WARNING:
Failure to use the Dexcom G6 Continuous Glucose Monitoring System (G6) and its components according to the instructions for use and all indications, contraindications, warnings, precautions, and cautions may result in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from G6 do not match your symptoms or expectations, use a fingerstick blood glucose value from your blood glucose meter to make diabetes treatment decisions. Seek medical attention when appropriate. Please review the product instructions before using the G6. Indications, contraindications, warnings, precautions, cautions, and other important user information can be found on the Dexcom website and in the product instructions that are included with, or accompany, the G6. Discuss with your healthcare professional how you should use the information displayed on the G6 to help manage your diabetes. The product instructions contain important information on troubleshooting the G6 and on the performance characteristics of the system.
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Appendix W – Australia Safety Statement (Indications for Use Statement and Important Warnings and Precautions) – Dexcom g5 Mobile CGM System (Australia Only)
Indications for Use
The Dexcom G5 Mobile Continuous Glucose Monitoring System is a glucose monitoring
system indicated for the management of type 1 diabetes in persons age 2 years and older.
The Dexcom G5 Mobile CGM System is designed to replace fingerstick blood glucose testing
for diabetes treatment decisions.
Interpretation of the Dexcom G5 Mobile CGM System results should be based on the glucose
trends and several sequential readings over time. The Dexcom G5 Mobile CGM System also
aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute
and long-term therapy adjustments.
The Dexcom G5 Mobile CGM System is intended for use by patients at home and in
healthcare facilities.
Intended Use
• The Dexcom G5 Mobile/G4 PLATINUM Sensor Kit CGM System is used alone.
• The option of sharing data are only with the use of the smart display devices such as
Apple iPhone that provides an optional feature of sharing CGM data remotely with the
user’s friends and family through the Dexcom Share.
• The Dexcom CGM System has the capability to communicate with authorized connected
devices such as third-party insulin pump systems. Subject to consideration of these
other indications for use, testing, validation, and country applications for use with thirdparty
insulin pump systems that are subject to separate approval.
• The Dexcom CGM Glucose Sensor is only intended to be used by patients (aged 2 years
and older) with type 1 diabetes.
• Health care professionals and consumers should be aware about the limitations of
available scientific evidence for use of this device in any other groups of patients who
require diabetes management.
• During times of rapidly changing glucose (more than 0.1 mmol/L (2 mg/dL) per minute),
interstitial fluid glucose levels as measured by the Dexcom CGM Glucose Sensor may
not accurately reflect blood glucose levels. Under these circumstances, check the
Sensor glucose readings by conducting a fingerstick test using a blood glucose meter.
• In order to confirm hypoglycaemia or impending hypoglycaemia as reported by the
Dexcom CGM Glucose Sensor, conduct a fingerstick test using a blood glucose meter.
• Do not ignore symptoms that may be due to low or high blood glucose. If you have
symptoms that do not match the Dexcom CGM Sensor reading or suspect that your
reading may be inaccurate, check the reading by conducting a fingerstick test using a
blood glucose meter. If you are experiencing symptoms that are not consistent with your
glucose readings, consult your health care professional.
• It would not be unreasonable to allow the clinical data derived from type 1 diabetes to
be adduced to other forms of diabetes which are truly insulin dependent or deficient,
including severe insulin deficient secondary diabetes, and some with cystic fibrosis
related diabetes, where the achievement of adequate glycaemic control may benefit
from continuous glucose monitoring or continuous subcutaneous insulin infusion.
Contraindications
MRI/CT/Diathermy
Remove the Dexcom G5 Mobile CGM System sensor, transmitter, and receiver before
Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency
electrical heat (diathermy) treatment.
The Dexcom G5 Mobile CGM System has not been tested during MRI or CT scans or with
diathermy treatment. The magnetic fields and heat could damage the components of the
Dexcom G5 Mobile CGM System, which may cause it to display inaccurate blood glucose
readings or may prevent alerts.
Medications
Taking medications with paracetamol/acetaminophen while wearing the Dexcom G5
Mobile CGM System may inaccurately raise the glucose readings generated by the
Dexcom G5 Mobile CGM System. The level of inaccuracy depends on the amount of
paracetamol/acetaminophen active in your body and is different for each person. Do not
rely on continuous glucose monitoring (CGM) data produced by the Dexcom G5 Mobile CGM
System if you have recently taken paracetamol/acetaminophen.
Warnings
Sensor Fractures
Do not ignore sensor fractures. Sensors may fracture or detach from the sensor pod on
rare occasions. If a sensor breaks and no portion of it is visible above the skin, do not
attempt to remove it. Seek professional medical help if you have symptoms of infection or
inflammation—redness, swelling or pain—at the insertion site. If you experience a broken
sensor, please report this to your local Dexcom representative.
Do Not Use Damaged Goods
If the Dexcom G5 Mobile CGM System Receiver or G5 Mobile Transmitter is damaged
or cracked, do not use it. This could create an electrical safety hazard causing possible
electrical shocks resulting in injury. In addition, a damaged or cracked G5 Mobile
Receiver or G5 Mobile Transmitter may cause the Dexcom G5 Mobile CGM System not to
function properly.
Choking
Do not allow young children to hold the sensor or transmitter without adult supervision. The
sensor and transmitter include small parts that may pose a choking hazard.
The following may result in:
• missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose)
• making a treatment decision that results in injury
Review Training Materials
Thoroughly review the training materials included with your Dexcom G5 Mobile
CGM System before use. Incorrect use of the Dexcom G5 Mobile CGM System could
lead you to misunderstand information produced by the system or might affect the
system’s performance.
The following may result in:
• missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose)
• making a treatment decision that results in injury
Diabetes Treatment Decisions
If your Dexcom G5 Mobile CGM System does not display a sensor glucose reading or if you
are getting inconsistent readings, use a fingerstick blood glucose value from your blood
glucose meter to make diabetes treatment decisions.
Do Not Ignore Low/High Symptoms
Do not ignore symptoms of low or high glucose. If your glucose alerts and readings do not
match your symptoms or expectations, you should obtain a fingerstick blood glucose value
from your blood glucose meter to make diabetes treatment decisions or seek immediate
medical attention.
Who Should Not Use
The Dexcom G5 Mobile CGM System was not evaluated or approved for the
following persons:
• Pregnant women
• Persons on dialysis
The Dexcom G5 Mobile CGM System’s accuracy has not been tested in people within these
groups and the system’s glucose readings may be inaccurate.
Calibrate on Schedule
Calibrate the Dexcom G5 Mobile CGM System at least once every 12 hours. The Dexcom
G5 Mobile CGM System needs to be calibrated in order to provide accurate readings.
Do not use the Dexcom G5 Mobile CGM System for diabetes treatment decisions unless
you have followed the prompts from the device and calibrated every 12 hours after the
initial calibration.
Placement
Do not insert the sensor component of the Dexcom G5 Mobile CGM System in a site other
than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years).
The placement and insertion of the sensor component of the Dexcom G5 Mobile CGM System
is not approved for other sites. If placed in other areas, the Dexcom G5 Mobile CGM System
may not function properly.
The following may result in:
• missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose)
• making a treatment decision that results in injury
Initial Calibration: Data/Alarm/Alert
Do not expect sensor glucose readings or alarms/alerts from the Dexcom G5 Mobile CGM
System until after the 2-hour startup. The Dexcom G5 Mobile CGM System will NOT provide
any sensor glucose readings or alarms/alerts until after the 2-hour startup ends AND you
complete the startup calibration. Use fingerstick glucose values from your blood glucose
meter during the 2-hour startup.
Sensor Storage
Store the sensor at temperatures between 2° C-25° C for the length of the sensor’s shelf life.
You may store the sensor in the refrigerator if it is within this temperature range. The sensor
should not be stored in the freezer.
Storing the sensor improperly might cause the sensor glucose readings to be inaccurate.
Smart Device Settings
Your smart device’s internal settings override any Dexcom G5 Mobile App setting.
To receive Alarm or Alerts you must:
• Make sure the notifications for the G5 Mobile App are turned on in the setting’s menu of
your smart device
• Check that the G5 Mobile App hasn’t been shut down by your smart device
• In order for the G5 Mobile App to function properly, you must turn on BluetoothR on your
smart device
• The Do Not Disturb feature on your smart device (if available) must be turned off
• Restart the G5 Mobile App after your smart device is restarted
• Set the volume on your smart device at a level you can hear
• Do not close the G5 Mobile App; always run the app in the background
If the settings on your smart device are incorrect your Dexcom G5 Mobile CGM System may
not function properly.
The Dexcom G5 Mobile CGM System Alarm/Alert vibrations are not any different from other
vibrating apps on your smart device. Medical device apps, like the Dexcom G5 Mobile CGM
System App, do not have any special priorities over your smart device’s features. You cannot
determine if a vibration is a notification from your Dexcom G5 Mobile CGM System App or
another app. The only way to know is to look at the screen.
The following may result in:
• missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose)
• making a treatment decision that results in injury
Missed an Alarm or Alert?
An Alarm or Alert from the Dexcom G5 Mobile CGM System App cannot be heard through
your smart device’s speakers if headphones are plugged in.
Make sure you unplug your headphones when you are done using them, otherwise you might
not hear an Alarm or Alert from the Dexcom G5 Mobile CGM System.
Precautions
Sensor Package
Do not use the G5 Mobile Sensor if its sterile package has been damaged or opened. Using a
non-sterile sensor might cause infection.
Clean and Dry Before Using
Do not open the sensor package until you have washed your hands with soap and water, and
let them dry. You may contaminate the insertion site and suffer an infection if you have dirty
hands while inserting the sensor.
Do not insert the sensor until you have cleaned the skin near the insertion site with a topical
antimicrobial solution, such as isopropyl alcohol, and allowed the skin to dry. Inserting into
unclean skin might lead to infection. Do not insert the sensor until the cleaned area is dry so
the sensor adhesive will stick better.
Reusable: Do Not Throw Away
Do not discard your transmitter. It is reusable. The same transmitter is used for each session
until you have reached the end of the transmitter’s battery life.
The following may result in:
• missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose)
• making a treatment decision that results in injury
Be Accurate, Be Quick
To calibrate the system, enter the exact blood glucose value displayed on your blood glucose
meter within five minutes of a carefully performed fingerstick glucose measurement.
Do not enter the Dexcom G5 Mobile CGM System’s sensor glucose readings for calibration.
Entering incorrect blood glucose values, blood glucose values obtained more than 5 minutes
before entry, or sensor glucose readings might affect sensor performance.
The following may result in:
• missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose)
• making a treatment decision that results in injury
Treatment Decisions
Make diabetes treatment decisions based on the combination of the sensor glucose reading,
trend arrow, trend graph, and/or actionable alerts generated by the Dexcom G5 Mobile
CGM System.
Expiration Date
Do not use Dexcom G5 Mobile CGM Sensors that are beyond their expiration date. Before
inserting a sensor, confirm the expiration date listed on the package label in the following
format: YYYY-MM-DD.
Do not use sensors that are beyond their expiration date because the sensor glucose
readings might not be accurate.
Sensor Placement
Avoid using the same spot repeatedly for sensor insertion. Rotate your sensor placement
sites, and do not use the same site for two sensor sessions in a row. Using the same site
might cause scarring or skin irritation.
Avoid inserting the sensor in areas that are likely to be bumped, pushed or compressed
or areas of skin with scarring, tattoos, or irritation as these are not ideal sites to measure
glucose. Insertion in these areas might affect sensor accuracy.
Avoid injecting insulin or placing an insulin pump infusion set within 7.5 cm of the sensor. The
insulin might affect sensor performance.
Use Correct Transmitter, Receiver, and Sensor
Different generations of Dexcom continuous glucose monitoring system transmitters and
receivers are not interchangeable with each other.
The Dexcom G5 Mobile CGM System’s transmitter and receiver are not compatible with
the Dexcom G4™ PLATINUM CGM System’s transmitter and receiver. The Dexcom G5
Mobile CGM System will not work if you mix transmitter and receiver components from
different generations.
You can use either a Dexcom G4 PLATINUM Sensor or Dexcom G5 Mobile/G4 PLATINUM
Sensor with your Dexcom G5 Mobile CGM System.
The following may result in:
• missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose)
• making a treatment decision that results in injury
Communication Range
Avoid separating the transmitter and receiver by more than 6 meters. The transmission
range from the transmitter to the receiver is up to 6 meters without obstruction. Wireless
communication does not work well through water so the range is much less if you are in a
pool, bathtub, or on a water bed, etc.
Types of obstruction differ and have not been tested. If your transmitter and receiver are
farther than 6 meters apart or are separated by an obstruction, they might not communicate
or the communication distance may be shorter.
Setting Alarm/Alert Notifications
When using both a receiver and a smart device with your Dexcom G5 Mobile CGM System,
you must set your settings separately in each. If you set up one device and then use another,
you might not get an Alarm or Alert.
Is It On?
If the receiver or smart device is turned off (Shut Down), it will not display sensor data,
information, Alarm or Alerts generated by the Dexcom G5 Mobile CGM System. Make sure
the Display Devices are turned on; otherwise you will not get sensor glucose readings or
Alarm or Alerts.
Keep Receiver Dry
Keep the USB port cover on the receiver closed whenever the USB cable is not attached. Do
not submerge the receiver in water.
If water gets into the USB port, the receiver could become damaged and stop displaying
readings or providing alerts.
No Alternative Site Testing
Do not use alternative blood glucose site testing (blood from your palm or forearm, etc.) for
calibration. Alternative site blood glucose values may be different than those taken from a
fingerstick blood glucose value and may not represent the timeliest blood glucose value.
Use a blood glucose value taken only from a fingerstick for calibration. Alternative site blood
glucose values might affect the Dexcom G5 Mobile CGM System’s accuracy.
The following may result in:
• missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose)
• making a treatment decision that results in injury
When Not to Calibrate
Do not calibrate if your blood glucose is changing at a significant rate, typically more than
0.11 mmol/L per minute. Do not calibrate when your receiver screen is showing the rising or
falling single arrow or double arrow, which indicates that your blood glucose is rapidly rising
or falling. Calibrating during rapid rise or fall of blood glucose may affect sensor accuracy.
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Appendix V – Australia Safety Statement (Indications for Use Statement and Important Warnings and Precautions) – Dexcom G4 Platinum CGM System (Australia Only)
IMPORTANT USER INFORMATION
Failure to use the Dexcom G4 PLATINUM CGM System and its components according to the instructions for use and all indications, contraindications, warnings, precautions, and cautions may result in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from your Dexcom G4 PLATINUM CGM System do not match your symptoms or expectations, use a fingerstick blood glucose value from your blood glucose meter to make diabetes treatment decisions. Seek medical attention when appropriate.
Please review the product instructions before using the Dexcom G4 PLATINUM CGM System. Indications, contraindications, warnings, precautions, cautions, and other important user information can be found in the product instructions that are included with, or accompany, the Dexcom G4 PLATINUM CGM System. Discuss with your healthcare professional how you should use the information displayed on the Dexcom G4 PLATINUM System to help manage your diabetes. The product instructions contain important information on troubleshooting the Dexcom G4 PLATINUM CGM System and on the performance characteristics of the system.
INDICATIONS FOR USE
The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a
glucose-monitoring device indicated for detecting trends and tracking patterns in
persons (age 2 and older) with type 1 diabetes. The system is intended for use
by patients at home and in healthcare facilities.
The Dexcom G4 PLATINUM System is indicated for use as an adjunctive device
to complement, not replace, information obtained from standard home glucose
monitoring devices.
The Dexcom G4 PLATINUM System aids in the detection of episodes of
hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy
adjustments, which may minimize these excursions. Interpretation of the
Dexcom G4 PLATINUM System results should be based on the trends and
patterns seen with several sequential readings over time.
INTENDED USE
• The Dexcom G4 Platinum Sensor Kit CGM System is used alone.
• The option of sharing data are only with the use of the smart display devices
such as Apple iPhone that provides an optional feature of sharing CGM data
remotely with the user’s friends and family through the Dexcom Share.
• The Dexcom CGM System has the capability to communicate with authorized
connected devices such as third-party insulin pump systems. Subject to
consideration of these other indications for use, testing, validation, and country
applications for use with third-party insulin pump systems that are subject to
separate approval.
• The Dexcom CGM Glucose Sensor is only intended to be used by patients
(aged 2 years and older) with type 1 diabetes.
• Health care professionals and consumers should be aware about the limitations
of available scientific evidence for use of this device in any other groups of
patients who require diabetes management.
• During times of rapidly changing glucose (more than 0.1 mmol/L (2 mg/dL) per
minute), interstitial fluid glucose levels as measured by the Dexcom CGM
Glucose Sensor may not accurately reflect blood glucose levels. Under these
circumstances, check the Sensor glucose readings by conducting a fingerstick
test using a blood glucose meter.
• In order to confirm hypoglycaemia or impending hypoglycaemia as reported by
the Dexcom CGM Glucose Sensor, conduct a fingerstick test using a blood
glucose meter.
• Do not ignore symptoms that may be due to low or high blood glucose. If you
have symptoms that do not match the Dexcom CGM Sensor reading or
suspect that your reading may be inaccurate, check the reading by conducting
a fingerstick test using a blood glucose meter. If you are experiencing
symptoms that are not consistent with your glucose readings, consult your
health care professional.
• It would not be unreasonable to allow the clinical data derived from type 1
diabetes to be adduced to other forms of diabetes which are truly insulin
dependent or deficient, including severe insulin deficient secondary diabetes,
and some with cystic fibrosis related diabetes, where the achievement of
adequate glycaemic control may benefit from continuous glucose monitoring or
continuous subcutaneous insulin infusion.
CONTRAINDICATIONS
• The blood glucose value from your blood glucose meter should be used for
treatment decisions, such as how much insulin you should take. The Dexcom
G4 PLATINUM System does not replace a blood glucose meter.
• The Dexcom G4 PLATINUM Sensor, Transmitter, and Receiver must be
removed prior to Magnetic Resonance Imaging (MRI), CT scan, or diathermy
treatment. The Dexcom G4 PLATINUM System has not been tested during
MRI or CT scans or with diathermy treatment, and it is unknown if there are
safety or performance issues.
• Taking acetaminophen (paracetamol) containing products (such as Tylenol)
while wearing the sensor may falsely raise your sensor glucose readings. The
level of inaccuracy depends on the amount of acetaminophen (paracetamol)
active in your body.
WARNINGS
• Do not use the Dexcom G4 PLATINUM CGM System until after you have been
trained or viewed the training materials included with your CGM system.
• The blood glucose value from your blood glucose meter should be used for
treatment decisions, such as how much insulin you should take. The Dexcom
G4 PLATINUM System does not replace a blood glucose meter. Blood glucose
values may differ from sensor glucose readings. The direction, rate of glucose
change, and trend graph on your Dexcom G4 PLATINUM System provide
additional information to help with your diabetes management decisions.
• Symptoms of high and low glucose should not be ignored. If your sensor
glucose readings do not fit with your symptoms, you should measure your
blood glucose with a blood glucose meter.
• Your sensor glucose readings may be inaccurate if you calibrate less than
every 12 hours.
• Sensors may fracture on rare occasions. If a sensor breaks and no portion of it
is visible above the skin, do not attempt to remove it. Seek professional medical
help if you have symptoms of infection or inflammation—redness, swelling or
pain—at the insertion site. If you experience a broken sensor, please report this
to your local distributor.
• The Dexcom G4 PLATINUM System is not approved for use in pregnant
women or persons on dialysis.
• Sensor placement is not approved for sites other than under the skin of the
belly (abdomen) or, in the case of patients between the ages of 2 and 17, the
belly or upper buttocks.
• If your transmitter or receiver case is damaged/cracked, do not use them, as
this could create an electrical safety hazard or malfunction.
• The sensor and transmitter include small parts that may pose a choking
hazard. Keep the transmitter kit box away from young children; it contains a
magnet that should not be swallowed.
PRECAUTIONS
• Before opening the sensor package, wash your hands with soap and water and
dry them to avoid contamination.
• Before inserting the sensor, always clean the skin at the sensor insertion
location with a topical antimicrobial solution, such as isopropyl alcohol. This
may help prevent infection. Do not apply the sensor until the cleaned area is
dry so that it will stick better.
• Change the site where you place your sensor with each insertion to allow your
skin to heal.
• Avoid areas that are likely to be bumped, pushed or compressed or areas of
skin with scarring, tattoos, or irritation as these are not ideal sites to measure
glucose.
• Avoid injecting insulin or placing an insulin pump infusion set within 7.62 cm of
the sensor in case the insulin affects the sensor glucose readings.
• The sensor is sterile in its unopened, undamaged package. Do not use any
sensor if its sterile package has been previously damaged or opened.
• To calibrate the system, you must enter the exact blood glucose value that
your blood glucose meter displays within 5 minutes of a carefully performed
blood glucose measurement. Entering incorrect blood glucose values or blood
glucose values from more than 5 minutes ago could result in inaccurate sensor
glucose readings.
• The transmission range from the transmitter to the receiver is up to 6 meters
without obstruction. Wireless communication does not work well through water
so the range is much less if you are in a pool, bathtub, water bed, etc.
• Sensors should be stored at temperatures between 2° C - 25° C for the length
of the shelf life. You may store your sensors in the refrigerator if it is within this
temperature range. Sensors should not be stored in a freezer.
• Keep the USB port cover on the receiver closed whenever the USB cable is not
attached. The receiver may malfunction if water gets into the USB port
