Dexcom G6 Pro Glucose Monitoring System User Guide

Blinded CGM
Patient Handout

G6 Pro Glucose Monitoring System

Healthcare Professional
Patient doesn’t have any display device and doesn’t see Dexcom G6 Pro Continuous Glucose
Monitoring System (G6 Pro) readings. Don’t give transmitter SN to blinded patient.
Healthcare professional: Insert sensor (Section A) and attach transmitter (Section B).
Complete section C. Review this handout with patient, then give to them to take home.

Insert Sensor

1. Gather materials: applicator, transmitter, and wipes.
2. Pick sensor site. Avoid bones, muscle, irritated skin, tattoos, areas that get bumped.
3. Clean sensor site with alcohol wipe.
4. Peel off adhesive backings.
5. Place adhesive on
6. Fold and break off
7. Press button to insert
8. Discard applicator. skin. safety guard. sensor. (follow local guidelines)

Attach Transmitter

1. Clean transmitter.
2. Insert transmitter. Only use alcohol tab first, into wipe. holder.
3. Crick tiockptiraacne flush with times. transmitter
4. Rubes-around patch 3 holder.

Transmitter removal date

Return transmitter——————–
In person——————-
Other————
Date———
Time——————-

Patient

What do I do?

• Shower and swim as normal
• Return to your healthcare professional as instructed

What don’t I do?

• No MRI’s
• No full-body scanners
• No sunscreen or lotions on transmitter
• No system parts in mouth, it’s a choking hazard
• Don’t remove transmitter, it’ll end your sensor session

G6 Pro Overview
G6 Pro takes your glucose reading every 5 minutes for 10 days. After returning the system, your healthcare professional reviews your glucose history and may adjust your medication, diet, or exercise.
What’s Next?
Once your 10-day sensor session ends, follow the instructions below to remove the patch from your body.
Return to your healthcare professional (see Section C).
Sensor must be returned within 30 days of starting session.

1. Peel the entire patch off like a bandage.
2. Place in bag and seal it.

Learn more about G6 Pro atdexcom.com/guides

Need help?
Contact your healthcare professional Patient
For medical issues:

• G6 Pro gets loose or removed
• Sensor wire breaks off
• Irritation at insertion site

Contact Technical Support
For technical issues:
1-844-607-8398
Available 24/7
Name—————————-
Phone—————-

Safety Statement

G6 Pro Safety Statements
Indications for Use
The Dexcom G6 Pro Continuous Glucose Monitoring System (Dexcom G6 Pro System) is a real time continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. The Dexcom G6 Pro System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the realtime Dexcom G6 Pro System results should be based on the glucose trends and several sequential readings over time.
The Dexcom G6 Pro System may also be used as a retrospective glucose recording device indicated for assessing glycemic variability in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. Retrospective interpretation of data recorded by the Dexcom G6 Pro System should be conducted solely by a healthcare professional. The Dexcom G6 Pro System aids in detecting glucose excursions facilitating care plan adjustments. The Dexcom G6 Pro System is also intended to interface with digitally connected devices. The Dexcom G6 Pro System can be used alone or in conjunction with these digitally connected medical devices for managing diabetes or assessing glycemic variability.
Important User Information Failure to use the G6 Pro and its components according to the instructions for use and all indications, contraindications, warnings, precautions, and cautions may result in missed glucose data.
Please review the product instructions before using the G6 Pro. Indications, contraindications, warnings, precautions, cautions, and other important user information can be found in the product instructions that are included with, or accompany, the G6 Pro. Discuss with your healthcare professional how you should use the information recorded by G6 Pro to help manage your diabetes. The product instructions contain important information on troubleshooting the G6 Pro and on the performance characteristics of the system.
Seek medical attention when appropriate.
Contraindication
No MRI/CT/Diathermy
Don’t wear your CGM (sensor, transmitter, or smart device) for magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment.
The G6 Pro hasn’t been tested in those situations. The magnetic fields and heat could damage the components of the G6 Pro, which may cause it to display inaccurate G6 Pro sensor glucose readings (G6 Pro readings).
Warnings
Where to Insert: Belly or Buttocks?
All patients can use their bellies (abdomen).
Patients 2 to 17 years old can also choose their upper buttocks. Look for a place on the belly or upper buttocks where there is some padding.
The sensor is not tested or approved for other sites. Talk to your Healthcare professional about the best site for you.
Where to Store Store sensors at room temperature or in a refrigerator – as long as it’s between 36°F and 86°F. Don’t store sensors in the freezer. Read User Materials Before using G6 Pro, carefully read the materials included with it. If the patient doesn’t, they might:
• Not use the G6 Pro correctly
• Not understand G6 Pro information
• Affect how well it works
Don’t use G6 Pro if pregnant, on dialysis, or critically ill It is not known how different conditions or medications common to these populations may affect performance of the system. G6 Pro readings may be inaccurate in these populations. Follow G6 Pro instructions. If not, patient could have a severe low or high glucose event.
Inspect
Don’t use a damaged or cracked transmitter. A damaged transmitter could cause injuries from electrical shocks and may make the G6 Pro not work correctly. Use as Directed
The transmitter is a small part and poses a choking hazard, particularly for children. Wire Breaks Off Don’t ignore broken or detached sensor wires. A sensor wire could remain under your skin. If this happens, please contact our 24/7
Technical Support.
If a sensor wire breaks off under the skin and your patient can’t see it, tell them not to remove it, but to contact you or seek professional medical help. Advise your patient to seek professional medical help if they have symptoms of infection or inflammation – redness, swelling, or pain – at the insertion site.
Precautions
Interfering Substance Risks Acetaminophen In previous generations of Dexcom CGM systems (G4/G5), acetaminophen could affect sensor readings, making them look higher than they really were. However, with the G6 Pro, patient can take a standard or maximum acetaminophen dose of 1 gram (1,000 mg) every 6 hours and still use the G6
Pro readings to make treatment decisions. Taking higher than the maximum dose of acetaminophen (e.g. > 1 gram every 6 hours in adults) may affect the G6 Pro readings and make them look higher than they really are.
Hydroxide
Hydroxyurea is a medication used in the treatment of diseases including cancer and sickle cell anemia; it is known to interfere with values from your sensor. If you are taking hydroxyurea, your sensor glucose values will be higher than the actual glucose which could make it difficult for your health care professional to accurately assess your glucose control. The level of inaccuracy depends on the amount of hydroxyurea in your body.
Follow G6 Pro instructions. If not, your patient could have a severe low or high glucose event.
Don’t Start Past Use By Date Don’t start a sensor past its Use By date because it may give incorrect results. The UseBy date is in YYYY-MM-DD (Year-Month- Day) format  n the sensor package label beside the hourglass symbol. Check Package
Don’t use sensor if its sterile package has been damaged or opened, because it might cause an infection. Clean and Dry Skin Clean and dry your hands, then put on your gloves before inserting sensor on patient. Clean insertion site with alcohol wipes to prevent infections. Don’t insert the sensor until-skin is dry. If insertion site is not clean and
completely dry, there’s a risk of infection or the transmitter holder not sticking well.
Make sure patient doesn’t have insect repellent, sunscreen, perfume, or lotion on their skin.
Where to Insert: Things to Check Don’t open packages until ready to use. Keep the safety guard on until you put the G6 Pro applicator against the patient’s skin. If you-remove the safety guard first, you may hurt the patient by accidentally pushing the button that inserts the sensor before you mean to.
Change the insertion site with each sensor.
Using the same site too often on the same patient might not allow the skin to heal, causing scarring or skin irritation. Sensor placement is important.
Choose a site:

• 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

Follow G6 Pro instructions. If not, your patient could have a severe low or high glucose event.
Use Correct Transmitter, and Sensor G6 Pro components are not compatible with any previous Dexcom products. Do not mix transmitters and sensors from different generations.
Avoid Sunscreen and Insect Repellent Some skin care products, such as sunscreen sand insect repellents, can make the plastic used in G6 Pro crack. Before using G6 Pro, make sure there are no cracks in transmitter, and transmitter holder. If you find a crack, please contact Technical Support.
Do not allow these skin care products to contact the G6 Pro. After using skin care products, wash hands before touching G6 Pro. If any skin care products get on G6 Pro, immediately wipe with a clean cloth.
Going Through Security Check Point When wearing G6 Pro, your patient should ask for hand-wanding or full-body pat-down and visual inspection instead of going throughout Advanced Imaging Technology (SIT) body scanner (also called a milometer wave scanner) or putting any part of the G6 Pro in the baggage x-ray machine.
Your patient can wear the G6 Pro for the walk through metal detector.
Not sure what kind of machine it is? Be safe – either ask the TA officer, request handwriting, or request full-body pat-down.
Caution
US Federal law restricts the sale of G6 Pro to be made by or on the order of a physician.
Risks and Benefits Risks
The risks with using G6 Pro are:

• Sensor insertion issues
• Local skin irritation from adhesive patch

Sensor Insertion Risks
It’s uncommon, but inserting the sensor can cause infection, bleeding, or pain. Only a few patients in the clinical studies got slight redness and swelling.
There is a remote chance a sensor wire could break or detach and remain under the skin. Sterile broken or detached sensor wires usually don’t pose a significant medical risk.
If a sensor wire breaks off or detaches and remains under your skin, the user should contact a Healthcare professional and
Technical Support (24/7):
Tech-support@dexcom.com
Toll free: 1.888.738.3646
Toll call: 1.858.200.0200
Benefits
Some benefits of using G6 Pro are:

• Knowing trends
• Assessment of your glucose control

Knowing Your Trends
The G6 Pro sends a reading every 5 minutes.
It also provides reports and views of your information so you can detect and reflect on trends, patterns, and how your body responds to different things, like exercise, stress, or food you have eaten. This provides you with a more complete picture of your glucose and lets you see how your daily habits impact your glucose control.
Helping Your Diabetes Management The glucose information will provide an insight to the state of your glucose control and the patterns you and your clinician observe may
help inform better treatment decisions.
References
Vigersky, Robert, Stradivari, Manganese. 2017.
“Role of continuous glucose monitoring for type 2 diabetes management and research.” Journal of Diabetes and Its Complications.
31(1):280-287.
Doi: 10.1016/j.jdiacomp.2016.10.007.
If you need more information about G6 Pro and the Symbols Glossary, read the G6 Pro User Guide, visit dexcom.com/symbols, or contact the Dexcom Technical Support team at 1.844.607.8398 for 24/7 support.
Dexcom, Inc.
6340 Sequence Drive
San Diego, CA 92121 USA
1.844.857.6319
dexcom.com

Dexcom and Dexcom G6 are either registered trademarks or trademarks of Dexcom, Inc. in the United States and/or other countries. All other product or company names that may be mentioned in this publication are trade-names, trademarks or registered trademarks of their respective owners.
© 2022 Dexcom, Inc. All rights reserved.
MT25845 / LBL017177 Rev 006 Rev Date: 03/2022

Instructions available in Spanish atdexcom.com/ayuda

References

• Dexcom Continuous Glucose Monitoring | Dexcom
• Dexcom Continuous Glucose Monitoring | Dexcom CGM
• Dexcom G7 and G6 CGM Quick Start User Guides | Dexcom
• dexcom.com/symbols

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