GIDE - Glucose Time-In-Range Development Evaluation
Phase: NA
Conditions: ICU, Dysglycemia
Sponsor: Washington University School of Medicine

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GIDE – Glucose Time-In-Range Development Evaluation 
 
(GIDE Study) 
 
 
 
 
 
 
 
 
Grant Bochicchio, M.D., M.P.H. 
Principal Investigator 
Washington University in St. Louis 
Department of Surgery 
660 S. Euclid Avenue 
Saint Louis, MO 63110-1093 
 
 
 
 
 
 
 
 
 

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TABLE OF CONTENTS 
 
Executive Summary 
 
 
 
 
1.0 
Introduction 
 
 
1.1 
Background and Rationale 
 
 
1.2 
Device Description 
 
 
1.3 
Indications For Use 
 
 
1.4 
Regulatory Status 
 
 
1.5 
Risks and Benefits 
 
 
 
 
2.0 
Study Objectives 
 
 
2.1 
Screening and Study Enrollment 
 
 
2.2 
Inclusion Criteria 
 
 
2.3 
Exclusion Criteria 
 
 
2.4 
Withdrawal of Subjects 
 
 
 
 
3.0 
Selection and Withdrawal of Subjects 
 
 
3.1 
Screening and Study Enrollment 
 
 
3.2 
Inclusion Criteria 
 
 
3.3 
Exclusion Criteria 
 
 
3.4 
Withdrawal of Subjects 
 
 
 
 
4.0 
Study Design 
 
 
4.1 
Study Design Description 
 
 
4.2 
Study Endpoints and Other Assessments 
 
 
4.3 
Sample Size 
 
 
4.4 
Duration of Subject Participation 
 
 
4.5 
Study Termination 
 

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5.0 
Assessment of Time-In-Range 
 
 
 
 
 
6.0 
Assessment of Safety 
 
 
 
 
 
7.0 
Statistics 
 
 
 
 
 
8.0 
Data Management 
 
 
 
 
 
9.0 
Investigator Responsibilities 
 
 
 
 
 
10.0 
Ethics 
 
 
 
 
 
11.0 
Data Handling and Record Keeping 
 
 
 
 
 
12.0 
Quality Control and Quality Assurance 
 
 
12.1 
Investigational Site Training 
 
 
12.2 
Clinical Case Technical Support 
 
 
 
 
 
13.0 
Adverse Events and Serious Adverse Events 
 
 
 
 
 
15.0 
Bibliography 
 
 
 
 
 

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EXECUTIVE SUMMARY 
 
Sponsor Name: 
This is an Investigator Initiated Study being funded by OptiScan 
Biomedical Corporation.   
Objectives: 
Assessment of glucose Time-in-Range (TIR) post implementation of 
the OptiScanner 5000 bedside glucose monitoring system (OptiScan 
Biomedical) in a Surgical ICU patient population. 
Assessment of the time it takes the patient to achieve in range 
glucose values (using participant’s clinical care defined glucose target 
range) while connected to the OptiScanner.  
Clinical Hypothesis: 
Preventing glucose variability has been shown to be strongly 
associated with increased survival in non-diabetic critically ill adults 
(6-8). In clinical practice, it is very challenging to maintain critically ill 
patients’ glucose values within a “target range” as the methods 
currently available to accomplish this are burdensome on the clinical 
care team and can be quite costly.    
The primary endpoint of this study is to assess the level of TIR 
obtained in a surgical ICU patient population after implementing the 
OptiScanner 5000 glucose monitoring systems. 
Name of Investigational 
Device(s): 
OptiScanner 5000 Glucose Monitoring System 
FDA Cleared on October 16, 2017 (K162042). The device will be used 
without Clinical Laboratory Improvement Amendments (CLIA) 
oversight for this study.  
Design: 
Single center, non-randomized, study evaluating the proportion of 
patients maintaining in range glucose values (using participants’ 
clinical care defined glucose target range) and the time it takes for 
patients to achieve in range glucose values in a Surgical ICU 
population after implementing the OptiScanner 5000 Glucose 
Monitoring system 
 
 

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Planned Enrollment: 
Enrollment into this trial will be in two phases. Phase One of the 
study will consist of study staff working with the clinical care team to 
operationalize the logistics involved with implementing the use of the 
OptiScanner.  In addition, phase one subjects will provide the 
opportunity for the PI to observe the OptiScanner utility as a 
complement to the current glucose management of the patient. The 
continuous glucose monitoring provided by the OptiScanner may 
introduce additional glucose measurement information that would 
not have been known if it occurred between the routine clinical care 
glucose measurements and the clinical care team will be advised to 
confirm any OptiScanner glucose value (using routine clinical care 
methods) before making any modifications to patients’ clinical care 
based on the OptiScanner glucose result.  A research team member 
will be at the patient’s bedside during his/her entire study 
participation to ensure that the clinical care team does not use the 
OptiScanner results independently to direct patient care and to 
observe how the additional glucose information is or is not used.  A 
minimum of 50 patients will be enrolled in phase one.  
Phase Two will commence after the data from phase one has been 
evaluated.   The protocol will be updated with Phase Two procedures 
after the completion of the analysis of phase one results.  
Study Completion: 
• The study will be completed after enrolling 50 phase one 
evaluable subjects. An evaluable subject is defined as a 
subject with a minimum of 48 hours of OptiScanner 
monitoring. 
Duration of 
Participation: 
Minimum of 48 hours of monitoring with the OptiScanner System 
Maximum of 72 hours of monitoring with the OptiScanner System 
Primary Endpoint: 
Time-in-range (TIR), post-OptiScanner system implementation: 
 
Target TIR 
 
Primary Endpoint 
According to 
participants’ 
clinical care 
defined target 
glucose range  
 
Evaluation of TIR 
 
Secondary Endpoint  
Assessment of the time it takes the patient to achieve in range 
glucose values while connected to the OptiScanner. 

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Safety Endpoints: 
The proportion of subjects that experience one or more Device 
Related Serious Adverse Events (DRSAEs). 
Incidence of hypo/hyperglycemia  
 
 
 
 
1.0 
Introduction  
 
1.1 
Background and Rationale  
 
 
Hyperglycemia [1-4], hypoglycemia [1,5] and glycemic variability [6-8] are independently 
associated with morbidity and mortality of critically ill patients.  Blood glucose control 
with insulin has the potential to decrease morbidity and mortality of intensive care unit 
(ICU) patients.  Blood glucose control with insulin, however, is associated with an 
increased risk of hypoglycemia and may not decrease glycemic variability.  In addition, 
blood glucose control with insulin utilizing manual systems for glucose measurement is 
blood-consuming and time-consuming, since frequent blood draws for glucose 
measurements are necessary in order to achieve blood glucose control. 
 
Severe hypoglycemia (blood glucose level < 40 mg/dl) is a feared complication of blood 
glucose control with insulin. Undoubtedly, with the implementation of blood glucose 
control with insulin the incidence of hypoglycemia increases [9-15].    Several reports 
showed a significant association between hypoglycemia and patient outcomes 
[1,5,8,16].  Recently, an association has even been suggested between moderate 
hypoglycemia (blood glucose level between 40–69 mg/dL) and patient outcomes.  
Incidences of moderate hypoglycemia are more prevalent than severe hypoglycemia.  
The risk of developing (severe or moderate) hypoglycemia hampers, at least in part, 
broad implementation of blood glucose control with insulin, in particular when aiming at 
normal blood glucose levels, such as 80 – 150 mg/dl [17,18]. 
 
Recent studies showed significant associations between glycemic variability and patient 
outcomes [6-8,19,20]. Krinsley, et al, demonstrated that a TIR of 70 to 140 mg/dl > 80% 
was strongly associated with survival in critically ill patients without diabetes, 
independent of ICU LOS or severity of illness [21]. 
 
 
Implementation strategies of blood glucose control have mostly been accomplished 
with manually operated portable whole blood glucose meters, which suffer from a 
variety of error sources that can put intensively managed patients at risk for insulin 

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over– and/or under–dosing [23].  Furthermore, all manually operated whole blood 
glucose monitoring measurement devices lack trending, though immediate feedback 
and predictability of the effects of insulin infusions are highly needed when infusing 
insulin in critically ill patients [24].  In addition, each blood glucose measurement not 
using a finger stick requires a substantial volume of blood and is time–consuming [25]. 
 
Automated, frequent, plasma-based glucose monitoring with the OptiScanner 5000 
glucose monitoring system has the potential to improve a patient’s glucose TIR by 
improving all 3 domains of glycemic control: reducing hyperglycemia while at the same 
time preventing hypoglycemia and reducing glycemic variability.  Second, it could 
reduce the workloads associated with the high number of blood samples to be obtained 
and analyzed [22,26-29].  
 
 
1.2 
 Device Description 
The OptiScanner® 5000 Glucose Monitoring System from OptiScan Biomedical 
Corporation is an automated, bedside glucose monitoring system designed to 
quantitatively measure the concentration of venous blood glucose. When attached to a 
patient, the OptiScanner® 5000 Glucose Monitoring System automatically draws a 3 mL 
blood sample, retains a micro-sample of blood for analysis (0.17 mL), and returns the 
remaining portion of the blood to the patient.  The OptiScanner® 5000 Glucose 
Monitoring System analyzes the retained portion of the blood sample and then displays 
a glucose value.  The OptiScanner® 5000 Glucose Monitoring System provides trending 
glucose information, which allows for decision-making based on a trend rather than any 
single glucose value. 
The OptiScanner automatically performs the following functions as part of its 
monitoring cycle: 
• Draws blood from the patient. 
• From the blood withdrawn, retains a micro-sample (0.17 mL) blood sample for 
glucose measurement. 
• Returns the unused blood to the patient along with a small (2.5 mL) amount of 
saline solution. 
• Spins the blood sample, separating plasma from red blood cells. 
• Measures optical signals from the plasma sample using a mid-infrared 
spectrometer. 
• Adjusts for interfering substances, referencing a proprietary measurement 
algorithm. 
• Calculates the latest blood glucose value, displays it on-screen, and updates the 
trending graph with patient’s real-time glucose information.  
 

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The OptiScanner disposable cartridge is the sterile container within which the blood 
sample is prepared and analyzed.  The Cartridge is for single patient use only.  A new 
sterile Cartridge must be used for each new patient.  In normal usage, the Cartridge will 
last for up to three days (72 hours) of monitoring.  
The connection between the OptiScanner and the patient is accomplished through a 
vascular access device.  Vascular access devices for OptiScanner connection include 
Central Venous Catheters (CVC) and Multi-lumen Access Catheters (MAC).  The 
OptiScanner patient connector design employs a standard universal luer connector and 
can be successfully used with these devices.  The type of device selected and its 
placement on the subject shall be determined by the user.  Placement of the vascular 
access device is performed in accordance with the vascular access devices instructions 
for use but must be connected to the venous side.  The OptiScanner must be connected 
to the most proximal port of the CVC or MAC. 
The OptiScanner is composed of three main components (see Figure 1 and 2): 
• OptiScanner Instrument with integrated pump, spectrometer, and user interface 
• OptiScanner Transport Cart with a single IV pole or double IV poles (Cart) 
• OptiScanner Disposable Cartridge (Cartridge) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Figure 1:  Instrument mounted on the transport cart (up to two poles may be 
assembled) 
 
Figure 2:  Disposable device 
 
 

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1.3 
Indications For Use 
The OptiScanner® 5000 Glucose Monitoring System is an automated, bedside glucose 
monitoring device indicated for detecting trends and tracking patterns in persons (age 
18 and older) in the surgical intensive care unit.  The system collects a venous whole 
blood sample via connection to a central venous catheter, centrifuges the sample, and 
measures the plasma glucose concentration.  It is not intended for the screening or 
diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.  The 
OptiScanner® 5000 Glucose Monitoring System is for in vitro diagnostic use. 
1.4 
Regulatory Status 
The OptiScanner 5000 Glucose Monitoring System was FDA-Cleared for 
commercialization in the USA on October 16, 2017 (K162042) however this device is not 
currently commercially available in the US.   
1.5 
Risks and Benefits 
There have been no serious adverse events related to the OptiScanner in any of the 
clinical studies performed to date.  
Risk management in accordance with EN 14971, was completed on the study device.  
The conclusion is that the OptiScanner has an acceptable safety profile. 
Because the OptiScanner system delivers automated, every 15 minutes glucose results 
and trends, it has the potential to improve a patient’s glucose TIR by providing earlier 
identification of abnormal glucose values that would otherwise remain unknown until 
the clinical care scheduled glucose value was obtained (which typically are collected 
every 1 to 4 hours, depending on the condition of the patient).  Therefore, the 
OptiScanner has the potential to improve all 3 domains of glycemic control: reducing 
hyperglycemia while at the same time preventing hypoglycemia and reducing glycemic 
variability.  In the future, the OptiScanner may also reduce the workload associated with 
the high number of blood samples to be obtained and analyzed [22, 26-29]. 
2.0 
Study Objectives 
 
The primary objective of this study is to observe the Time-in-Range for patients whose glycemic 
control is being monitored with the OptiScanner system.  A secondary objective is assessment 
of the time it takes the patient to achieve in range glucose values while connected to the 
OptiScanner.  The study will evaluate patients requiring frequent glucose monitoring in a 
Surgical ICU. 
 
3.0 
Selection and Withdrawal of Subjects 
 

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3.1 
Screening and Study Enrollment 
The study population includes surgical critical care patients who require blood glucose 
monitoring.   
Subjects must have a vascular access device [i.e., Central Venous Catheters (CVC), Multi-
lumen Access Catheters (MAC) either in place or to be placed with an expected usage of 
at least 48 hours.   
Subjects that meet all of the eligibility criteria and are deemed suitable by the 
Investigator will be invited to participate in the study.   
Each potential study subject, or their legally authorized representative, must provide 
written Informed Consent using the Institutional Review Board (IRB)/Ethics Committee 
(EC) approved Informed Consent Form before undergoing any study-related procedures. 
A subject is considered enrolled in the study once the informed consent has been signed 
and all eligibility criteria have been verified, and the OptiScanner system has begun 
monitoring. 
3.2 
Inclusion Criteria 
All subjects are required to meet the following inclusion criteria in order to be 
considered eligible for participation in this study: 
1. Signed informed consent by the participant or his/her legally authorized 
representative; 
2. At least 18 years old; 
3. Admitted to a Surgical ICU or planned admission to a Surgical ICU at time of 
screening  
4. Expected SICU stay of at least 48 hours at the time of enrollment 
5. A vascular access device available for connection to the OptiScanner is either already 
in-place, or is planned to be placed with an expected usage of at least 48 hours. 
 
3.3 
Exclusion Criteria 
Patients will be excluded from participating in this study if they meet any of the 
following exclusion criteria: 
1. Positive HcG (serum or urine ) in women of childbearing potential (age < 60) who are 
not known to be surgically sterile and those that are obviously pregnant.  
2. Patients undergoing peritoneal dialysis within the past week. 
3. Patients actively receiving intravenous immunoglobulin therapy. 
4. Patients receiving intravenous administration of high dose ascorbate (IVC) for the 
treatment of patients with cancer. 
5. Patients following the administration of a D-Xylose absorption test < 12 hours 

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6. Patients being treated with Sodium Thiosulfate. 
7. Patients being receiving IV glycerol. 
8.  Patients receiving substances containing maltose, or substances that can be 
metabolized into maltose.  These substances include Extranneal, Gamimune N, 
HepaGam B, Octagam, Vaccinia Immune Globulin, and WinRho SDF Liquid. 
9. Hct <15% within 24 hours of screening visit.  
 
3.4 
Withdrawal of Subjects 
Subjects may voluntarily withdraw from the study at any time for any reason if they 
wish to do so, without any consequences.  The PI may withdraw a subject from the 
study at his discretion due to safety or any other concerns (i.e. deliberate non-
compliance). 
4.0 
Study Design  
 
4.1 
Study Design Description 
This is a Single-center, non-randomized, study evaluating the TIR in a Surgical ICU population 
after implementing the OptiScanner system. 
 
4.2 
Insulin administration during the Study: 
4.2.1 Phase One 
4.2.1.1 During Phase One of the trial, the hospital’s current standard of care for 
glucose management will be followed. Currently glucose values are 
measured using point of care glucose meters and/or by collecting a blood 
sample and sending it to the hospital laboratory. Patients’ glucose values 
are currently monitored depending on their clinical condition with the 
frequency of glucose measurement typically occurring every one to four 
hours. Patients enrolled in this study will still be monitored in this same 
manner, depending on their clinical condition (using point of care meters 
and/or blood collection for the lab). The additional continuous 
monitoring provided by the OptiScanner may introduce additional 
glucose measurements. The clinical care team will be advised to confirm 
any OptiScanner glucose value (using routine clinical care methods) 
before making any modifications to the patient’s clinical care based on 
the OptiScanner result (i.e. increase, decrease, stop insulin drip, etc.). The 
glucose results from the OptiScanner will not be recorded in the medical 
record. A research team member will be at the bedside during the 
patients’ connection to the OptiScanner to ensure that the clinical team 
does not use the OptiScanner results to direct patient care and to 
observe the overall clinical care glucose management of the patient.  
Representatives from the sponsor may be present at the participant’s 

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bedside to provide the research team technical support and assistance.  
The sponsor representatives will not have access to the protected health 
information for the participant.  
4.2.2 Phase Two 
Following the 1st phase of the trial, data on time-in-range and patient 
glucose management activities and responsiveness to insulin adjustments 
will be assessed by the PI, a statistician, OptiScan and potentially, ICU 
nursing and physician leadership.  Phase II Study procedures will be 
developed based on the results.   
4.3 
Study Endpoints and Other Assessments 
4.3.1 Primary Endpoint 
The primary endpoint is an evaluation of the Glucose Time-in-range (TIR). 
4.3.2     Secondary Endpoint 
 
Assessment of the time it takes the patient to achieve in range glucose values  
while connected to the OptiScanner. 
Target TIR 
 
Primary Endpoint 
According to 
participants’ 
clinical care 
defined target 
glucose range 
 
Evaluation of TIR 
 
 
4.3.2 Additional Data Collected 
The following data will be collected during the OptiScanner evaluation: 
§ Demographic Data  
§ Date of admission 
§ Primary and secondary diagnosis 
§ History of thromboembolic events and clotting disorders 
§ Medications administered during ICU stay 
§ Insulin administration: timing, dosage, route and protocol used 
§ Insulin adjustment: reason for the adjustment, OS glucose value prior 
to insulin adjustment and standard of care confirmatory glucose value 
obtained if adjustment was related to an abnormal OS glucose value, 
timing of insulin adjustment, dosage, and route 
§ Dextrose administration/IV: timing, and dosage 
§ Dextrose adjustment:  reason for the adjustment, OS glucose value 
prior to insulin adjustment and standard of care confirmatory glucose 

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value obtained if adjustment was related to an abnormal OS glucose 
value, timing of dextrose adjustment, dosage, and route 
§ TPN and other nutrition 
§ TPN and other nutrition adjustment 
§ Number of Hypoglycemic events (defined as glucose < 70 mg/dL) 
§ Number of Hyperglycemic events (defined as glucose > 200 mg/dL) 
§ Ventilator days, ICU LOS, and HLOS 
§ Infection outcome data  
§ Procedures including imaging, dialysis, and transfusions 
§ Date and time of OS connection/disconnect  
§ Contrast administration  
§ Discharge disposition (i.e. home, rehab, nursing home, death, etc.) 
§ Device related AE’s and SAE’s  
Additional data not typically collected in the patient’s medical records: 
§ Types and frequency of alarms (both dysglycemia and others) 
downloaded from the OptiScanner after the case 
§ The frequency of CVC maintenance incidents requiring disconnection 
from the OptiScanner system 
§ Comparator measurements (at the start, at approximately 24-hour 
intervals, and when prompted by the OptiScanner (i.e. cartridge 
change) Patients will have a study blood draw after OptiScanner 
connection, at approximately 24-hour intervals, and when prompted 
by the OptiScanner (i.e. cartridge change). The sample may be point 
of care or sent to the laboratory for analysis.  
§ History of CVC line (occlusions, other clotting disorders, age, etc) 
§ Clinical care team action/inaction details related to all glucose values 
(both OptiScanner and standard of care values). 
4.3.3 Safety Endpoint 
The proportion of subjects that experience one or more Device Related Serious 
Adverse Events (DRSAEs). Incidence of hypo/hyperglycemia.  
4.4 
Sample Size 
A minimum of 50 subjects will be enrolled in the study.  The study will be divided into 2 
phases:  Phase One and Phase Two.  
4.4.1 Phase One:  
Phase One of the study will consist of study staff working with the clinical care team to 
operationalize the logistics involved with implementing the OptiScanner.  In addition, 
phase one subjects will provide the opportunity for the PI to observe the OptiScanner 

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utility as a complement to the current glucose management of the patient. The 
continuous glucose monitoring provided by the OptiScanner may introduce additional 
glucose measurement information that would not have been known if it occurred 
between the routine clinical care glucose measurements and the clinical care team will 
be advised to confirm any OptiScanner glucose value (using routine clinical care 
methods) before making any modifications to patients’ clinical care based on the 
OptiScanner glucose result.  A research team member will be at the patient’s bedside 
during his/her entire study participation to ensure that the clinical care team does not 
use the OptiScanner results independently to direct patient care and to observe how the 
additional glucose information is or is not used.  A minimum of 50 patients will be 
enrolled in phase one.  
4.4.2 Phase Two:  
Following the 1st phase of the trial, data on time-in-range and patient glucose 
management activities and responsiveness to insulin adjustments will be assessed by 
the PI, a statistician, OptiScan and potentially, ICU nursing and physician leadership.  
Phase II Study procedures will be developed based on the results.   
4.5 
 Duration of Subject Participation 
Overall study enrollment is estimated to take approximately 12 months.  Subjects 
enrolled in the study will participate for at least 48 hours and up to 72 hours.  There are 
no follow-up visits or evaluation. 
Participation in the study will be complete when either the subject is discharged from 
the SICU or hospital, or after 72 hours, whichever comes first. 
4.6 
Study Termination 
The Principal Investigator, Grant Bochicchio, MD, MPH, FACS, may discontinue the study 
at any stage. 
 
5.0 
Assessment of Time-in-Range (TIR) 
TIR is calculated as the number of points in range divided by the total number of measurements 
presented.  When the smart alarm is active, readings during that period are excluded from the 
calculation. 
6.0 
Assessment of Safety  
The rate of Device-Related Serious Adverse Events (DRSAEs). The relationship of the event to 
the study device and whether the event is considered serious will be determined by the 
Investigator. 

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7.0 
Statistics 
 
For Phase One of this study, no formal statistics will be performed as this phase is strictly 
observational. Results of Phase One will be used to inform the power analysis for the 2nd phase 
of the study.   
 
 
 
 
8.0 
Data Management 
 
The Investigator is responsible for the development of appropriate case report forms.  The 
Investigator will be responsible for the accurate and timely collection of data during the study.  
Quality assurance procedures will be established to ensure that complete, accurate and timely 
data are collected, that protocol requirements are followed, and that complications, adverse 
events and adverse device effects are correctly reported and investigated, as appropriate.  The 
Investigator and site CRC will maintain all source documents as required by the protocol, 
supporting medical records, and signed Informed Consent Forms.  All glucose data will be 
stored within the OptiScanner and will be downloaded for data analysis purposes and the 
electronic files will be submitted to the Investigator.  The OptiScanner calculates percent in 
range. 
 
9.0 
Investigator Responsibilities  
 
The Investigator is responsible for ensuring that this study is conducted according to this 
protocol and that a signed approved Informed Consent Form is obtained from each patient 
prior to their inclusion in this study.  The Investigator will also ensure that all staff assisting with 
this study have the appropriate qualifications and are fully instructed on the study procedures 
and respect patient confidentiality, as specified in the Health Insurance Portability and 
Accountability Act (HIPAA) requirements. 
 
The Investigator is responsible for ensuring that the conduct of this study conforms to with his 
or her IRB/EC requirements and provides all necessary communication with the IRB/EC 
including, but not limited to, annual study reports and required AE notifications. 
The Investigator and study staff should make every possible effort to ensure that complete data 
is obtained for each study patient.   
 
 
 
 
 
10.0 
Ethics  
 
 
 
 
10.1 
Study Conduct 
The study will be performed in accordance with the relevant parts of the U.S. Code of 
Federal Regulations (including 21 CFR parts 50, 54, 56 and 812), ICH Guidelines for Good 

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Clinical Practices, the European Standard ISO 14155, the Declaration of Helsinki, and any 
regional and/or national regulations. 
10.2 
Ethics Review 
Before any subject can be enrolled in this study, the IRB or EC for the specific institution 
must review and approve this protocol.   
 
10.3 
Informed Consent 
Informed consent will be required  
 
11.0 
Data Handling and Record Keeping  
The Investigator must maintain detailed source documents on all subjects who are enrolled in 
the study.  Source documents include medical records, hospital charts, clinic charts, Investigator 
study files, as well as the results of diagnostic tests (e.g., medication records, laboratory tests, 
hemodynamic studies). 
The following minimum information should be entered into the subject’s study and/or medical 
record: 
• The date of enrollment and study ID 
• The study protocol name and number 
• Documented eligibility requirements (e.g., medical history, study procedures and/or 
evaluations) 
• The duration of study participation 
• Evidence that required evaluations were completed 
• Use of any concurrent medications during study enrollment, and where infused 
• Transfusions or Dialysis 
• Documentation of specific device used 
• Occurrence and status of any adverse events that in the Investigator’s opinion are 
related to the OptiScanner  
• All OptiScanner alarms 
• The date the subject exited the study and a notation as to whether the subject 
completed the study or was discontinued, including the reason for discontinuation 
• The insulin, dextrose, and nutrition administration delivery 
 
 
12.0 
Training and Case Support 
 
 
12.1 
Investigational Site Training 

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To ensure appropriate and reliable use of the OptiScanner system, OptiScan Biomedical 
(manufacturer) will provide didactic and hands-on training for all designated users.  
OptiScan Biomedical will outline an installation and continuous education program that 
is adequate for the hospital’s SICU predefined users.  
All device training will be documented in a training log that will be maintained in the site 
regulatory binder. 
 
12.2 
Clinical Case Technical Support 
OptiScan Biomedical will assign a cross-functional team with clinical expertise to 
conduct training and support the SICU’s clinical staff with any device related technical 
questions during all cases conducted in this study. 
 
13.0 
Adverse Events and Serious Adverse Events 
It is anticipated that subjects in this study will experience a large number of adverse events 
associated with their underlying condition, which have no relationship to the study device.  
Therefore, for this study, Investigator will record only Adverse Events (AEs) that, in the 
Investigator’s opinion, are possible, probably or definitely related to the study device.  All such 
events must be recorded in the patient study and/or medical record.  A description of the 
event, including the start date, resolution date, action taken, and the outcome should be 
recorded, along with the Investigator’s assessment of the relationship between the event and 
the OptiScanner device. 
 
 
 

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14.0 
Bibliography  
 
 
 
1. Bagshaw SM, Egi M, George C, Bellomo R. Early blood glucose control and mortality in 
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