Safety and Effectiveness Study of the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System
Phase: NA
Conditions: Diabetes, Diabetes Mellitus
Sponsor: Biolinq Inc.



                                               
 
 
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Safety and Effectiveness Study of the Biolinq MicroArray Intradermal 
Continuous Glucose Biowearable System 
 
Protocol Number: CP-011 
 
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: 1 
 
 
Version Date: February 03, 2025 
 
 
 

                                               
 
 
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Table of Contents 
2 
PROTOCOL SIGNATURE PAGE ............................................................................................................... 5 
3 
ABBREVIATIONS .......................................................................................................................................... 6 
4 
PROTOCOL SYNOPSIS .............................................................................................................................. 7 
5 
SCHEMA ....................................................................................................................................................... 14 
6 
SCHEDULE OF ACTIVITIES (SOA)......................................................................................................... 15 
7 
INTRODUCTION ......................................................................................................................................... 16 
8 
STUDY MATERIALS ................................................................................................................................... 16 
8.1 
Biolinq MicroArray IntraDermal Continuous Glucose Biowearable System ............................. 16 
8.1.1 
System Overview .......................................................................................................... 17 
8.2 
Other Study device/Materials .......................................................................................................... 19 
8.2.1 
Commercial CGM .......................................................................................................... 19 
8.2.2 
Self-Monitoring Blood Glucose (SMBG) .................................................................... 20 
8.2.3 
Activity Tracker and Electronic Subject Log .............................................................. 20 
8.2.4 
Laboratory Analyzer ...................................................................................................... 20 
9 
POTENTIAL RISKS AND BENEFITS ....................................................................................................... 20 
9.1 
Study Device Risks ........................................................................................................................... 20 
9.2 
Study Risks ........................................................................................................................................ 21 
9.3 
Summary of Potential Risks and Benefits ..................................................................................... 22 
10 
RATIONALE FOR THE STUDY DESIGN ................................................................................................ 22 
11 
STUDY OBJECTIVES ................................................................................................................................ 23 
11.1 
Purpose of Study .............................................................................................................................. 23 
11.2 
Co-Primary Performance Endpoints .............................................................................................. 23 
11.3 
Device Safety .................................................................................................................................... 23 
11.4 
Device Precision ............................................................................................................................... 24 
12 
STUDY POPULATION ............................................................................................................................... 24 
12.1 
Diversity Plan ..................................................................................................................................... 24 
12.2 
Inclusion Criteria ............................................................................................................................... 24 
12.3 
Exclusion Criteria .............................................................................................................................. 25 
13 
STUDY DESIGN .......................................................................................................................................... 26 
13.1 
Design Summary .............................................................................................................................. 26 
13.2 
Duration of Participation................................................................................................................... 26 
13.3 
Estimated Study Duration ................................................................................................................ 26 
13.4 
Study Centers .................................................................................................................................... 26 
14 
STUDY ENROLLMENT .............................................................................................................................. 26 
14.1 
Strategies for Recruitment and Retention ..................................................................................... 26 
14.2 
Informed Consent ............................................................................................................................. 26 
14.3 
Enrollment .......................................................................................................................................... 27 
14.4 
Screening ........................................................................................................................................... 27 
14.5 
Device Assignment ........................................................................................................................... 27 
15 
STUDY PROCEDURES ............................................................................................................................. 28 

                                               
 
 
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16 
DESCRIPTION OF SAFETY EVALUATION ........................................................................................... 32 
16.1 
Definitions of Adverse Events (AE) ................................................................................................ 32 
16.1.1 
Adverse Device Effect (ADE) ...................................................................................... 32 
16.1.2 
Serious Adverse Events (SAE) ................................................................................... 32 
16.1.3 
Unanticipated Adverse Device Effect (UADE) .......................................................... 32 
16.2 
Severity of Adverse Events ............................................................................................................. 33 
16.3 
Relationship of Adverse Event to the Study Device .................................................................... 33 
16.4 
Adverse Event Reporting ................................................................................................................. 33 
16.4.1 
Serious Adverse Event (SAE) Reporting ................................................................... 33 
16.4.2 
Unanticipated Adverse Device Effect (UADE) Reporting ........................................ 34 
16.5 
Device Observation Reporting ........................................................................................................ 34 
17 
STATISTICAL ANALYSIS & METHODS ................................................................................................. 34 
18 
DATA MANAGEMENT PLAN .................................................................................................................... 38 
18.1 
Case Report Forms (CRFs) ............................................................................................................ 38 
18.2 
Source Documents ........................................................................................................................... 38 
18.3 
Data Management ............................................................................................................................ 39 
18.4 
Device Data Download..................................................................................................................... 39 

                                               
 
 
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18.5 
Data Collection .................................................................................................................................. 40 
19 
ETHICAL CONSIDERATIONS .................................................................................................................. 41 
19.1 
Statement of Compliance ................................................................................................................ 41 
19.2 
Protocol Approval and Amendments ............................................................................................. 41 
20 
REPORTS .................................................................................................................................................... 42 
21 
MONITORING .............................................................................................................................................. 42 
21.1.1 
Protocol Deviations ....................................................................................................... 42 
22 
STUDY TERMINATION .............................................................................................................................. 42 
23 
INVESTIGATOR RESPONSIBILITES ...................................................................................................... 42 
24 
SPONSOR RESPONSIBILITES ............................................................................................................... 43 
24.1 
Conflict of Interest Policy ................................................................................................................. 43 
24.2 
Study Records ................................................................................................................................... 43 
24.3 
Investigational Device Accountability ............................................................................................. 43 
24.4 
Data Collection and Management Responsibilities ..................................................................... 43 
24.5 
Confidentiality and Privacy .............................................................................................................. 44 
25 
REFERENCES ............................................................................................................................................ 44 
26 
APPENDICES .............................................................................................................................................. 46 
26.1 
Appendix 1 – In-Clinic Guidelines .................................................................................................. 46 
 
 
 

                                               
 
 
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2 
PROTOCOL SIGNATURE PAGE 
Protocol Title: Safety and Effectiveness Study of the Biolinq MicroArray Intradermal Continuous Glucose 
Biowearable System 
Protocol Number-Version: CP-011, Version 1 
Protocol Date: February 03, 2025 
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 
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 
IIT 
Intensive Insulin Therapy 
IMU 
Inertial Measurement Unit 
IV 
Intra Venous 
LA 
Laboratory Analyzer 
MARD 
Mean Absolute Relative Difference 
mg/dL 
Milligrams per deciliter 
NFC 
Near Field Communication 
NIIT 
Non-Intensive Insulin Therapy 
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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Sample Size 
Statistical 
Rationale: 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
Inclusion 
Criteria: 
Individuals may be included in the study if they satisfy all the following: 
General 
1. ≥ 22 years old. 
2. Willing and able to provide written signed and dated informed consent. 
3. Access to phone or computer with internet to complete subject log. 
Diabetes History and Health 
4. Diagnosis of type 1 diabetes (T1D)/ LADA or type 2 diabetes (T2D) and on intensive 
insulin therapy (IIT) with known dosing parameters for at least three (3) months prior to 
the Screening Visit with an A1c of 5.5%-10% or diagnosis of type 2 diabetes (T2D) and 
on non-intensive insulin therapy (NIIT) or T2D not using insulin with an A1c of 7.5% to 
11%.  
5. Weigh at least 110 lbs (50 kilograms). 
6. Be otherwise in good health, as determined by a medical care professional. 
7. Willing to refrain from Acetaminophen use for the duration of study enrollment. 
8. If using an automated insulin delivery (AID) system, willing to disable automated features 
and go into open loop mode during the duration of in-clinic days. 
Device and Glucose Assessments – Willing to: 
9. Wear one (1) commercial CGM system 
 on the abdomen per approved 
labeling and have up to 1 replacement. 
10. Wear up to two (2) Biolinq Biowearables simultaneously following the application 
procedures on the volar forearm for up to 7 days. 
11. Participate in two (2) In-Clinic sessions lasting up to 11.5 hours of blood draws 
(anticipated up to 13 hours on site per visit) each. 
12. Perform up to five (5) fingersticks a day with the SMBG device provided during non-in-
clinic days. 
13. Avoid immersing study devices into water (e.g., no hot tub, SCUBA diving). 
14. Wear an activity tracker or record activity levels on a daily log.  

                                               
 
 
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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.  
5. Known allergy to medical grade adhesives, acrylic, latex, or isopropyl alcohol. 
6. 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). 
7. For subjects of child-bearing potential, pregnant or not practicing an acceptable form of 
birth control during the study.  
8. 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% 
9. Have donated blood, had significant blood loss, or participated in a study with significant 
blood sampling (340 cc or more) within 56 days prior to study enrollment or plan to 
participate in such activities during study wear. 
 
10. Required or scheduled to have diathermy, X-ray, MRI, or CT during study wear. 
11. 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 

                                               
 
 
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Methodology: 
This is an open label, single arm, multi-center study conducted in 5-8 investigational sites in 
the United States. Enroll up to 247 subjects to yield at least 206 treated subjects assuming 
up to 18.2  % screen failures. 
Consent and Screening: 
Subjects are considered enrolled after signing and dating an Institutional Review Board (IRB) 
approved informed consent form (ICF). 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. 
Subjects who passed the screening activities will be randomized
 
 
 

                                               
 
 
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The YSI STAT PLUS 2300 Glucose and L-Lactate Analyzer will be used to measure glucose 
values (reference data) for all blood draws during in-clinic sessions. Four active venous 
blood draws will be done every hour (one blood draw every 15 ± 7 minutes). A matching 
SMBG fingerstick on the same arm as the Biolinq Biowearable will be taken simultaneously 
with the draw for three (3) out of every four (4) blood draws for comparative purposes.  
Using glucose measurements taken under close direction and observation of the investigator 
staff, insulin dosing (for subjects on insulin) and meal composition/timing may be 
manipulated during the in-clinic session to obtain sufficient data variation between 40-400 
mg/dL and attain sample sizes required for performance evaluation to support device 
commercial application. 
Investigators or designated staff will monitor subjects for safety during an in-clinic session. 
In-Clinic Guidelines (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. A “crash cart” will be prepared 
and easily accessible for potential emergency situations. At a minimum, this cart should 
include vial(s) of insulin, normal saline, blood pressure cuff, defibrillator, a bag-valve mask, 
carbohydrate snacks, glucose tabs or gel, glucagon, and dextrose solutions. Subjects will be 
discharged at the end of the in-clinic day according to investigator discretion per Appendix 1 
– In-Clinic Guidelines. 
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 

                                               
 
 
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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 all devices fail 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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5 
SCHEMA 

                                               
 
 
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6 
SCHEDULE OF ACTIVITIES (SOA) 
 

                                               
 
 
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7 
 
INTRODUCTION 
There are 27 million people in the US with Type 2 diabetes on non-insulin therapies and three million with Type 2 
diabetes requiring basal insulin only.1,2,3 At a population level, glycemic control in people with diabetes has worsened 
over the past 10-15 years despite the introduction of six new drug therapeutic categories, as published in the New 
England Journal of Medicine.4 Recent studies have demonstrated CGM’s effectiveness in people with Type 2 
diabetes, including those not using insulin,5,6,7 and the American Diabetes Association recommends CGM use in 
persons with Type 2 diabetes. ADA recommends intermittent use of CGM to aid in evaluating periods of 
hyperglycemia to make medication dose adjustments.8 Despite these recommendations, less than 1% of the Type 
2 non-insulin using population are estimated to be using conventional CGM. Commonly cited barriers to 
conventional CGM adoption for all diabetes populations include cost, discomfort/pain on insertion, skin/adhesive 
problems, size/form factor, disruptive alerts, and difficulty interpreting CGM data.9,10 
The absence of a device specifically designed to support disease management for people with Type 2 diabetes 
leaves these individuals with inadequate options to improve metabolic health. Currently, people with Type 2 
diabetes are required to make the choice between using CGMs designed and optimized for people with Type 1 
diabetes or continuing to rely on discrete blood glucose measurements produced by test strips. These blood 
glucose measurements can be painful and inconvenient to use and provide limited context on personal health 
trends and patterns, including the impact of food, medications, and activity on glycemic variability. Given the rising 
rates of Type 2 diabetes and prediabetes globally, as well as the increased risk for diabetes diagnoses following 
COVID-19 infection, there is a clear and growing need for more accessible, less invasive, and easier-to-use CGM 
devices designed specifically for people with Type 2 diabetes.  
The primary objective of the study is to evaluate the safety and effectiveness of the Biolinq MicroArray Intradermal 
Continuous Glucose Biowearable System over a 5-day period in adults with diabetes mellitus. Data collected from 
this study is intended to be used to support commercial marketing application(s) for the intended commercial patient 
population of non-insulin-users. 
8 
STUDY MATERIALS 
8.1 
BIOLINQ MICROARRAY INTRADERMAL CONTINUOUS GLUCOSE BIOWEARABLE SYSTEM 

                                               
 
 
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The reportable glucose range for the sensor is between 70 mg/dL and 400 mg/dL. BLINQ does not provide glucose 
information below 70 mg/dL to mitigate the risk of off-label use by those who need more information about 
hypoglycemia, such as persons requiring multiple daily insulin injections.  Additionally, 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.  
8.1.1 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  
The Biolinq sensor consists of a sterile microarray sensor stack assembly that resides in the upper strata of the 
reticular dermis to measure interstitial glucose. The sensor is directly connected to a wearable that is adhered to 
the skin and is applied using the Applicator assembly. The Biolinq System measures and reports glucose 
information for up to five (5) days. The Biolinq System is designed to measure glucose levels for up to five (5) days. 
The wearable applied may also contain non-medical device designated off the shelf-components that capture 
actigraphy and environmental information to transfer to secondary display 
 
 
  

                                               
 
 
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8.2 
OTHER STUDY DEVICE/MATERIALS 
8.2.1 
COMMERCIAL CGM  
 
 
 

                                               
 
 
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8.2.2 
SELF-MONITORING BLOOD GLUCOSE (SMBG) 
 
 
 
8.2.3 
ACTIVITY TRACKER AND ELECTRONIC SUBJECT LOG 
Subjects will be provided with an activity tracker device to wear throughout the study to capture subject activity 
levels. 
 
 
 
  
8.2.4 
LABORATORY ANALYZER 
During In-Clinic Days, the FDA-cleared laboratory analyzer (LA) [YSI 2300 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. 
9 
POTENTIAL RISKS AND BENEFITS 
9.1 
STUDY DEVICE RISKS 

                                               
 
 
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10 RATIONALE FOR THE STUDY DESIGN 

                                               
 
 
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All subjects will wear a minimum of one Biolinq wearable each; a random subset of subjects will wear two 
wearables simultaneously for precision analysis. The study enrollment is designed to ensure a diverse population 
is evaluated when establishing a potentially new commercial product in the United States and other countries 
where the data may also be accepted to support marketing authorization.  
11 STUDY OBJECTIVES 
11.1 PURPOSE OF STUDY 
The primary objective of the study is to evaluate the safety and effectiveness of the Biolinq MicroArray Intradermal 
Continuous Glucose Biowearable System, which is intended to be worn for up to five (5) days (up to 120 hours) in 
adults with diabetes mellitus (DM). Data collected from this study is intended to be used to support commercial 
marketing application(s) for the intended commercial patient population of non-insulin-users. 
11.2 CO-PRIMARY PERFORMANCE ENDPOINTS 
Biolinq System performance will be characterized with respect to laboratory reference venous measurements. The 
primary endpoint, matched paired (Sensor-YSI) measurements, will be collected during multiple in-clinic sessions 
on days 1, 3, and/or 5 of wear.  
• 
For all available matched pair data points when the Biowearable displays BLUE (“in target” color indicator), 
the percentage of reference blood glucose values between 55-207 mg/dL must be calculated, and the lower 
one-sided 95% confidence bound 
 
• 
For all available matched pair points when the Biowearable displays YELLOW (“above target” color 
indicator), the percentage of reference blood glucose values between 154-460 mg/dL must be calculated, 
and the lower one-sided 95% confidence bound 
 
 
 
 
11.3 DEVICE SAFETY 
Safety of the Biolinq System will be characterized by the: 
1. Overall adverse device effect rate 
2. Individual adverse device effect rates 
3. Distribution of Draize assessments for erythema and edema for Biolinq Biowearable by Adverse Device 
Effects (ADEs) and Serious Adverse Device Effects (SADEs) experience by study participants. 
 
 

                                               
 
 
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11. Participate in two (2) In-Clinic sessions lasting up to 11.5 hours of blood draws (anticipated up to 13 hours on 
site per visit) each. 
12. Perform up to five (5) fingersticks a day with the SMBG device provided during non-in-clinic days. 
13. Avoid immersing study devices into water (e.g., no hot tub, SCUBA diving). 
14. Wear an activity tracker or record activity levels on a daily log. 
12.3 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.  
5. Known allergy to medical grade adhesives, acrylic, latex, or isopropyl alcohol. 
6. 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). 
7. For subjects of child-bearing potential, pregnant or not practicing an acceptable form of birth control during the 
study.  
8. 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% 
9. Have donated blood, had significant blood loss, or participated in a study with significant blood sampling (340 
cc or more) within 56 days prior to study enrollment or plan to participate in such activities during study wear.  
10. Required or scheduled to have diathermy, X-ray, MRI, or CT during study wear. 
11. 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 
 
 

                                               
 
 
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13 STUDY DESIGN 
13.1 DESIGN SUMMARY 
This study will be a clinical safety and effectiveness study of the Biolinq System. The study will be an open label, 
prospective, multi-center, single arm study conducted in the United States.  
13.2 DURATION OF PARTICIPATION 
 
 
 
 
13.3 ESTIMATED STUDY DURATION 
 
 
 
13.4 STUDY CENTERS 
A minimum of five (5) and up to eight (8) centers in the United States will participate in the study. 
14 STUDY ENROLLMENT  
14.1 STRATEGIES FOR RECRUITMENT AND RETENTION 
Subjects will be recruited through various IRB-approved advertising methods including but not limited to digital 
campaigns, available Investigator treatment databases, print, radio, or the like.  All advertising materials will be 
pre-approved by the reviewing IRB prior to implementation. 
14.2 INFORMED CONSENT 
To protect the rights, safety, and welfare of subjects, the study is conducted in accordance with the 21 CFR 50, 
Protection of Human Subjects. The Principal Investigator or designee, as delegated by Principal Investigator on 
site delegation of authority log, will explain the study nature, overview, purpose, objectives, expected participation 
duration, study activities, risks of study participation, alternative treatment, participation benefit, study sponsor, 
cost for participation, new information sharing, medical cost coverage if he/she gets hurt, stipend amounts, 
confidentiality, and IRB contact information. Subjects will be given ample time to consider their voluntary 
participation in the study and to ask questions. Potential subjects may take a copy of the IRB Approved Informed 
Consent Form (ICF) home to review with family and friends prior to deciding on whether to participate in the 
study. 
Participants must be informed that participation is voluntary and that they may withdraw from the study at any 
time, without prejudice. A copy of the Informed Consent Form will be offered to the participants for their records. 
The informed consent process will be conducted and documented within the IRB approved Informed Consent 
Document, with required signatures obtained, before the participant participates in any study activities. The rights 
and welfare of the participants will be protected by emphasizing to them that the quality of their medical care will 
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14.3 ENROLLMENT 
Subjects who sign the IRB approved ICF will be considered “Enrolled” in this study.  
14.4 SCREENING 
14.5 DEVICE ASSIGNMENT 

                                               
 
 
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15 STUDY PROCEDURES 

                                               
 
 
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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). 
16.2 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). 
 
16.3 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.  
• 
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. 
16.4 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.  
16.4.1 
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. 

                                               
 
 
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16.4.2 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. 
16.5 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. 
17 STATISTICAL ANALYSIS & METHODS 
17.1 ANALYSIS COHORTS 
Analysis cohorts for the study are prospectively defined and are described in the following subsections. To ensure 
that the calculated percentage of points is representative across all glucose ranges (i.e. data from each of the 
glucose range should be adequately represented and not heavily weighted toward the midrange at the expense of 
the high and low range glucose values), glucose levels will be manipulated during the in-clinic sessions (Table 5).  
Information pertaining to the statistical analysis methods using these cohorts is provided in the subsequent sections. 
17.1.1 ENROLLED COHORT 
The Enrolled Cohort includes all subjects who sign the study IRB approved informed consent. Analyses pertaining 
to screening eligibility, safety, and protocol compliance prior to the Biolinq application, and study exit will be 
performed using the Enrolled Cohort. 
17.1.2 TREATED COHORT (ANALYSIS POPULATION) 
All enrolled subjects who have undergone device application will be included in all analyses. All data that is 
collected during the study will be included in the analysis.
 
 
  
17.2 STATISTICAL METHODS FOR SAFETY OUTCOME  
Overall and individual adverse events are summarized for safety outcome by frequency and percentage. In 
addition, the number of AEs, ADEs, SAEs, SADEs, and UADE and percentage of Subjects with events are 
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The erythema and edema Draize assessment at each biowearable wear location is another safety outcome that 
will be analyzed and reported.
 
s. 
17.3 METHOD DEFINITIONS FOR PERFORMANCE METRICS 

                                               
 
 
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18 DATA MANAGEMENT PLAN 
18.1 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.  
18.2 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 

                                               
 
 
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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 the qualified individual generating the record and/or investigator when 
applicable.  
18.3 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.  
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. 
18.4 DEVICE DATA DOWNLOAD 

                                               
 
 
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19 ETHICAL CONSIDERATIONS 
 
19.1 STATEMENT OF COMPLIANCE 
The trial will be carried out in accordance with ISO 14155:2020 Clinical Investigation of medical devices for human 
subjects – Good clinical practice, International Conference on Harmonization Good Clinical Practice (ICH GCP) and 
the following: United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 
21 CFR Part 50, 21 CFR Part 56, and/or 21 CFR Part 812). 
The study will also be conducted in accordance with the Declaration of Helsinki (1964). 
19.2 PROTOCOL APPROVAL AND AMENDMENTS 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the 
Institutional Review Board (IRB)/ Ethics Committee (EC) for review and approval. Approval of both the protocol 
and the consent form must be obtained before any participant is enrolled.  

                                               
 
 
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All revisions and/or amendments to the protocol and informed consent must be approved in writing by the 
Sponsor, the appropriate IRB, and regulatory body, as appropriate. 
20 REPORTS 
The Investigator or designee is responsible for completing the Case Report Forms (CRFs) or Electronic Data 
Capture (EDC), as applicable. The Sponsor and Investigator will submit any progress or safety reports that the 
IRB or applicable regulatory authorities may require, including any final close-out reports.  
21 MONITORING 
Monitoring will be conducted by trained and experienced clinical professionals in accordance with Biolinq’s standard 
operating procedures. Monitors will evaluate study conduct and documentation on an ongoing basis to ensure that 
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).  
21.1.1 
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. 
 
22 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.  
23 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 

                                               
 
 
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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. 
24 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. 
24.1 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. 
24.2 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. 
24.3 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.  
24.4 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 
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commercial CGM and glucometers, and the activity trackers 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.  
24.5 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. 
 
25 REFERENCES 
 
1. ElSayed, et al. (2022). Classification and diagnosis of diabetes: Standards of care in diabetes. Diabetes 
Care, 46(Supplement_1), S19–S40. https://doi.org/10.2337/dc23-s002 
2. Dexcom 2023 Investor Day presentation available 
at https://s201.q4cdn.com/758408164/files/doc_presentation/2023/06/Investor-Day-Presentation_June-
2023.pdf  .  
3. ADA press release available at https://www.diabetes.org/newsroom/press-releases/2020/statement-high-
cost-insulin.  
4. Fang M. et al., “Trends in Diabetes Treatment and Control in U.S. Adults, 1999–2018” N Engl J Med 
2021; 384:2219-2228.  
5. Martens T., et al., “Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 
Diabetes Treated With Basal Insulin” JAMA. 2021;325(22):2262-2272.  
6. Karter A. et al., “Association of Real-time Continuous Glucose Monitoring With Glycemic Control and 
Acute Metabolic Events Among Patients With Insulin-Treated Diabetes” JAMA. 2021;325(22):2273-2284.  
7. Abbott Press Release available at https://abbott.mediaroom.com/2020-06-13-New-Late-Breaking-Data-
Show-Use-of-Abbotts-FreeStyle-R-Libre-System-Significantly-Reduces-HbA1C-Levels-in-People-with-
Type-2-Diabetes-Using-Insulin-or-Not. 
8. American Diabetes Association Professional Practice Committee. 7. Diabetes Technology: Standards of 
Medical Care in Diabetes—2022. (2021). Diabetes Care, 45(Supplement_1), S97–S112. 
https://doi.org/10.2337/dc22-s007 
9. dQ&A data available on request.  
10. Tanenbaum, M.L., et al., Diabetes Device Use in Adults With Type 1 Diabetes: Barriers to Uptake and 
Potential Intervention Targets. Diabetes Care, 2017. 40(2): p. 181-187. 
11. Fitzpatrick, T.B., The Validity and Practicality of Sun-Reactive Skin Types I Through VI. Archives of 
Dermatology, 1988. 124(6): p. 869-871. 
12. Fitzpatrick skin phototype. [cited 2020 23 March]; Available from: 
https://www.arpansa.gov.au/sites/default/files/legacy/pubs/RadiationProtection/FitzpatrickSkinType.pdf. 
13. Johnson AW, Goodwin BF. The Draize test and modifications. Curr Probl Dermatol. 1985;14:31-8. doi: 
10.1159/000411605. PMID: 4064749. 

                                               
 
 
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14. 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. 
15. 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. 
16. JD Best & JB Halter: Release and clearance rates of epinephrine in man: Importance of arterial 
measurements. J. Clin. Endocrinol. Metab. 55: 263-268, 1982. 
17. 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. 
18. Clinical and Laboratory Standards Institute (CLSI). Performance Metrics for Continuous Interstitial 
Glucose Monitoring; Approved Guideline, CLSI, POCT05-0A, Vol.28 No. 33. 
19. Iqbal, A. and S. Heller, Managing hypoglycaemia. Best Pract Res Clin Endocrinol Metab, 2016. 30(3): p. 
413-30. 
20. Siperstein, M.D., Diabetic ketoacidosis and hyperosmolar coma. Endocrinol Metab Clin North Am, 1992. 
21(2): p. 415-32. 
21. Kitabchi, A.E., et al., Hyperglycemic crises in adult patients with diabetes. Diabetes Care, 2009. 32(7): p. 
1335-43. 
22. 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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26 APPENDICES 
26.1 APPENDIX 1 – IN-CLINIC GUIDELINES  
26.1.1 PURPOSE  
To outline guidelines for performing an In-Clinic Day to assess performance of the Biolinq System relative to an 
FDA-cleared glucose laboratory analyzer (YSI 2300 STAT PLUS Analyzer).  
26.1.2 IN-CLINIC OBJECTIVE 
The primary objective of an In-Clinic Day is to safely obtain sufficient data variation between 60-400 mg/dL to 
evaluate the performance of the Biolinq Biowearable in and around its measuring range of 70-400 mg/dL. 
Commercially available comparator devices (SMBG, CGM) will also be evaluated for reference analysis during an 
In-Clinic Day. 
26.1.3 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 and target glucose ranges, as outlined in this document 
 
The Principal investigator shall maintain final discretion for any In-Clinic procedures and methods used based on 
their medical expertise and/or training.   
26.1.4 SAFETY MEASURES 
 
 

                                               
 
 
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