Dexcom 9496 User Manual

Enter Stress Event

(Continued from previous page)

14

Tur n to landscape.

The receiver and app don’t talk to one another. If you enter an Event only into the receiver,
while the information will appear on Dexcom reports, you won’t get an Event marker on your
app’s Trend screen.

The app has Event markers on its screen, the receiver doesn’t.
There may be times when you want or need to enter Events on the Dexcom G5

Mobile Receiver.

Enter Events: Dexcom G5 Mobile Receiver

While the Event data is the same between display devices, the flow is not the same, including
how to enter the Event’s date and time. The following table reviews how to enter the same
Carb/Stress Event data from the previous scenario: Carbs at 85, and a Stress Event.

Entering Events: Receiver

Step What you see What you do

Enter Carbs Event

1

Default screen
Press

Select

to go to Main Menu.

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168Daily Events Aect Your Glucose Trends and Patterns

Enter Carbs Event

2

(Continued from previous page)

Press

Down Arrow
Select

Press

.

until

Events

is highlighted.

3

Highlight
Press

Carbs

Select

.

.

Add up all carb grams from lunch.

4

5

6

Arrow up to “85.”
Press

Select

.

Press Left/

Right Arrows

• Left: Backwards

• Right: Forward

Press

Select

.

Confirmation screen.
Press

Select

.

(Continued on next page)

to change time and date.

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169

Enter Health Event

(Continued from previous page)

7

8

9

Press

Down Arrow

Press

Down Arrow

Press

Select

.

Press

Left/Right Arrows

• Left: Backwards

• Right: Forward

Press

Select

.

until

Health

.

to

Stress

.

to change time and date.

Verify information is correct.

10

Left/Right Arrows

Press Up/
Press

Select

Down Arrows

to save.

to highlight field.

to change numbers.

Press

10.4 Viewing Events

Events entered into your receiver can only be viewed on a Dexcom report; there are no
markers on your receiver’s screen.

On your smart device, turn to landscape to view your Event markers. A single small
square marks all Events. Slide your finger across the screen or tap the square to get your
Event’s information.

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170Daily Events Aect Your Glucose Trends and Patterns

Landscape What it does What you do

Landscape Only

Show Event details.

Landscape Only

• Tap

square

• Slide finger across
screen

Once you have allowed your Share Follower’s access to your Trend screen, they too will be
able to view your Events. See Part 5 for more information.

Summary

Now You Can:

• Define Event

• Describe each Event

• Create an Event
○ Dexcom G5 Mobile App
○ Dexcom G5 Mobile Receiver

• Recognize Event Markers on the Dexcom G5 Mobile App
○ Describe how Event Markers are different in portrait and landscape view

• Describe how to view Events entered via your receiver

What’s Next?

In the next chapter, you will learn about your trend’s Alarm and Alerts helping you monitor
you glucose levels. You’ll also learn how you know when your system loses its signal and
stops communicating.

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172Daily Events Aect Your Glucose Trends and Patterns

Chapter 11

Next Steps:

Sensor Glucose Alarm and Alerts

11.1 Introduction

Monitoring your glucose trends is critical in managing your diabetes. But what happens if
you’re driving, in a meeting, at the movies, and can’t or, don’t want to, keep looking at your
display device?

Dexcom’s G5 Mobile CGM System understands there are times when you can’t look at your
receiver or smart device; however you still need to know of actionable glucose trends or if
you’re not getting your sensor glucose readings.

This chapter reviews the sensor glucose Alarm and Alerts based on your sensor glucose
readings, allowing you to proactively manage your glucose trend levels and make sure your
transmitter is communicating with your display device.

In the next chapter, you’ll learn how to customize the Alarm and Alerts.
After this chapter you will be able to:

• Define an Alarm

• Define an Alert

• Identify the different types of Alerts

• Describe the difference between an Alarm and an Alert

• Recognize different Alarm/Alert prompts and sounds

• Determine signal loss is preventing you from getting an Alarm or Alert

• Describe recommended app settings

• Successfully clear an Alert notification
○ Dexcom G5 Mobile App
○ Dexcom G5 Mobile Receiver

Your trending information is one of the greatest benefits of the Dexcom G5 Mobile System.
It’s important to focus on your trends and rate of change arrows, rather than the exact
number of your glucose reading

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173

11.2 Safety Statements

The Alarm and Alerts were designed to keep you safe, helping you avoid severe lows and
highs or from missing your readings. The following safety statements help ensure you get
your Alerts and Alarm.

WARNING

Do:

Verify your smart device settings let you get Alarm and Alerts.

To receive Alarm/Alerts you must:

1. Make sure Dexcom G5 Mobile App Notifications are turned on in

2. Verify app hasn’t been shut down.

3. Adjust volume so you can hear sounds.

4. Tur n

5. Tur n off

Bluetooth

Do Not Disturb

on.

.

6. Keep Dexcom G5 Mobile App running in the background.

7. Restart app after device is restarted.

Why: Your apps settings do not override phone settings.
Consequences: Missing severe low or high Alarm or Alerts.

WARNING

Don’t:

Never assume the Dexcom G5 Mobile CGM System’s Alarm/Alert vibrations are

different from other vibrating apps.

Do:

Look at your smart device and check if vibration is a Dexcom G5 Mobile CGM System

Alarm or Alert.

Why: Medical device apps don’t have special priority over your smart device’s features.
You can’t determine if the vibration is coming from your Dexcom G5 Mobile App or
another app.

Consequences: Missing severe low or high Alarm or Alerts.

Settings

menu

WARNING

Do:

Unplug headphones from your smart device when not in use.

Why: If headphones are plugged in while not being used, you won’t hear an Alarm or Alert.
Consequences: Missing severe low or high Alarm or Alerts.

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174Sensor Glucose Alarm and Alerts

PRECAUTION

Don’t:

Never prevent communication between transmitter and display devices.

Do:

Keep smart device and receiver within 20 feet of transmitter and away

from obstructions.

Why: If your transmitter display device(s) are more than 20 feet apart or are separated by
an obstruction, they might not communicate.

Types of obstruction differ and not all types have been tested. Obstructions can include
water, walls, metal, etc.

Water (e.g., swimming, surfing, bathing, etc.) can severely limit communication range.
Consequences: Missing severe low or high Alarm or Alerts.

PRECAUTION

Do:

Set smart device and receiver settings separately.

Why: Settings are specific to each display device and don’t carry over to other devices. If
you set up one device and then use another, you won’t get an Alarm or Alert.

Consequences: Missing severe low or high Alarm or Alerts.

PRECAUTION

Do:

Verify smart device and receiver are turned on.

Why: Neither the receiver nor smart device will generate sensor glucose readings, Alarm
or Alerts if turned off.

Consequences: Missing severe low or high Alarm or Alerts.

11.3 Alarm and Alerts

As part of managing your diabetes, you learned how to read your Trend screen and how
to enter Events. In this chapter, you’ll learn how Alarm and Alerts can keep you safe from
severe lows or highs.

Depending on your display device, you can customize how you receive your Alarm or Alerts.

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175

What Is an Alarm?

While there are a variety of Alerts, there is just one Alarm

set at 55 mg/dL. The Alarm will repeat every 5 minutes until you clear the Alarm (see Chapter
12 on how to customize the sounds). If you clear the Alarm and your sensor glucose readings
do not go over 55 mg/dL in the next 30 minutes, you get another Alarm.

Unlike Alerts, the Urgent Low Alarm setting can’t be changed or turned off

safety net: your glucose level is dangerously low—pay attention now!

, the Urgent Low Alarm (Alarm) is

. Think of it as a

What Are Alerts?

An Alert is a message telling you your glucose trend levels need attention.
Low/High glucose Alerts tell you when your sensor glucose readings are outside your target

glucose ranges. Think of them as an FYI: You need to know what’s happening, Rising/Falling
Alerts tell you your glucose levels are changing quickly. Their default settings are Off (see
Chapter 12 on how to turn them on).

Alerts message you with vibrations (vibrations not available on all smart devices), visual
prompts, sounds, or a combination of all three.

Unlike the Alarm, you can customize your different Alert’s target range (Chapter 12).
During your initial set up, you establish your low and high alert levels. As mentioned before,

this chapter is a review of the Alarm and Alerts, recommended smart device settings and the
receiver’s default Alert settings.

Chapter 12 will show you how to change their settings: customize glucose levels prompts,
how you are notified, and in some cases, how often you get notified. The following are
the defaults.

Default Alerts

Low/High Alerts

Your Low/High Alerts have the same color coding as your Trend Graph screen:

1. Red: Glucose levels are below your low threshold.

a. Default setting of 80 mg/dL.

2. Gray: Glucose levels are within your high/low Alert levels.

a. No Alerts.

3. Yellow: Glucose levels are above your high threshold.

a. Default setting of 200 mg/dL.

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176Sensor Glucose Alarm and Alerts

Rise Rate/Fall Rate/Repeat/Signal Loss Alerts

Rise Rate and Fall Rate Alerts warn you when your glucose levels are changing rapidly, either
down or up, and look similar to the rate of change arrows. Repeat Alerts let you know if your
sensor glucose readings continue to be above or below your Alert levels.

Glucose Level Alerts

1. Rise Rate

a. Default setting is Off—No Alert.
b. Need to change settings to receive Rising Alert.

2. Fall Rate

a. Default setting is Off—No Alert.
b. Need to change settings to receive Falling Alert.

3. Repeat

a. Default setting is Off—No Alert.
b. Need to change settings to receive Repeat Alert.

Signal Loss Alert

Signal Loss tells you when you and the transmitter are too far from your display device
or something is blocking your transmitter signal, causing you not to get sensor glucose
readings. The default setting for Signal Loss is On.

Now you have the basics for Dexcom’s G5 Mobile’s Alarm/Alerts feature. Next, you will learn
about each Alarm/Alert in more detail.

11.4 Alarm and Alerts Screens

When you fall within an Alarm or Alert target range, your display device tells you. As
mentioned in previous chapters you won’t get any Alarm or Alerts within five minutes
of calibration.

Let’s first review how the information is presented visually across the devices. While the
Alarm/Alerts prompts look different on the display devices, they reflect the same information.

After prompts we’ll separately review the vibration and audible Alarm/Alerts for app
and receiver.

Alarm and Alerts look different based on your display device, but reflect the
same information.

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177

Urgent Low Glucose Alarm

Device What you see What it means

Smart Device:
Lock Screen

Sensor glucose reading at or below 55

Smart Device:
In App

Receiver

mg/dL.
Shows last glucose value.
Arrows reflect rate of change.
Check BG meter to make treatment

decisions.

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178Sensor Glucose Alarm and Alerts

Low/High Glucose Alerts

Device What you see What it means

Smart Device:
Lock Screen

Sensor glucose reading at or below your
low Alert level.

Smart Device:
In App

Receiver

(Continued on next page)

Shows most current sensor glucose
reading.

Arrows reflect rate of change.
Can be set to repeat between 15 minutes

to 4 hours.
Check your BG meter to make any

treatment decisions.

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179

(Continued from previous page)

Device What you see What it means

Smart Device:
Lock Screen

Sensor glucose reading at or above your
high Alert level.

Smart Device:
In App

Receiver

Shows most current sensor glucose
reading.

Arrows reflect rate of change.
Can be set to repeat between 15 minutes

to 4 hours.
Check BG meter to make treatment

decisions.

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180Sensor Glucose Alarm and Alerts

Rise Rate/Fall Rate Alerts

Device What you see What it means

Smart Device:
Lock Screen

Sensor glucose readings

Smart Device:
In App

rising quickly.
Number of arrows shows

how fast (2 mg/dL/min;
3+ mg/dL/min).

Check BG meter to make
any treatment decisions.

Receiver

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Sensor Glucose Alarm and Alerts

(Continued on next page)

181

(Continued from previous page)

Device What you see What it means

Smart Device:
Lock Screen

Sensor glucose readings

Smart Device:
In App

falling quickly.
Number of arrows shows

how fast (2 mg/dL/min;
3+ mg/dL/min).

Check BG meter to make
any treatment decisions.

Receiver

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182Sensor Glucose Alarm and Alerts

Signal Loss Alert

Device What you see What it means

Smart Device:
Lock Screen

Smart Device:
In App

Your receiver and transmitter are not
communicating.

You will not receive Alarm/Alerts.
Check BG meter to check your glucose and

make any treatment decisions.

Receiver

11.5 App: Alarm/Alert Recommended Settings

The receiver is a stand-alone medical device and used solely to monitor your glucose trends.

The app cannot override the smart devices general settings.

The app can’t override your smart device settings:

• When your smart device is on Silent, you’ll still receive Alarms and Alerts visual prompts

and messages, but not vibrations if you haven’t adjusted your smart device settings

• Some smart devices don’t have a Vibration feature, so you won’t get any

vibration notifications

• When your ringer’s volume is low, you may not hear an Alarm or Alert

• When your smart device is in Do Not Disturb mode, you won’t receive any Alarm/Alerts.

The Dexcom G5 Mobile App can’t override the Do Not Disturb setting

• If you don’t enable your Dexcom G5 Mobile push Notifications settings during set up, you

won’t get any Alarm/Alerts

• Check in Settings under Notifications on how your Alarm/Alerts are prioritized

For information on smart device settings, see your smart device’s instructions.

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183

If you are concerned about missing an Alarm or Alert (e.g., due to smart device settings,
app shutting off due to lack of storage, low smart device battery, etc.), bring your receiver
with you.

11.6 Receiver: Default Beeps and Vibrations

The Dexcom G5 Mobile Receiver’s Alarm/Alerts are vibrations and a beep, or a series of
beeps, based on the Alarm or Alert. Beeps and vibrations are preprogrammed into the
receiver, and unlike the smart device, the volume can’t be changed.

In Chapter 12 you’ll learn how to adjust the volume and intensity of your Alarm/Alerts.
The following is a table of the receiver’s default beep and vibration patterns. If you clear

the Alert’s initial vibration, you won’t get any beeps or sounds unless you’ve turned on the
Repeat Alert.

In the next section, you’ll learn how to clear the Alarm/Alerts.

Urgent Low Glucose Alarm

What you see Beeps and vibration

Initial Default Alert:

Vibrates 4x’s.

After 5 Minutes:

Vibrates/beeps 4x’s every 5 minutes until cleared or sensor
glucose readings go above Alarm level.

After 30 Minutes:

After clearing Alarm, continues to notify if sensor glucose
readings remain at or below Alarm level.

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184Sensor Glucose Alarm and Alerts

Low/High Glucose Alerts

What you see Beeps and vibration

Initial Default Alert:

Vibrates 3x’s.

After 5 Minutes:

Vibrates/beeps 3x’s every 5 minutes until cleared.
Trend screen will continue to reflect Alert until sensor

glucose readings go above Alert level.

Initial Default Alert:

Vibrates 2x’s.

After 5 Minutes:

Vibrates/beeps 2x’s every 5 minutes until cleared.
Trend screen will continue to reflect Alert until sensor

glucose readings go below Alert level.

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185

Rise Rate/Fall Rate Alerts

What you see Beeps and vibration

Initial Default Alert:

None/Off.

After Setting Change:

Vibrates 2x’s, 2 sounds.

After 5 Minutes:

Vibrates/beeps 2x’s every 5 minutes until cleared.

Initial Default Alert:

None/Off.

After Setting Change:

Vibrates 3x’s.

After 5 Minutes:

Vibrates/beeps 3x’s every 5 minutes until cleared or sensor
glucose reading drops below Alert level.

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186Sensor Glucose Alarm and Alerts

Low Repeat/High Repeat

What you see Beeps and vibration

Initial Default Alert:

None/Off.

After Setting Change:

Vibrates 3x’s.

After 5 Minutes:

Vibrates/beeps 3x’s every 5 minutes until cleared.
Will re-alert if sensor glucose readings drop at or below 55

mg/dL.

Initial Default Alert:

None/Off.

After Setting Change:

Vibrates 2x’s.

After 5 Minutes:

Vibrates/beeps 2x’s every 5 minutes until cleared.

Signal Loss Alert

What you see Beeps and vibration

Initial Default Alert:

On.

After Setting Change:

Vibrates 1x.

After 5 Minutes:

Vibrates/beeps 1x every 5 minutes for a total of 6 times if not
cleared.

After 6 times it will not alert again.

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187

11.7 Clearing Alarm/Alerts

Alerts require you to acknowledge and clear them. How this is done depends on your display
device. If using both display devices, you’ll need to clear each separately.

Due to their medical importance, the Alarm is more persistent. Even after acknowledging and
clearing an Alarm, if your sensor’s glucose readings remain at or below 55 mg/dL, an Alarm
will sound every 30 minutes until readings are above 55 mg/dL.

Clearing Your Smart Device

Device What you see What you do

Smart Device:
Lock Screen

Smart Device:
In App

Slide

Alarm

or

Alert

to access app.

Tap OK to accept Alarm or Alert.

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188Sensor Glucose Alarm and Alerts

Clearing Your Receiver

What you see What you do

Press

Select

.

Once cleared, you won’t receive the same Alert unless you hit the Alert’s target range
again. Your Alarm will repeat even after clearing if your glucose levels do not return to your
target range.

Summary

Now You Can:

• Define an Alarm

• Define an Alert

• Identify the different types of Alerts

• Describe the difference between an Alarm and an Alert

• Recognize different Alarm/Alert prompts and sounds

• Determine if signal loss is preventing you from getting an Alarm/Alert

• Describe recommended app settings

• Successfully clear an Alert notification
○ Dexcom G5 Mobile App
○ Dexcom G5 Mobile Receiver

What’s Next?

Up to now, you have learned about the Alarm or Alert default settings. But what do you
do if you want to decrease the High Alert glucose level threshold, or you want to continue
getting a Low Alert notification if your glucose levels don’t improve, even though you cleared
the message?

How do you make your Alarm/Alerts fit your needs?

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190Sensor Glucose Alarm and Alerts

Chapter 12

Next Steps:

On the Go With G5: Customizing Your Alarm
and Alerts

12.1 Introduction

The receiver and app come with default glucose Alert level settings, but perhaps they don’t
reflect the glucose level that works best for you.

Perhaps you’re in a meeting and can only clear an Alert, yet want to make sure your Alert
repeats, or continues, until you’re able to take corrective measures. Maybe you’d like to get a
Rising/Falling glucose Alert, but their settings are off by default. How do you turn them on?

In this chapter, you’ll learn how to personalize your Alarm and Alerts tones and
glucose levels.

Afterwards, you will be able to:

• Customize your Low/High Alerts
○ Dexcom G5 Mobile App
○ Dexcom G5 Mobile Receiver

• Adjust Alarm sound notification

• Use receiver’s Advanced Alerts
○ Low/High Repeat
○ Rise/Fall Alerts
○ Signal Loss

Each display device has customization options; however the setup flow is different. Before
making any changes to your Alert levels, talk with your healthcare professional.

First, let’s take a look at personalizing your app Alarm and Alerts, and then we’ll review the
same process for the receiver.

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191

12.2 Safety Statement

WARNING

Do:

If using both receiver and app for to get an Alarm or Alert, change settings in each

display device.

Why: Any changes to the G5 Mobile app will not carry over to the receiver.
Consequences: Missing severe low or high Alarm or Alerts.

12.3 Changing App Alarm and Alerts

App Screen Overview

The Alerts Main Menu lists all customizable Alerts and Alarm and their current settings. Part
of your initial set up included setting your Low/High Alerts. In this chapter, you’ll learn how to
change them.

Before learning how to change your settings, let’s review the app’s Alerts Main Menu screen.

Customizing Alerts: App Alarm/Alerts Screen
Overview

Step What you see What it means What you do

1 Access Main Menu. Tap

(Continued on next page)

Dexcom G5 Mobile System User Guide

Main Menu

icon.

192On the Go With G5: Customizing Your Alarm and Alerts

(Continued from previous page)

Step What you see What it means What you do

2

Access Alerts Main
Menu.

Tap

Alerts

.

All customizable Alarm
and Alerts.

Current Alert settings.

3

All alerts have:

•

On/Off

switch

•

Notify me

•

Sound

options

options

Tap

Alarm/Alert

want to change.

you

(Continued on next page)

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193

(Continued from previous page)

Step What you see What it means What you do

“?” explains:

4

• Message options

• Recommended
settings

Urgent Low Glucose
Alarm:

• Preset at 55
mg/dL and cannot

• Each Alarm/Alert

5

be changed

•

Repeat

preset at 30
minutes and can’t
be changed

•

Sound

is the only

change option

Tap

“?”

for Alarm/Alert

information.

Tap

Sound

sound.

to change

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194On the Go With G5: Customizing Your Alarm and Alerts

Steps to Customize App Alarm/Alerts

Although the results will vary depending on what Alarm or Alert you are customizing, the
steps to change your Alarm or Alert are the same:

From app’s Main Menu:

1. Tap

Alerts

.

2. Tap the

3. Tap

4. Tap

5. Tap

In this following example, we’ll change the High Alert level from 200 mg/dL to 190 mg/dL,
repeating every hour if you continue to stay high, with a Door Bell sound.

Alert

you want.

a. Tap On or

Notify me

Off

switch to turn on desired Alerts.

.

a. Change the Alert glucose level (mg/dL).

i. Scroll selection wheel, find your desired Alert level.
ii. Tap to highlight.
iii. Tap

Save

.

Repeat

.

a. Change the amount of time you want between your High/Low Alerts if your

sensor glucose readings continue to be low or high.

i. Scroll selection wheel, find your desired Alert level.
ii. Tap to highlight.
iii. Tap

Save

.

Sound

.

a. Assign a different sound to each Alarm or Alert.

i. Scroll selection wheel, find your desired sound.
ii. Tap to highlight.
iii. Tap

back arrow

.

Customizing Alerts: App

Step What you see What it means What you do

Access Alerts’ Main Menu

1

Dexcom G5 Mobile System User Guide

On the Go With G5: Customizing Your Alarm and Alerts

Access Main Menu. Tap

(Continued on next page)

Main Menu

icon.

195

Access Alerts’ Main Menu

(Continued from previous page)

2

Access Alerts Main
Menu.

(Continued on next page)

Tap

Alerts

.

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196On the Go With G5: Customizing Your Alarm and Alerts

Changing an Alert

(Continued from previous page)

3

Access High Alert
settings (mg/dL).

Shows High Alert

4

options and current
settings.

Tap

High mg/dL

Check

High Alerts

• On - Orange

• Off - Gray

.

is On.

(Continued on next page)

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197

Changing an Alert

5

(Continued from previous page)

Won’t get Alerts if Off.

If Off:

On

Slide to On.

• On - Orange

• Off - Gray

6

Dexcom G5 Mobile System User Guide

Change High Alert
(mg/dL).

(Continued on next page)

Tap

Notify Me Above

.

198On the Go With G5: Customizing Your Alarm and Alerts

Changing an Alert

(Continued from previous page)

Change glucose level

7

from current level
(mg/dL).

Scroll selection wheel.
Stop at 190.

Saves new High Alert
glucose level (mg/dL).

8

Returns to

Alert
Notify Me Above

High Glucose

screen options.

set at

Tap

Save

.

190 mg/dL.

(Continued on next page)

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199

Changing an Alert

9

10

(Continued from previous page)

Changes how often
your High Alert repeats
after initial Alert and
confirmation.

Repeats only if you are
above your high glucose
level.

Changing the current
repeat setting.

Can select in five
minute steps (range 15
minutes-4 hours).

Tap

Repeat

.

Scroll selection wheel.
Stop at 1 hour.

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(Continued on next page)

200On the Go With G5: Customizing Your Alarm and Alerts

Changing an Alert

11

(Continued from previous page)

Saves your new repeat
timing.

Returns to

Alert
Repeat

High Glucose

screen options.

shows how often

you’ll get notified.

Tap

Save

.

12

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On the Go With G5: Customizing Your Alarm and Alerts

Customize Alert sound. Tap

(Continued on next page)

Sound

.

201

Changing an Alert

13

14

(Continued from previous page)

Changes current sound
setting.

Saves your new Alert
sound.

Return to High Glucose
Alert Menu.

Tap

Doorbell

Tap

Sound

again to hear

sound sample.

Tap

Back Arrow

.

.

Dexcom G5 Mobile System User Guide

(Continued on next page)

202On the Go With G5: Customizing Your Alarm and Alerts

Changing an Alert

(Continued from previous page)

15

16

Return to Main Menu. Tap

Tap

Return to trend screen.

Or
Swipe right.

“X”

.

Menu

icon

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203

Any changes to the app will not carry over to the receiver. If using both, make the same
changes in the receiver you made in your smart device. If you don’t, you may miss an Alarm
or Alert.

12.4 Changing Receiver Alarm and Alerts

You’ll notice a flow difference between the app and the receiver when personalizing your
Alarm/Alerts. With the app, all Alert adjustments are made from one screen, whereas in the
receiver, you make changes in different screens.

Unlike the app, you change your receiver’s tones (known as Profiles) through a number of
different screens in the Profiles menu.

Profiles

Profiles determine the sound and volume of your Alarm and Alerts.
As mentioned in the previous chapter, the receiver uses a series of beeps/vibrations for an

Alarm or Alert. The receiver doesn’t have the same variety of tones as the app; however you
can adjust their volume. While the receiver doesn’t have a silent mode, selecting
replace audible beeps with quiet vibrations. The only exception is the Alarm: the urgent low
Alarm can’t be turned off.

Changes made in
(see next table), all Alerts are in Soft mode. In Chapter 10, you learned how many beeps each
Alarm/Alert has.

Normal

is the default setting for your receiver sound Profiles.

Attentive

The receiver first vibrates when sending you an Alarm or Alert. If you clear the alert at the
first vibration by pressing the
Alarm/Alert tones. If you would like to continue to get your Alarm or Alert after clearing, later
in this chapter you’ll learn about setting up Repeat Alerts.

uses a rising or falling melody instead of beeps.

HypoRepeat

every 5 seconds until your sensor glucose value rises above 55 mg/dL or you confirm by
pressing the

The next table lists the different sound Profiles, starting with the quietest, working its way up
to the loudest.

Profiles

are applied to all of the receiver’s Alarm/Alerts. If you choose

Select

is very similar to the

Select

button.

button on your navigation wheel, you won’t get any

Normal

Profile, but keeps repeating the fixed low alarm

Vibrate

will

Soft

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204On the Go With G5: Customizing Your Alarm and Alerts

Alarm/Alert Sound Profiles

Icon Profile name Notification description

Vibration only.

Vibrate

Soft Lower volume beeps.

Only sound is your receiver vibrating.
Vibrate is not available for the Alarm.

Normal

Medium volume beeps.
Default Profile.

No beeps.

Attentive

• Rising melody for High and Rising Alerts

• Dropping melody for Low and Falling Alerts

Medium volume beeps.
Urgent low Alarm only.

HypoRepeat

Repeats fixed low alarm every 5 seconds until
sensor glucose reading rises above 55 mg/dL or is
confirmed.

Try It Sample

Profile

setting before selecting.

After choosing your sound profile, changing it is just a few steps away! Change your
throughout the day depending on what lays ahead: In a meeting? Select
ball game after work? Select

Attentive

.

Vibrate

. Going to a

The next table shows how to change a sound Profile, then sample how it sounds.

Profile

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205

Customizing Sound Profiles: Receiver

Step What you see What it means What you do

1 Go to Main Menu. Press

2

Second Main Menu
screen.

Press

Profiles

screen.

Press

3

Profiles adjusts volume
of Alarm/Alerts.

Stop at
Press

Press

4

Choose sound

Profile

.

Stop at desired
Press

(Continued on next page)

Select

.

Down Arrow

.

on second

Up/Down Arrow

Profiles

.

Select

.

Up/Down Arrow

Profile

Select

.

.

.
.

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206On the Go With G5: Customizing Your Alarm and Alerts

(Continued from previous page)

Step What you see What it means What you do

Sample sound:
Press

Down Arrow

5

Selected
marked.

Profile

check

Stop at
Press

sound play.

Try It

Select

.

.

to have the

Exit Profiles:
Press

Left Arrow

.

Repeat steps 2-5 to
change Profile.

6 N/A Repeat as needed.

To Exit:

Left Arrow

Press

Main Menu

to

.

Profiles allow you to change your Alarm and Alerts tones. The Alerts menu gives you options
for personalizing your glucose level Alerts, repeating Alerts, turning your Rising/Falling Alerts
on and turning on your Signal Loss Alert.

Alerts Main Menu

Low/High
Advanced

Loss Alert.

Alert option lets you adjust your low/high glucose Alert level (mg/dL).

gives you options to turn on Low/High Repeat, Rise/Fall Alerts and Signal

Low/High Repeat

In the previous chapter, you learned clearing an Alert stops it from repeating. If you want to
continue to be re-alerted until your glucose levels are back in your target range, turn on the

Repeat

option.

Rise/Fall Rate

Your trend screen provides visual cues letting you know your sensor glucose readings are
falling or rising rapidly.

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207

Constantly looking at your screen may not be practical. You can customize your Rise/Fall
Alert with vibrations or beeps letting you know when your glucose is rising or falling (2
mg/dL/min or 30 mg/dL up or down in 15 minutes) or rising or falling rapidly (3 or more
mg/dL/min or 45 mg/dL or more up or down in 15 minutes).

The default setting for Repeat and Rise/Fall Rate is
It’s important you discuss your alert settings with your healthcare professional.

Off

.

Signal Loss

Signal Loss Alert tells you when your transmitter and receiver aren’t communicating. Set the
Signal Loss and get alerted if your sensor glucose readings have stopped due to a signal loss
anywhere from 20 to 200 minutes.

The default setting for Signal Loss is On.

Steps to Customize Receiver Alarm/Alerts

Using the same example from changing your app Alerts, let’s change the receiver’s High Alert
notification level from 200 mg/dL to 190 mg/dL, repeating every 60 minutes.

Follow the same steps turning on the Rise/Fall Alerts, and adjusting your Low Alerts.

Customizing Alerts: Receiver

Step What you see What it means What you do

Change High Alert Level

1

Dexcom G5 Mobile System User Guide

Go to Main Menu. Press

(Continued on next page)

Select

.

208On the Go With G5: Customizing Your Alarm and Alerts

Change High Alert Level

2

(Continued from previous page)

Alerts option from the
Main Menu.

Press

Stop

Down Arrow

at Alerts

.

.

3

Enter Alerts menu
option.

Press

Select

.

Alerts’ option menu.

4

High/Low/Advanced
(Repeat, Rise/Fall,

Lists different Alerts:

Press Up/
Stop at
Press

Down Arrow

High Alert

Select

.

.

.

Signal Loss) Alerts.

Press

Alert’s current settings.

5

Change your current
High Alert level.

Current setting.
Use

6

Up/Down

change your High Alert

arrows to

Down Arrow

Stop at
Press

Press

Level

Select

Down Arrow

Stop at 190 mg/dL.

.

.

.

.

level (mg/dL).

(Continued on next page)

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Change High Alert Level

7

Turn Repeart On

(Continued from previous page)

Saves new High Alert
level.

Return to Alerts Menu.

Press
To exit:
Press

Select

.

Left Arrow

.

10

11

Alerts Menu.

8

Choose Advanced to get
to Repeat Alert.

9

Enter Advanced Alert
options.

Press

Down Arrow

Stop at

Press

Select

Advanced

Advanced

on

.

.

.

Main Advanced screen.
Set Repeat Alerts.
Turn On Rise/Fall Rate

Arrow to
Press

High Repeat

Select

.

.

Alerts.

Initial screen shows
current repeat minutes.

Change time frame in 5

Press Up/

Down Arrow

Stop at 60 minutes.

.

minute increments.

(Continued on next page)

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210On the Go With G5: Customizing Your Alarm and Alerts

Turn Repeat On

(Continued from previous page)

12

13

Changed
High Alert.

Changed completed.
Return to

Repeat

time for

Alerts Menu

Press

Select

.

To exit:

.

Press

Left Arrow

.

It doesn’t matter which device you first use to customize your Alarm/Alert settings, key is
making sure you make the same changes in both or you may miss an Alarm or Alert.

Summary

Now You Can:

• Customize your glucose trend Low/High level notifications
○ Dexcom G5 Mobile App
○ Dexcom G5 Mobile Receiver

• Adjust Alarm tones

• Set up receiver’s Advanced Alerts
○ Low/High Repeat
○ Rise/Fall Rate
○ Signal Loss

What’s Next?

Believe it or not, you are becoming a pro at using your Dexcom G5 Mobile CGM System!
You’ve set up the app and receiver, started a session, calibrated, followed your glucose
trends, paid attention to your Alarm/Alerts, prompts, and ended a session!

The next chapters begin our fourth part of the user guide: information you need to know, but
unlike the previous chapters, typically not part of your day-to-day Dexcom G5 Mobile CGM
System experience.

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The next part, Part 4: Everything Else G5, reviews the technical specifications, the warranty,
how to take care of the Dexcom G5 Mobile components, going through security when
traveling, contacting the Help Desk, Troubleshooting information, and symbols on system
components and packages.

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212On the Go With G5: Customizing Your Alarm and Alerts

EVERYTHING ELSE G5

• Warranty

• Maintenance

• Travel Tips

• Customer Service Contacts

• Technical Information

• Troubleshooting

• Package Symbols

Page intentionally left blank

Chapter 13

Everything Else G5:

Warranty: The Fine Print

13.1 Introduction

Sometimes stuff happens. Dexcom has you covered!
The following is our warranty information outlining what we do cover, what we don’t and

for how long. First the receiver’s limited warranty information, then the transmitter’s limited
warranty information.

13.2 Receiver Warranty Information

Dexcom G5 Mobile CGM System’s Limited Warranty

What’s Covered and for How Long?

Dexcom, Inc. (“Dexcom”) provides a limited warranty to the original purchaser (“you” or
“Purchaser”) that the Dexcom G5 Mobile Receiver (the “Receiver”) is free from defects
in material and workmanship under normal use (“Limited Warranty”) for the period
starting from the shipment date and continuing for a year following the shipment date
(“Warranty Period”):

Dexcom G5 Mobile Receiver: 1 year from shipment date
NOTE: If you received this Receiver as a replacement for an in-warranty Receiver, the Limited

Warranty for the original Receiver shall continue for the Warranty Period on the original
Receiver, but the replacement is not subject to any other warranty.

What’s Not Covered?

This Limited Warranty is based on the Purchaser properly using the CGM system in
accordance with the documentation provided by Dexcom. You are not permitted to use
the CGM system otherwise. You understand that misusing the CGM system, improperly
accessing it or the information it processes and transmits, “jailbreaking” your CGM system or
cell phone, and taking other unauthorized actions may put you at risk, cause the CGM system
to malfunction, is not permitted and voids your Limited Warranty.

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215

This Limited Warranty does not cover:

1. Defects or damage resulting from accident, misuse, abuse, neglect, unusual physical,

electrical or electromechanical stress, modification of any part of the product, or
cosmetic damage.

2. Equipment with the ID number removed or made illegible.

3. All surfaces and other externally exposed parts that are scratched or damaged due to

normal use.

4. Malfunctions resulting from the use of the Receiver in conjunction with accessories,

ancillary products, and peripheral equipment, whether hardware or software, not
furnished or approved by Dexcom.

5. Defects or damage from improper testing, operation, maintenance, installation,

or adjustment.

6. Installation, maintenance, and service of products or services other than the CGM

system (which may be subject to a separate limited warranty), whether provided by
Dexcom or any other party; this includes your cell phone or smart device and your
connection to the Internet.

7. Equipment which has been taken apart physically or which has had any of its software

accessed in any unauthorized manner.

8. Water damage to the Receiver.

a. Receiver is not water resistant.
b. Do not get the receiver wet at any time.

Dexcom’s Obligations Under the Limited Warranty

During the Warranty Period, Dexcom will replace, without charge to purchaser, any defective
Dexcom G5 Mobile Receiver.

To return, you must send the Receiver to an authorized Dexcom Technical Support
Department. Make sure you package the Receiver adequately for shipping.

The return package needs to include:

1. Receiver

2. Sales receipt or comparable substitute proof of sale showing the date of purchase

3. Receiver’s Serial Number

4. Seller’s name and address

Call Dexcom Technical Support Department for delivery information help:

• Toll free: 1.877.339.2664

• Charges may apply: 1.858.200.0200

Upon receipt, Dexcom will promptly replace the defective Receiver.

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216Warranty: The Fine Print

If Dexcom determines the Receiver isn’t covered by this Limited Warranty, Purchaser must
pay all shipping charges for the Receiver’s return by Dexcom.

Limits on Dexcom’s Warranty and Liability Obligations

The Limited Warranty described above is the exclusive warranty for the Receiver, and in lieu
of all other warranties, expressed or implied, either in fact or by operation of law, statutory
or otherwise.

Dexcom expressly excludes and disclaims all other warranties, including without limitation
any warranty of merchantability, fitness for a particular purpose, or non-infringement, except
to the extent prohibited by applicable law.

Dexcom shall not be liable for any special, incidental, consequential, or indirect damages,
however caused, and on any theory of liability, arising in any way out of the sale, use,
misuse, or inability to use, any Dexcom G5 Mobile CGM System or any feature or service
provided by Dexcom for use with the Dexcom G5 Mobile CGM System.

These limits on Dexcom’s warranty and liability obligations apply even if Dexcom, or its
agent, has been advised of such damages and notwithstanding any failure of essential
purpose of this Limited Warranty and the limited remedy provided by Dexcom.

This Limited Warranty is only provided to the original Purchaser and can’t be transferred to
anyone else, and states Purchaser’s exclusive remedy.

If any portion of this Limited Warranty is illegal or unenforceable by reason of any law, such
partial illegality or enforceability shall not affect the enforceability of the remainder of this
Limited Warranty. This Limited Warranty will be enforced to the maximum extent permitted
by law.

13.3 Transmitter Warranty Information

Dexcom G5 Mobile Transmitter Limited Warranty

What’s Covered and for How Long?

Dexcom, Inc. (“Dexcom”) provides a limited warranty to the original purchaser that the
Dexcom G5 Mobile Transmitter is free from defects in material and workmanship under
normal use for the period commencing on the date of first use by the original purchaser (the
“Date of First Use”) and expiring three (3) months thereafter; provided, that, the Date of First
use occurs within five (5) months of the date of shipment (or disbursement) of the transmitter
to the original purchaser.

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NOTE: If you received this Transmitter as a replacement for an in-warranty Transmitter, the
Limited Warranty for the original Transmitter shall continue for the Warranty Period on the
original Transmitter, but the replacement is not subject to any other warranty.

What’s Not Covered?

This Limited Warranty is based on the Purchaser properly using the CGM system in a
timely manner and in accordance with the documentation provided by Dexcom. You are not
permitted to use the CGM system otherwise. You understand that misusing the CGM system,
improperly accessing it or the information it processes and transmits, “jailbreaking” your
CGM system or cell phone, and taking other unauthorized actions may put you at risk, cause
the CGM system to malfunction, is not permitted and voids your Limited Warranty.

This Limited Warranty does not cover:

1. Defects or damage resulting from accident, misuse, abuse, neglect, unusual physical,

electrical or electromechanical stress, modification of any part of the product, or
cosmetic damage.

2. Equipment with the ID number removed or made illegible.

3. All surfaces and other externally exposed parts that are scratched or damaged due to

normal use.

4. Malfunctions resulting from the use of the Transmitter in conjunction with accessories,

ancillary products, and peripheral equipment, whether hardware or software, not
furnished or approved by Dexcom.

5. Defects or damage from improper testing, operation, maintenance, installation,

or adjustment.

6. Installation, maintenance, and service of products or services other than the CGM

system (which may be subject to a separate limited warranty), whether provided by
Dexcom or any other party; this includes your cell phone or smart device and your
connection to the Internet.

7. Equipment which has been taken apart physically or which has had any of its software

accessed in any unauthorized manner.

8. Water damage to Transmitter.

a. Beyond specifications listed in Dexcom G5 Mobile CGM System’s User Guide.
b. User Guide is included in the Dexcom G5 Mobile System’s Receiver package.
c. Located on dexcom.com.

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218Warranty: The Fine Print

13.4 Dexcom’s Obligations Under the Limited
Warranty

During the Warranty Period, Dexcom will replace, without charge to purchaser, any defective
Dexcom G5 Mobile Transmitter.

To return, you must send the Transmitter to an authorized Dexcom Technical Support
Department. Make sure you package the Transmitter adequately for shipping.

The return package needs to include:

1. Transmitter

2. Sales receipt or comparable substitute proof of sale showing the date of purchase

3. Transmitter’s Serial Number

4. Seller’s name and address

Call Dexcom Technical Support Department for delivery information or help:

• Toll free: 1.877.339.2664

• Charges may apply: 1.858.200.0200

Upon receipt, Dexcom will promptly replace the defective Transmitter.
If Dexcom determines the Transmitter isn’t covered by this Limited Warranty, Purchaser must

pay all shipping charges for the Transmitter’s return by Dexcom.

Limits on Dexcom’s Warranty and Liability Obligations

The Limited Warranty described above is the exclusive warranty for the Transmitter, and
in lieu of all other warranties, expressed or implied, either in fact or by operations of law,
statutory or otherwise.

Dexcom expressly excludes and disclaims all other warranties, including without limitation
any warranty merchantability, fitness for a particular purpose, or non-infringement, except to
the extent prohibited by applicable law.

Dexcom shall not be liable for any special, incidental, consequential, or indirect damages,
however caused, and on any theory of liability, arising in any way out of the sale, use,
misuse, or inability to use, any Dexcom G5 Mobile CGM System or any feature or service
provided by Dexcom for use with the Dexcom G5 Mobile CGM System.

These limits on Dexcom’s warranty and liability obligations apply even if Dexcom, or its
agent, has been advised of such damages and notwithstanding any failure of essential
purpose of this Limited Warranty and the limited remedy provided by Dexcom.

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219

This Limited Warranty is only provided to the original Purchaser and can’t be transferred to
anyone else, and states Purchaser’s exclusive remedy.

If any portion of this Limited Warranty is illegal or unenforceable by reason of any law, such
partial illegality or enforceability shall not affect the enforceability of the remainder of this
Limited Warranty.

This Limited Warranty will be enforced to the maximum extent permitted by law.

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220Warranty: The Fine Print

Chapter 14

Everything Else G5:

How to Take Care of Your Dexcom G5 Mobile
CGM System

14.1 Introduction

There are not a lot of moving parts in the Dexcom G5 Mobile CGM System, so maintenance
is relatively simple: keep it clean, keep display device (s) dry and protected, use accessory
parts, like the USB cable, etc., given to you with the system and store according to each
piece’s labeling instructions.

This chapter only covers Dexcom parts (sensor, transmitter, and receiver). Follow the
manufacturer’s instructions when caring for your smart device.

After this chapter, you will be able to:

1. Demonstrate proper maintenance

a. Sensor
b. Transmitter
c. Receiver
d. Charge receiver battery

2. Determine what accessories you may use

3. Identify the best storage methods

a. Sensor
b. Transmitter
c. Receiver

4. How to safely dispose of

a. Sensor
b. Transmitter
c. Receiver

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14.2 Basic Maintenance

Sensor

1. Keep in sterile package until ready for use.

2. Check package label for expiration date.

a. Expiration date format is YYYY-MM-DD (year-month-day) format.
b. Don’t use if sensor has expired.

i. May provide inaccurate sensor glucose readings.
ii. May be unsterile.

Transmitter

1. Keep in box until ready for use.

a. Check transmitter and don’t use if damaged.

2. Transmitter is reusable, however only by the same person.

a. Never share transmitter with anyone.

3. Between uses, clean outside of the transmitter with damp cloth or alcohol wipes. Let

dry before use or storage.

4. When not in use.

a. Protect transmitter by returning to its packaging or another safe place.
b. Store between 32° F-113° F.

Receiver

1. Check receiver casing, if it’s cracked or damaged, don’t use.

a. May get an electric shock.

2. Keep receiver dry—it is only splash resistant.

a. Don’t submerge in liquid.
b. Don’t spill fluids on receiver.

3. Keep battery charged.

a. Only use Dexcom USB charging/download cable.

4. Keep the micro USB port cover closed if not using USB cable.

a. Prevents fluid from getting inside receiver.

Charging Receiver’s Battery

The receiver’s status bar lets you see its battery level and prompts you when the battery is
getting low. While the receiver is being charged, you will continue to get your sensor glucose
readings if the transmitter and receiver are within 20 feet of each other.

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Each charge lasts approximately three days. If your receiver’s battery was drained, after
charging, you may need to reset its time and date. If this is required, the system tells you to
reset and takes you to the time/date setting screens.

Step What you see What it means What you do

1 Low Battery Charge your battery.

Open

USB port door

2

Micro USB Port

Plug

USB cable

for recharging.

(Continued on next page)

.

into port

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(Continued from previous page)

Step What you see What it means What you do

3 Micro USB Cable

4

Wall Charger

(Continued on next page)

Plug into

receiver

to

charge battery.
Don’t plug into a

computer port to charge
Don’t use an external

USB hub, it doesn’t
provide enough power to
charge battery.

Battery can only be
charged using the
adapter/wall charger.

Charge battery before
each new sensor
session.

Plug

USB cable

adapter/wall charger

into

.

Plug wall charger into
an electrical outlet
to charge receiver’s
battery.

Don’t block access to
the charger.

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(Continued from previous page)

Step What you see What it means What you do

5 Battery Charging

6

Battery Charged

Keep charging until
icons are solid.

Unplug

wall charger

from outlet when fully
charged.

Remove

USB cable

receiver.
Close

6

USB Port Door

USB port door

after removing USB
cable to keep receiver
clean and dry.

Accessories

1. Only use Dexcom-supplied parts (including cables and chargers).

a. Use of non-Dexcom supplied parts may affect safety and performance.

2. Insert cables only as directed.

a. Do not force cables in place.

3. Look at cables for signs of wear and tear. Do not use if worn or damaged.

There is no repair service available for any Dexcom G5 Mobile CGM System parts.

from

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If you experience problems, call Dexcom Technical Support, available 24 hours, 7 days a
week, toll free at 1.877.339.2664 or toll at 1.858.200.0200 to report the issue.

14.3 Storage

Storing your Dexcom G5 Mobile CGM System correctly helps prevents system failures.

Sensor

1. Keep the sensor in its sterile packaging until you are ready to use it.

2. Store at temperatures between 36° F-77° F.

a. Stored outside of this range may cause inaccurate sensor glucose readings.
b. May store in refrigerator if it’s within this temperature range.
c. Sensors should not be stored in freezer.

3. Store at humidity levels between 15%-85% relative humidity.

Transmitter

1. Keep transmitter protected when not in use.

2. Store at temperatures between 32° F-113° F.

3. Store at humidity levels between 10%-95% relative humidity.

Receiver

1. Keep receiver protected when not in use.

2. Fully charge the battery before storing for over 3 months.

3. Store at temperatures between 32° F-104° F.

4. Store at humidity levels between 10%-95% relative humidity.

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14.4 Checking App and Receiver Information

CHECKING YOUR APP & RECEIVER SOFTWARE VERSION

You can check your app or receiver for information about your CGM system at any time.

Receiver

1. From the Settings menu, press Up or

2. Press

Select

. Information about your sensor session and system will show.

App

1. From Main Menu, tap

2. Tap

Device Info.

Settings.

Available Information

• Insertion Time

• Last Calibration

• Transmitter Battery

• Transmitter SN

• Serial Number

• Part Number

• Part Revision

• Software Number

Down arrows

to scroll to “Device Info.”

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14.5 System Disposal

Different municipalities have different requirements when throwing away electronics
(receiver and transmitter) and parts that have come in contact with blood or other bodily
fluids (sensor).

Consult your area’s local waste management authorities for proper disposal instructions.
Taking care of your Dexcom G5 Mobile CGM System is pretty easy. In the next chapter,

traveling with your Dexcom G5 Mobile CGM System, you’ll learn how simple it is to see the
world with your Dexcom G5 Mobile CGM System!

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Chapter 15

Everything Else G5:

On the Go With Dexcom G5 Mobile CGM
System: Getting Through Security

15.1 Introduction

Dexcom G5 Mobile can be a great travel companion; you can go through metal detectors, be
handwanded, and even keep your receiver on during your flight.

This chapter only covers the Dexcom G5 Mobile CGM System. It doesn’t cover steps you need
to take when traveling with your smart device. See your smart device’s instruction for use to
learn how to travel with it.

After this chapter, you will be able to:

1. Explain proper procedure if you prefer a full body pat down.

2. Describe steps needed for a TSA officer to inspect Dexcom G5 Mobile CGM

System components.

3. Identify when your display device(s) can be on during a flight.

4. Contact TSA directly with your security questions.

15.2 Going Through Security

Walk-Through Metal Detectors

Transmitter and Sensor

No worries about wearing your transmitter and sensor when going through security.
Go through walk-in metal detectors or, if you prefer, be handwanded without worrying about

damaging your transmitter or sensor.
If you’re concerned or uncomfortable about walking through the metal detector, the

Transportation Security Administration (TSA) requests you tell the Security Officer you’re
wearing a continuous glucose monitor and want a full-body pat-down with a visual
inspection of your sensor and transmitter.

Let the Security Officer know the sensor can’t be removed because it’s inserted under the skin.

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X-Ray Machines

Receiver, Extra Sensors

Don’t put your Dexcom G5 Mobile CGM System components through x-ray machines.
Before your screening process begins, ask the TSA Officer to perform a visual inspection of

the receiver and your extra sensors. Place all Dexcom G5 Mobile components in a separate
bag before handing over to the Security Officer.

For other medical supplies, such as medications, meters, and strips, check manufacturer’s
instructions or the TSA website.

Body Scanners

Use of AIT body scanners has not been studied and therefore we recommend hand-wanding
or full body pat down and visual inspection in those situations.

In the Plane

You may keep the receiver on:

1. Before take-off

2. While in flight

3. After landing

The Dexcom G5 Mobile CGM System is safe for use on U.S. commercial airlines.
If you choose to use your smart device, the airlines request you put your smart devices

in airplane mode. You can do this, but still keep your
receive sensor glucose information on your smart device.

Bluetooth

on and you will be able to

Technical Information

The Dexcom G5 Mobile Transmitter is an M-PED with emission levels that meet
RTCA/DO160, Section 21, Category M. Per FAA Advisory, Circular #91-21, 1B,
dated 8/25/06.

Any M-PED that meets this standard in all modes may be used onboard the aircraft without
any further testing by the operator.

This device can withstand exposure to common electrostatic (ESD) and electromagnetic
interference (EMI).

Still Have Questions?

Visit the TSA’s website if you have any questions or concerns at tsa.gov.

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230On the Go With Dexcom G5 Mobile CGM System: Getting Through Security

Email: [email protected]
Phone: Call 1.866.289.9673

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232On the Go With Dexcom G5 Mobile CGM System: Getting Through Security

Chapter 16

Everything Else G5:

Need Help? You’re Not Alone!

Dexcom has two support teams to help you, each with their own specialty:

• Technical Support Team

• Patient Care Team

16.1 Dexcom Technical Support

Provides replacement units, resolves technical issues or takes product complaints.
Call your Dexcom Technical Support Team, 24 hours a day, 7 days a week, if something is

wrong with your Dexcom G5 Mobile CGM System.

By Phone

Dexcom Technical Support Phone Numbers:
Toll Free: 1.877.339.2664
Toll Call: 1.858.200.0200

By Email

Email: [email protected]
If you prefer to email, to help us help you best, include the following information in your email:

• Name of patient

• Date of Birth

• The technical issue you

• When the problem happened (date and time)

• Patient’s address

• Patient’s phone number

• Item SKU number and description (e.g., name of the device)

• Lot number and/or serial number(s) of affected devices (e.g., sensor)

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233

What Can They Help Me With?

The Dexcom Technical Support Team helps you with all CGM system related issues as well
as software related issues.

Dexcom Technical Support does not offer medical advice.

16.2 Patient Care Team

The Patient Care Team (PCT) is a group of Certified Diabetes
Educators (CDE®) and Registered Nurses (RNs) offering you customer
care and individualized education services around Dexcom CGM.

Your PCT provides education and support throughout your CGM experience, such as:

• Initial CGM Product Training

• Ongoing Dexcom product education (e.g., how to use a specific feature)

• How to maximize Dexcom CGM use

• Dexcom CGM reporting software and features

• How to review and understand Dexcom CGM reports

By Phone

Available Monday-Friday 5:30 am-8:00 pm PST (subject to change)
Toll Free: 1.877.339.2664
Toll Call: 1.858.200.0200

By Email

Email: [email protected]
If you prefer to email, to help us help you best, include the following information in your email:

• Name

• DOB

• Contact phone number

• Reason for inquiry or education needed

For additional Dexcom CGM education, check the Dexcom website:
dexcom.com/web-based-education

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234Need Help? You’re Not Alone!

16.3 Sales Support Team

Inside Sales Support Team

For help with:

• First-time orders

• Re-orders

• Tracking shipments

• Locating a local Dexcom representative

By Phone

Dexcom Inside Sales Support Phone Numbers:
Toll Free: 1.877.339.2664
Toll Call: 1.858.200.0200

By Email

Dexcom Inside Sales Support Email: [email protected]

By Fax

1.877.633.9266

16.4 Corporate

Dexcom Website:

Dexcom.com

Dexcom Address:

6340 Sequence Drive
San Diego, CA 92121

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236Need Help? You’re Not Alone!

Chapter 17

Everything Else G5:

Technical Information

17.1 Device Performance Characteristics

NOTE: We recommend that you review the information in this chapter with your healthcare

professional to understand how well the Dexcom G5 Mobile CGM System performs.
The Dexcom G5 Mobile CGM System (the System) uses a glucose sensor to continuously measure and

monitor your glucose levels. The sensor is “calibrated” using a commercially available blood glucose
meter. Once calibrated, the System reports glucose readings up to every 5 minutes. The System was
evaluated clinical studies in which System readings were compared to blood glucose values to assess
its performance and how well the System readings compare to a laboratory test method that measures
blood glucose values. Additionally, subjects performed self-monitoring blood glucose meter tests at
home to assess the System performance in real use environment.

Although the performance characteristics of the System are presented in the following, there is no
commonly accepted statistical approach for capturing performance of continuous glucose monitors
(CGMs), such as the Dexcom G5 Mobile CGM System.

Clinical Study Overview

The System performance was evaluated in four separate prospective clinical studies. Two studies
included adults, and two studies included pediatrics. In the following sections and tables, the studies
will be identified as follows:

Adult Studies (18 years and older)

Original Adult Study: the Receiver included software version SW10050

Software 505 Adult Study: the Receiver included software version SW10505

Pediatric Studies (2 to 17 years)

Original Pediatric Study: the Receiver included software version SW10050

Software 505 Pediatric Study: the Receiver included software version SW10505

The Dexcom G5 Mobile CGM System incorporates the algorithm from software version SW10505 and
has a new software number.

Overview of Adult Studies

The System performance for adults was evaluated in two separate prospective clinical studies:

Original Adult Study (software SW10050) and the Software 505 Adult Study (software SW10505).

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237

Differences between the studies include the number of subjects enrolled, the number of Systems worn
by each participant, the SMBG meter used, and the number of clinic days each subject participated in
during the study. An overview of each study is provided here.

The Original Adult Study enrolled 72 subjects, and the Software 505 Adult Study enrolled 51
subjects. All subjects had Type 1 or Type 2 diabetes mellitus, and required insulin or oral medication to
manage their diabetes. In the Original Adult Study, 83% of subjects had Type 1 diabetes, and 17% of
subjects had Type 2 diabetes. In the Software 505 Adult Study, 86% of subjects had Type 1 diabetes,
and 14% of subjects had Type 2 diabetes. Both studies included subjects greater than 18 years of age.

Subjects in both studies used the System for seven days. In the Original Adult Study, thirty-six
subjects each wore 2 sensors; in the Software 505 Adult Study, all subjects wore 1 sensor only.
Throughout the 7-day wear period, the sensor was calibrated with an average of 2 fingersticks per
day (approximately once every 12 hours). In the Original Adult Study, subjects used the LifeScan
OneTouch

®

Ultra®2 meter and in the Software 505 Adult Study, subjects used Bayer’s CONTOUR®

®

NEXT USB meter.
In the Original Adult Study, all subjects were evaluated in a controlled clinic environment on all three

clinic days: Day 1, Day 4, and Day 7 of the 7-day wear period. In the Software 505 Adult Study,
subjects were evaluated in one of the three clinic days so there are fewer data samples than in the

Original Adult Study. While using the System in the clinic, subjects had their blood glucose measured

every 15 minutes with a reliable laboratory method, the Yellow Springs Instrument 2300 STAT Plus

™

Glucose Analyzer. This instrument is referred to as the “YSI.” Readings from the System were reported
every 5 minutes and paired with YSI values in order to characterize how well the System readings
agreed with laboratory standard blood glucose results. The remainder of the study took place at home,
and the System performance was also paired with the comparative meter results, referred to as the
“SMBG.”

Overview of Pediatric Studies

The System performance for children and adolescents was evaluated in two separate prospective
clinical studies: the Original Pediatric Study (SW10050) and the Software 505 Pediatric Study
(SW10505). Differences between the studies include the number of subjects enrolled, the number of
Systems worn by each participant, the SMBG meter used, the length of time subjects were evaluated
in a controlled clinic environment and whether or not subjects ages 13-17 had their glucose levels
intentionally manipulated during the study. An overview of each study is provided here.

The Original Pediatric Study enrolled 176 subjects, with 16% of subjects younger than 6-years old,
and the Software 505 Pediatric Study enrolled 79 subjects, with 20% of subjects younger than
6-years old. All subjects had Type 1 or Type 2 diabetes mellitus and required insulin or oral medication
to manage their diabetes. In the Original Pediatric Study, about 99% of subjects had Type 1 diabetes
and 1% had Type 2 diabetes. In the Software 505 Pediatric Study, all subjects had Type 1 diabetes.
Sensors were inserted in either the abdomen or upper buttocks.

Subjects in all studies used the System for seven days. In the Original Pediatric Study, all subjects
wore 2 sensors; in the Software 505 Pediatric Study, all subjects wore 1 sensor only. Throughout

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238Technical Information

the 7-day wear period, the sensors were calibrated with an average of 2 fingersticks per day
(approximately once every 12 hours), using self-monitoring blood glucose (SMBG) meter values. The

Original Pediatric Study used the LifeScan

Study used Bayer’s CONTOUR

®

NEXT USB meter.

®

OneTouch® Verio® IQ meter; the Software 505 Pediatric

All subjects were evaluated in a controlled clinic environment on Day 1, Day 4 or Day 7 of the
7-day wear period. While using the System in the clinic, subjects provided at least two fingerstick
measurements per hour, and subjects ages 6-17 also provided venous blood for comparison to
a laboratory method, the Yellow Springs Instrument 2300 STAT Plus

™

Glucose Analyzer. This
instrument is referred to as the “YSI.” In the Original Pediatric Study, subjects’ glucose levels were
not intentionally manipulated during this study; in the Software 505 Pediatric Study, subjects ages
13-17 had their glucose levels intentionally manipulated during the clinic session. Readings from the
System were reported every 5 minutes and paired with YSI values collected every 15 minutes in order
to characterize how well the System readings agreed with laboratory standard blood glucose results.
The remainder of the study took place at home, and the System performance was also paired with the
comparative meter results, referred to as the “SMBG.”

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239

Table 1-A. System Agreement to YSI within CGM Glucose Ranges (Adult)

CGM

Glucose

Range1

Study

(mg/dL)

Overall

40-60

61-80

81-180

181-300

30 1-35 0

351-40 0

1

CGM readings are within 40-400 mg/dL, inclusive.

2

Both sets of study data are presented and are labeled as Original (SW10050) or Software 505

Original 9152 7 1% 82% 92% 3%

Software 505 2263 86% 93% 98% 1%

Original 512 67% 78% 88% 6%

Software 505 120 89% 94% 98% 0%

Original 781 73% 85% 94% 2%

Software 505 226 91% 96% 99% 0%

Original 3853 67% 78% 91% 3%

Software 505 738 84% 92% 98% 1%

Original 2784 72% 84% 93% 4%

Software 505 798 86% 93% 98% 1%

Original 775 82% 91% 97% 2%

Software 505 229 86% 94% 98% 1%

Original 447 74% 84% 91% 5%

Software 505 152 80% 92% 97% 0%

2

Number
of Paired
CG M-YSI

Percent

Within

15/15%

YSI

Percent

Within

20/20%

YSI

Percent

Within

30/30%

YSI

(SW10505).

Percent
Greater

than

40/40%

YSI

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240Technical Information

Table 1-B. System Agreement to YSI within CGM Glucose Ranges
(Pediatric)

CGM

Glucose

Range1

(mg/dL)

Overall

40-60

61-80

81-180

181-300

30 1-35 0

351-40 0

1

CGM readings are within 40-400 mg/dL, inclusive.

2

Both sets of study data are presented and are labeled as Original (SW10050) or Software 505

Study

Original 2922 55% 68% 85% 7%

Software 505 2262 81% 91% 96% 2%

Original 19 63% 74% 79% 21%

Software 505 86 54% 74% 9 1% 3%

Original 76 61% 82% 92% 4%

Software 505 142 77% 82% 90% 3%

Original 1155 56% 69% 84% 6%

Software 505 805 78% 88% 97% 1%

Original 1380 55% 68% 85% 7%

Software 505 957 89% 96% 99% 1%

Original 206 48% 62% 80% 11%

Software 505 209 81% 91% 94% 5%

Original 86 48% 61% 79% 12%

Software 505 63 64% 81% 83% 8%

2

Number
of Paired
CG M-YSI

Percent

Within

15/15%

YSI

Percent

Within

20/20%

YSI

Percent

Within

30/30%

YSI

(SW10505).

Percent
Greater

40/40%

than

YSI

Agreement Relative to YSI

Agreement between the System and blood glucose values is characterized using paired System and
YSI values. The System and YSI results were compared by pairing the YSI blood glucose value to a
System glucose reading that occurred immediately after the YSI was collected.

The agreement of the System to blood glucose value was assessed by calculating the percentage
of System readings that were within 15%, 20%, 30% and greater than 40% of the YSI values. For
readings less than or equal to 80 mg/dL the absolute difference in mg/dL between the two glucose
results was calculated. For values greater than 80 mg/dL the absolute percent difference (%) from
the YSI values was calculated. The percentages of total readings within 15 mg/dL or 15%, 20 mg/dL

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241

or 20%, 30 mg/dL or 30% or greater than 40 mg/dL or 40% are provided in Table 1-A and 1-B. The
tables are categorized within CGM glucose ranges. When you see a CGM reading on your receiver,
this table shows you how likely that reading matches your blood glucose level (measured by YSI in
the study).

For example, in the SW10505 Adult Study (Table 1-A), the total number of data pairs considered in
the analysis was 2263. Of these, 93% of the System readings fall within ± 20 mg/dL of the YSI blood
glucose values ≤ 80 mg/dL and within ± 20% of YSI blood glucose values > 80 mg/dL.

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242Technical Information

Table 2-A. Number and Percentage of YSI Values When CGM Readings are
“LOW” or “HIGH” (Adult)

YSI mg/dL

CGM

Readings

Study

1

CG M-YSI

Pairs

< 55 < 60 < 70 < 80 ≥ 80

n 66 84 123 142 13 155

Original

“LOW”

Software

505

Cumulative

Percent

42% 54% 79% 92% 8%

n 11 16 17 18 0 18

Cumulative

Percent

61% 89% 94% 100% 0%

YSI mg/dL

CGM

Readings

Study

1

CG M-YSI

Pairs

> 340 > 320 > 280 > 240 ≤ 240

n 189 220 238 246 2 248

Original

“HIGH”

Software

505

1

Both sets of study data are presented and are labeled as Original (SW10050) or Software 505

Cumulative

Percent

76% 89% 96% 99% 1%

n 40 43 45 45 0 45

Cumulative

Percent

89% 96% 100% 100% 0%

(SW10505).

Tot al

Tot al

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243

Table 2-B. Number and Percentage of YSI Values When CGM Readings are
“LOW” or “HIGH” (Pediatric)

YSI mg/dL

CGM

Readings

“LOW”

CGM

Readings

“HIGH”

1

Both sets of study data are presented and are labeled as Original (SW10050) or Software 505

Study

Original

Software

505

Study

Original

Software

505

1

1

CG M-YSI

Pairs

n 0 0 0 0 13 13

Cumulative

Percent

n 3 5 10 15 1 16

Cumulative

Percent

CG M-YSI

Pairs

n 38 51 68 69 1 70

Cumulative

Percent

n 14 19 22 23 1 24

Cumulative

Percent

< 55 < 60 < 70 < 80 ≥ 80

0% 0% 0% 0% 100%

19% 31% 63% 94% 6%

YSI mg/dL

> 340 > 320 > 280 > 240 ≤ 240

54% 73% 97% 99% 1%

58% 79% 92% 96% 4%

(SW10505).

Tot al

Tot al

Agreement When CGM Reads “LOW” or “HIGH”

The System reports glucose readings between 40 and 400 mg/dL. When the System determines the
glucose reading is below 40 mg/dL, it displays “LOW” in the Receiver Status Box. When the Dexcom
G5 Mobile System determines that the glucose level is above 400 mg/dL, it displays “HIGH” in the
Receiver Status Box. Because the System does not display glucose values below 40 mg/dL or above
400 mg/dL, the comparisons to the actual blood glucose levels (as determined by the YSI analyzer)
when CGM is classified as “LOW” or “HIGH” are included separately in Table 2-A and 2-B. The tables
include the numbers and the cumulative percentages when YSI values were less than certain glucose
levels (for “LOW”), and when YSI values were greater than certain glucose levels (for “HIGH”).

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244Technical Information

For example, in the Software 505 Adult Study (Table 2-A), when the System displayed “LOW” (18
occasions), 100% (18 out of 18) of the YSI values were less than 80 mg/dL, and 94% (17 out of 18) of
the YSI values were less than 70 mg/dL. When the System displayed “HIGH” (45 occasions), 100% (45
out of 45) of the YSI values were greater than 240 mg/dL, and 100% (45 out of 45) of the YSI values
were greater than 280 mg/dL.

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245

Table 3-A. Concurrence of CGM Readings and YSI Values (Original Adult
Study)

CGM

(mg/dL)

Row Percentage of Matched Pairs in each CGM Glucose Range

40-6061-8081-

< 40

120

< 40 6% 48% 37% 7% 1% 0% 0% 0% 0% 0% 0% 155

40-60 4% 49% 36% 11% 1% 0% 0% 0% 0% 0% 0% 512

61-80 0% 22% 51% 24% 1% 0% 0% 0% 0% 0% 0% 781

81-120 0% 2% 17% 66% 13% 1% 0% 0% 0% 0% 0% 17 06

121-160 0% 0% 1% 25% 60% 13% 2% 0% 0% 0% 0% 14 92

161-200 0% 0% 0% 2% 28% 53% 16% 2% 0% 0% 0% 1240

201- 250 0% 0% 0% 0% 3% 21% 51% 21% 3% 1% 0% 1181

251- 300 0% 0% 0% 0% 0% 4% 19% 49% 24% 3% 0% 1018

301- 350 0%

0% 0% 0% 0% 0% 3% 28% 51% 16% 1% 775

351- 400 0% 0% 0% 0% 0% 0% 3% 10% 43% 38% 7% 447

> 400 0% 0% 0% 0% 0% 0% 1% 6% 21% 57% 15% 248

YSI (mg/dL)

121-

160

161­200

201-

250

251-

300

301-

350

351­400> 400

Number
of Paired
CG M-YS I

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246Technical Information

Table 3-B. Concurrence of CGM Readings and YSI Values (Software 505

Adult Study)

CGM

(mg/dL)

Row Percentage of Matched Pairs in each CGM Glucose Range

40-6061-8081-

< 40

120

< 40 6% 83% 11% 0% 0% 0% 0% 0% 0% 0% 0% 18

40-60 2% 74% 22% 3% 0% 0% 0% 0% 0% 0% 0% 12 0

61-80 0% 19% 68% 13% 0% 0% 0% 0% 0% 0% 0% 226

81-120 0% 0% 19% 72% 8% 1% 0% 0% 0% 0% 0% 347

121-160 0% 0% 0% 17 % 72% 11% 0% 0% 0% 0% 0% 246

161-200 0% 0% 0% 0% 25% 59% 16% 0% 0% 0% 0% 286

201- 250 0% 0% 0% 0% 0% 16% 70% 13% 1% 0% 0% 376

251- 300 0% 0% 0% 0% 0% 2% 16% 6 1% 14% 7% 0% 281

301- 350 0%

0% 0% 0% 0% 0% 2% 28% 59% 10% 1% 229

351- 400 0% 0% 0% 0% 0% 0% 0% 4% 47% 45% 5% 152

> 400 0% 0% 0% 0% 0% 0% 0% 0% 20% 38% 42% 45

YSI (mg/dL)

121-

160

161­200

201-

250

251-

300

301-

350

351­400> 400

Number
of Paired
CG M-YS I

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247

Table 3-C. Concurrence of CGM Readings and YSI Values (Original

Pediatric Study)

CGM

(mg/dL)

Row Percentage of Matched Pairs in each CGM Glucose Range

40-6061-8081-

< 40

120

< 40 0% 0% 0% 54% 31% 15% 0% 0% 0% 0% 0% 13

40-60 0% 21% 58% 16% 5% 0% 0% 0% 0% 0% 0% 19

61-80 0% 21% 45% 30% 4% 0% 0% 0% 0% 0% 0% 76

81-120 0% 1% 20% 66% 12% 1% 0% 0% 0% 0% 0% 338

121-160 0% 0% 1% 36% 54% 7% 1% 0% 0% 0% 0% 511

161-200 0% 0% 0% 4% 40% 48% 6% 1% 0% 0% 0% 596

201- 250 0% 0% 0% 1% 9% 4 4% 41% 5% 0% 0% 0% 658

251- 300 0% 0% 0% 0% 2% 7% 50% 36% 3% 0% 2% 432

301- 350 0%

0% 0% 0% 0% 2% 18% 59% 21% 0% 0% 206

351- 400 0% 0% 0% 0% 0% 0% 3% 28% 50% 16% 2% 86

> 400 0% 0% 0% 0% 0% 0% 1% 14% 41% 36% 7% 70

YSI (mg/dL)

121-

160

161­200

201-

250

251-

300

301-

350

351­400> 400

Number
of Paired
CG M-YS I

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248Technical Information

Table 3-D. Concurrence of CGM Readings and YSI Values (Software 505

Pediatric Study)

CGM

(mg/dL)

Row Percentage of Matched Pairs in each CGM Glucose Range

40-6061-8081-

< 40

120

< 40 6% 25% 63% 6% 0% 0% 0% 0% 0% 0% 0% 16

40-60 0% 33% 60% 6% 1% 0% 0% 0% 0% 0% 0% 86

61-80 0% 8% 64% 26% 2% 0% 0% 0% 0% 0% 0% 142

81-120 0% 1% 15% 69% 13% 1% 1% 0% 0% 0% 0% 314

121-160 0% 0% 0% 15% 66% 18% 1% 0% 0% 0% 0% 313

161-200 0% 0% 0% 1% 18% 66% 15% 0% 0% 0% 0% 355

201- 250 0% 0% 0% 0% 1% 17% 68% 14% 0% 0% 0% 444

251- 300 0% 0% 0% 0% 0% 0% 26% 58% 16 % 0% 0% 336

301- 350 0%

0% 0% 0% 0% 0% 4% 40% 46% 9% 0% 209

351- 400 0% 0% 0% 0% 0% 0% 3% 14% 62% 21% 0% 63

> 400 0% 0% 0% 0% 0% 0% 4% 13% 29% 38% 17% 24

YSI (mg/dL)

121-

160

161­200

201-

250

251-

300

301-

350

351­400> 400

Number
of Paired
CG M-YS I

Concurrence of System and Laboratory Reference

Table 3-A (Original Adult Study), 3-B (Software 505 Adult Study), 3-C (Original Pediatric Study)
and 3-D (Software 505 Pediatric Study) are categorized by ranges of CGM glucose readings. These
tables describe, for each range of CGM glucose readings, what percentage of paired YSI values were in
the same glucose range (shaded) or in glucose ranges above and below the paired CGM readings. For
example, based on the Software 505 Adult Study, when CGM readings are within 81 to 120 mg/dL,
you can expect your blood glucose levels are within 81 to 120 mg/dL 72% of time.

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249

Table 4-A. System Difference to YSI within CGM Glucose Ranges (Adult)

CGM

Glucose

Range1

Study

(mg/dL)

Overall

*40-60

*61-80

81-180

181-300

301-350

351-400

1

CGM readings are within 40 to 400 mg/dL, inclusive.

2

Both sets of study data are presented and are labeled as Original (SW10050) or Software 505

Original 915 2 2.9% 1.7% 13.3% 9.8%

Software 505 2263 2.5% 2.4% 9.0% 7.0%

Original 512 -10.0 -8.2 13.5 9.7

Software 505 120 -3.3 -2.1 6.9 4.8

Original 781 -2.4 -0.4 11.4 8.6

Software 505 226 0.8 1.4 6.7 5.4

Original 3853 4.8% 3.0% 13.8% 9.8%

Software 505 738 3.9% 4.1% 9.6% 8.2%

Original 2784 2.1% 0.0% 11. 9% 9.2%

Software 505 798 0.6% 0.4% 8.0% 6.1%

Original 775 3.8% 2.8% 9.8% 7.9%

Software 505 229 4 .1% 3.4% 8.0% 5.8%

Original 447 10.4% 7.7 % 12.8% 9.1%

Software 505 152 7. 2% 6.3% 9.2% 7.2%

2

Number
of Paired
CG M-YSI

Mean

Percent

Difference

Median

Percent

Difference

Mean

Absolute

Percent

Difference

(SW10505).

*

For CGM ≤ 80 mg/dL, the difference and absolute difference in mg/dL are included instead of percent

differences (%).

Median

Absolute

Percent

Difference

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250Technical Information

Table 4-B. System Difference to YSI within CGM Glucose Ranges
(Pediatric)

CGM

Glucose

Range1

(mg/dL)

Overall

*40-60

*61-80

81-180

181-300

301-350

351-400

1

CGM readings are within 40 to 400 mg/dL, inclusive.

2

Both sets of study data are presented and are labeled as Original (SW10050) or Software 505

Study

Original 2922 13.5% 11.6 % 17. 4% 13.5%

Software 505 2262 1.8% 1.2 % 10.4% 7. 9%

Original 19 -18.1 -9.1 19.2 9.1

Software 505 86 -15.3 -13 .2 16.1 13 .2

Original 76 -3.7 -2.3 13.4 10.6

Software 505 142 -4.8 -1.0 11.8 7.7

Original 115 5 11. 9% 9.7% 17. 0% 13.0%

Software 505 805 1.9 % 0.7% 10.6% 8.1%

Original 1380 14.8% 12.4% 17.4% 13.3%

Software 505 957 2.2% 1.0% 8.1% 6.5%

Original 206 19.2% 15.9 % 19.4% 15 .9%

Software 505 209 7.8% 6.5% 11.0% 7.9%

Original 86 18.5% 15.5% 19.1% 15.5%

Software 505 63 14.9% 11.6% 15. 2% 11.6%

2

Number
of Paired
CG M-YSI

Mean

Percent

Difference

Median

Percent

Difference

Mean

Absolute

Percent

Difference

(SW10505).

*

For CGM ≤ 80 mg/dL, the difference and absolute difference in mg/dL are included instead of percent

differences (%).

Median

Absolute

Percent

Difference

Accuracy Relative to YSI

Accuracy between matched pairs was also estimated by calculating the percent difference between
the System reading and the YSI value. For example, if the YSI value is 100 mg/dL and the System
reading is 90 mg/dL, a 10% difference between the System and the YSI is reported. The System and
YSI values were compared by pairing the System reading that fell immediately after the YSI value
was collected.

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In the example above, the System reading is less than the YSI value, so the percent difference reading
is negative. The mean percent difference is the average of all positive and negative percent differences
between the two devices; it tells you if the System reads higher or lower on average than the YSI
within each glucose range.

Another estimate used to show the accuracy of the System is the absolute percent difference. The
absolute percent difference tells you the percent difference or “distance” between the System and YSI
values, but does not tell you whether the System is reading, on average, higher or lower than the YSI
laboratory standard. The mean absolute percent difference is the average “distance” (regardless if
positive or negative) between System readings and YSI values.

Accuracy measures in differences for both the Original Adult and Software 505 Adult Studies are
summarized in Table 4-A. Accuracy measures in differences for both the Original Pediatric and

Software 505 Pediatric Studies are summarized in Table 4-B. Table 4-A and 4-B are categorized

within CGM glucose ranges.
For example, in the Software 505 Adult Study (Table 4-A), overall, on average, the System reads

2.5% different (Mean Percent Difference) than the reference and 9.0% absolute different (Mean
Absolute Difference) than the reference values. The Median Percent Difference shows that half of
the time the System reads 2.4% or less than the YSI blood glucose values and the Median Absolute
Percent Difference shows that half of the time the System reads about 7.0% or less than the YSI blood
glucose values.

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Table 5-A. Hypoglycemia Alert and Detection Rate Evaluation in
Reference to YSI 15 Minutes Before and After (Adult)

Hypoglycemia

Alert Level

Study

1

(mg/dL)

55

60

70

80

90

1

Both sets of study data are presented and are labeled as Original (SW10050) or Software 505

Original 50% 50% 71% 29%

Software 505 71% 29% 68% 32%

Original 64% 36% 75% 25%

Software 505 85% 15% 83% 17%

Original 79% 21% 83% 17%

Software 505 92% 8% 91% 9%

Original 87% 13% 86% 14%

Software 505 95% 5% 90% 10%

Original 90% 10% 89% 11%

Software 505 96% 4% 94% 6%

(SW10505).

Tru e
Alert
Rate

False
Alert

Rate

Hypoglycemia

Detection Rate

Hypoglycemia

Missed

Detection Rate

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Table 5-B. Hypoglycemia Alert and Detection Rate Evaluation in
Reference to YSI 15 Minutes Before and After (Pediatric, Ages 6-17 Years)

Hypoglycemia

Alert Level

Study

1

(mg/dL)

55

60

70

80

90

100

1

Both sets of study data are presented and are labeled as Original (SW10050) or Software 505

Original 0% 100% 0% 100%

Software 505 22% 78% 75% 25%

Original 11% 89% 25% 75%

Software 505 42% 58% 78% 23%

Original 47% 53% 50% 50%

Software 505 68% 32% 75% 25%

Original 55% 45% 55% 45%

Software 505 86% 14% 9 1% 9%

Original 69% 31% 62% 38%

Software 505 90% 10% 93% 7%

Original 75% 25% 62% 38%

Software 505 91% 9% 93% 7%

(SW10505).

Tru e
Alert
Rate

False
Alert

Rate

Hypoglycemia

Detection Rate

Hypoglycemia

Missed

Detection Rate

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Table 5-C. Hypoglycemia Alert and Detection Rate Evaluation in
Reference to SMBG 30 Minutes Before and After (Pediatric, Ages 2-5
Years)

Hypoglycemia

Alert Level

(mg/dL)

55

60

70

80

90

100

1

Both sets of study data are presented and are labeled as Original (SW10050) or Software 505

Software 505 25% 75% 100 % 0%

Software 505 20% 80% 100 % 0%

Software 505 20% 80% 100 % 0%

Software 505 61% 39% 100 % 0%

Software 505 78% 22% 100% 0%

Software 505 82% 18% 100% 0%

1

Study

Original 3% 97% 57% 43%

Original 11% 89% 62% 38%

Original 29% 71% 77% 23%

Original 35% 65% 85% 15%

Original 51% 49% 89% 11%

Original 64% 36% 91% 9%

(SW10505).

Tru e
Alert
Rate

False
Alert

Rate

Hypoglycemia

Detection Rate

Hypoglycemia

Missed

Detection Rate

Low and High Glucose Alerts

The ability of the System to detect high and low glucose levels is assessed by comparing System
results to YSI results at low and high blood glucose levels and determining if the alert may have
sounded. The System and YSI values were compared by pairing the System reading that occurred
immediately after the YSI value was collected. We suggest that you ask your doctor what alert settings
would be best for you.

The Low Glucose Alert

Estimates of how well the adjustable Low Glucose Alert performs are presented in Table 5-A, 5-B and
5-C. Table 5-A represents the hypoglycemia alert evaluation within 15 minutes of the YSI value in the
adult studies. Table 5-B represents the alert evaluation within 15 minutes of the YSI value for a subset
of the pediatric population—subjects age 6 to 17 years who had YSI measurements every 15 minutes.

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Table 5-C represents the alert evaluation within 30 minutes of an SMBG reading for 2- to 5-year old
subjects in the pediatric studies.

Hypoglycemia Alert Rate

The Alert Rate shows how often the alert is right or wrong. The True Alert Rate is the % of time
the device alarmed when the blood glucose level was at or below the alert setting within 15 or 30
minutes before or after the device alarmed. The False Alert Rate is the % of time the device alarmed
when the blood glucose level was above the alert setting within 15 or 30 minutes before or after the
device alarmed.

For example, if you set the Low Glucose Alert to 70 mg/dL and your alarm sounds, how often can you
expect your blood sugar to actually be low? In the Software 505 Adult Study (Table 5-A), when your
alarm sounds, you can expect your blood sugar to be below 70 mg/dL approximately 92% of the time
and above 70 mg/dL approximately 8% of the time within the 15 minute period before or after your
alarm sounds.

Hypoglycemia Detection Rate

The Detection Rate shows how often the device recognizes and alerts you to an episode of
hypoglycemia or how often it misses such an event. The Hypoglycemia Detection Rate is the % of
time the blood glucose level was at or below the alert setting and device alarmed within 15 or 30
minutes before or after the blood glucose was at or below the alert settings. The Hypoglycemia Missed
Detection Rate is the % of time the blood glucose was at or below the alert setting, but the device did
not alarm within 15 or 30 minutes before or after the blood glucose was at or below the alert setting.

For example, if you set the Low Glucose alert to 70 mg/dL, how often will your alarm alert you if your
blood glucose goes below 70 mg/dL? In the Software 505 Adult Study (Table 5-A), when your blood
sugar goes below 70 mg/dL, you can expect your alarm to sound 91% of the time and not to sound
approximately 9% of time within the 15 minute period before or after your blood sugar goes below
70 mg/dL.

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Table 6-A. Hyperglycemia Alert and Detection Rate Evaluation in
Reference to YSI 15 Minutes Before and After (Adult)

Hyperglycemia

Alert Level

Study

1

(mg/dL)

120

140

180

200

220

240

300

1

Both sets of study data are presented and are labeled as Original (SW10050) or Software 505

Original 95% 5% 98% 2%

Software 505 98% 2% 100% 0%

Original 94% 6% 97% 3%

Software 505 97% 3% 99% 1%

Original 92% 8% 97% 3%

Software 505 97% 3% 99% 1%

Original 92% 8% 97% 3%

Software 505 96% 4% 98% 2%

Original 91% 9% 95% 5%

Software 505 94% 6% 98% 2%

Original 91% 9% 94% 6%

Software 505 93% 7% 95% 5%

Original 82% 18% 86% 14%

Software 505 86% 14% 90% 10%

(SW10505).

Tru e
Alert
Rate

False
Alert

Rate

Hyperglycemia
Detection Rate

Hyperglycemia

Missed

Detection Rate

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Table 6-B. Hyperglycemia Alert and Detection Rate Evaluation in
Reference to YSI 15 Minutes Before and After (Pediatric, Ages 6-17 Years)

Hyperglycemia

Alert Level

Study

1

(mg/dL)

120

140

180

200

220

240

300

1

Both sets of study data are presented and are labeled as Original (SW10050) or Software 505

Original 91% 9% 98% 2%

Software 505 98% 2% 99% 1%

Original 87% 13% 99% 1%

Software 505 97% 3% 98% 2%

Original 75% 25% 99% 1%

Software 505 94% 6% 98% 2%

Original 71% 29% 98% 2%

Software 505 94% 6% 97% 3%

Original 67% 33% 97% 3%

Software 505 93% 7% 96% 4%

Original 62% 38% 96% 4%

Software 505 88% 12% 94% 6%

Original 43% 57% 93% 7%

Software 505 69% 31% 8 4% 16%

(SW10505).

Tru e
Alert
Rate

False
Alert

Rate

Hyperglycemia
Detection Rate

Hyperglycemia

Missed

Detection Rate

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Table 6-C. Hyperglycemia Alert and Detection Rate Evaluation in
Reference to SMBG 30 Minutes Before and After (Pediatric, Ages 2-5
Years)

Hyperglycemia

Alert Level

(mg/dL)

120

140

180

200

220

240

300

1

Both sets of study data are presented and are labeled as Original (SW10050) or Software 505

Software 505 97% 3% 99% 1%

Software 505 98% 2% 100% 0%

Software 505 99% 1% 93% 7%

Software 505 98% 2% 93% 7%

Software 505 10 0% 0% 97% 3%

Software 505 99% 1% 98% 2%

Software 505 95% 5% 96% 4%

1

Study

Original 92% 8% 98% 2%

Original 90% 10% 98% 2%

Original 87% 13% 96% 4%

Original 85% 15% 96% 4%

Original 81% 19% 95% 5%

Original 80% 20% 95% 5%

Original 71% 29% 90% 10%

(SW10505).

Tru e
Alert
Rate

False
Alert

Rate

Hyperglycemia
Detection Rate

Hyperglycemia

Missed

Detection Rate

The High Glucose Alert

Estimates of how well the adjustable High Glucose Alert performs are presented in Table 6-A, 6-B and
6-C. Table 6-A represents the hyperglycemia alert evaluation within 15 minutes of the YSI value in the
adult studies. Table 6-B represents the alert evaluation within 15 minutes of the YSI value for a subset
of the pediatric population—subjects age 6 to 17 years who had YSI measurements every 15 minutes.
Table 6-C represents the alert evaluation within 30 minutes of an SMBG reading for 2- to 5-year old
subjects in the pediatric studies.

Hyperglycemia Alert Rate

The Alert Rate shows how often the alert is right or wrong. The True Alert Rate is the % of time
the device alarmed when the blood glucose level was at or above the alert setting within 15 or 30

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minutes before or after the device alarmed. The False Alert Rate is the % of time the device alarmed
when the blood glucose level was below the alert setting within 15 or 30 minutes before or after the
device alarmed.

For example, if you set the High Glucose alert to 200 mg/dL and your alarm sounds, how often can you
expect your blood sugar to actually be high? In the Software 505 Adult Study (Table 6-A), when your
alarm sounds, you can expect your blood sugar to be at or above 200 mg/dL approximately 96% of the
time and not be above 200 mg/dL approximately 4% of the time within the 15 minute period before or
after your alarm sounds.

Hyperglycemia Detection Rate

The Detection Rate shows how often the device recognizes and alerts you to an episode of
hyperglycemia or how often it misses such an event. The Hyperglycemia Detection Rate is the % of
time the blood glucose level was at or above the alert setting and the device alarmed within 15 or
30 minutes before or after the blood glucose was at or above the alert settings. The Hyperglycemia
Missed Detection Rate is the % of time the blood glucose was at or above the alert setting, but the
device did not alarm within 15 or 30 minutes before or after the blood glucose was at or above the
alert setting.

For example, if you set your High Glucose alert to 200 mg/dL, how often will your alarm alert you if
your blood glucose goes at or above 200 mg/dL? In the Software 505 Adult Study (Table 6-A), when
your blood sugar goes above 200 mg/dL, you can expect your alarm to sound 98% of the time and not
to sound approximately 2% of time within the 15 minute period before or after your blood sugar goes
above 200 mg/dL.

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Table 7-A. Percentage of System Readings1 within YSI Values With Data
Stratified in 2-Hour Increments After Calibration (Adult)

Percent

Within

15/15%

YSI

Time from

Calibration

0-2 hours

2-4 hours

4-6 hours

6-8 hours

8-10 hours

10-12 ho urs

12-14 hours

1

CGM readings are within 40 to 400 mg/dL, inclusive.

2

Both sets of study data are presented and are labeled as Original (SW10050) or Software 505

Study

Original 1929 78% 88% 96% 2%

Software 505 469 93% 97% 99% 0%

Original 1516 69% 8 1% 91% 4%

Software 505 389 90% 97% 99% 0%

Original 15 47 69% 79% 91% 5%

Software 505 383 85% 91% 97% 2%

Original 1520 68% 79% 92% 3%

Software 505 380 79% 90% 97% 2%

Original 1555 71% 82% 92% 4%

Software 505 347 83% 92% 98% 0%

Original 1068 65% 77% 91% 4%

Software 505 295 80% 90% 98% 0%

Original 17 65% 76% 82% 12%

Software 505 0 -- -- -- --

2

Number
of Paired
CG M-YSI

Percent

Within

20/20%

YSI

Percent

Within

30/30%

YSI

(SW10505).

Percent

Greater

than

40/40%

YSI

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Table 7-B. Percentage of System Readings1 within YSI Values with Data
Stratified in 2-Hour Increments after Calibration (Pediatric)

Percent

within

15/15%

YSI

Time from

Calibration

0-2 hours

2-4 hours

4-6 hours

6-8 hours

8-10 hours

10-12 ho urs

12-14 hours

1

CGM readings are within 40 to 400 mg/dL, inclusive.

2

Both sets of study data are presented and are labeled as Original (SW10050) or Software 505

Study

Original 648 65% 75% 87% 7%

Software 505 545 83% 91% 97% 1%

Original 649 51% 67% 86% 7%

Software 505 460 72% 89% 96% 2%

Original 630 51% 61% 80% 10%

Software 505 428 77% 88% 95% 2%

Original 409 52% 68% 85% 5%

Software 505 325 88% 92% 94% 3%

Original 296 53% 69% 84% 7%

Software 505 305 86% 93% 97% 1%

Original 253 58% 74% 89% 5%

Software 505 198 89% 94% 98% 0%

Original 37 32% 38% 65% 22%

Software 505 1 10 0% 100% 100% 10 0%

2

Number
of paired
CG M-YSI

Percent

within

20/20%

YSI

Percent

within

30/30%

YSI

(SW10505).

Percent

greater

than

40/40%

YSI

Calibration Stability

The System must be calibrated every 12 hours. To demonstrate performance of the System over a
12-hour calibration period, Systems were evaluated to verify that performance remains consistent
over the 12-hour calibration period. Systems were evaluated in 2-hour increments after calibration.
Performance was estimated at each 2-hour interval and stratified by glucose values by calculating
the percentage of System readings within 15 mg/dL or 15%, 20 mg/dL or 20%, 30 mg/dL or 30%, 40
mg/dL or 40% and greater than 40 mg/dL or 40% of the YSI values in Table 7-A and 7-B.

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Table 8-A. Sensor Stability Relative to YSI (Accuracy Over Time1) - (Adult)

Number

Day

of

Wear

Day

1

Day

4

Day

7

1

CGM readings are within 40 to 400 mg/dL, inclusive.

2

Both sets of study data are presented and are labeled as Original (SW10050) or Software 505

2

Study

Original 3023 16.7% 13.2% 59% 71% 86% 6%

Software 505 680 10.7% 7. 9% 77% 84% 96% 2%

Original 3108 11.4% 8.2% 77% 87% 95% 2%

Software 505 777 8.0% 6.4% 89% 96% 99% 0%

Original 3021 11.9 % 8.9% 76% 87% 95% 2%

Software

505

of

Paired

CGM-

YSI

806 8.5% 7. 2% 90% 97% 99% 0%

Mean

Absolute

Percent

Differences

Median

Absolute

Percent

Differences

Percent

Within

15/15%

YSI

Percent

Within

20/20%

YSI

Percent

Within

30/30%

(SW10505).

YSI

Percent

Greater

than

40/40%

YSI

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Table 8-B. Sensor Stability Relative to YSI (Accuracy Over Time1) ­(Pediatric, Ages 6-17 Years)

Number

Day

of

Wear

Day

1

Day

4

Day

7

1

CGM readings are within 40 to 400 mg/dL, inclusive.

2

Both sets of study data are presented and are labeled as Original (SW10050) or Software 505

2

Study

Original 1016 21.2% 15.8% 48% 61% 78% 15%

Software 505 74 0 12.7% 8.5% 75% 83% 91% 4%

Original 810 16.0% 13.9% 52% 66% 87% 3%

Software 505 795 8.1% 6.7% 89% 97% 100% 0%

Original 1096 15.1% 11. 3% 63% 76% 89% 4%

Software

505

of

Paired

CGM-

YSI

727 10.4% 8.4% 80% 91% 98% 1%

(SW10505).

Mean

Absolute

Percent

Differences

Median

Absolute

Percent

Differences

Percent

Within

15/15%

YSI

Percent

Within

20/20%

YSI

Percent

Within

30/30%

YSI

Percent

Greater

than

40/40%

YSI

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Table 8-C. Sensor Stability Relative to SMBG (Accuracy Over Time1) ­(Pediatric, Ages 2-17 Years)

Number

Day

of

Wear

Day

1

Day

2

Day

3

Day

4

Day

5

Day

6

Day

7

1

CGM readings are within 40 to 400 mg/dL, inclusive.

2

Both sets of study data are presented and are labeled as Original (SW10050) or Software 505

2

Study

Original 3216 18.8% 14.2% 53% 65% 81% 10%

Software 505 893 14.8% 10.7% 64% 79% 91% 5%

Original 2148 16.2% 12.4% 60% 74% 87% 6%

Software 505 436 13. 2% 10.4% 69% 81% 95% 3%

Original 1977 15.2 % 11. 0% 63% 76% 89% 5%

Software 505 441 13.8% 11.3 % 66% 77% 91% 2%

Original 2830 14.0% 10.9% 66% 79% 91% 4%

Software 505 850 10.7% 8.5% 79% 91% 97% 1%

Original 1768 15.4% 10.7% 67% 78% 90% 5%

Software 505 374 11.4% 8.7% 74% 86% 96% 1%

Original 1704 14.3% 9.8% 68% 79% 90%

Software 505 410 12.3% 9.2% 72% 80% 93% 2%

Original 2675 12.4% 9.2% 72% 83% 94% 3%

Software 505 860 11. 3% 8.6% 79% 90% 96% 2%

of

Paired

CGM-

SMBG

(SW10505).

Mean

Absolute

Percent

Differences

Median

Absolute

Percent

Differences

Percent

Within

15/15%

SMBG

Percent

Within

20/20%

SMBG

Percent

Within

30/30%

SMBG

Percent

Greater

than

40/40%

SMBG

4%

Sensor Stability

Relative to YSI

Sensors can be worn for up to 7 days. Performance was estimated by calculating the percentage of
System readings within 15 mg/dL or 15%, 20 mg/dL or 20%, 30 mg/dL or 30% , 40 mg/dL or 40%
and greater than 40 mg/dL or 40% of the YSI values at the beginning (Day 1), middle (Day 4) and
end (Day 7) of the System lifecycle. The average and median of the absolute percent differences are
included in Table 8-A and 8-B showing consistent accuracy and sensor stability over the 7-day life of
the sensor.

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Relative to SMBG (Pediatric Study)

Performance was also estimated by calculating the percentage of system readings within various
percentages of the SMBG values at each day of the sensor wear period (Table 8-C). The average and
median of the absolute percent differences are included in the table.

Precision of System Readings

A subset of subjects wore two Systems at the same time. This was to look at how similarly two
Systems function on the same subject (sensor precision). Precision was evaluated by comparing the
glucose readings from the two Systems worn on the same subject at the same time.

In the Original Adult Study, 36 subjects wore two Systems. Results showed that System readings
from the two sensors generally agreed with each other within 9% (absolute percent difference) with
a 7% coefficient of variation. In the Original Pediatric Study, all subjects wore two Systems. Results
showed that System readings from the two sensors generally agreed with each other within 10%
(absolute percent difference) with a 7% coefficient of variation. Only one System was worn in the

Software 505 Adult and Software 505 Pediatric Studies so precision data was not collected.

Sensor Life

Sensors may be worn for up to 7 days (168 hours). To estimate how long a sensor will work over
7 days, all sensors worn were evaluated to determine how many days/hours of readings each
sensor provided.

In the Original Adult Study, 108 sensors were evaluated. Ninety-four percent (94%) of the sensors
lasted until Day 7 (145-168 hours). There were 6 (6%) sensors that ended early, four of which lasted
more than 3 days.

In the Software 505 Adult Study, 51 sensors were evaluated. Ninety-eight percent (98%) of the
sensors lasted until Day 7 (145-168 hours). There was 1 (2%) sensor that ended early, which lasted
until day 5 of the sensor wear.

In the Original Pediatric Study, 351 sensors were evaluated. Eighty-five percent (85%) of the sensors
lasted until Day 7 (145-168 hours).

In the Software 505 Pediatric Study, 77 sensors were evaluated. Ninety-four percent (94%) of the
sensors lasted until Day 7 (145-168 hours).

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Table 9-A. Number of Readings Provided by Each Sensor Over 7-Days
(Adult)

% of Total Possible
Readings Provided

0-25%

26-50%

51-75%

76 -100%

1

Both sets of study data are presented and are labeled as Original (SW10050) or Software 505

Study

Original 16 7-491 2%

Software 505 0 0%

Original 719-914 4%

Software 505 856-856 2%

Original 1267-126 7 1%

Software 505 1253-1253 2%

Original 1811-19 92 94%

Software 505 1497-1992 96%

(SW10505).

1

Total Readings

Provided

(Min-Max)

% of Systems Providing

That Number of Readings

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