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Continuous Glucose
Monitoring System
User Guide
Insertion p 21
Removal p 31
WARNING:
Please review the product instructions before using the Dexcom Pro Q Continuous
Glucose Monitoring System (Pro Q). Indications, contraindications, warnings,
precautions, cautions, and other important user information can be found in the
product instructions that are included with, or accompany, the Pro Q.
Dexcom Pro Q System User Guide
2
Table of Contents
Part 1: System Overview
Chapter 1 | Dexcom Pro Q System
1.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . 4
1.2 Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.3 Resources . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.4 Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . .7
Chapter 2 | Indications for Use and
Safety Statements
2.1 Dexcom Pro Q Safety Statements . . . . 9
Chapter 3 | Risks and Benefits
3.1 Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.2 Benefits. . . . . . . . . . . . . . . . . . . . . . . . . . 13
Part 2: Insertion & Removal
Chapter 4 | Insertion
4.1 Introduction . . . . . . . . . . . . . . . . . . . . . . 15
4.2 Prepare to Insert Sensor . . . . . . . . . . . 15
4.4 Insert Sensor . . . . . . . . . . . . . . . . . . . . . 18
4.5 Attach Transmitter . . . . . . . . . . . . . . . . 22
Chapter 5 | Removal
5.1 Introduction . . . . . . . . . . . . . . . . . . . . . . 24
5.2 Remove Sensor and Transmitter . . . . 24
Part 3: Troubleshooting
Chapter 6 | Troubleshooting
6.1 Introduction . . . . . . . . . . . . . . . . . . . . . . 27
6.2 Applicator. . . . . . . . . . . . . . . . . . . . . . . . 27
6.3 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Part 4: Appendices
Appendix A | Support Teams ........34
Appendix B
| Security and
Air Travel..........................36
Appendix C
| Care of
Dexcom Pro Q.....................38
Appendix D
| Warranty .............39
Appendix E
| Technical
Information .......................43
Appendix F
| Label Symbols ........ 66
Index .............................69
1
System Overview
• Introduction
• Indications for Use and Safety Statement
• Risks and Benefits
Dexcom Pro Q System User Guide
4Chapter 1: System Overview
Chapter 1 | System Overview
1.1 Introduction
The Dexcom Pro Q Continuous Glucose Monitoring System tracks and stores a
participant's glucose data every 5 minutes. The glucose data is downloaded and
reviewed by a health assessment program. The program, which can review glucose
trends and may propose adjustments to a participant's medication, diet, or exercise as
needed for healthier living.
Dexcom Pro Q is blinded; the participant won’t see their current readings. However, the
readings are recorded and are downloaded later.
An authorized data extraction tool downloads glucose data after a sensor session. See
dexcom.com/guides for instruction related to data extraction.
Please note: Images in this User Guide are representational and may differ from the
Dexcom Pro Q.
1.2 Parts
This section is a quick overview of each component. Specifics for each are in the
following chapters.
The Dexcom Pro Q has these parts:
• Single-use applicator and built-in sensor
• Single-use transmitter
Applicator
For safety, the applicator is packaged in a
sterile sealed pouch. The applicator inserts
the built-in sensor. The sensor is held in the
body by an adhesive patch. The transmitter
snaps into a holder on the outside of that
patch. The transmitter holder is held on the
body with the adhesive patch.
Dexcom Pro Q System User Guide
5Chapter 1: System Overview
The sensor wire is made of silver and platinum with polymer membranes. Once
inserted, the thin, flexible wire measures glucose levels in the interstitial fluid for up to
10 days.
Applicator with built-in sensor:
• Inserts sensor wire under the skin
• Disposable, for one use only
Sensor:
• Measures glucose levels in fluid in between cells (interstitial fluid)
• Disposable, for one use only
Transmitter
The transmitter snaps into the transmitter holder and records glucose information.
Transmitter:
• Stores sensor readings for future analysis
• One use only
• Water resistant
Chapter 4 has more information on sensor insertion and transmitter attachment.
Dexcom Pro Q System User Guide
6Chapter 1: System Overview
1.3 Resources
There are three resources for Dexcom Pro Q:
Participant Guide
This sheet is given to the participant. It is their primary source of information and a
helpful reminder of when to return for Pro Q removal.
User Guide
This User Guide is an encyclopedia of Pro Q knowledge. It provides an overview of the
Dexcom Pro Q, detailing features, important safety information, and more.
Download the User Guide or ask for a printed version:
• Download a PDF at dexcom.com/guides
• Ask for a free copy by phone:
• Toll free: 1.844.857.6319 (M – F, 6 AM – 6 PM PST)
Insertion/Removal Instructions
This sheet is in the sensor box. It is a short, step-by-step guide on inserting and
removing the Dexcom Pro Q.
Dexcom Pro Q System User Guide
7Chapter 1: System Overview
1.4 Glossary
A1C
Blood test used to diagnose type 1 or 2 diabetes and to gauge
how well someone is managing their diabetes. A1C reflects
average blood sugar level for the past 2 to 3 months.
Blood Glucose
(BG) Value
Amount of glucose in the blood measured by a meter.
Continuous
Glucose Reading
Sensor inserted under the skin checks glucose levels in interstitial
fluid. A transmitter stores readings to be retrieved later.
Contraindication
Situations in which the Pro Q shouldn't be used because it may be
harmful to the user.
Default Preset option for a device setting.
Hyperglycemia High BG. Same as "high" or "high blood sugar."
Hypoglycemia Low BG. Same as "low" or "low blood sugar."
Indications
How, for what purposes, and under what circumstances the Pro Q
should be used.
IP
The International Electrotechnical Commission (IEC) is a nonprofit,
non-governmental, international organization created to produce
safety standards for electronics. One of the safety standards
is the Ingress Protection (IP) Marking, which classifies and
rates how protected an electronic device is against dust, water,
accidental contact, etc.
Dexcom Pro Q System User Guide
8Chapter 1: System Overview
mg/dL
Milligrams per deciliter. The standard unit of measure for BG
readings in the United States.
Precaution Special care for the safe and effective use of the Pro Q.
Safety
Statement
Intended uses of Pro Q and relevant warnings, precautions, and
contraindications.
Sensor Glucose
Reading (sensor
reading)
The glucose concentration measured in the interstitial fluid.
Sensor Session
The period (up to 10 days) after inserting a new sensor. During
this time glucose is recorded every 5 minutes for retrieval later.
Warning
Describes serious and life-threatening circumstances, the
consequences, and how to avoid the hazard while using the
Pro Q.
Dexcom Pro Q System User Guide
9Chapter 2: Indications for Use and Safety Statements
Chapter 2 | Indications for Use and
Safety Statements
2.1 Dexcom Pro Q Safety Statements
Indications for Use
The Dexcom Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a
factory calibrated continuous glucose recording device indicated for the retrospective
discovery, analysis and interpretation of glycemic variability in persons age 2 years and
older under the supervision of a healthcare professional. The Dexcom Pro Q System
collects and processes data for aiding in the management of a disease or condition
related to glycemic control.
Interpretation of the data recorded by the Dexcom Pro Q System results should be
made only by a qualified healthcare professional based on glucose trends and several
sequential readings over time. The Dexcom Pro Q System aids in detecting glucose
excursions facilitating care plan adjustments. The Dexcom Pro Q System is also
intended to interface with digitally connected devices.
Contraindication
• No MRI/CT/Diathermy – MR Unsafe
Don’t wear the system (sensor, transmitter) for magnetic resonance imaging (MRI),
computed tomography (CT) scan, or high-frequency electrical heat (diathermy)
treatment.
The Dexcom Pro Q hasn’t been tested in those situations. The magnetic fields
and heat could damage the components of the Dexcom Pro Q, which may cause
inaccurate Dexcom Pro Q sensor glucose readings (Dexcom Pro Q readings).
Warnings
• Do not use the Dexcom Pro Q if participant is pregnant, on dialysis, or critically
ill. It is not known how different conditions or medications common to theses
populations may affect performance of the system.
MR
Dexcom Pro Q System User Guide
10Chapter 2: Indications for Use and Safety Statements
• Don’t ignore broken or detached sensor wires. A sensor wire could remain under
the skin. If this happens, please contact our 24/7 Technical Support.
• If a sensor wire breaks off under the skin and it can't be seen, don’t try to remove
it. Contact a HCP. Also seek professional medical help if participant has symptoms
of infection or inflammation – redness, swelling, or pain – at the insertion site.
• Don’t use a damaged or cracked transmitter. A damaged transmitter could cause
injuries from electrical shocks and may make the Dexcom Pro Q not work correctly.
• Don’t modify any component or accessory in order to maintain safety.
• The transmitter is small and may pose a choking hazard. Don’t put it in mouth or let
children hold it without adult supervision.
• The sensor is approved for use in the following sites:
Ages 2-17 years: Insert in abdomen or upper buttocks
Ages 18 years and older: Insert on abdomen
• Store sensors at room temperature or in a refrigerator with a temperature range
between 36°F and 86°F. Don’t store sensors in the freezer.
Cautions
• Some skin care products, such as sunscreens and insect repellents, can make the
plastic used in the Dexcom Pro Q crack. Before using the Dexcom Pro Q, make sure
there are no cracks in the transmitter, and transmitter holder. If there is a crack,
Dexcom Pro Q System User Guide
11Chapter 2: Indications for Use and Safety Statements
please contact Technical Support. Do not allow these skin care products to contact
the Dexcom Pro Q. After using skin care products, wash hands before touching the
Dexcom Pro Q. If any skin care products get on the Dexcom Pro Q, immediately
wipe with a clean cloth.
• Don’t use expired sensors. Check the package label for the expiration date. It’s in
YYYY-MM-DD (Year-Month-Day) format.
• Don’t use sensor if its sterile package has been damaged or opened, because it
might cause an infection.
• Sensor insertion/removal should only be conducted by, or under the supervision of,
a healthcare practitioner.
• Clean and dry hands and put on gloves before inserting a sensor.
• Clean the insertion site with alcohol wipes to prevent infections. Don’t insert the
sensor until skin is dry. If the insertion site is not clean and completely dry, it may
run the risk of infection or the transmitter holder not sticking well.
• Keep the safety guard on until the Dexcom Pro Q applicator is placed against
participant's skin. Accidentally pushing the button before the applicator is placed
against the participant's skin may cause injury.
• Sensor placement cautions:
– At least 3 inches from insulin pump infusion set or injection site
– Away from waistband, scarring, tattoos, irritation, and bones
– Unlikely to be bumped, pushed, or laid on while sleeping
• The Dexcom Pro Q is a prescription-only medical device and is meant for the
intended patient’s use only. Never share the transmitter; it is tied to the Dexcom Pro
Q readings.
• The Dexcom Pro Q system is not for screening or diagnosis of diabetes.
• When wearing the Dexcom Pro Q, a patient should ask for hand-wanding or
full-body pat-down and visual inspection instead of going through the Advanced
Imaging Technology (AIT) body scanner (also called a millimeter wave scanner) or
putting any part of the Dexcom Pro Q in the baggage x-ray machine.
Dexcom Pro Q System User Guide
12Chapter 3: Risks and Benefits
Chapter 3 | Risks and Benefits
When using any medical device, there are risks and benefits.
3.1 Risks
The risks with using Dexcom Pro Q are:
• Sensor insertion issues
• Interfering substance risks
This section covers each of those risks in detail.
Follow system instructions.
Sensor Insertion Risks
It’s uncommon, but inserting the sensor can cause infection, bleeding, or pain, and
wearing the adhesive patch can irritate the skin. Only a few patients in the clinical
studies supporting Dexcom Pro Q got slight redness and swelling.
No sensor wires broke in the supporting clinical studies; however, there is a remote
chance a sensor wire could break or detach and remain under the skin. Sterile broken
sensor wires usually don’t pose a significant medical risk. If a sensor wire breaks off or
detaches and remains under the skin, contact your HCP and Technical Support
(M – F, 6 AM – 6 PM PST):
• Toll free: 1.844.857.6319
Interfering Substance Risks
• Hydroxyurea Precaution
Hydroxyurea is a medication used in the treatment of diseases including cancer
and sickle cell anemia; it is known to interfere with values from the sensor. If your
patient is taking hydroxyurea, their sensor glucose values will be higher than the
actual glucose, which could result in errors in retrospective discovery, analysis,
and interpretation of glycemic variability. The level of inaccuracy depends on the
amount of hydroxyurea in the body. Do not use Dexcom CGM System for assessing
glucose control if your patient is taking hydroxyurea.
Dexcom Pro Q System User Guide
13Chapter 3: Risks and Benefits
• Acetaminophen Precaution
In previous generations of Dexcom CGM systems (G4/G5), acetaminophen could
affect sensor readings. However, with the Dexcom Pro Q, a participant can take a
standard or maximum acetaminophen dose of 1 gram (1,000 mg) every 6 hours.
Taking higher than the maximum dose of acetaminophen (e.g. > 1 gram every 6
hours in adults) may affect the Dexcom Pro Q readings and make them look higher
than they really are.
3.2 Benefits
Some benefits of using the Dexcom Pro Q are:
• Reviewing historical glucose levels
Knowing Your Trends
The Dexcom Pro Q records a glucose reading every 5 minutes for up to 10 days. After
the wear period, it will provide reports and views of a participant's glucose information
so they can identify and reflect on trends, patterns, and how their body responds to
different things, like exercise or pizza. This provides a better picture of a participant's
glucose and lets them see how their daily habits impact their glucose trends.
2
Insertion & Removal
• Insertion
• Removal
Dexcom Pro Q System User Guide
15Chapter 4: Insertion
Chapter 4 | Insert Dexcom Pro Q
4.1 Introduction
Sensor insertion should only be conducted by, or under the supervision of, a healthcare
practitioner. After this chapter, the user will be able to:
• Prepare for sensor insertion
• Insert a sensor
• Attach transmitter to transmitter holder
4.2 Prepare to Insert Sensor
Before inserting a sensor, gather:
Dexcom Items (confirm both boxes are Pro Q):
• Sensor pack
– Check expiration date on sensor. Don’t use if expired.
– Don’t open the sensor until ready to insert the sensor.
• Transmitter box
User's Items:
• Alcohol wipes
• Gloves
PRECAUTION
Check Package
Don’t use sensor if its sterile package has been damaged or opened, because it
might cause an infection.
Dexcom Pro Q System User Guide
16Chapter 4: Insertion
PRECAUTION
Don’t Use if Expired
Don’t use expired sensors, because they may give incorrect results. Check the
package label for the expiration date, which is in YYYY-MM-DD format.
4.3 Choose Sensor Site
Choosing a comfortable, effective place for the sensor is important. Discuss ideal
sensor insertion sites with the participant.
Those 18 years and older can only use their abdomen.
People from 2 to 17 years old can use either their abdomen or upper buttocks.
Tips
Do:
• Make sure area is clean and free of lotions, perfumes, and medications
• If needed, shave the area so adhesive patch sticks securely
Don’t:
• Don't use bony sites, such as over the ribs
• Don't use sites where sensor can be rubbed – by a belt, waist band, seat belt
strap – or lain on while sleeping
18 years and older
2-17 years
or
Dexcom Pro Q System User Guide
17Chapter 4: Insertion
PRECAUTION
Where to Insert: Things to Check
Keep the safety guard on until the Pro Q applicator has been placed against skin. If
the safety guard is removed first, someone may get hurt by accidentally pushing the
button that inserts the sensor before it is ready.
Sensor placement is important. Choose a site:
• Away from waistband, scarring, tattoos, irritation, and bones
• Unlikely to be bumped, pushed, or lain on while sleeping
Dexcom Pro Q System User Guide
18Chapter 4: Insertion
4.4 Insert Sensor
The sensor is inside the applicator. Before inserting the sensor, become familiar with
its applicator.
Safety Guard
Protects button
Remove when ready to insert sensor
Button
Inserts sensor under the skin
Sensor
Sensor inserts through this hole
Adhesive
Transmitter Holder
Transmitter snaps in
Keeps sensor and transmitter
holder on skin
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