Acetaminophen Interferent Evaluation of the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System
Phase: NA
Conditions: Diabetes, Diabetes Mellitus
Sponsor: Biolinq Inc.



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Acetaminophen Interferent Evaluation of the Biolinq MicroArray 
Intradermal Continuous Glucose Biowearable System 
 
Protocol Number: CP-013 
 
Investigational Device: The Biolinq MicroArray Intradermal Continuous Glucose Biowearable System 
          
 
 
 
  
 
Study Sponsor: Biolinq, Inc. 
 
Study Contacts: 
 
 
 
Biolinq, Inc.  
Director, Clinical Affairs & Biostatistics  
10260 Sorrento Valley Road 
San Diego, CA 92121 
  
 
 
 
Biolinq, Inc. 
Senior Manager, Clinical Affairs 
10260 Sorrento Valley Road 
San Diego, CA 92121 
 
 
 
Version Number: 0 
 
 
Version Date: August 6, 2024 
 
 
 

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Table of Contents 
2 
PROTOCOL SIGNATURE PAGE ............................................................................................................... 5 
3 
ABBREVIATIONS .......................................................................................................................................... 6 
4 
PROTOCOL SYNOPSIS .............................................................................................................................. 7 
5 
SCHEDULE OF ACTIVITIES (SOA)......................................................................................................... 13 
6 
INTRODUCTION ......................................................................................................................................... 13 
7 
STUDY MATERIALS ................................................................................................................................... 14 
7.1 
Biolinq MicroArray IntraDermal Continuous Glucose Biowearable System ............................. 14 
7.1.1 
System Overview .......................................................................................................... 14 
 
 
 
 
 
 
7.1.5 
Accessory components ................................................................................................ 17 
7.2 
Other Study device/Materials .......................................................................................................... 17 
7.2.1 
Commercial Continuous GLucose Monitoring (CGM) ............................................. 17 
7.2.2 
Self-Monitoring Blood Glucose (SMBG) .................................................................... 17 
7.2.3 
Laboratory Analyzer (LA) ............................................................................................. 17 
8 
POTENTIAL RISKS AND BENEFITS ....................................................................................................... 17 
8.1 
Study Device Risks ........................................................................................................................... 17 
8.2 
Study Risks ........................................................................................................................................ 18 
9 
RATIONALE FOR THE STUDY DESIGN ................................................................................................ 20 
10 
STUDY OBJECTIVES ................................................................................................................................ 20 
10.1 
Purpose of Study .............................................................................................................................. 20 
10.2 
Primary Performance Endpoints ..................................................................................................... 20 
10.3 
Device Safety .................................................................................................................................... 20 
11 
STUDY POPULATION ............................................................................................................................... 20 
11.1 
Inclusion Criteria ............................................................................................................................... 21 
11.2 
Exclusion Criteria .............................................................................................................................. 21 
12 
STUDY DESIGN .......................................................................................................................................... 22 
12.1 
Design Summary .............................................................................................................................. 22 
12.2 
Duration of Participation................................................................................................................... 22 
12.3 
Estimated Study Duration ................................................................................................................ 22 
12.4 
Study Centers .................................................................................................................................... 22 
13 
STUDY ENROLLMENT .............................................................................................................................. 22 
13.1 
Strategies for Recruitment and Retention ..................................................................................... 22 
13.2 
Informed Consent ............................................................................................................................. 23 
13.3 
Enrollment .......................................................................................................................................... 23 
13.4 
Screening ........................................................................................................................................... 23 
14 
STUDY PROCEDURES ............................................................................................................................. 24 
 
 
 
 
 
 
 
 
 
 
 
 
 

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15 
DESCRIPTION OF SAFETY EVALUATION ........................................................................................... 26 
15.1 
Definitions of Adverse Events (AE) ................................................................................................ 26 
15.1.1 
Adverse Device Effect (ADE) ...................................................................................... 26 
15.1.2 
Serious Adverse Events (SAE) ................................................................................... 27 
15.1.3 
Unanticipated Adverse Device Effect (UADE) .......................................................... 27 
15.2 
Severity of Adverse Events ............................................................................................................. 27 
15.3 
Relationship of Adverse Event to the Study Device .................................................................... 27 
15.4 
Adverse Event Reporting ................................................................................................................. 28 
15.4.1 
Serious Adverse Event (SAE) Reporting ................................................................... 28 
15.4.2 
Unanticipated Adverse Device Effect (UADE) Reporting ........................................ 28 
15.5 
Device Observation Reporting ........................................................................................................ 28 
16 
STATISTICAL ANALYSIS & METHODS ................................................................................................. 28 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
17 
DATA MANAGEMENT PLAN .................................................................................................................... 31 
17.1 
Case Report Forms (CRFs) ............................................................................................................ 31 
17.2 
Source Documents ........................................................................................................................... 31 
17.3 
Data Management ............................................................................................................................ 31 
17.4 
Device Data Download..................................................................................................................... 32 
17.5 
Data Collection .................................................................................................................................. 33 
18 
ETHICAL CONSIDERATIONS .................................................................................................................. 34 
18.1 
Statement of Compliance ................................................................................................................ 34 
18.2 
Protocol Approval and Amendments ............................................................................................. 34 
19 
REPORTS .................................................................................................................................................... 34 
20 
MONITORING .............................................................................................................................................. 34 
20.1.1 
Protocol Deviations ....................................................................................................... 35 
21 
STUDY TERMINATION .............................................................................................................................. 35 
22 
INVESTIGATOR RESPONSIBILITES ...................................................................................................... 35 
23 
SPONSOR RESPONSIBILITES ............................................................................................................... 36 
23.1 
Conflict of Interest Policy ................................................................................................................. 36 

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23.2 
Study Records ................................................................................................................................... 36 
23.3 
Investigational Device Accountability ............................................................................................. 36 
23.4 
Data Collection and Management Responsibilities ..................................................................... 36 
23.5 
Confidentiality and Privacy .............................................................................................................. 36 
24 
REFERENCES ............................................................................................................................................ 37 
25 
APPENDIX: IN-CLINIC GUIDELINES ...................................................................................................... 39 
25.1 
Purpose .............................................................................................................................................. 39 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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2 
PROTOCOL SIGNATURE PAGE 
Protocol Title: Acetaminophen Interferent Evaluation of the Biolinq MicroArray Intradermal Continuous Glucose 
Biowearable System 
Protocol Number-Version: CP-013, Version 0 
Protocol Date: August 6, 2024 
Sponsor: Biolinq, Inc. 
 
The undersigned have read and understand the Protocol specified above and agree on its content. I/we agree to 
conduct this study in accordance with applicable FDA regulations, including parts 11 (Electronic records; 
electronic signatures), 50 (Protection of human subjects), 54 (Financial disclosure by clinical Investigators), and 
56 (Institutional Review Boards), of CFR Title 21. Investigators shall also conduct this study in accordance with 
any IRB requirements and local laws. 
 
 
 
 
_________________________________________________ 
Investigator Signature 
__________________ 
Date 
 
_________________________________________________ 
Investigator Name 
 
_________________________________________________ 
Name of Institution 
 
 
 
 
 
 

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3 
ABBREVIATIONS 
Table 1 Abbreviations 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AFE 
Analog Front End 
APAP 
N-acetyl-para-aminophenol (commonly known as acetaminophen or paracetamol) 
ARD 
Absolute Relative Difference 
BMI 
Body Mass Index 
CFR 
Code of Federal Regulations 
CGM 
Continuous Glucose Monitor/Monitoring 
CRF 
Case Report Form 
DKA 
Diabetic Ketoacidosis 
EDC 
Electronic Data Capture 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HbA1c 
Glycosylated Hemoglobin 
HIV 
Human Immunodeficiency Virus 
ICH 
International Conference on Harmonisation  
IDE 
Investigational Device Exemption 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
IMU 
Inertial Measurement Unit 
IV 
Intra Venous 
LA 
Laboratory Analyzer 
MARD 
Mean Absolute Relative Difference 
mg/dL 
Milligrams per deciliter 
NFC 
Near Field Communication 
OCT 
Optical Coherence Tomography 
PCB 
Printed Circuit Board 
PI 
Principal Investigator 
POC 
Point of Care 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMBG 
Self-Monitoring Blood Glucose 
SOA 
Schedule of Activities 
YSI 
YSI 2300 STAT PLUS Analyzer 
UADE 
Unanticipated Adverse Device Effect 
US 
United States 
 
 

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4 
 
PROTOCOL SYNOPSIS  
Table 2 Protocol Synopsis 
Title: 
Acetaminophen Interferent Evaluation of the Biolinq MicroArray Intradermal Continuous 
Glucose Biowearable System 
Study Sponsor: 
Biolinq, Incorporated 
Investigational 
Device: 
Biolinq System: Biolinq MicroArray Intradermal Continuous Glucose Biowearable System  
Reference 
Device: 
FDA-cleared Laboratory Analyzer (LA) 
• 
YSI STAT PLUS 2300 Glucose and L-Lactate Analyzer (Yellow Springs, Ohio) 
Comparator 
Devices: 
FDA-cleared Self-monitoring blood glucose (SMBG) meter and Continuous Glucose 
Monitoring (CGM) 
 
 
 
 
 
Design: 
Open label, prospective, observational, single-site, and single-arm 
This study is designed to be a Non-Significant Risk study with no deliberate manipulation of 
glucose in subjects with diabetes. 
Objective: 
The primary objective of the study is to evaluate the interference effect of acetaminophen 
(APAP) on the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System 
during 
 
Study 
Population 
Otherwise, healthy adult subjects (≥ 18 years old) with diabetes. 
Number of 
Subjects: 
Up to 35 subjects enrolled
 
 
Number of 
Centers: 
One (1) investigational center in the United States will participate in the study.  
Estimated 
Duration: 
 
 
 
 

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3. Diagnosis of diabetes (Type 1, 2 or LADA) 
4. Weigh at least 110 lbs (50 kilograms). 
5. Be otherwise in good health, as determined by a medical care professional. 
6. Willing to refrain from Acetaminophen (APAP) use for 72 hours prior to Biolinq 
application and for the duration of the study the duration of study enrollment (except for 
as administered In-Clinic). 
Device and Glucose Assessments – Willing to: 
7. Wear one (1) Biolinq Biowearable following the application procedure on the volar 
forearm for up to 3 days. 
8. Wear one (1) commercial CGM (
) on the abdomen for up to 3 
days per approved labeling. 
9. Participate in one (1) In-Clinic session lasting up to 8 hours of blood draws (anticipated 
up to 10 hours on site). 
10. Perform up to five (5) fingersticks a day with the SMBG device provided during non-in-
clinic days. 
11. Avoid immersing study devices into water (e.g., no hot tub, SCUBA diving). 
Exclusion 
Criteria: 
Individuals with any of the following will be excluded: 
General 
1. Current participation in another investigational study protocol. (If a subject has recently 
completed participation in another drug study, the subject must have completed that 
study at least 30 days prior to being enrolled in this study.) Note: Subjects will not be 
excluded if enrolled in another observational trial, wherein the subject is in the follow-up 
phase and no tests/procedures impacting the subject’s health are required. Subjects will 
be excluded if they have been previously enrolled in this study.  
2. Work for, are family members with, or live with someone that works for the sponsor or 
competitor diabetes-related company (includes social media influencers or bloggers). 
3. In the investigator’s opinion, any reason that may lead to subject non-compliance with 
study requirements or confound study data. 
Health 
4. Currently taking Hydroxyurea or chronic use of a medication containing acetaminophen 
in the last 30 days.  
5. Known allergy to medical grade adhesives, acrylic, latex, or isopropyl alcohol. 
6. Known contraindication to taking the In-Clinic recommended oral dose of APAP (e.g., 
cirrhosis, chronic heavy ethanol use, breast feeding). 
7. Have dermatological conditions that preclude wearing Biolinq Biowearables (e.g., 
extensive psoriasis, recent burns, severe sunburn, extensive eczema, extensive 
scarring, dermatitis herpetiformis, skin lesions, erythema, infection, or other conditions 
at the discretion of the investigator). 
8. For subjects of child-bearing potential, pregnant or not practicing an acceptable form of 
birth control during the study.  
9. Hematocrit measurement via point-of-care (POC) or laboratory testing that is less than 
the applicable below-mentioned value: 
a. Male: 36.0% 
b. Female: 33.0% 

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10. Have donated blood, had significant blood loss, or participated in a study with significant 
blood sampling (420 cc or more) within 56 days prior to study enrollment or plan to 
participate in such activities during study wear. 
 
11. Required or scheduled to have diathermy, X-ray, MRI, or CT during study wear. 
12. In the investigator’s opinion, the subject has a history of concomitant medical condition 
that could interfere with the study participation or present a risk to the safety and welfare 
of the subject or study staff. Such historical conditions include but are not limited to: 
a. Syncope in past 6 months 
b. Severe hypoglycemia (loss of consciousness, seizure, or emergency medical 
technician assistance within the past 6 months) 
c. Diabetic ketoacidosis (DKA) requiring hospital admission in the past 6 months 
d. Coagulopathy 
e. Chronic infectious disease (e.g., HIV/AIDS, Hepatitis B or C) 
f. 
End stage renal disease and currently managed by dialysis or anticipating initiating 
dialysis during the study wear period 
g. History of congestive heart failure 
Methodology: 
Consent and Screening: 
Subjects are considered enrolled after signing and dating an Institutional Review Board (IRB) 
approved informed consent form (ICF). Screening activities must be completed within 30 
days prior to the Biolinq application and include eligibility criteria, vitals, demographics, 
medical history review, Fitzpatrick Skin assessment, pregnancy testing (as applicable), A1c 
and hematocrit tests. Subjects who meet the study eligibility criteria will be scheduled for 
Biolinq Biowearable application. Screen failures must exit the study and reasons for exit are 
documented. Subjects who do not complete screening activities within 30 days are still 
eligible to participate in the study but must be reconsented and re-screened. 
Device Applications (Day 1):  
A POC pregnancy re-test is required if the previous test is greater than 3 days prior to 
application day. 
 
 
 
 
 
  
 
 
 
 
 
 
 
Home Use (Non-in-clinic Day): 

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Subjects will be asked to perform up to five (5) SMBG fingersticks on all days after Device 
Application Day when not attending an in-clinic day.  The recommended timing of these 
samples is as follows: 1 for fasting morning, 3 at 1-hour post-meal, and 1 at bedtime. 
In-Clinic Day with Removal Visit (Day 3):  
All subjects will participate in one (1) in-clinic session
 
of the device intended wear period.  Subjects are required to bring all 
devices to the visit. 
Subjects will arrive at the clinic for the observational in-clinic session lasting up to 10 hours 
(8 hours of active blood draws). 
 
 
 
 
 
.  
The YSI STAT PLUS 2300 Glucose and L-Lactate Analyzer will be used to measure glucose 
values (reference data) for all blood draws during the in-clinic session.  Measurements will 
be made at 15 ± 7-minute intervals throughout the in-clinic session.  An SMBG fingerstick 
on the same arm as the Biolinq Biowearable will be taken every at every 30- minute intervals 
corresponding to every other blood draw for comparative purposes. No glucose 
manipulations/challenges will be performed.  Additional or more frequent blood draws or 
fingersticks may be performed as per investigator or designee discretion for 
monitoring/treating hypoglycemia or hyperglycemia. 
 
 
 
 
Investigators or designated staff will monitor subjects for safety during an in-clinic session. 
Appendix 1 – In-Clinic Guidelines will be provided as guidance, but the investigator or 
designee will maintain final discretion for any in-clinic procedures and methods used based 
on their medical expertise and training. Fast-acting carbohydrates, glucagon, and ketone 
testing kits will be available at clinical sites for safety of subjects. Subjects will be discharged 
at the end of the in-clinic day according to investigator discretion (recommended discharge 
guidelines provided in Appendix 1 – In-Clinic Guidelines). 
Device Removal (After In-Clinic Discharge) 
Device removal will occur after completion of the scheduled In-Clinic. 
 
 
 
 
 

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Adverse Event, Protocol Deviation and Device Observation Assessments: 
After consent and through study exit, each subject will be monitored for any new onset and/or 
worsening of adverse events regardless of the relatedness to the investigational device, 
procedure, protocol deviations, or device observations. Adverse events will be followed 
through resolution. If the investigator deemed the event is stable and requires no additional 
follow-up, then the subject may exit the study. Protocol Deviations and Device Observations 
will be documented and reported as applicable.  
Study Exit: 
Subjects may exit the study after screen failure, if Biolinq Biowearable fails prior to end of 
wear period, or at subject completion of protocol after device removal and resolution of any 
ongoing adverse events. Subjects lost-to-follow-up may exit after at least three (3) attempts 
to contact the subject have been documented. Subjects may also exit study at any time with 
their withdrawal of consent or an investigator decision to withdraw the subject for cause. 
Reason for study exit for each subject must be documented. 
Sponsor and 
Contact 
Information: 
 
 
 
Biolinq, Incorporated 
10260 Sorrento Valley Road 
San Diego, California 92121 
 
 
 
 
 
 
 
 
 
 
 
 

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influenced by substances that can shift the measured glucose in one direction or the other10, 11. As CGM 
technology progressed and non-adjunctive use indications became the goal, new generations of CGM Systems 
have demonstrated resistance to various interferents.1, 12, 13  
 
One of the commonly evaluated interferents, acetaminophen (APAP), also known as paracetamol in many 
countries, is a widely used non-opioid pain-relieving and fever-reducing agent14. 
 
. 
 
The primary objective of the study is to evaluate the interference effect of acetaminophen (APAP) on the Biolinq 
MicroArray Intradermal Continuous Glucose Biowearable System.  For the purposes of the study, the maximum 
recommended adult dose for any 6-hour period will be evaluated2. Because APAP reaches peak concentration in 
the blood within 90 minutes (with a half-life of 1.5-2.5 hours)3,
 
 
  
 
 
7 
STUDY MATERIALS 
7.1 
BIOLINQ MICROARRAY INTRADERMAL CONTINUOUS GLUCOSE BIOWEARABLE SYSTEM 
 
 
 
 
 
 
 
 
  
The reportable glucose range for the sensor is between 70 mg/dL and 400 mg/dL. The device does not have any 
audible or vibratory alerts or alarms. 
A summary of clinical studies conducted by Biolinq with the current version Biolinq MicroArray Intradermal 
Continuous Glucose System is provided in a Report of Prior Investigations.  
7.1.1 SYSTEM OVERVIEW 
The Biolinq MicroArray Intradermal Continuous Glucose Biowearable System consists of multiple components 
broadly categorized as follows:  
i. 
Biolinq Microarray Sensor 
ii. 
Biolinq wearable 
iii. 
Biolinq applicator  

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7.2 
OTHER STUDY DEVICE/MATERIALS 
7.2.1 
COMMERCIAL CONTINUOUS GLUCOSE MONITORING (CGM) 
 
 
7.2.2 
SELF-MONITORING BLOOD GLUCOSE (SMBG) 
 
 
 
7.2.3 
LABORATORY ANALYZER (LA) 
During the In-Clinic Day, the FDA-cleared laboratory analyzer (LA) machine (YSI 2300D STAT PLUS Analyzer 
(Yellow Springs, Ohio)) will be used to measure venous sample glucose concentrations. Venous samples will be 
drawn according to a pre-specified protocol schedule and per the In-Clinic Guidelines located in Appendix 1 – In-
Clinic Guidelines. 
8 
POTENTIAL RISKS AND BENEFITS 
8.1 
STUDY DEVICE RISKS 
 
 
 

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11.1 INCLUSION CRITERIA 
Individuals may be included in the study if they satisfy all the following: 
General 
1. ≥ 18 years old. 
2. Willing and able to provide written signed and dated informed consent. 
Diabetes History and Health 
3. Diagnosis of diabetes (Type 1, 2 or LADA) 
4. Weigh at least 110 lbs (50 kilograms). 
5. Be otherwise in good health, as determined by a medical care professional. 
6. Willing to refrain from Acetaminophen (APAP) use for 72 hours prior to Biolinq application and for the duration 
of the study the duration of study enrollment (except for as administered In-Clinic). 
Device and Glucose Assessments – Willing to: 
7. Wear one (1) Biolinq Biowearable following the application procedure on the volar forearm for up to 3 days. 
8. Wear one (1) commercial CGM (
 on the abdomen for up to 3 days per approved 
labeling. 
9. Participate in one (1) In-Clinic session lasting up to 8 hours of blood draws (anticipated up to 10 hours on site). 
10. Perform up to five (5) fingersticks a day with the SMBG device provided during non-in-clinic days. 
11. Avoid immersing study devices into water (e.g., no hot tub, SCUBA diving). 
11.2 EXCLUSION CRITERIA 
Individuals with any of the following will be excluded: 
General 
1. Current participation in another investigational study protocol. (If a subject has recently completed participation 
in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in 
this study.) Note: Subjects will not be excluded if enrolled in another observational trial, wherein the subject is 
in the follow-up phase and no tests/procedures impacting the subject’s health are required. Subjects will be 
excluded if they have been previously enrolled in this study.  
2. Work for, are family members with, or live with someone that works for the sponsor or competitor diabetes-
related company (includes social media influencers or bloggers). 
3. In the investigator’s opinion, any reason that may lead to subject non-compliance with study requirements or 
confound study data. 
Health 
4. Currently taking Hydroxyurea or chronic use of a medication containing acetaminophen in the last 30 days.  
5. Known allergy to medical grade adhesives, acrylic, latex, or isopropyl alcohol. 
6. Known contraindication to taking the In-Clinic recommended oral dose of APAP (e.g., cirrhosis, chronic heavy 
ethanol use, breast feeding). 
7. Have dermatological conditions that preclude wearing Biolinq Biowearables (e.g., extensive psoriasis, recent 
burns, severe sunburn, extensive eczema, extensive scarring, dermatitis herpetiformis, skin lesions, erythema, 
infection, or other conditions at the discretion of the investigator). 
8. For subjects of child-bearing potential, pregnant or not practicing an acceptable form of birth control during the 
study.  

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9. Hematocrit measurement via point-of-care (POC) or laboratory testing that is less than the applicable below-
mentioned value: 
a. Male: 36.0% 
b. Female: 33.0% 
10. Have donated blood, had significant blood loss, or participated in a study with significant blood sampling (420 
cc or more) within 56 days prior to study enrollment or plan to participate in such activities during study wear.  
11. Required or scheduled to have diathermy, X-ray, MRI, or CT during study wear. 
12. In the investigator’s opinion, the subject has a history of concomitant medical condition that could interfere with 
the study participation or present a risk to the safety and welfare of the subject or study staff. Such historical 
conditions include but are not limited to: 
a. Syncope in past 6 months 
b. Severe hypoglycemia (loss of consciousness, seizure, or emergency medical technician assistance within 
the past 6 months) 
c. Diabetic ketoacidosis (DKA) requiring hospital admission in the past 6 months 
d. Coagulopathy 
e. Chronic infectious disease (e.g., HIV/AIDS, Hepatitis B or C) 
f. 
End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study 
wear period 
g. History of congestive heart failure 
12 STUDY DESIGN 
12.1 DESIGN SUMMARY 
The study will be an open label, prospective, observational, single-site, and single-arm non-significant risk study 
conducted in the United States.  
12.2 DURATION OF PARTICIPATION 
 
 
 
 
12.3 ESTIMATED STUDY DURATION 
 
 
12.4 STUDY CENTERS 
One (1) investigational center in the United States will participate in the study. 
13 STUDY ENROLLMENT  
13.1 STRATEGIES FOR RECRUITMENT AND RETENTION 

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o 
 
 
 
 
14 STUDY PROCEDURES 
14.1   DEVICE APPLICATION VISIT/STUDY TREATMENT START 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
14.2 HOME USE 
 
 
 
 
 
 
  
 
 
 

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• 
 
 
  
 
 
. 
14.3.3 
DIABETES MANAGEMENT 
 
   
 
 
 
 
14.3.4 
DISCHARGE  
 
  
14.3.5 
DEVICE REMOVAL 
  
 
  
 
 
 
 
14.3.6 
STUDY EXIT 
 
 
 
 
15 DESCRIPTION OF SAFETY EVALUATION 
15.1 DEFINITIONS OF ADVERSE EVENTS (AE) 
An adverse event means any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the Biolinq 
MicroArray System. This definition includes events related to the Biolinq MicroArray System as well as events 
related to the procedures involved. All suspected adverse events will be assessed and monitored by the Principal 
Investigator, or designee, and recorded in the appropriate source worksheet and transcribed to Case Report Form. 
15.1.1 ADVERSE DEVICE EFFECT (ADE) 

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An adverse device effect is an adverse event related to the use of the Biolinq MicroArray System. 
15.1.2 SERIOUS ADVERSE EVENTS (SAE)  
An adverse event (AE) is considered "serious" if, in the view of either the investigator or Biolinq, it results in any of 
the following outcomes: 
a) Death 
b) Serious deterioration in the health of the subject, that either resulted in: 
• 
A life-threatening illness or injury, or  
• 
A permanent impairment of a body structure or a body function, or  
• 
In-patient or prolonged hospitalization, or  
• 
Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a 
body structure or a body function 
c) Led to fetal distress, fetal death or a congenital abnormality or birth defect 
15.1.3 UNANTICIPATED ADVERSE DEVICE EFFECT (UADE)  
An UADE is not expected to occur; however, an unanticipated adverse device effect (UADE) is defined as any 
serious adverse effect on health or safety or any life-threatening problem or death caused by – or associated with 
– the device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence 
in the investigational plan (including documents such as the protocol, the Informed Consent Form, and other study-
related documents), or any other unanticipated serious problem associated with the device that relates to the rights, 
safety, or welfare of subjects.  
An Unanticipated Adverse Device Effect (UADE) is a serious adverse device effect that has not been previously 
identified in nature, severity or degree of incidence in the investigational plan (including documents such as the 
protocol, the informed consent form, and other study-related documents). 
15.2 SEVERITY OF ADVERSE EVENTS 
All adverse events will be classified by the Principal Investigator or designee. The following guidelines will be used 
to describe severity.  
• 
Mild – Awareness of signs or symptoms, but easily tolerated; are of minor irritant type; causing no loss of time 
from normal activities; symptoms would not require medication or a medical evaluation; signs and symptoms 
are transient. 
• 
Moderate – Discomfort severe enough to cause interference with usual activities, requiring treatment but not 
extended hospitalization or intensive care for the subject. 
• 
Severe – Incapacitating, causing inability to do work or usual activities; signs and symptoms may be of systemic 
nature or require medical evaluation and/or treatment, requiring additional hospitalization or intensive care 
(prolonged hospitalization). 
 
15.3 RELATIONSHIP OF ADVERSE EVENT TO THE STUDY DEVICE 
The Principal Investigator, or designee, will assess all adverse events (AEs) and determine their relation to the 
Biolinq MicroArray System. The Principal Investigator, or designee, will use his/her clinical judgment to examine 
and evaluate the adverse event based on an examination of the subject and the temporal relationship with the 
use of the device. The degree of certainty about causality will be graded using the categories below.  

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• 
Definitely Related – There is clear evidence to suggest a causal relationship, and other possible contributing 
factors can be ruled out. The clinical event occurs in a plausible time relationship to administration of the study 
device and cannot be explained otherwise.  
• 
Probably Related –The AE has a strong temporal relationship to use of the investigational device and another 
etiology is unlikely.  
• 
Potentially Related – The AE has a strong temporal relationship to the use of the investigational device and 
an alternative etiology is equally or less likely compared to the potential relationship to the investigational device.  
• 
Unlikely to be related – The AE has minimum or no temporal relationship to use of the investigational device 
and/or a more likely alternative etiology exists. 
• 
Not Related – The AE is completely independent of the investigational device and is due to an underlying 
disease state or concomitant medication or therapy not related to the study device. 
All device-related irritation will be recorded. Post-removal follow-up may be requested until resolution in the case 
of any ongoing adverse events. 
15.4 ADVERSE EVENT REPORTING  
Any AE not considered an SAE, occurring during the study will be documented by the Principal Investigator or 
designee on the appropriate source worksheet, entered into the Electronic Data Capture system, and reported to 
the Sponsor within 30 days of the occurrence of the adverse event. All adverse events (mild, moderate, and 
severe) will be reported in the final Clinical Study Report.  
15.4.1 
SERIOUS ADVERSE EVENT (SAE) REPORTING  
Any SAE, including death, that may occur during a clinical study must be reported immediately (within 24 hours of 
awareness) to Biolinq, Inc. Clinical Affairs personnel will document details and Clinical Affairs management’s 
assessment of the SAE in a timely manner. The Sponsor contacts are listed on the protocol title page. 
15.4.2 UNANTICIPATED ADVERSE DEVICE EFFECT (UADE) REPORTING 
During the review of a reported SAE, if the PI, or designee, determines the severity or extent of the event was not 
cited in this protocol or the report of prior investigations, and the event was classified as at a minimum, possibly 
related to the device, the event will be documented as an UADE.  
If the event is classified as an UADE, the PI or designee must notify their IRB and Biolinq will notify the FDA, 
reviewing IRBs, and other participating Investigators, as applicable, within ten (10) working days of the original 
SAE notification.  
If it is determined that the UADE presents an unreasonable risk to subjects, Biolinq will terminate all investigations 
or parts of investigations presenting that risk as soon as possible, but not later than 5 working days after such 
determination is made and not later than 15 working days after Biolinq first receives notice of the original SAE. 
Biolinq will not resume a terminated study without IRB and FDA approval, as applicable. 
15.5 DEVICE OBSERVATION REPORTING  
A Device Observation (DO) is defined as any suspected inadequacy in the identity, quality, durability, reliability, 
safety or performance of an investigational device, including malfunction, misuse or use errors, or inadequacy in 
information supplied by the Sponsor. 
Site will document Device Observations on source documents and CRFs at each occurrence and notify sponsor. 
All applicable DOs will be recorded on the Investigational Product Accountability log. 
16 STATISTICAL ANALYSIS & METHODS 
16.1 ANALYSIS COHORTS 
Analysis cohorts for the study are prospectively defined and are described in the following subsections.  

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16.8 STATISTICAL METHODS FOR SCREENING, BASELINE, PROCEDURAL AND STUDY EXIT 
DATA 
 
 
 
16.9 OTHER STATISTICAL CONSIDERATIONS 
 
 
17 DATA MANAGEMENT PLAN 
17.1 CASE REPORT FORMS (CRFS) 
Investigators are responsible for delegating personnel to complete the appropriate case report forms for each 
subject enrolled in the study. The CRFs should be completed within 5 working days of study visit or the day data 
is received. The Investigator must sign for data accuracy and completeness contained on each CRF. Biolinq will 
provide training and instructions to each investigational site on how to properly complete these CRFs.  
17.2 SOURCE DOCUMENTS 
Source documents refer to the records on which clinical observations are first recorded. Original source 
documentation must be maintained at the investigational site to substantiate data entered on the CRFs. Source 
documentation must be made available by the investigational site so that information entered on CRFs is verified 
and facilitates monitoring by Biolinq or its authorized representative. Source documents must also be made 
available to any regulatory agency in the event of an inspection so that the integrity of study data may be verified. 
The Sponsor will provide sample source worksheets to help with the collection of information for transfer to the 
EDC System. Sample source worksheets may be revised by site to match workflow or site requirements provided 
that all required data is collected. In cases where no original source data otherwise exists, a source document 
worksheet provided by the site or sponsor may be used to establish a source record. To minimize data-related 
errors, considerations should be taken to avoid duplicative generation of source documentation. All source 
documents must be signed and dated by a qualified individual generating the record and/or investigator when 
applicable.  
17.3 DATA MANAGEMENT 
A 21 CFR Part 11 compliant electronic data capture (EDC) system will be used for data collection in the study. 
User Acceptance Testing will be performed to validate each eCRFs utilized in the study prior to its use and all 
subsequent updates. Data is entered into the EDC system by trained delegated personnel as indicated on the 
Delegation of Responsibilities Log and on its appropriate electronic case report forms (eCRFs). The eCRFs must 
be completed or updated to reflect the latest data on each Subject participating in the study. The Investigator or 
authorized Sub-investigator electronically signs the eCRFs testifying data entry accuracy and completeness.  

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No study document should be destroyed without prior written agreement between Biolinq and the investigational 
site. If an investigational site is no longer enrolling Subjects or following any enrolled Subjects, an investigator 
may transfer custody of study records to Biolinq providing a notice of such transfer is given within 10 working 
days. 
The investigational site must maintain study documentation on paper or electronic file for each Subject file. If 
additional study documentation is required for submission to Biolinq, it must be redacted to remove the Subject’s 
name or other Subject identification, and the Subject’s unique identification code inserted prior to being sent to 
Biolinq. 
In the Subject file, information should include corresponding follow-up dates, data noted on Table 8, and reasons 
for early withdrawal from the study if applicable or study exit after activity completion per protocol. It must be 
possible to verify subject consent to participate in the study, inclusion, and exclusion criteria in the study from the 
Subject file. These documents should identify the Subject. Evaluation of these records should be documented as 
necessary, signed, and dated by the Investigator. All data recorded on the eCRFs must be in the Subject’s source 
data. 
17.4 DEVICE DATA DOWNLOAD 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 

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the rights and well-being of trial participants are protected, that the reported trial data are accurate, complete, and 
verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with 
International Conference on Harmonisation Good Clinical Practice (ICH GCP), and with applicable regulatory 
requirement(s).  
20.1.1 
PROTOCOL DEVIATIONS  
The Investigator or designee is required to conduct the study in accordance with the protocol, the Study 
Agreement, and all applicable local and national regulations. A protocol deviation exists when a requirement in 
the protocol is not followed. All protocol deviations must be reported to the Sponsor using the appropriate source 
worksheet and entered into the Electronic Data Capture (EDC) system.  
All protocol deviations that have the potential to affect the reliability or integrity of the study data will be reported to 
the sponsor and evaluated by the Principal Investigator, or designee, and Sponsor. Any protocol deviations that 
have the potential to adversely affect the health and safety of study subjects, adversely affect the reliability and 
integrity of the data, constitute a breach of subject confidential information, constitute a deviation from the IRB 
requirements for the study or constitute a failure to adhere to local, state, or federal regulations must be reported to 
the IRB and the FDA as required. 
 
21 STUDY TERMINATION 
Each subject’s participation in the study will be terminated following the completion skin site evaluations after device 
removal, or when all adverse events have been resolved or deemed as ongoing but stable. The study will be 
terminated for a subject if they become acutely ill during the study.  
Prior to sensor removal, the subject may voluntarily withdraw at any point in the study or the investigator and/or 
Sponsor may determine it is in the best interest of the subject to be terminated from the study. The reason for 
participant discontinuation or withdrawal from the study will be recorded on the appropriate source worksheet and 
entered into the Electronic Data Capture (EDC) system  
The clinical study in its entirety will be considered complete upon completion of a final Clinical Study Report and 
per Biolinq’s standard operating procedures.  
22 INVESTIGATOR RESPONSIBILITES 
The Investigator’s signature on this protocol confirms that Investigator is familiar with all sections of the protocol 
and agrees to conduct this study in accordance with the provisions of the protocol and applicable regulations. The 
Investigator must sign this protocol prior to commencement of any study-related activities (e.g., screening). 
Investigator and designees are responsible for protecting the rights, safety, and welfare of subjects under the 
Investigator’s care. The Investigator and designees are also responsible for obtaining IRB approval prior to study 
start and the written informed consent of each subject before he/she participates in this study. The informed 
consent must comply with FDA regulations and be approved by the IRB.  
Other Investigator and designee responsibilities include ensuring completion of appropriate source worksheets, 
and entry into the Electronic Data Capture (EDC) system per the study timelines discussed in this protocol, the 
site initiation visit and subsequent monitoring visits. In certain circumstances Investigators or designee must 
report serious adverse events to the Sponsor and reviewing IRB as soon as made aware (without a delay that 
cannot be justified). 
Investigator or designee will retain study records until the latter of the following: 2 years after the last approval of a 
marketing application and until there are no pending or contemplated marketing applications or at least 2 years 
have elapsed since the formal discontinuation of clinical development of the investigational product. No records 
will be destroyed without the written consent of the sponsor. It is the responsibility of the sponsor to inform the 
investigator or designee when these documents no longer need to be retained. 

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23 SPONSOR RESPONSIBILITES 
Biolinq, Inc. is the Sponsor of this study. The Sponsor is responsible for selecting qualified Investigators and 
providing them with the information needed to conduct the investigation properly. The Sponsor will ensure proper 
monitoring of the investigation and that IRB and FDA approvals have been obtained prior to the Investigator or 
designee commencing study-related activities. The Sponsor is also responsible for ensuring that the reviewing IRBs 
and FDA, if applicable, are promptly informed of significant new information. 
23.1 CONFLICT OF INTEREST POLICY 
This study is sponsored by Biolinq as part of the commercial development of the Biolinq MicroArray System. The 
Principal Investigator(s) is not an employee of Biolinq and any disclosable financial arrangement will be documented 
as appropriate on a financial disclosure form and reported to IRB as required. The Informed Consent process will 
be conducted by the Principal Investigator(s) or designee. 
23.2 STUDY RECORDS 
This study will be conducted in accordance with Biolinq’s standard operating procedures. All clinical study sites will 
provide direct access to all trial related source data/documents, and reports for the purpose of monitoring and 
auditing by the sponsor, and inspection by local and regulatory authorities. 
23.3 INVESTIGATIONAL DEVICE ACCOUNTABILITY 
Designated staff will maintain appropriate records of each device intended for the clinical study. (e.g., record of the 
subject device assignments, such as serial number of the device, subject ID, expiration dates, and date which the 
device was applied to/removed from subjects). At the conclusion of the study, the devices may undergo post-study 
investigation, as applicable. After processing, the devices will be cleaned, disposed of, and/or documented per 
appropriate regulations. The commercially available CGM used for the study will be transported, stored, and 
disposed of according to the instructions for use provided with the packaging.  Designated staff will keep records of 
the serial and/or lot numbers, subject ID, and dates of insertion and removal of study-assigned devices.  
23.4 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection is the responsibility of the clinical study staff at the site under the supervision of the Principal 
Investigator, or designee, at that site. The Principal Investigator, or designee, is responsible for ensuring the 
accuracy, completeness, legibility, and timeliness of the data reported. All source documents should be completed 
in a neat, legible manner to ensure accurate interpretation of data. Study data collection may be through paper 
source and/or electronic data capture (EDC) format, per current Sponsor processes. As applicable, hard copies of 
the study visit Case Report Forms may be provided for use as source document worksheets for recording data for 
each participant enrolled in the study. In addition, electronic data will be downloaded from the Biolinq System, 
commercial CGM, and glucometers, and will be maintained per sponsor guidelines. Clinical data (including adverse 
events (AEs), concomitant medications, and expected adverse reactions data) and clinical laboratory data, if 
applicable, will be entered into the subject-specific study binders or EDC system, as applicable.  
23.5 CONFIDENTIALITY AND PRIVACY  
The Sponsor and Investigator must treat Subjects’ identity as confidential. Subjects must not be identified in any 
publicly released reports of the study. All records are kept confidential to the extent provided by national or local 
law. The study monitors and other authorized representatives of the Sponsor may inspect all documents and 
records that are required to be maintained by the Investigator, including but not limited to, medical records. 
Regulatory agencies also maintain the right to review records pertinent to the study. Unless required by law, the 
sponsor and investigator must report de-identified data to secure subject confidentiality. 

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24 REFERENCES 
1. Calhoun, Peter & Johnson, Terri & Hughes, Jonathan & Price, David & Balo, Andrew. (2018). Resistance to 
Acetaminophen Interference in a Novel Continuous Glucose Monitoring System. Journal of Diabetes Science 
and Technology. 12. 193229681875579. 10.1177/1932296818755797. 
2. Hodgman MJ, Garrard AR. A review of acetaminophen poisoning. Crit Care Clin. 2012;28(4):499-516.  
3. Critchley JA, Critchley LA, Anderson PJ, Tomlinson B. Differences in the single-oral-dose pharmacokinetics 
and urinary excretion of paracetamol and its conjugates between Hong Kong Chinese and Caucasian 
subjects. J Clin Pharm Ther. 2005;30(2):179-184. 
4. Basu A, Slama MQ, Nicholson WT, et al. Continuous glucose monitor interference with commonly prescribed 
medications: a pilot study. J Diabetes Sci Technol. 2017;11(5):936-941.  
5. Basu A, Veettil S, Dyer R, Peyser T, Basu R. Direct evidence of acetaminophen interference with 
subcutaneous glucose sensing in humans: a pilot study. Diabetes Technol Ther. 2016;18(suppl 2):S243-
S247.  
6. Maahs DM, DeSalvo D, Pyle L, et al. Effect of acetaminophen on CGM glucose in an outpatient 
setting. Diabetes Care. 2015;38(10):e158-e159.  
7. Dexcom. Dexcom G5 mobile continuous glucose monitoring system user guide. San Diego, CA: Dexcom, 
Inc; 2016. Available at: https://s3-us-west-2.amazonaws.com/dexcompdf/LBL013990-REV003-G5-Mobile-
User-Guide-NA-Android-US.pdf (accessed January 17, 2024).  
8. Medtronic. MiniMed 670G system user guide. Northridge, CA: Medtronic Minimed; 2016. Available 
at: https://www.medtronicdiabetes.com/sites/default/files/library/download-library/user-
guides/MiniMed%20670G%20System%20User%20Guide.pdf (accessed January 17, 2024).  
9. Abbott. FreeStyle Libre Flash glucose monitoring system: User’s manual. Alameda, CA: Abbott Diabetes 
Care Inc; 2017. Available at: https://www.accessdata.fda.gov/cdrh docs/pdf15/P150021C.pdf (accessed 
January 17, 2024).  
10. Zhang Y, Hu Y, Wilson GS, Moatti-Sirat D, Poitout V, Reach G. Elimination of the acetaminophen 
interference in an implantable glucose sensor. Anal Chem. 1994;66(7):1183-1188.  
11. Heinemann L. Interferences With CGM Systems: Practical Relevance? Journal of Diabetes Science and 
Technology. 2022;16(2):271-274. doi:10.1177/19322968211065065 
12. Denham D. Effect of Repeated Doses of Acetaminophen on a Continuous Glucose Monitoring System with 
Permselective Membrane. J Diabetes Sci Technol. 2021 Mar;15(2):517-518. doi: 
10.1177/1932296820948544. Epub 2020 Aug 29. PMID: 32865043; PMCID: PMC8256057. 
13. Dexcom, Dexcom G6 Continuous Glucose Monitoring System User Guide, 2020 (LBL014003 Ver 11). San 
Diego, CA. 
14. Gerriets V, Anderson J, Nappe TM. Acetaminophen. 2023 Jun 20. In: StatPearls [Internet]. Treasure Island 
(FL): StatPearls Publishing; 2023 Jan–. PMID: 29493991. 
15. Fitzpatrick, T.B., The Validity and Practicality of Sun-Reactive Skin Types I Through VI. Archives of 
Dermatology, 1988. 124(6): p. 869-871. 
16. Fitzpatrick skin phototype. [cited 2020 23 March]; Available from: 
https://www.arpansa.gov.au/sites/default/files/legacy/pubs/RadiationProtection/FitzpatrickSkinType.pdf. 
17. D. Liu, E. Moberg, M. Kollind, P.-E. Lins a, U. Adamson and I. A. Macdonald . Arterial, arterialized venous, 
venous and capillary blood glucose measurements in normal man during hyperinsulinaemic euglycaemia and 
hypoglycaemia. Diabetologia (1992) 35:287-290. 
18. WE Clutter, DM Bier , SD Shah & PE Cryer: Epinephrine plasma metabolic clearance rates and physiologic 
thresholds for metabolic and hemodynamic actions in man. J. Clin. Invest. 66: 94-101, 1980. 
19. JD Best & JB Halter: Release and clearance rates of epinephrine in man: Importance of arterial 
measurements. J. Clin. Endocrinol. Metab. 55: 263-268, 1982. 
20. DE Matthews, G Pesola & RG Campbell: Effect of epinephrine upon amino acid and energy metabolism in 
humans. Am. J. Physiol. Endocrinol. Metab. 258: E948-E956, 1990. 
21. Iqbal, A. and S. Heller, Managing hypoglycaemia. Best Pract Res Clin Endocrinol Metab, 2016. 30(3): p. 413-
30. 
22. Siperstein, M.D., Diabetic ketoacidosis and hyperosmolar coma. Endocrinol Metab Clin North Am, 1992. 
21(2): p. 415-32. 
23. Kitabchi, A.E., et al., Hyperglycemic crises in adult patients with diabetes. Diabetes Care, 2009. 32(7): p. 
1335-43. 

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24. Fayfman, M., F.J. Pasquel, and G.E. Umpierrez, Management of Hyperglycemic Crises: Diabetic 
Ketoacidosis and Hyperglycemic Hyperosmolar State. Med Clin North Am, 2017. 101(3): p. 587-606. 
 
 

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25 APPENDIX: IN-CLINIC GUIDELINES 
25.1 PURPOSE  
To outline guidelines for performing an In-Clinic Day including an interferent challenge to assess performance of 
the Biolinq System relative to a commercial CGM, an SMBG meter and an FDA-cleared glucose laboratory analyzer 
(LA)  
25.2 IN-CLINIC OBJECTIVE 
The primary objective of an In-Clinic Day is to safely obtain sufficient data to support the primary efficacy endpoint 
(Biolinq Biowearable vs. YSI assessment) as relative to interference effect. Commercially available comparator 
devices (CGM and SMBG) will also be evaluated for reference analysis during an In-Clinic Day. 
25.3 RESPONSIBILITIES 
The investigator and investigator’s staff or qualified designees are responsible for: 
• 
Inserting intravenous catheter(s) for each subject 
• 
Monitoring subjects for safety, including blood glucose levels 
• 
Obtaining blood samples as outlined in this document 
• 
Providing meal options to subjects 
• 
Providing interferent (APAP) doses and measurement of APAP levels 
 
The Principal investigator shall maintain final discretion for any In-Clinic procedures and methods used based on 
their medical expertise and/or training.   
25.4 SAFETY MEASURES