shaginian@ascensia.com 
22.0 Handling and Reporting of Device Deficiencies 
22.1 Any functional problems with the investigational BGMS will be considered a device 
deficiency and will be documented by the study staff and reported timely to Ascensia.   
22.2 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.   
22.3 Malfunctioning BGMs will be replaced and this will be documented for device tracking. 
22.4 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. 
22.5 Device deficiencies that did not lead to an AE but could have led to a medical occurrence 
shall be reported to the sponsor without delay.  
22.6 All device deficiencies are to be reviewed and documented in writing whether they could 
have led to a SADE. 

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 32 of 42 
23.0 Vulnerable population 
23.1 While the samples will be taken from neonates, who are in the vulnerable population 
category, the procedure does not involve additional risk since the samples are residual with 
no additional sampling required.  
23.2 If the IRB determines consent is required, then proxy consent by an LAR shall be provided 
to protect the rights of the subject.  
24.0 Suspension/Premature termination and Subject Withdrawal Criteria 
24.1 In the event the study is prematurely suspended or terminated, the sponsor shall be notified 
as well as the IRB. 
24.2 The subject’s sample may be withdrawn from the study at the discretion of the Investigator.  
25.0 Results Handling 
Results of the study will not be shared with subjects. There is no plan for treating or following up 
with subjects based on the investigational results from this study. 
26.0 Publication policy  
26.1 The results will be published in regulatory databases, Clinicaltrials.gov and EUDAMED. 
 
26.2 In general, for publication of data, the principles of GCP 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. 

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 33 of 42 
27.0 Administration 
All investigator and site staff communications regarding the study should be directed to the 
Ascensia Study Manager. If at any time questions or problems arise concerning the evaluation, 
please contact the Ascensia Study Manager at the telephone number listed below. 
Maria Teresa Viggiani 
Phone (Office): 914-236-1836                
Direct: 914-417-9310 
E-mail: maria.viggiani@ascensia.com   
OR 
Rosanna Cirio 
Phone (Office): 862-225-3414 
Direct: 914-343-5736 
E-mail: rosanna.cirio@ascensia.com 
28.0 Bibliography   
1. Adamkin DH. Postnatal glucose homeostasis in late-preterm and term infants. Pediatrics 2011; 
127: 575–79. 
2. British Association of Perinatal Medicine. Identification and management of neonatal 
hypocycaemia in the full term infant. A BAPM framework for practice. 2017. 
https://www.bapm.org/resources/40-identification-and-management-of-
neonatalhypoglycaemia-in-the-full-term-infant-2017 (accessed  Sept 23, 2020). 
3. CLSI. Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved 
Guideline – Third Edition. CLSI document POCT 12–A3. Wayne, PA: Clinical and Laboratory 
Standards Institute; 2013. 
4. Draper, N.R. and Smith, H. (1998). Applied Regression Analysis, 3rd Ed., John Wiley and Sons, 
NY. 
5. Harris DL, Weston PJ, Harding JE. Incidence of neonatal hypoglycemia in babies identified as 
at risk. J Pediatr. 2012;161:787-791.  
6. 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. 
7. ISO 20916: 2019. In vitro diagnostic medical devices—clinical performance studies using 
specimens fro human subjects—Good Study Practice. Geneva: International Organization for 
Standardization (ISO); 2019. 
8. ISO 22870: 2016. Point-of-care testing (POCT)—requirements for quality and competence. 
Geneva: International Organization for Standardization (ISO); 2016. 
9. Lucas A, Morley R, Cole TJ. Adverse neurodevelopmental outcome of moderate neonatal 
hypoglycaemia. BMJ 1988;297:1304–8. 
10. Movalia MK, Ogino MT. Point of care glucose testing in neonatal hypoglycemia. Point Care. 
2006;5:95–9. 
11. Nuntnarumit P, Chittamma A, Pongmee P, Tangnoo A, Goonthon S. Clinical performance of 
the new glucometer in the nursery and  neonatal intensive care unit. Pediatr Int. 2011;53:218–
23. 
12. Roth-Kleiner M, Stadelmann Diaw C, Urfer J, Ruffieux C, Werner D. Evaluation of different 
POCT devices for glucose measurement in a clinical neonatal setting. Eur J Pediatr. 
2010;169:1387–95.  
13. Rozance PJ, Hay WW. Hypoglycemia in newborn infants: features associated with adverse 
outcomes. Biol Neonate. 2006;90:74-86. 

Protocol /CIP: GCA-PRO-2021-003-01 - Amendment 1  
 
 
 
Ascensia Diabetes Care 
Version: 14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
 
Page 34 of 42 
Appendix A - Instructions for Cleaning and Disinfecting Meters 
Study staff will clean and disinfect meters according to the UG instructions for HCPs. 
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.  Centers for Disease Control and 
Prevention. 

Protocol/CIP: GCA-PRO-2021-003-01 – Amendment 1 
 
 
 
 
Ascensia Diabetes Care 
Version:14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
Page 35 of 42 
 
Appendix B - Instructions for Processing of Blood for the glucose analyzer 
 
Processing of Neonatal Blood for laboratory glucose analysis  
Once collected, process the microtainer tube for laboratory glucose analysis as follows:   
• Label all tubes with the subject number using a Sharpie®-like marker.   
• Gently invert the microtainer tube several times to mix the anticoagulant.  
• Centrifuge the whole blood immediately to separate the plasma from the red blood cells.  The 
centrifugation start time must occur within 10 minutes of the first meter blood test.  The timing 
of all meter testing/centrifugation will be recorded on the appropriate CRF.   
• It is recommended that after centrifugation, the plasma is transferred from the microtainer tube 
to a small clean tube or container with a cap.   Ensure the tube is labeled and the cap is secured, 
and proceed with the site’s laboratory glucose analyzer procedures.  
• 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.  
• Insufficient (or suspected to be insufficient) samples, missing samples, and other sample issues 
should be recorded in the CRF and on the glucose analyzer printout, as appropriate.  If a sample 
is hemolyzed, record it in the CRF.   
 

Protocol/CIP: GCA-PRO-2021-003-01 – Amendment 1 
 
 
 
 
Ascensia Diabetes Care 
Version:14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
Page 36 of 42 
 
Appendix C - Instructions for Tracking Accuracy and Precision of the 
Laboratory Glucose Analyzer 
Procedure for Tracking Accuracy and Precision of Site Laboratory Analyzer  
Performance of the Cobas 6000 will be assessed to ensure accuracy.  Analyzer performance will 
be tracked by two methods: the Laboratory Analyzer QC procedure regularly applied by the 
clinical site, and the testing of serum controls provided by Ascensia. 
The following are the procedures required for each method: 
I. 
Laboratory Analyzer QC Procedure  
The Cobas 6000 will be maintained and operated according to the instructions in the 
manufacturer’s operating manual by the 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 Controls1 
A set of three serum control levels will be provided to the investigator to document the 
performance of the Cobas 6000 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 subject 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 the 
Monday and Friday of the first week, and then on one day for each week that the study 
continues.  
• Record all data on the CRF.  One reading will be recorded for each control level (for a total 
of 3 readings per run).   
 
 
1 Caution: The serum glucose traceability controls are human serum-based and must be handled using universal 
precautions. 

Protocol/CIP: GCA-PRO-2021-003-01 – Amendment 1 
 
 
 
 
Ascensia Diabetes Care 
Version:14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
Page 37 of 42 
 
 
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. 
• Store the frozen controls in a -20C freezer upon arrival.  
• Thaw the frozen control amber glass vials at 2-8ºC for 2-3 days in the refrigerator.  Each 
vial holds approximately 2.0 mL. 
• Before opening, mix the vials well by gently inverting them at least 10 times. 
• 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). 
• Store any remaining control in the amber glass vials at 2-8ºC. 
• Before running a control sample on the laboratory analyzer, mix the aliquot tubes by gently 
inverting them. 
• 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. 
• The thawed control use life is two weeks.  Discard all thawed control—aliquot tubes and 
amber glass vials—after two weeks. 
• Since slow thawing for 2-3 days is recommended, it is advisable to keep an extra thawed 
set available for testing. 
 
 
 

Protocol/CIP: GCA-PRO-2021-003-01 – Amendment 1 
 
 
 
 
Ascensia Diabetes Care 
Version:14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
Page 38 of 42 
 
Appendix D - Instructions for Hematocrit Sample Preparation and Testing 
 
Staff will follow the instructions in the hematocrit reader user manual.   
1. At least one microhematocrit tube, but preferably two, will be filled with residual capillary 
blood from each subject sample.  One tube will be measured, and the result recorded on the 
form.  The second tube is a backup and will be measured only if the first tube was not adequate 
for measurement, or is broken.     
• Ensure the tube setting on the HemataStat II™ is set to 0.5 mm ID (inner diameter). 
• Samples collected from residual capillary blood (heel-stick) will be collected in treated 
micro-hematocrit tubes.    
2. Place a microhematocrit tube against the surface of the blood drop. 
3. Fill the microhematocrit tube about halfway.  Do not over-fill.  Then immediately place one of 
the microhematocrit tube openings in the clay sealant.  Press into the clay 2-3 times to make 
sure enough sealant is transferred. 
4. Place the sealed microhematocrit tube into the Hematastat II™ micro-centrifuge.  Note: it is 
very important to place the microhematocrit tube in centrifuge rotor with clay side down.  
Balance the rotor with another hematocrit tube containing water.  
5. Click run to spin for the preset 60 seconds.  
6. Measure hematocrit using the Hematastat reader or other hematocrit reader approved by the 
sponsor.  
7. Summary of Instructions for the Hematastat reader: 
• After collection and centrifugation of hematocrit, place tube in the reader slot, with clay 
side to the left.  Press enter to read. 
• Slide the marker on the reader to the exact line where the clay and red blood cells meet.  
Press enter to “enter interface: sealant/RBCs.”   
• Then move the marker to the exact line where the red blood cells meet the plasma. Press 
enter to “enter interface: RBCs/plasma.”  
• Slide the marker to the exact line where the plasma ends. Press enter to “enter interface: 
plasma/air.” 
• The result in the display is the hematocrit percentage for that sample. 
8. Record hematocrit result on the appropriate form. 
 
 

Protocol/CIP: GCA-PRO-2021-003-01 – Amendment 1 
 
 
 
 
Ascensia Diabetes Care 
Version:14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
Page 39 of 42 
 
Attachment 1 - CONTOUR NEXT User Guide 
 
 
 
 

Protocol/CIP: GCA-PRO-2021-003-01 – Amendment 1 
 
 
 
 
Ascensia Diabetes Care 
Version:14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
Page 40 of 42 
 
 

Protocol/CIP: GCA-PRO-2021-003-01 – Amendment 1 
 
 
 
 
Ascensia Diabetes Care 
Version:14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
Page 41 of 42 
 
Attachment 2 - CONTOUR PLUS ELITE User Guide 
 
 
 
 

Protocol/CIP: GCA-PRO-2021-003-01 – Amendment 1 
 
 
 
 
Ascensia Diabetes Care 
Version:14Oct2022 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
Page 42 of 42