Dexcom 9496 Spread Spectrum Device User Manual Part 2

Dexcom, Inc. Spread Spectrum Device Part 2

Contents

User Manual Part 2

Dexcom G5 Mobile System User Guide168Daily Events Aect Your Glucose Trends and Patterns(Continued from previous page)Enter Stress Event14 Turn 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 ReceiverWhile 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: ReceiverStep What you see What you doEnter Carbs Event1Default screenPress Select to go to Main Menu.(Continued on next page)
169Dexcom G5 Mobile System User GuideDaily Events Aect Your Glucose Trends and Patterns(Continued from previous page)Enter Carbs Event2Press Down Arrow until Events is highlighted.Press Select.3Highlight Carbs.Press Select.4Add up all carb grams from lunch.Arrow up to “85.”Press Select.5Press Left/Right Arrows to change time and date.• Left: Backwards• Right: ForwardPress Select.6Confirmation screen.Press Select.(Continued on next page)
Dexcom G5 Mobile System User Guide170Daily Events Aect Your Glucose Trends and Patterns(Continued from previous page)Enter Health Event7Press Down Arrow until Health.8Press Down Arrow to Stress.Press Select.9Press Left/Right Arrows to change time and date.• Left: Backwards• Right: ForwardPress Select.10Verify information is correct.Press Left/Right Arrows to highlight field.Press Up/Down Arrows to change numbers.Press Select to save.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.
171Dexcom G5 Mobile System User GuideDaily Events Aect Your Glucose Trends and PatternsLandscape What it does What you doLandscape OnlyShow Event details.Landscape Only• Tap square• Slide finger across screenOnce 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.SummaryNow 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 receiverWhat’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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173Dexcom G5 Mobile System User GuideSensor Glucose Alarm and Alerts11.1 IntroductionMonitoring 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 ReceiverYour 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 readingChapter 11Next Steps:Sensor Glucose Alarm and Alerts
Dexcom G5 Mobile System User Guide174Sensor Glucose Alarm and Alerts11.2 Safety StatementsThe 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. WARNINGDo: 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 Settings menu2. Verify app hasn’t been shut down.3. Adjust volume so you can hear sounds.4. Turn Bluetooth on.5. Turn off Do Not Disturb.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.WARNINGDon’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.WARNINGDo: 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.
175Dexcom G5 Mobile System User GuideSensor Glucose Alarm and AlertsPRECAUTIONDon’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.PRECAUTIONDo: 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.PRECAUTIONDo: 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 AlertsAs 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.
Dexcom G5 Mobile System User Guide176Sensor Glucose Alarm and AlertsWhat Is an Alarm?While there are a variety of Alerts, there is just one Alarm, the Urgent Low Alarm (Alarm) is 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. Think of it as a safety net: your glucose level is dangerously low—pay attention now!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 AlertsLow/High AlertsYour 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.
177Dexcom G5 Mobile System User GuideSensor Glucose Alarm and AlertsRise Rate/Fall Rate/Repeat/Signal Loss AlertsRise 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 Alerts1. Rise Ratea. Default setting is Off—No Alert.b. Need to change settings to receive Rising Alert.2. Fall Ratea. Default setting is Off—No Alert.b. Need to change settings to receive Falling Alert. 3. Repeata. Default setting is Off—No Alert.b. Need to change settings to receive Repeat Alert.Signal Loss AlertSignal 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 ScreensWhen 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.
Dexcom G5 Mobile System User Guide178Sensor Glucose Alarm and AlertsUrgent Low Glucose AlarmDevice What you see What it meansSmart Device: Lock ScreenSensor glucose reading at or below 55 mg/dL.Shows last glucose value.Arrows reflect rate of change.Check BG meter to make treatment decisions.Smart Device: In AppReceiver
179Dexcom G5 Mobile System User GuideSensor Glucose Alarm and AlertsLow/High Glucose AlertsDevice What you see What it meansSmart Device: Lock ScreenSensor glucose reading at or below your low Alert level.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.Smart Device: In AppReceiver(Continued on next page)
Dexcom G5 Mobile System User Guide180Sensor Glucose Alarm and Alerts(Continued from previous page)Device What you see What it meansSmart Device: Lock ScreenSensor glucose reading at or above your high Alert level.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.Smart Device: In AppReceiver
181Dexcom G5 Mobile System User GuideSensor Glucose Alarm and AlertsRise Rate/Fall Rate AlertsDevice What you see What it meansSmart Device: Lock ScreenSensor glucose readings rising quickly.Number of arrows shows how fast (2 mg/dL/min; 3+ mg/dL/min).Check BG meter to make any treatment decisions.Smart Device: In AppReceiver (Continued on next page)
Dexcom G5 Mobile System User Guide182Sensor Glucose Alarm and Alerts(Continued from previous page)Device What you see What it meansSmart Device: Lock ScreenSensor glucose readings falling quickly.Number of arrows shows how fast (2 mg/dL/min; 3+ mg/dL/min).Check BG meter to make any treatment decisions.Smart Device: In AppReceiver
183Dexcom G5 Mobile System User GuideSensor Glucose Alarm and AlertsSignal Loss AlertDevice What you see What it meansSmart Device: Lock ScreenYour receiver and transmitter are not communicating.You will not receive Alarm/Alerts.Check BG meter to check your glucose and make any treatment decisions.Smart Device: In AppReceiver11.5 App: Alarm/Alert Recommended SettingsThe 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 prioritizedFor information on smart device settings, see your smart device’s instructions.
Dexcom G5 Mobile System User Guide184Sensor Glucose Alarm and AlertsIf 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 VibrationsThe 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 AlarmWhat you see Beeps and vibrationInitial 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.
185Dexcom G5 Mobile System User GuideSensor Glucose Alarm and AlertsLow/High Glucose AlertsWhat you see Beeps and vibrationInitial 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.
Dexcom G5 Mobile System User Guide186Sensor Glucose Alarm and AlertsRise Rate/Fall Rate AlertsWhat you see Beeps and vibrationInitial 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.
187Dexcom G5 Mobile System User GuideSensor Glucose Alarm and AlertsLow Repeat/High RepeatWhat you see Beeps and vibrationInitial 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 AlertWhat you see Beeps and vibrationInitial 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.
Dexcom G5 Mobile System User Guide188Sensor Glucose Alarm and Alerts11.7 Clearing Alarm/AlertsAlerts 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 DeviceDevice What you see What you doSmart Device: Lock Screen Slide Alarm or Alert to access app.Smart Device: In App Tap OK to accept Alarm or Alert.
189Dexcom G5 Mobile System User GuideSensor Glucose Alarm and AlertsClearing Your ReceiverWhat you see What you doPress 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.SummaryNow 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 ReceiverWhat’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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191Dexcom G5 Mobile System User GuideOn the Go With G5: Customizing Your Alarm and Alerts12.1 IntroductionThe 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 LossEach 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.Chapter 12Next Steps:On the Go With G5: Customizing Your Alarm and Alerts
Dexcom G5 Mobile System User Guide192On the Go With G5: Customizing Your Alarm and Alerts12.2 Safety StatementWARNINGDo: 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 AlertsApp Screen OverviewThe 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 OverviewStep What you see What it means What you do1 Access Main Menu. Tap Main Menu icon.(Continued on next page)
193Dexcom G5 Mobile System User GuideOn the Go With G5: Customizing Your Alarm and Alerts(Continued from previous page)Step What you see What it means What you do2Access Alerts Main Menu. Tap Alerts.3All customizable Alarm and Alerts.Current Alert settings.All alerts have:• On/Off switch• Notify me options• Sound optionsTap Alarm/Alert you want to change.(Continued on next page)
Dexcom G5 Mobile System User Guide194On the Go With G5: Customizing Your Alarm and Alerts(Continued from previous page)Step What you see What it means What you do4“?” explains:• Each Alarm/Alert• Message options• Recommended settingsTap “?” for Alarm/Alert information.5Urgent Low Glucose Alarm:• Preset at 55 mg/dL and cannot be changed• Repeat preset at 30 minutes and can’t be changed• Sound is the only change optionTap Sound to change sound.
195Dexcom G5 Mobile System User GuideOn the Go With G5: Customizing Your Alarm and AlertsSteps to Customize App Alarm/AlertsAlthough 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 Alert you want.a. Tap On or Off switch to turn on desired Alerts.3. Tap Notify me.a. Change the Alert glucose level (mg/dL).i. Scroll selection wheel, find your desired Alert level.ii. Tap to highlight.iii. Tap Save.4. Tap 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.5. Tap 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.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.Customizing Alerts: AppStep What you see What it means What you doAccess Alerts’ Main Menu1Access Main Menu. Tap Main Menu icon.(Continued on next page)
Dexcom G5 Mobile System User Guide196On the Go With G5: Customizing Your Alarm and Alerts(Continued from previous page)Access Alerts’ Main Menu2Access Alerts Main Menu. Tap Alerts.(Continued on next page)
197Dexcom G5 Mobile System User GuideOn the Go With G5: Customizing Your Alarm and Alerts(Continued from previous page)Changing an Alert3Access High Alert settings (mg/dL). Tap High mg/dL.4Shows High Alert options and current settings.Check High Alerts is On.• On - Orange• Off - Gray(Continued on next page)
Dexcom G5 Mobile System User Guide198On the Go With G5: Customizing Your Alarm and Alerts(Continued from previous page)Changing an Alert5Won’t get Alerts if Off.If Off: OnSlide to On.• On - Orange• Off - Gray6Change High Alert (mg/dL). Tap Notify Me Above.(Continued on next page)
199Dexcom G5 Mobile System User GuideOn the Go With G5: Customizing Your Alarm and Alerts(Continued from previous page)Changing an Alert7Change glucose level from current level (mg/dL).Scroll selection wheel.Stop at 190.8Saves new High Alert glucose level (mg/dL).Returns to High Glucose Alert screen options.Notify Me Above set at 190 mg/dL.Tap Save.(Continued on next page)
Dexcom G5 Mobile System User Guide200On the Go With G5: Customizing Your Alarm and Alerts(Continued from previous page)Changing an Alert9Changes how often your High Alert repeats after initial Alert and confirmation.Repeats only if you are above your high glucose level.Tap Repeat.10Changing the current repeat setting.Can select in five minute steps (range 15 minutes-4 hours).Scroll selection wheel.Stop at 1 hour.(Continued on next page)
201Dexcom G5 Mobile System User GuideOn the Go With G5: Customizing Your Alarm and Alerts(Continued from previous page)Changing an Alert11Saves your new repeat timing.Returns to High Glucose Alert screen options.Repeat shows how often you’ll get notified.Tap Save.12 Customize Alert sound. Tap Sound.(Continued on next page)
Dexcom G5 Mobile System User Guide202On the Go With G5: Customizing Your Alarm and Alerts(Continued from previous page)Changing an Alert13 Changes current sound setting.Tap Doorbell.Tap Sound again to hear sound sample.14Saves your new Alert sound.Return to High Glucose Alert Menu.Tap Back Arrow.(Continued on next page)
203Dexcom G5 Mobile System User GuideOn the Go With G5: Customizing Your Alarm and Alerts(Continued from previous page)Changing an Alert15 Return to Main Menu. Tap “X”.16 Return to trend screen.Tap Menu iconOrSwipe right.
Dexcom G5 Mobile System User Guide204On the Go With G5: Customizing Your Alarm and AlertsAny 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 AlertsYou’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.ProfilesProfiles 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 Vibrate will replace audible beeps with quiet vibrations. The only exception is the Alarm: the urgent low Alarm can’t be turned off.Changes made in Profiles are applied to all of the receiver’s Alarm/Alerts. If you choose Soft (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 uses a rising or falling melody instead of beeps.The receiver first vibrates when sending you an Alarm or Alert. If you clear the alert at the first vibration by pressing the Select button on your navigation wheel, you won’t get any 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.HypoRepeat is very similar to the Normal Profile, but keeps repeating the fixed low alarm every 5 seconds until your sensor glucose value rises above 55 mg/dL or you confirm by pressing the Select button.The next table lists the different sound Profiles, starting with the quietest, working its way up to the loudest.
205Dexcom G5 Mobile System User GuideOn the Go With G5: Customizing Your Alarm and AlertsAlarm/Alert Sound ProfilesIcon Profile name Notification descriptionVibrateVibration only.Only sound is your receiver vibrating.Vibrate is not available for the Alarm.Soft Lower volume beeps.Normal Medium volume beeps.Default Profile.AttentiveNo beeps.• Rising melody for High and Rising Alerts• Dropping melody for Low and Falling AlertsHypoRepeatMedium volume beeps.Urgent low Alarm only.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 Profile throughout the day depending on what lays ahead: In a meeting? Select Vibrate. Going to a ball game after work? Select Attentive.The next table shows how to change a sound Profile, then sample how it sounds.
Dexcom G5 Mobile System User Guide206On the Go With G5: Customizing Your Alarm and AlertsCustomizing Sound Profiles: ReceiverStep What you see What it means What you do1 Go to Main Menu. Press Select.2Second Main Menu screen.Press Down Arrow.Profiles on second screen.3Profiles adjusts volume of Alarm/Alerts.Press Up/Down Arrow.Stop at Profiles.Press Select.4Choose sound Profile.Press Up/Down Arrow.Stop at desired Profile.Press Select.(Continued on next page)
207Dexcom G5 Mobile System User GuideOn the Go With G5: Customizing Your Alarm and Alerts(Continued from previous page)Step What you see What it means What you do5Selected Profile check marked.Sample sound:Press Down Arrow.Stop at Try It.Press Select to have the sound play.Exit Profiles:Press Left Arrow.6N/A Repeat as needed.Repeat steps 2-5 to change Profile.To Exit: Press Left Arrow to Main Menu.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 MenuLow/High Alert option lets you adjust your low/high glucose Alert level (mg/dL).Advanced gives you options to turn on Low/High Repeat, Rise/Fall Alerts and Signal Loss Alert.Low/High RepeatIn 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 RateYour trend screen provides visual cues letting you know your sensor glucose readings are falling or rising rapidly.
Dexcom G5 Mobile System User Guide208On the Go With G5: Customizing Your Alarm and AlertsConstantly 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 Off.It’s important you discuss your alert settings with your healthcare professional.Signal LossSignal 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/AlertsUsing 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: ReceiverStep What you see What it means What you doChange High Alert Level1Go to Main Menu. Press Select.(Continued on next page)
209Dexcom G5 Mobile System User GuideOn the Go With G5: Customizing Your Alarm and Alerts(Continued from previous page)Change High Alert Level2Alerts option from the Main Menu.Press Down Arrow.Stop at Alerts.3Enter Alerts menu option. Press Select.4Alerts’ option menu.Lists different Alerts: High/Low/Advanced (Repeat, Rise/Fall, Signal Loss) Alerts.Press Up/Down Arrow.Stop at High Alert.Press Select.5Alert’s current settings.Change your current High Alert level.Press Down Arrow.Stop at Level.Press Select.6Current setting.Use Up/Down arrows to change your High Alert level (mg/dL).Press Down Arrow.Stop at 190 mg/dL.(Continued on next page)
Dexcom G5 Mobile System User Guide210On the Go With G5: Customizing Your Alarm and Alerts(Continued from previous page)Change High Alert Level7Saves new High Alert level.Return to Alerts Menu.Press Select.To exit:Press Left Arrow.Turn Repeart On8Alerts Menu.Choose Advanced to get to Repeat Alert.Press Down Arrow.Stop at Advanced.9Enter Advanced Alert options.Press Select on Advanced.10Main Advanced screen.Set Repeat Alerts.Turn On Rise/Fall Rate Alerts.Arrow to High Repeat.Press Select.11Initial screen shows current repeat minutes.Change time frame in 5 minute increments.Press Up/Down Arrow.Stop at 60 minutes.(Continued on next page)
211Dexcom G5 Mobile System User GuideOn the Go With G5: Customizing Your Alarm and Alerts(Continued from previous page)Turn Repeat On12 Changed Repeat time for High Alert. Press Select.13 Changed completed.Return to Alerts Menu.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.SummaryNow 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 LossWhat’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.
Dexcom G5 Mobile System User Guide212On the Go With G5: Customizing Your Alarm and AlertsThe 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.
• Warranty• Maintenance• Travel Tips• Customer Service Contacts• Technical Information• Troubleshooting• Package SymbolsEVERYTHING ELSE G5
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215Dexcom G5 Mobile System User GuideWarranty: The Fine Print13.1 IntroductionSometimes 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 WarrantyWhat’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 dateNOTE: 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.Chapter 13Everything Else G5:Warranty: The Fine Print
Dexcom G5 Mobile System User Guide216Warranty: The Fine PrintThis 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 WarrantyDuring 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. Receiver2. Sales receipt or comparable substitute proof of sale showing the date of purchase 3. Receiver’s Serial Number 4. Seller’s name and addressCall Dexcom Technical Support Department for delivery information help:• Toll free: 1.877.339.2664• Charges may apply: 1.858.200.0200Upon receipt, Dexcom will promptly replace the defective Receiver.
217Dexcom G5 Mobile System User GuideWarranty: The Fine PrintIf 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 ObligationsThe 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 WarrantyWhat’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.
Dexcom G5 Mobile System User Guide218Warranty: The Fine PrintNOTE: 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.
219Dexcom G5 Mobile System User GuideWarranty: The Fine Print13.4 Dexcom’s Obligations Under the Limited WarrantyDuring 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. Transmitter2. Sales receipt or comparable substitute proof of sale showing the date of purchase 3. Transmitter’s Serial Number 4. Seller’s name and addressCall 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 ObligationsThe 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.
Dexcom G5 Mobile System User Guide220Warranty: The Fine PrintThis 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.
221Dexcom G5 Mobile System User GuideHow to Take Care of Your Dexcom G5 Mobile CGM System14.1 IntroductionThere 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. Sensorb. Transmitterc. Receiverd. Charge receiver battery2. Determine what accessories you may use3. Identify the best storage methodsa. Sensorb. Transmitterc. Receiver4. How to safely dispose ofa. Sensorb. Transmitterc. ReceiverChapter 14Everything Else G5:How to Take Care of Your Dexcom G5 Mobile CGM System
Dexcom G5 Mobile System User Guide222How to Take Care of Your Dexcom G5 Mobile CGM System14.2 Basic MaintenanceSensor1. 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.Transmitter1. 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.Receiver1. 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 BatteryThe 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.
223Dexcom G5 Mobile System User GuideHow to Take Care of Your Dexcom G5 Mobile CGM SystemEach 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 do1Low Battery Charge your battery.2Micro USB PortOpen USB port door.Plug USB cable into port for recharging.(Continued on next page)
Dexcom G5 Mobile System User Guide224How to Take Care of Your Dexcom G5 Mobile CGM System(Continued from previous page)Step What you see What it means What you do3Micro USB CablePlug into receiver to charge battery.Don’t plug into a computer port to chargeDon’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.4Wall ChargerPlug USB cable into adapter/wall charger.Plug wall charger into an electrical outlet to charge receiver’s battery.Don’t block access to the charger.(Continued on next page)
225Dexcom G5 Mobile System User GuideHow to Take Care of Your Dexcom G5 Mobile CGM System(Continued from previous page)Step What you see What it means What you do5Battery Charging Keep charging until icons are solid.6Battery ChargedUnplug wall charger from outlet when fully charged.6USB Port DoorRemove USB cable from receiver.Close USB port door after removing USB cable to keep receiver clean and dry.Accessories1. 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.
Dexcom G5 Mobile System User Guide226How to Take Care of Your Dexcom G5 Mobile CGM SystemIf 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 StorageStoring your Dexcom G5 Mobile CGM System correctly helps prevents system failures. Sensor1. 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.Transmitter1. 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.Receiver1. 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.
227Dexcom G5 Mobile System User GuideHow to Take Care of Your Dexcom G5 Mobile CGM System14.4 Checking App and Receiver InformationCHECKING YOUR APP & RECEIVER SOFTWARE VERSIONYou can check your app or receiver for information about your CGM system at any time.Receiver 1. From the Settings menu, press Up or Down arrows to scroll to “Device Info.”2. Press Select. Information about your sensor session and system will show.App 1. From Main Menu, tap Settings.2. Tap Device Info.Available Information• Insertion Time• Last Calibration• Transmitter Battery• Transmitter SN• Serial Number• Part Number• Part Revision• Software Number
Dexcom G5 Mobile System User Guide228How to Take Care of Your Dexcom G5 Mobile CGM System14.5 System DisposalDifferent 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!
229Dexcom G5 Mobile System User GuideOn the Go With Dexcom G5 Mobile CGM System: Getting Through Security15.1 IntroductionDexcom 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 SecurityWalk-Through Metal DetectorsTransmitter and SensorNo 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.Chapter 15Everything Else G5:On the Go With Dexcom G5 Mobile CGM System: Getting Through Security
Dexcom G5 Mobile System User Guide230On the Go With Dexcom G5 Mobile CGM System: Getting Through SecurityX-Ray MachinesReceiver, Extra SensorsDon’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-off2. 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 Bluetooth on and you will be able to receive sensor glucose information on your smart device.Technical InformationThe 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.
231Dexcom G5 Mobile System User GuideOn the Go With Dexcom G5 Mobile CGM System: Getting Through SecurityEmail: TSA-ContactCenter@dhs.govPhone: Call 1.866.289.9673
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233Dexcom G5 Mobile System User GuideNeed Help? You’re Not Alone!Dexcom has two support teams to help you, each with their own specialty:• Technical Support Team• Patient Care Team16.1 Dexcom Technical SupportProvides 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 PhoneDexcom Technical Support Phone Numbers:Toll Free: 1.877.339.2664Toll Call: 1.858.200.0200By EmailEmail: TechSupport@dexcom.com 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)Chapter 16Everything Else G5:Need Help? You’re Not Alone!
Dexcom G5 Mobile System User Guide234Need Help? You’re Not Alone!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 TeamThe 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 reportsBy PhoneAvailable Monday-Friday 5:30 am-8:00 pm PST (subject to change) Toll Free: 1.877.339.2664Toll Call: 1.858.200.0200By EmailEmail: patientcare@dexcom.comIf 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 neededFor additional Dexcom CGM education, check the Dexcom website: dexcom.com/web-based-education
235Dexcom G5 Mobile System User GuideNeed Help? You’re Not Alone!16.3 Sales Support TeamInside Sales Support TeamFor help with:• First-time orders• Re-orders• Tracking shipments • Locating a local Dexcom representativeBy PhoneDexcom Inside Sales Support Phone Numbers:Toll Free: 1.877.339.2664Toll Call: 1.858.200.0200By EmailDexcom Inside Sales Support Email: CustomerService@dexcom.com By Fax1.877.633.926616.4 Corporate Dexcom Website:Dexcom.comDexcom Address:6340 Sequence DriveSan Diego, CA 92121
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237Dexcom G5 Mobile System User GuideTechnical Information17.1 Device Performance CharacteristicsNOTE: 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 OverviewThe 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 SW10505The Dexcom G5 Mobile CGM System incorporates the algorithm from software version SW10505 and has a new software number.Overview of Adult StudiesThe 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). Chapter 17Everything Else G5:Technical Information
Dexcom G5 Mobile System User Guide238Technical InformationDifferences 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 StudiesThe 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
239Dexcom G5 Mobile System User GuideTechnical Informationthe 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® OneTouch® Verio® IQ meter; the Software 505 Pediatric Study used Bayer’s CONTOUR® NEXT USB meter.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.”
Dexcom G5 Mobile System User Guide240Technical InformationTable 1-A. System Agreement to YSI within CGM Glucose Ranges (Adult)CGM Glucose Range1 (mg/dL)Study2Number of Paired CGM-YSIPercent Within 15/15% YSIPercent Within 20/20% YSIPercent Within 30/30% YSIPercent Greater than 40/40%YSIOverall Original 9152 71% 82% 92% 3%Software 505 2263 86% 93% 98% 1%40-60 Original 512 67% 78% 88% 6%Software 505 120 89% 94% 98% 0%61-80 Original 781 73% 85% 94% 2%Software 505 226 91% 96% 99% 0%81-180 Original 3853 67% 78% 91% 3%Software 505 738 84% 92% 98% 1%181-300 Original 2784 72% 84% 93% 4%Software 505 798 86% 93% 98% 1%301-350 Original 775 82% 91% 97% 2%Software 505 229 86% 94% 98% 1%351-400 Original 447 74% 84% 91% 5%Software 505 152 80% 92% 97% 0%1CGM readings are within 40-400 mg/dL, inclusive.2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).
241Dexcom G5 Mobile System User GuideTechnical InformationTable 1-B. System Agreement to YSI within CGM Glucose Ranges (Pediatric)CGM Glucose Range1 (mg/dL)Study2Number of Paired CGM-YSIPercent Within 15/15% YSIPercent Within 20/20% YSIPercent Within 30/30% YSIPercent Greater than 40/40%YSIOverall Original 2922 55% 68% 85% 7%Software 505 2262 81% 91% 96% 2%40-60 Original 19 63% 74% 79% 21%Software 505 86 54% 74% 91% 3%61-80 Original 76 61% 82% 92% 4%Software 505 142 77% 82% 90% 3%81-180 Original 1155 56% 69% 84% 6%Software 505 805 78% 88% 97% 1%181-300 Original 1380 55% 68% 85% 7%Software 505 957 89% 96% 99% 1%301-350 Original 206 48% 62% 80% 11%Software 505 209 81% 91% 94% 5%351-400 Original 86 48% 61% 79% 12%Software 505 63 64% 81% 83% 8%1CGM readings are within 40-400 mg/dL, inclusive.2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).Agreement Relative to YSIAgreement 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
Dexcom G5 Mobile System User Guide242Technical Informationor 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.
243Dexcom G5 Mobile System User GuideTechnical InformationTable 2-A. Number and Percentage of YSI Values When CGM Readings are “LOW” or “HIGH” (Adult)YSI mg/dLTotalCGM Readings Study1CGM-YSI Pairs < 55 < 60 < 70 < 80 ≥ 80“LOW”Originaln66 84 123 142 13 155Cumulative Percent 42% 54% 79% 92% 8%Software 505n11 16 17 18 018Cumulative Percent 61% 89% 94% 100% 0%YSI mg/dLTotalCGM Readings Study1CGM-YSI Pairs > 340 > 320 > 280 > 240 ≤ 240“HIGH”Originaln189 220 238 246 2248Cumulative Percent 76% 89% 96% 99% 1%Software 505n40 43 45 45 045Cumulative Percent 89% 96% 100% 100% 0%1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).
Dexcom G5 Mobile System User Guide244Technical InformationTable 2-B. Number and Percentage of YSI Values When CGM Readings are “LOW” or “HIGH” (Pediatric)YSI mg/dLTotalCGM Readings Study1CGM-YSI Pairs < 55 < 60 < 70 < 80 ≥ 80“LOW”Originaln000013 13Cumulative Percent 0% 0% 0% 0% 100%Software 505n3 5 10 15 116Cumulative Percent 19% 31% 63% 94% 6%YSI mg/dLTotalCGM Readings Study1CGM-YSI Pairs > 340 > 320 > 280 > 240 ≤ 240“HIGH”Originaln38 51 68 69 170Cumulative Percent 54% 73% 97% 99% 1%Software 505n14 19 22 23 124Cumulative Percent 58% 79% 92% 96% 4%1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).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”).
245Dexcom G5 Mobile System User GuideTechnical InformationFor 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.
Dexcom G5 Mobile System User Guide246Technical InformationTable 3-A. Concurrence of CGM Readings and YSI Values (Original Adult Study)CGM (mg/dL)YSI (mg/dL)Row Percentage of Matched Pairs in each CGM Glucose Range< 40 40-6061-8081-120121-160161-200201-250251-300301-350351-400> 400Number of Paired CGM-YSI< 40 6% 48% 37% 7% 1% 0% 0% 0% 0% 0% 0% 15540-60 4% 49% 36% 11% 1% 0% 0% 0% 0% 0% 0% 51261-80 0% 22% 51% 24% 1% 0% 0% 0% 0% 0% 0% 78181-120 0% 2% 17% 66% 13% 1% 0% 0% 0% 0% 0% 1706121-160 0% 0% 1% 25% 60% 13% 2% 0% 0% 0% 0% 1492161-200 0% 0% 0% 2% 28% 53% 16% 2% 0% 0% 0% 1240201- 250 0% 0% 0% 0% 3% 21% 51% 21% 3% 1% 0% 1181251- 300 0% 0% 0% 0% 0% 4% 19% 49% 24% 3% 0% 1018301- 350 0% 0% 0% 0% 0% 0% 3% 28% 51% 16% 1% 775351- 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
247Dexcom G5 Mobile System User GuideTechnical InformationTable 3-B. Concurrence of CGM Readings and YSI Values (Software 505 Adult Study)CGM (mg/dL)YSI (mg/dL)Row Percentage of Matched Pairs in each CGM Glucose Range< 40 40-6061-8081-120121-160161-200201-250251-300301-350351-400> 400Number of Paired CGM-YSI< 40 6% 83% 11% 0% 0% 0% 0% 0% 0% 0% 0% 1840-60 2% 74% 22% 3% 0% 0% 0% 0% 0% 0% 0% 12061-80 0% 19% 68% 13% 0% 0% 0% 0% 0% 0% 0% 22681-120 0% 0% 19% 72% 8% 1% 0% 0% 0% 0% 0% 347121-160 0% 0% 0% 17% 72% 11% 0% 0% 0% 0% 0% 246161-200 0% 0% 0% 0% 25% 59% 16% 0% 0% 0% 0% 286201- 250 0% 0% 0% 0% 0% 16% 70% 13% 1% 0% 0% 376251- 300 0% 0% 0% 0% 0% 2% 16% 61% 14% 7% 0% 281301- 350 0% 0% 0% 0% 0% 0% 2% 28% 59% 10% 1% 229351- 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
Dexcom G5 Mobile System User Guide248Technical InformationTable 3-C. Concurrence of CGM Readings and YSI Values (Original Pediatric Study)CGM (mg/dL)YSI (mg/dL)Row Percentage of Matched Pairs in each CGM Glucose Range< 40 40-6061-8081-120121-160161-200201-250251-300301-350351-400> 400Number of Paired CGM-YSI< 40 0% 0% 0% 54% 31% 15% 0% 0% 0% 0% 0% 1340-60 0% 21% 58% 16% 5% 0% 0% 0% 0% 0% 0% 1961-80 0% 21% 45% 30% 4% 0% 0% 0% 0% 0% 0% 7681-120 0% 1% 20% 66% 12% 1% 0% 0% 0% 0% 0% 338121-160 0% 0% 1% 36% 54% 7% 1% 0% 0% 0% 0% 511161-200 0% 0% 0% 4% 40% 48% 6% 1% 0% 0% 0% 596201- 250 0% 0% 0% 1% 9% 44% 41% 5% 0% 0% 0% 658251- 300 0% 0% 0% 0% 2% 7% 50% 36% 3% 0% 2% 432301- 350 0% 0% 0% 0% 0% 2% 18% 59% 21% 0% 0% 206351- 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
249Dexcom G5 Mobile System User GuideTechnical InformationTable 3-D. Concurrence of CGM Readings and YSI Values (Software 505 Pediatric Study)CGM (mg/dL)YSI (mg/dL)Row Percentage of Matched Pairs in each CGM Glucose Range< 40 40-6061-8081-120121-160161-200201-250251-300301-350351-400> 400Number of Paired CGM-YSI< 40 6% 25% 63% 6% 0% 0% 0% 0% 0% 0% 0% 1640-60 0% 33% 60% 6% 1% 0% 0% 0% 0% 0% 0% 8661-80 0% 8% 64% 26% 2% 0% 0% 0% 0% 0% 0% 14281-120 0% 1% 15% 69% 13% 1% 1% 0% 0% 0% 0% 314121-160 0% 0% 0% 15% 66% 18% 1% 0% 0% 0% 0% 313161-200 0% 0% 0% 1% 18% 66% 15% 0% 0% 0% 0% 355201- 250 0% 0% 0% 0% 1% 17% 68% 14% 0% 0% 0% 444251- 300 0% 0% 0% 0% 0% 0% 26% 58% 16% 0% 0% 336301- 350 0% 0% 0% 0% 0% 0% 4% 40% 46% 9% 0% 209351- 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% 24Concurrence of System and Laboratory ReferenceTable 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.
Dexcom G5 Mobile System User Guide250Technical InformationTable 4-A. System Difference to YSI within CGM Glucose Ranges (Adult)CGM Glucose Range1 (mg/dL)Study2Number of Paired CGM-YSIMean Percent Difference Median Percent Difference Mean Absolute Percent Difference Median Absolute Percent Difference Overall Original 9152 2.9% 1.7% 13.3% 9.8%Software 505 2263 2.5% 2.4% 9.0% 7.0%*40-60 Original 512 -10.0 -8.2 13.5 9.7Software 505 120 -3.3 -2.1 6.9 4.8*61-80 Original 781 -2.4 -0.4 11.4 8.6Software 505 226 0.8 1.4 6.7 5.481-180 Original 3853 4.8% 3.0% 13.8% 9.8%Software 505 738 3.9% 4.1% 9.6% 8.2%181-300 Original 2784 2.1% 0.0% 11.9% 9.2%Software 505 798 0.6% 0.4% 8.0% 6.1%301-350 Original 775 3.8% 2.8% 9.8% 7.9%Software 505 229 4.1% 3.4% 8.0% 5.8%351-400 Original 447 10.4% 7.7 % 12.8% 9.1%Software 505 152 7.2% 6.3% 9.2% 7. 2%1CGM readings are within 40 to 400 mg/dL, inclusive.2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).*For CGM ≤ 80 mg/dL, the difference and absolute difference in mg/dL are included instead of percent differences (%).
251Dexcom G5 Mobile System User GuideTechnical InformationTable 4-B. System Difference to YSI within CGM Glucose Ranges (Pediatric)CGM Glucose Range1 (mg/dL)Study2Number of Paired CGM-YSIMean Percent Difference Median Percent Difference Mean Absolute Percent Difference Median Absolute Percent Difference Overall Original 2922 13.5% 11.6% 17.4% 13.5%Software 505 2262 1.8% 1.2% 10.4% 7.9%*40-60 Original 19 -18.1 -9.1 19.2 9.1Software 505 86 -15.3 -13.2 16.1 13.2*61-80 Original 76 -3.7 -2.3 13.4 10.6Software 505 142 -4.8 -1.0 11.8 7.781-180 Original 1155 11.9% 9.7% 17.0% 13.0%Software 505 805 1.9% 0.7% 10.6% 8.1%181-300 Original 1380 14.8% 12.4% 17.4% 13.3%Software 505 957 2.2% 1.0% 8.1% 6.5%301-350 Original 206 19.2% 15.9% 19.4% 15.9%Software 505 209 7.8% 6.5% 11.0% 7.9%351-400 Original 86 18.5% 15.5% 19.1% 15.5%Software 505 63 14.9% 11.6% 15.2% 11.6%1CGM readings are within 40 to 400 mg/dL, inclusive.2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).*For CGM ≤ 80 mg/dL, the difference and absolute difference in mg/dL are included instead of percent differences (%).Accuracy Relative to YSIAccuracy 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.
Dexcom G5 Mobile System User Guide252Technical InformationIn 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.
253Dexcom G5 Mobile System User GuideTechnical InformationTable 5-A. Hypoglycemia Alert and Detection Rate Evaluation in Reference to YSI 15 Minutes Before and After (Adult)HypoglycemiaAlert Level(mg/dL)Study1True Alert RateFalse Alert RateHypoglycemia Detection RateHypoglycemia Missed Detection Rate55 Original 50% 50% 71% 29%Software 505 71% 29% 68% 32%60 Original 64% 36% 75% 25%Software 505 85% 15% 83% 17%70 Original 79% 21% 83% 17%Software 505 92% 8% 91% 9%80 Original 87% 13% 86% 14%Software 505 95% 5% 90% 10%90 Original 90% 10% 89% 11%Software 505 96% 4% 94% 6%1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).
Dexcom G5 Mobile System User Guide254Technical InformationTable 5-B. Hypoglycemia Alert and Detection Rate Evaluation in Reference to YSI 15 Minutes Before and After (Pediatric, Ages 6-17 Years)HypoglycemiaAlert Level(mg/dL)Study1True Alert RateFalse Alert RateHypoglycemia Detection RateHypoglycemia Missed Detection Rate55 Original 0% 100% 0% 100%Software 505 22% 78% 75% 25%60 Original 11% 89% 25% 75%Software 505 42% 58% 78% 23%70 Original 47% 53% 50% 50%Software 505 68% 32% 75% 25%80 Original 55% 45% 55% 45%Software 505 86% 14% 91% 9%90 Original 69% 31% 62% 38%Software 505 90% 10% 93% 7%100 Original 75% 25% 62% 38%Software 505 91% 9% 93% 7%1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).
255Dexcom G5 Mobile System User GuideTechnical InformationTable 5-C. Hypoglycemia Alert and Detection Rate Evaluation in Reference to SMBG 30 Minutes Before and After (Pediatric, Ages 2-5 Years)HypoglycemiaAlert Level(mg/dL)Study1True Alert RateFalse Alert RateHypoglycemia Detection RateHypoglycemia Missed Detection Rate55 Original 3% 97% 57% 43%Software 505 25% 75% 100% 0%60 Original 11% 89% 62% 38%Software 505 20% 80% 100% 0%70 Original 29% 71% 77% 23%Software 505 20% 80% 100% 0%80 Original 35% 65% 85% 15%Software 505 61% 39% 100% 0%90 Original 51% 49% 89% 11%Software 505 78% 22% 100% 0%100 Original 64% 36% 91% 9%Software 505 82% 18% 100% 0%1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).Low and High Glucose AlertsThe 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 AlertEstimates 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.
Dexcom G5 Mobile System User Guide256Technical InformationTable 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 RateThe 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 RateThe 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.
257Dexcom G5 Mobile System User GuideTechnical InformationTable 6-A. Hyperglycemia Alert and Detection Rate Evaluation in Reference to YSI 15 Minutes Before and After (Adult)HyperglycemiaAlert Level(mg/dL)Study1True Alert RateFalse Alert RateHyperglycemia Detection RateHyperglycemia Missed Detection Rate120 Original 95% 5% 98% 2%Software 505 98% 2% 100% 0%140 Original 94% 6% 97% 3%Software 505 97% 3% 99% 1%180 Original 92% 8% 97% 3%Software 505 97% 3% 99% 1%200 Original 92% 8% 97% 3%Software 505 96% 4% 98% 2%220 Original 91% 9% 95% 5%Software 505 94% 6% 98% 2%240 Original 91% 9% 94% 6%Software 505 93% 7% 95% 5%300 Original 82% 18% 86% 14%Software 505 86% 14% 90% 10%1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).
Dexcom G5 Mobile System User Guide258Technical InformationTable 6-B. Hyperglycemia Alert and Detection Rate Evaluation in Reference to YSI 15 Minutes Before and After (Pediatric, Ages 6-17 Years)HyperglycemiaAlert Level(mg/dL)Study1True Alert RateFalse Alert RateHyperglycemia Detection RateHyperglycemia Missed Detection Rate120 Original 91% 9% 98% 2%Software 505 98% 2% 99% 1%140 Original 87% 13% 99% 1%Software 505 97% 3% 98% 2%180 Original 75% 25% 99% 1%Software 505 94% 6% 98% 2%200 Original 71% 29% 98% 2%Software 505 94% 6% 97% 3%220 Original 67% 33% 97% 3%Software 505 93% 7% 96% 4%240 Original 62% 38% 96% 4%Software 505 88% 12% 94% 6%300 Original 43% 57% 93% 7%Software 505 69% 31% 8 4% 16%1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).
259Dexcom G5 Mobile System User GuideTechnical InformationTable 6-C. Hyperglycemia Alert and Detection Rate Evaluation in Reference to SMBG 30 Minutes Before and After (Pediatric, Ages 2-5 Years)HyperglycemiaAlert Level(mg/dL)Study1True Alert RateFalse Alert RateHyperglycemia Detection RateHyperglycemia Missed Detection Rate120 Original 92% 8% 98% 2%Software 505 97% 3% 99% 1%140 Original 90% 10% 98% 2%Software 505 98% 2% 100% 0%180 Original 87% 13% 96% 4%Software 505 99% 1% 93% 7%200 Original 85% 15% 96% 4%Software 505 98% 2% 93% 7%220 Original 81% 19% 95% 5%Software 505 100% 0% 97% 3%240 Original 80% 20% 95% 5%Software 505 99% 1% 98% 2%300 Original 71% 29% 90% 10%Software 505 95% 5% 96% 4%1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).The High Glucose AlertEstimates 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 RateThe 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
Dexcom G5 Mobile System User Guide260Technical Informationminutes 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 RateThe 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.
261Dexcom G5 Mobile System User GuideTechnical InformationTable 7-A. Percentage of System Readings1 within YSI Values With Data Stratified in 2-Hour Increments After Calibration (Adult)Time from Calibration Study2Number of Paired CGM-YSIPercent Within 15/15% YSIPercent Within 20/20% YSIPercent Within 30/30% YSIPercent Greater than 40/40%YSI0-2 hours Original 1929 78% 88% 96% 2%Software 505 469 93% 97% 99% 0%2-4 hours Original 1516 69% 81% 91% 4%Software 505 389 90% 97% 99% 0%4-6 hours Original 1547 69% 79% 91% 5%Software 505 383 85% 91% 97% 2%6-8 hours Original 1520 68% 79% 92% 3%Software 505 380 79% 90% 97% 2%8-10 hours Original 1555 71% 82% 92% 4%Software 505 347 83% 92% 98% 0%10-12 hours Original 1068 65% 77% 91% 4%Software 505 295 80% 90% 98% 0%12-14 hours Original 17 65% 76% 82% 12%Software 505 0-- -- -- --1CGM readings are within 40 to 400 mg/dL, inclusive.2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).
Dexcom G5 Mobile System User Guide262Technical InformationTable 7-B. Percentage of System Readings1 within YSI Values with Data Stratified in 2-Hour Increments after Calibration (Pediatric)Time from Calibration Study2Number of paired CGM-YSIPercent within 15/15% YSIPercent within 20/20% YSIPercent within 30/30% YSIPercent greater than 40/40%YSI0-2 hours Original 648 65% 75% 87% 7%Software 505 545 83% 91% 97% 1%2-4 hours Original 649 51% 67% 86% 7%Software 505 460 72% 89% 96% 2%4-6 hours Original 630 51% 61% 80% 10%Software 505 428 77% 88% 95% 2%6-8 hours Original 409 52% 68% 85% 5%Software 505 325 88% 92% 94% 3%8-10 hours Original 296 53% 69% 84% 7%Software 505 305 86% 93% 97% 1%10-12 hours Original 253 58% 74% 89% 5%Software 505 198 89% 94% 98% 0%12-14 hours Original 37 32% 38% 65% 22%Software 505 1100% 100% 100% 100%1CGM readings are within 40 to 400 mg/dL, inclusive.2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).Calibration StabilityThe 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.
263Dexcom G5 Mobile System User GuideTechnical InformationTable 8-A. Sensor Stability Relative to YSI (Accuracy Over Time1) - (Adult)Day of WearStudy2Number of Paired CGM-YSIMean Absolute Percent Differences Median Absolute Percent Differences Percent Within 15/15% YSIPercent Within 20/20% YSIPercent Within 30/30% YSIPercent Greater than 40/40% YSIDay 1 Original 3023 16.7% 13.2% 59% 71% 86% 6%Software 505 680 10.7% 7.9% 77% 84% 96% 2%Day 4 Original 3108 11.4% 8.2% 77% 87% 95% 2%Software 505 777 8.0% 6.4% 89% 96% 99% 0%Day 7Original 3021 11.9% 8.9% 76% 87% 95% 2%Software 505 806 8.5% 7.2% 90% 97% 99% 0%1CGM readings are within 40 to 400 mg/dL, inclusive.2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).
Dexcom G5 Mobile System User Guide264Technical InformationTable 8-B. Sensor Stability Relative to YSI (Accuracy Over Time1) - (Pediatric, Ages 6-17 Years)Day of WearStudy2Number of Paired CGM-YSIMean Absolute Percent Differences Median Absolute Percent Differences Percent Within 15/15% YSIPercent Within 20/20% YSIPercent Within 30/30% YSIPercent Greater than 40/40% YSIDay 1 Original 1016 21.2% 15.8% 48% 61% 78% 15%Software 505 740 12.7% 8.5% 75% 83% 91% 4%Day 4 Original 810 16.0% 13.9% 52% 66% 87% 3%Software 505 795 8.1% 6.7% 89% 97% 100% 0%Day 7Original 1096 15.1% 11.3% 63% 76% 89% 4%Software 505 727 10.4% 8.4% 80% 91% 98% 1%1CGM readings are within 40 to 400 mg/dL, inclusive.2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).
265Dexcom G5 Mobile System User GuideTechnical InformationTable 8-C. Sensor Stability Relative to SMBG (Accuracy Over Time1) - (Pediatric, Ages 2-17 Years)Day of WearStudy2Number of Paired CGM-SMBGMean Absolute Percent Differences Median Absolute Percent Differences Percent Within 15/15% SMBGPercent Within 20/20% SMBGPercent Within 30/30% SMBGPercent Greater than 40/40% SMBGDay 1Original 3216 18.8% 14.2% 53% 65% 81% 10%Software 505 893 14.8% 10.7% 64% 79% 91% 5%Day 2Original 2148 16.2% 12.4% 60% 74% 87% 6%Software 505 436 13.2% 10.4% 69% 81% 95% 3%Day 3Original 1977 15.2% 11.0% 63% 76% 89% 5%Software 505 441 13.8% 11.3% 66% 77% 91% 2%Day 4Original 2830 14.0% 10.9% 66% 79% 91% 4%Software 505 850 10.7% 8.5% 79% 91% 97% 1%Day 5Original 1768 15.4% 10.7% 67% 78% 90% 5%Software 505 374 11.4% 8.7% 74% 86% 96% 1%Day 6Original 1704 14.3% 9.8% 68% 79% 90% 4%Software 505 410 12.3% 9.2% 72% 80% 93% 2%Day 7Original 2675 12.4% 9.2% 72% 83% 94% 3%Software 505 860 11.3% 8.6% 79% 90% 96% 2%1CGM readings are within 40 to 400 mg/dL, inclusive.2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).Sensor StabilityRelative to YSISensors 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.
Dexcom G5 Mobile System User Guide266Technical InformationRelative 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 ReadingsA 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 LifeSensors 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).
267Dexcom G5 Mobile System User GuideTechnical InformationTable 9-A. Number of Readings Provided by Each Sensor Over 7-Days (Adult)% of Total Possible Readings Provided Study1Total Readings Provided (Min-Max)% of Systems Providing That Number of Readings0-25% Original 167-491 2%Software 505 00%26-50% Original 719-914 4%Software 505 856-856 2%51-75% Original 1267-1267 1%Software 505 1253-1253 2%76-100% Original 1811-1992 94%Software 505 1497-1992 96%1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).
Dexcom G5 Mobile System User Guide268Technical InformationTable 9-B. Number of Readings Provided by Each Sensor Over 7-Days (Pediatric)% of Total Possible Readings Provided Study1Total Readings Provided (Min-Max)% of Systems Providing That Number of Readings0-25% Original 103-427 3%Software 505 60-223 4%26-50% Original 569-954 3%Software 505 877-891 3%51-75% Original 1006-1484 9%Software 505 1131-1342 3%76-100% Original 1518-1992 86%Software 505 1623-1990 91%1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).
269Dexcom G5 Mobile System User GuideTechnical InformationTable 10-A. System Readings Within Wear Days (Adult)Statistic Study1Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 All Days2Mean Original 98% 98% 98% 98% 97% 99% 95% 97%Software 505 98% 99% 98% 98% 96% 99% 97% 98%Median Original 100% 100% 100% 100% 100% 100% 100% 100%Software 505 99% 100% 100% 100% 100% 100% 100% 100%Standard DeviationOriginal 5% 3% 9% 8% 10% 3% 11% 8%Software 505 3% 2% 8% 11% 15% 2% 13% 9%1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).2A total of 108 sensors were included with the Original Study and 51 sensors were included with the Software 505 Study.
Dexcom G5 Mobile System User Guide270Technical InformationTable 10-B. System Readings within Wear Days (Pediatric)Statistic Study1Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 All Days2Mean Original 97% 96% 96% 95% 94% 94% 92% 95%Software 505 96% 96% 95% 96% 93% 95% 93% 95%Median Original 99% 99% 99% 99% 99% 99% 98% 99%Software 505 99% 98% 99% 99% 97% 97% 98% 98%Standard DeviationOriginal 6% 10% 9% 12% 14% 14% 17% 12%Software 505 9% 6% 12% 10% 15% 7% 12% 11%1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).2A total of 108 sensors were included with the Original Study and 77 sensors were included with the Software 505 Study.Number of Readings ProvidedThe System is capable of providing a reading up to every 5 minutes, or up to 288 readings per day. For a variety of reasons, the System may not display a glucose reading and readings are “skipped.” Table 9-A and 9-B estimate the number of readings you can expect to receive from the System over the entire 7-day period after calibration. Table 10-A and 10-B show the number of readings you can expect to receive from the System within each system wear day.For the Software 505 Adult Study (SW10505), 96% of Systems provided between 1,497 and 1,992 valid glucose readings (or more than 75% of the expected number of readings) as seen in Table 9-A. Adjusted within each system wear-day, the System in the Software 505 Adult Study provided an average of 98% of all expected glucose readings (288) as seen in Table 10-A.
271Dexcom G5 Mobile System User GuideTechnical InformationTable 11-A. System Agreement to SMBG Within CGM Glucose Ranges (Adult)CGM Glucose Range1 (mg/dL)Study2Number of Paired CGM-SMBGPercent Within 15/15% SMBGPercent Within 20/20% SMBGPercent Within 30/30% SMBGPercent Greater than 40/40%SMBGOverall Original 7508 69% 81% 94% 2%Software 505 2992 77% 87% 96% 1%40-60 Original 731 75% 84% 92% 4%Software 505 221 73% 80% 87% 7%61-80 Original 968 78% 86% 95% 1%Software 505 336 77% 85% 95% 1%81-180 Original 3141 65% 78% 93% 2%Software 505 1362 74% 85% 96% 1%181-300 Original 1960 68% 81% 94% 3%Software 505 826 80% 90% 97% 1%301-350 Original 450 77% 88% 98% 1%Software 505 161 83% 93% 99% 0%351-400 Original 258 75% 85% 95% 2%Software 505 86 90% 93% 98% 1%1CGM readings are within 40 to 400 mg/dL, inclusive.2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).
Dexcom G5 Mobile System User Guide272Technical InformationTable 11-B. System Agreement to SMBG Within CGM Glucose Ranges (Pediatric)CGM Glucose Range1 (mg/dL)Study2Number of Paired CGM-SMBGPercent Within 15/15% SMBGPercent Within 20/20% SMBGPercent Within 30/30% SMBGPercent Greater than 40/40%SMBGOverall Original 16318 64% 76% 89% 5%Software 505 4264 73% 84% 94% 2%40-60 Original 487 44% 55% 68% 19%Software 505 240 54% 71% 86% 7%61-80 Original 1340 59% 70% 85% 7%Software 505 399 64% 76% 92% 2%81-180 Original 7084 62% 74% 90% 5%Software 505 1650 72% 84% 95% 2%181-300 Original 5627 69% 80% 90% 5%Software 505 1526 79% 89% 97% 2%301-350 Original 1176 65% 77% 90% 4%Software 505 319 72% 83% 94% 2%351-400 Original 604 58% 72% 86% 6%Software 505 130 69% 79% 86% 8%1CGM readings are within 40 to 400 mg/dL, inclusive.2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).
273Dexcom G5 Mobile System User GuideTechnical InformationTable 12-A. System Difference to SMBG Within CGM Glucose Ranges (Adult)CGM Glucose Range1 (mg/dL)Study2Numberof Paired CGM-SMBGMean Percent Difference Median Percent Difference Mean Absolute Percent Difference Median Absolute Percent Difference Overall Original 7508 -0.4% -1.4% 14.0% 11.0%Software 505 2992 -2.6% -2.7% 11.3% 8.6%*40-60 Original 731 -9.3 -8.0 11.7 8.0Software 505 221 -10.3 -6.0 13.0 8.0 *61-80 Original 968 -1.0 1.0 10.7 8.0Software 505 336 -4.0 -2.0 10.1 7.0 81-180 Original 3141 1.4% 0.0% 14.2% 11.0%Software 505 1362 -2.6% -3.1% 11.4% 8.9%181-300 Original 1960 -0.7% -2.8% 13.0% 10.3%Software 505 826 -1.4% -2.0% 9.5% 7.4%301-350 Original 450 -0.7% -2.6% 10.5% 8.6%Software 505 161 -0.0% 0.0% 8.3% 6.0%351-400 Original 258 5.0% 3.0% 11.9% 8.6%Software 505 86 3.9% 3.2% 8.1% 6.7%1CGM readings are within 40 to 400 mg/dL, inclusive.2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).*For CGM ≤ 80 mg/dL, the differences in mg/dL are included instead of percent differences (%).
Dexcom G5 Mobile System User Guide274Technical InformationTable 12-B. System Difference to SMBG Within CGM Glucose Ranges (Pediatric)CGM Glucose Range1 (mg/dL)Study2Numberof Paired CGM-SMBGMean Percent Difference Median Percent Difference Mean Absolute Percent Difference Median Absolute Percent Difference Overall Original 16318 2.2% 0.9% 15.3% 11.1%Software 505 4264 -0.7% -1.1% 12.5% 9.5%*40-60 Original 487 -22.1 -17.0 23.9 18.0Software 505 240 -15.9 -14.0 16.9 14.0*61-80 Original 1340 -11.8 -8.0 17.0 11.0Software 505 399 -7.8 -6.0 13.7 10.081-180 Original 7084 1.1% -1.0% 15.4% 11.4%Software 505 1650 -1.2% -2.6% 12.1% 9.5%181-300 Original 5627 5.7% 3.4% 13.5% 9.5%Software 505 1526 1.7% 0.9% 10.1% 7.7%301-350 Original 1176 9.6% 7.2% 14.2% 10.4%Software 505 319 6.7% 5.9% 11.8% 8.9%351-400 Original 604 12.7% 10.2% 16.1% 11.9%Software 505 130 12.0% 8.9% 15.7% 10.6%1CGM readings are within 40 to 400 mg/dL, inclusive.2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).*For CGM ≤ 80 mg/dL, the differences in mg/dL are included instead of percent differences (%).Agreement and Accuracy Relative to SMBGAgreement between the System and blood glucose values is also characterized using paired System and SMBG results (Table 11 to 12). The System and SMBG values were compared by pairing the comparative SMBG value to a System glucose reading that occurred immediately after the SMBG was collected. These results characterize the performance subjects expect during real-time use of the System in their daily diabetes management when comparing the System readings to their home blood glucose meter results. 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 SMBG values was calculated. The percentages of total readings within
275Dexcom G5 Mobile System User GuideTechnical Information15 mg/dL or 15%, 20 mg/dL or 20%, 30 mg/dL or 30%, 40 mg/dL or 40% or greater than 40 mg/dL or 40% were then calculated. For example, if the System reads 100 mg/dL, it is between 81-180 mg/dL range and you can expect the System readings to be within 20% of the SMBG values 85% of the time for the Software 505 Adult Study, as seen in Table 11-A. Overall, the System in the Software 505 Adult Study reads, on average, 2.6% lower (Mean Percent Difference) than SMBG values and 11.3% absolute different (Mean Absolute Percent Difference) than the SMBG values. The Median Percent Difference shows that half of the time the System reads lower in 2.7% or less than the SMBG values and the Median Absolute Percent Difference shows that half of the time the System reads about 8.6% or less different than SMBG values, as seen in Table 12-A.Adverse EventsNo serious adverse events or device-related serious adverse events occurred during the studies. Mild to moderate skin irritation, such as erythema or edema, occurred at the sensor needle insertion area or around the adhesive area. No infection, bruising, or bleeding occurred at the sensor needle insertion area or the adhesive area.17.2 Product SpecificationsUser is the single use operator in the home environment.Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.Do not touch the metal connectors on the bottom of the transmitter and other open connectors on the receiver, charging cable and charger.Sensor Product SpecificationsGlucose Range 40-400 mg/dLSensor Life Up to 7 daysCalibration Commercially available blood glucose meterCalibration Range 40-400 mg/dLStorage Condition Temperature: 36° F-77° FHumidity: 15%-85% RHSterilization Sterile by radiation
Dexcom G5 Mobile System User Guide276Technical InformationTransmitter Product SpecificationsPart Number 9438-06Dimensions (Including Sensor Pod)Length: 1.5 inchesWidth: 0.9 inchesThickness: 0.5 inchesWeight (Including Sensor Pod) 0.4 ouncesPower Supply Silver oxide batteries (not replaceable)Operational ConditionsAmbient temperature is 10° C-42° C (50° F-107.6° F)Equilibrium temperature of less than 0.5° C (0.9° F) above ambientHumidity: 10%-95% RHStorage Conditions Temperature: 32° F-113° FHumidity: 10%-95% RHOperating Altitude -1300 feet to 13800 feetLimited Warranty 3 monthsMoisture Protection IP28: Protection against insertion of large objects and immersion in water for up to 8 feet for 24 hoursProtection Against Electrical Shock Type BF applied partTransmitter Performance CharacteristicsParameter Performance CharacteristicTX/RX Frequencies 2.402-2.480 GHzBandwidth 1.02 MHzMaximum Output Power 1.0 mW EIRPModulation Gaussian Frequency-Shift KeyingData Rate 1 MbpsData Communication Range 20 feetThe Dexcom G5 Mobile CGM System is safe for use on U.S. commercial airlines. The Dexcom G5 Mobile CGM System 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
277Dexcom G5 Mobile System User GuideTechnical Informationmodes 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).Guidance and Manufacturer’s Declaration – Electromagnetic ImmunityThe transmitter (P/N 9438-06) is intended for use in the electromagnetic environment specified in the next table. The customer or the user of the transmitter should ensure that it is used in such an environment.Transmitter Electromagnetic Immunity SpecificationsImmunity Test IEC 60601 Test LevelTransmitter Compliance LevelElectromagnetic Environment GuidanceElectrostatic Discharge (ESD) IEC 61000-4-2± 8 kV Contact± 15 kV Air± 8 kV Contact± 15 kV AirFloors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.Power Frequency(50/60 Hz) Magnetic FieldIEC 61000-4-830 A/m 30 A/mPower frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.Receiver Product Specifications Part Number MT22719Reading Frequency Every 5 minutesDimensionsLength: 4.0 inchesWidth: 1.8 inchesThickness: 0.5 inchesTX/RX Frequencies 2.402-2.480 GHzBandwidth 1.22 MHzMaximum Output Power 2.5 mW EIRPModulation Gaussian Frequency-Shift KeyingData Rate 1 Mbps(Continued on next page)
Dexcom G5 Mobile System User Guide278Technical Information(Continued from previous page)Weight 2.4 ouncesReceiver Input 5V DC, 1APower Supply MT21255Communication Range 20 feetMemory Storage 30 days of glucose data7 days of tech support dataRe-Chargeable Battery Use 3 daysCharging Time3 hours wall outletThe device behaves normally while being chargedDo not hold the receiver while charging for over a minuteThere are no risks to connecting any part of the system to an MSO (Multiple Socket Outlet)Storage/Operating ConditionsTemperature: 32° F-104° FHumidity: 15%-95% RH, (Storage 10%-95% RH)Operating Altitude -1300 feet to 13800 feetMedium Priority Alarm Audible Output 50 dBa at 1 meterMoisture Protection IP22: Vertically falling dropsProtection against insertion of large objects and dripping waterLimited Warranty 1 yearControl Classification Class II equipmentNo cleaning methods are recommended or tested for the receiver. The warranty life of the receiver is 1 year. The service life for the accessories is noted to be up to one year. If you have difficulty reading your receiver in bright sunlight, you may need to seek a shady location. Do not connect the receiver to any equipment not specified in IFU.Guidance and Manufacturer’s Declaration – Electromagnetic ImmunityThe receiver (MT22719) is intended for use in the electromagnetic environment specified in the next table. The customer or the user of the receiver should ensure that it is used in such an environment.
279Dexcom G5 Mobile System User GuideTechnical InformationReceiver Electromagnetic Immunity SpecificationsImmunity Test IEC 60601 Test LevelTransmitter Compliance LevelElectromagnetic Environment GuidanceElectrostatic Discharge (ESD) IEC 61000-4-2± 8 kV Contact± 15 kV Air± 8 kV Contact± 15 kV AirFloors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.Electrical Fast Transient/BurstIEC 61000-4-4± 2 kV for power supply lines± 1 kV for input/output lines± 2 kV for power supply linesNot applicableMains power quality should be that of a typical commercial or hospital environment.SurgeIEC 61000-4-5± 1 kV line(s) to line(s)± 2 kV line(s) to earth± 1 kV line(s) to line(s)Not applicableMains power quality should be that of a typical commercial or hospital environment.SurgeIEC 61000-4-5± 1 kV line(s) to line(s)± 2 kV line(s) to earth± 1 kV line(s) to line(s)Not applicableMains power quality should be that of a typical commercial or hospital environment.Voltage Dips, Short Interruptions and Voltage Variations on Power Supply Input LinesIEC 61000-4-11IEC 60601-1-110% UT for 1 cycle0% UT for 0.5 cycle at 8 phase angles70% UT (30% dip in Ut) for 25 cycles0% UT for 250 cycles0% UT for 1 cycle0% UT for 0.5 cycle at 8 phase angles70% UT (30% dip in Ut) for 25 cycles0% UT for 250 cyclesMains power quality should be that of a typical commercial or hospital environment.Power Frequency(50/60 Hz) Magnetic FieldIEC 61000-4-830 A/m 30 A/mPower frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.NOTE: UT is the a.c. mains voltage prior to application of the test level.Guidance and Manufacturer’s Declaration – Electromagnetic ImmunityThe Dexcom G5 Mobile System is intended for use in the electromagnetic environment specified in the next table. The customer or the user of the Dexcom G5 Mobile System should ensure that it is used in such an environment.
Dexcom G5 Mobile System User Guide280Technical InformationSystem Electromagnetic Immunity SpecificationsImmunity Test IEC 60601 Test LevelTransmitter Compliance LevelElectromagnetic Environment GuidanceConducted RFIEC 61000-4-6(Receiver only)3 Vrms150 kHz to 80 MHz 6 VrmsFloors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.Recommended Separation Distanced = 1.2 √P 150 kHz to 80 MHzd = 1.2 √P 80 MHz to 800 MHzd = 2.3 √P 800 MHz to 2.5 GHzWhere P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb.Interference may occur in the vicinity of equipment marked with following symbol:Radiated RFIEC 61000-4-310 V/m at 80 MHz to 2700 MHz (AM Modulation)10 V/mNOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Dexcom G5 MOBILE System is used exceeds the applicable RF compliance level above, the Dexcom G5 MOBILE System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Dexcom G5 MOBILE System.b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
281Dexcom G5 Mobile System User GuideTechnical InformationGuidance and Manufacturer’s Declaration – Electromagnetic EmissionsThe Dexcom G5 Mobile System is intended for use in the electromagnetic environment specified in the next table. The customer or the user of the Dexcom G5 Mobile System should ensure that it is used in such an environment.Electromagnetic Emissions SpecificationsEmissions Test Compliance Electromagnetic Environment GuidanceRF EmissionsCISPR 11 Group 1The Dexcom G5 Mobile System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.RF EmissionsCISPR 11 Class BThe Dexcom G5 Mobile System is suitable for use in all establishments including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the ReceiverThe receiver is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the receiver can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the receiver as recommended in the next table, according to the maximum output power of the communications equipment. Portable and mobile RF equipment include: baby monitors, Bluetooth wireless headsets, wireless routers, microwave ovens, laptops with internal Wi-Fi adapters, GSM cell phones, RFID scanners and hand-held security metal detector often used by security screeners.Minimum Recommended Distance Between Other RF Transmitters and the Dexcom Transmitter/ReceiverRated Maximum Output Power of Transmitter (W)Separation Distance According to Frequency of Transmitter (m)150 kHz to 80 MHzd = 1.2 P½80 MHz to 800 MHzd = 1.2 P½800 MHz to 2.5 GHzd = 2.3 P½0.01 0.12 0.12 0.23(Continued on next page)
Dexcom G5 Mobile System User Guide282Technical Information(Continued from previous page)Rated Maximum Output Power of Transmitter (W)Separation Distance According to Frequency of Transmitter (m)150 kHz to 80 MHzd = 1.2 P½80 MHz to 800 MHzd = 1.2 P½800 MHz to 2.5 GHzd = 2.3 P½0.1 0.38 0.38 0.7311.2 1.2 2.310 3.8 3.8 7.3100 12 12 23For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in feet can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacture.NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.USB Charging/Download Cable* SpecificationsPart Number MT20655Input/Output 5V DC, 1AType USB A to USB micro BLength 3 feet*The power supply/charger can be connected to the USB charging/download cable for charging using an AC power outlet. Misuse of the USB cable can present a strangulation risk. Isolation of system is by unplugging charger from wall.Power Supply/Charger SpecificationsPart Number MT21255Class IIInput AC Input 100-240 Vac, 50/60Hz, 0.2A, 0.2A rms at 100 VacDC Output 5V DC, 1A (5.0 Watts)
283Dexcom G5 Mobile System User GuideTechnical Information17.3 FCC RequirementsThe transmitter and receiver covered by this user guide have been certified under FCC ID: • G5 Mobile Transmitter: PH29715• G5 Mobile Receiver: PH29496Although the transmitter and receiver have been approved by the Federal Communications Commission, there is no guarantee that they will not receive interference or that any particular transmission from either device will be free from interference.Compliance Statement (Part 15.19)This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause undesired operation.Warning (Part 15.21)Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. No modification of the equipment is allowed as it could create an unsafe condition.FCC Interference Statement (Part 15.105 (b))This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one of the following measures:1. Reorient or relocate the receiving antenna.2. Increase the separation between the equipment and receiver.3. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.4. Consult the dealer or an experienced radio/TV technician for help.This portable transmitter with its antenna complies with FCC/IC RF exposure limits for general population/uncontrolled exposure.
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285Dexcom G5 Mobile System User GuideTroubleshooting18.1 IntroductionSensor pod not sticking? Prompt won’t go away? Not getting your sensor glucose readings? Don’t know when to replace your transmitter? This chapter will help you figure it out!Troubleshooting sections are categorized by function or system component. The solutions here are meant to be brief and not all inclusive, some have audible prompts, and others don’t. When more detailed answers or preventative measures are in a chapter, you’ll get a brief explanation here, and then get directed to the applicable chapter and section.After looking at the troubleshooting chapter, are you still not sure what to do? Or maybe your problem is hardware (e.g., receiver or transmitter failure).If your problem is not found here, follow the steps listed on your app screen, or call Technical Support.Please call the Dexcom Technical Support Team, 24/7, toll free at 1.877.339.2664 or toll at 1.858.200.0200 if any of these errors continue and the instructions don’t resolve the issue.18.2 Safety StatementsFollowing are the Safety Statements for the Troubleshooting chapter.WARNINGDo: Calibrate at least once every 12 hours.Why: Calibrating less often than every 12 hours might cause inaccurate sensor glucose readings.Consequences: Missing severe low (hypoglycemia) or high (hyperglycemia) Alarm or Alerts.Chapter 18Everything Else G5:Troubleshooting
Dexcom G5 Mobile System User Guide286TroubleshootingPRECAUTIONDo: Enter the exact BG value displayed on your BG meter within five minutes of a carefully performed fingerstick measurement.Why: Entering the wrong blood glucose values, or waiting more than five minutes before entry, might affect sensor accuracy. Consequences: You may miss a severe low or high glucose events.PRECAUTIONDon’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.
287Dexcom G5 Mobile System User GuideTroubleshooting18.3 TroubleshootingNo Alarm/AlertsDevice What you see Problem What you doSmart Device: In AppNot receiving AlertsSee Chapter 11.Check Alarm/Alerts, sound and/or vibrations for notifications are on.Check your smart device is not on mute (if applicable).Receiver(Continued on next page)
Dexcom G5 Mobile System User Guide288TroubleshootingSensor Glucose ReadingsDevice What you see Problem What you doBG MeterSensor readings and BG meter glucose values often don’t show the sameSee Chapter 7.Differences are not uncommon.Readings from different body fluids reflect different numbers:Meter - from bloodSensor - from interstitial fluid20/20 RuleIf the meter shows 80 or less, CGM should read within ± 20 points.If the meter shows 80 or above, the CGM should read ± 20%.Example: a 202 mg/dL sensor reading and a 188 mg/dL glucose meter value = a 7% difference (this is still considered accurate).Outside of 20/20 rule: Calibrate again.Smart Device: In AppReceiver(Continued on next page)
289Dexcom G5 Mobile System User GuideTroubleshooting(Continued from previous page)Device What you see Problem What you doSmart Device: In AppNot getting sensor glucose readingsSee Chapter 9.Don’t calibrate.Wait for more prompts.System may correct problem itself and continue to provide sensor glucose readings. 3 hours since last sensor reading: call Technical Support (see Section 16.1).ReceiverSmart Device: In AppNot getting sensor glucose readingsSee Chapter 9.WaitSystem will often resolve itself.If this continues for an extended period of time, call Technical Support to report error (see Section 16.1).Receiver(Continued on next page)
Dexcom G5 Mobile System User Guide290Troubleshooting(Continued from previous page)Device What you see Problem What you doSmart Device: In AppSystem display device and transmitter not communicatingSee Chapter 9.Don’t calibrate.Wait 10 minutes.Move display device and transmitter within 20 feet of each other without obstruction.Wait another 10 minutes.App (if not resolved):1. Go to Settings.2. Tap Bluetooth.3. Turn Bluetooth Off and On.ReceiverSmart Device: In AppNo sensor glucose readingsSee Chapter 7.Wait up to 2 hours.System is counting down to when you do your initial calibration.Receiver
291Dexcom G5 Mobile System User GuideTroubleshootingApplicatorPicture Problem What you doSafety lock stuckSee Chapter 6.Pull safety lock straight out:• Away from your body• Follow direction of safety lock Up ArrowCollar won’t pull upSee Chapter 6.Use force when pulling the collar up.Check white plunger is completely down—flush to the applicator barrel.Can’t remove transmitter latchSee Chapter 6.Don’t pull it straight off.Hold sensor pod with one hand.Twist transmitter latch with other hand to break transmitter latch off.Sensor pod won’t stickSee Chapter 6.Put medical tape over sensor pod’s white adhesive patch (e.g., Blenderm).Don’t place tape over the transmitter.
Dexcom G5 Mobile System User Guide292TroubleshootingHardware ErrorDevice What you see Problem What you doReceiver Won’t turn on:Battery deadSee Chapter 4.Charge receiver using electrical outlet, not computer/laptop.Full charge may take up to five hours.ReceiverAfter full charge session:Won’t turn onSee Chapter 4.Reset receiver.Connect receiver to charger.Insert end of paper clip into small circular hole on receiver’s back.Push down on paper clip.Receiver will vibrate.Processing screen appears.Charge receiver.Receiver Receiver Low BatterySee Chapter 4.Charge receiver.(Continued on next page)
293Dexcom G5 Mobile System User GuideTroubleshooting(Continued from previous page)Device What you see Problem What you doReceiver Corrupted databaseSee Chapter 16.Write down error code.Contact Dexcom Technical Support (see Section 16.1).Check BG value using BG meter.Prompt: Vibrates one time for four seconds and four beeps.Receiver System RecoverySee Chapter 16.Do nothing.Receiver is able to continue to work and recover from an error.App: Tap OK to clear Alert.Receiver: Press Select to clear Alert.Smart Device: In AppNo BluetoothSee Chapter 5.Go to smart device’s Settings.Make sure Bluetooth is On.If problem persists, please contact device’s manufacturer.
Dexcom G5 Mobile System User Guide294TroubleshootingCalibration ErrorDevice What you see Problem What you doBG MeterSystem will not accept calibration if outside of the 40-400 mg/dL rangeSee Chapter 7.Wait until your glucose is between 40-400 mg/dL.Calibrate only when your BG meter values are between 40-400 mg/dL.Smart Device: In App System didn’t accept recent calibration (see Sensor Glucose Readings troubleshooting for a possible reason)No sensor glucose readings will be displayed until error is resolvedSee Chapter 7.Wait 15 minutes.Enter 1 calibration.If error screen still appears enter 1 more BG meter value.Wait 15 minutes. If no sensor glucose readings appear on the display, the sensor needs to be replaced. Call Technical Support to report error (see Section 16.1).App: Follow same instructions.Tap question mark to get more information.Receiver(Continued on next page)
295Dexcom G5 Mobile System User GuideTroubleshooting(Continued from previous page)Device What you see Problem What you doSmart Device: In AppSystem didn’t accept recent calibrationSee Chapter 7.Wait 15 minutes.Enter 1 BG meter value.Wait 15 more minutes.If error screen still appears enter 1 more BG meter value.Wait 15 minutes. If no sensor glucose readings appear on the display, the sensor needs to be replaced. Call Technical Support (see Section 16.1) to report error.Receiver
Dexcom G5 Mobile System User Guide296TroubleshootingTransmitter Error:Device What you see Problem What you doSmart Device: In App Transmitter not workingSensor session automatically stoppedNo sensor glucose readings displayedSee Chapter 16.Contact Technical Support to report issue (Section 16.1).Start checking BG value using BG meter.App:Tap OK to clear Alert.Receiver:Press Select to clear.Will not re-alert once cleared.Order new transmitter.ReceiverSmart Device: In AppPairing FailedSee Chapter 6.Check Transmitter SN in display device is correct.If wrong:Stop sensor session.Re-Enter correct transmitter SN.App:Menu > Trans SN > Enter correct SNReceiver:Settings > Trans SN > Enter correct SNIf correct:Call Tech Support (see Chapter 16).Receiver(Continued on next page)
297Dexcom G5 Mobile System User GuideTroubleshooting(Continued from previous page)Device What you see Problem What you doSmart Device: In AppTransmitter Low BatterySee Chapter 16.App:Tap OK to clear Receiver:Press Select to clear.Will not re-alert once cleared.Order new transmitter.Receiver
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299Dexcom G5 Mobile System User GuideSymbols on Package LabelsThe following symbols may be found on the sensor, transmitter, and receiver package labels. These symbols tell you about the proper and safe use of the Dexcom G5 Mobile System.Some of these symbols may not have meaning in your region, and are listed for informational purposes only. This table shows what each symbol means.Use By Date Batch/Lot NumberCaution REF Part/Catalog NumberDate of ManufactureSTERILE RSterile by RadiationDo Not Reuse Temperature LimitationSNSerial NumberIP28: Protection Against Insertion of Large Objects and Immersion in WaterClass II EquipmentIP22: Protection Against Insertion of Large Objects and Dripping WaterAlternating Current Direct Current(Continued on next page)Chapter 19Everything Else G5:Symbols on Package Labels
Dexcom G5 Mobile System User Guide300Symbols on Package Labels(Continued from previous page)Type BF Applied Part EC REP Authorized Representative in the European CommunityManufacturer Non-Ionizing RadiationHumidity LimitationMarking Certifies Device Meets European Council Directive 93/42/EECEuropean Union WEEE Directive 2012/19/EUDo Not Use if Package is DamagedElectrical Equipment Designed Primarily for Indoor Use Ship By DateInput Prescription RequiredKeep Dry MR UnsafeRefer to Instruction Manual/BookletBluetooth
• Dexcom ShareSHARING IS CARING
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303Dexcom G5 Mobile System User GuideSharing Is Caring20.1 Learning About Dexcom ShareGlossaryAirplane Mode A setting on a smart device where wireless features are disabled in order to comply with airline regulations.Application or App A software program, such as the Dexcom G5 Mobile App and the Dexcom Follow App, designed to run on a smart device.App Store Internet store for downloading applications to a smart device.Blood Glucose MeterA device used to measure how much glucose is in the blood.BG Value The measurement of glucose in the blood.Bluetooth Bluetooth wireless technology allows devices to wirelessly communicate with each other.Default A manufacturer’s preset option for a device setting.Delay Amount of set time that passes before a notification is sent to a Follower.Dexcom Share CloudA secure online storage server where Dexcom Share feature information is stored and then shared with Followers.Dexcom Follow App Gets the Sharer’s glucose information and prompt data from the Dexcom Share Cloud.Dexcom G5 Mobile/G4 PLATINUM SensorThe Dexcom G5 Mobile System part that includes an applicator and sensor wire.(Continued on next page)Chapter 20Sharing Is Caring:Dexcom Share
Dexcom G5 Mobile System User Guide304Sharing Is Caring(Continued from previous page)Dexcom G5 Mobile SystemCGM system made of a sensor, transmitter, and smart device/receiver.Dexcom G5 Mobile TransmitterThe Dexcom G5 Mobile System part that wirelessly sends glucose information to the Dexcom G5 Mobile App.Dexcom G5 Mobile AppReceives glucose information from the Dexcom G5 Mobile Transmitter. Sends glucose information to the Dexcom Cloud using an Internet connection.Dexcom Share Secondary notification using the following parts:• Dexcom G5 Mobile System• Bluetooth wireless technology• Sharer’s smart device• Dexcom G5 Mobile App• Internet• Follower’s smart device • Dexcom Follow AppDo Not Disturb A setting on a smart device where all incoming calls, alerts, and notifications are silenced.Do Not Disturb can be set to specific times and can be set to allow exceptions (people who can disturb you).Follower A person that gets the Sharer’s shared information in the Dexcom Follow App.Follow Dashboard™On the Dexcom Follow App, the Follow Dashboard shows the glucose information of up to five (5) Sharers.Follower’s Smart DeviceRuns the Dexcom Follow App.Hyperglycemia High BG. Same as “high.”The default high alert in the Dexcom G5 Mobile CGM System is set to 200 mg/dL.Consult your healthcare professional to determine the appropriate hyperglycemic setting for you.(Continued on next page)
305Dexcom G5 Mobile System User GuideSharing Is Caring(Continued from previous page)Hypoglycemia Low BG. Same as “low.”The default low alert the Dexcom G5 Mobile CGM System is set to 80 mg/dL.Consult your healthcare professional to determine the appropriate hypoglycemic setting for you.Invite/Follow Invitation EmailAn email request for a person to download the Dexcom Follow App and get the Sharer’s shared information.Jailbroken The removal of limitations set by the manufacturer on a smart device.Do not use jailbroken smart devices with Dexcom Share.mg/dL Milligrams per deciliter. The standard unit of measure for sensor glucose information in the United States.Mobile Data ConnectionsCellular networks, such as 3G, 4G and LTE™, used by a smart device to access the Internet.No More Data promptPrompts the Follower when the Sharer is unable to share glucose information.Not Sharing When the Sharer chooses to temporarily not share glucose data with the Follower.Obstruction An object that stops the wireless communication between devices, such as wall thickness or radio waves.Profile Located in Follow Dashboard and displays the Sharer’s glucose information, trend arrow and profile picture.Prompt A visual message that appears on the screen of the Follower’s smart device. Prompt may also include a sound, depending on the smart device’s settings.Range Maximum distance two devices can communicate wirelessly without obstruction.(Continued on next page)
Dexcom G5 Mobile System User Guide306Sharing Is Caring(Continued from previous page)Real-Time CGM Data the Sharer receives on the Dexcom G5 Mobile App.Although your Dexcom Follow App might be similar to what you see on your app, it cannot be considered real-time because there are layers of communication between the Dexcom G5 Mobile App and the Dexcom Follow App.Repeat Amount of time the Follower chooses before they wish to receive a repeated notification.Sensor Glucose ReadingA glucose measurement taken by the Dexcom G5 Mobile System.Sharer The person who uses the Dexcom G5 Mobile System.Sharing The act of electronically transmitting glucose information from the Sharer’s smart device to the Follower’s smart device.Simultaneous Voice and DataThe ability to make a phone call and access the Internet on the same cellular connection at the same time.Smart Device A smart device is a cordless electronic device (unless charging), mobile (easily transportable), connected (via Wi-Fi, 3G, 4G, etc.) that can operate the Dexcom G5 Mobile App or the Dexcom Follow App.Examples of smart devices are smartphones or tablets.For a list of compatible smart devices, see dexcom.com/compatibility.Standard Home Glucose MonitoringSelf-monitoring of BG using blood taken from the finger and a BG meter.Trend Arrow The arrow next to the Sharer’s glucose value, located on the Sharer’s profile on the Dexcom Follow App.This is the same trend arrow that is found on the Dexcom G5 Mobile Receiver.Trend Graph Displays the pattern of the Sharer’s glucose information.(Continued on next page)
307Dexcom G5 Mobile System User GuideSharing Is Caring(Continued from previous page)Wi-Fi or Wireless InternetA wireless technology that allows electronic devices access to the Internet. These networks can include your home Internet or one found at a public location.20.2 Dexcom Share OverviewDexcom Share is a feature within the Dexcom G5 Mobile App. It allows for remote monitoring from one person, the Sharer, of Dexcom G5 Mobile CGM data to another person, the Follower.Dexcom Share includes: • Dexcom G5 Mobile CGM System• Sharer’s smart device• Dexcom G5 Mobile App• Internet connection• Follower’s smart device • Dexcom Follow App You cannot use the Share feature with Dexcom G5 Mobile Receiver.Once the Sharer activates the Share feature in their Dexcom G5 Mobile App, the smart device transfers sensor glucose readings to the Dexcom Share Cloud using either Wi-Fi or a cellular data plan. Then, the sensor glucose readings are sent from the Dexcom Share Cloud to the Follower’s smart device using Wi-Fi or the Follower’s cellular data plan.Figure 10. SharingThe Sharer must be within 20 feet of their smart device in order to send data to their Follower or it will not work.
Dexcom G5 Mobile System User Guide308Sharing Is CaringDexcom Share PartsSharer’s smart device*1Follower’s smart device*1Dexcom G5 Mobile AppDexcom Follow AppDexcom G5 Mobile Transmitter*Dexcom G5 Mobile/G4 PLATINUM Sensor*Internet/Wi-Fi or mobile data service/3G/4G/LTE*Bluetooth*Must be purchased separately.1A list of compatible devices can be found at dexcom.com/compatibility.
309Dexcom G5 Mobile System User GuideSharing Is CaringConditions Affecting UseOnce sharing is active, make sure the Share’s and Follower’s smart device settings are not altered.Make sure the Sharer’s and Follower’s smart devices have:• Enough battery power to maintain sharing• Sharer’s smart device has Internet connection• Notifications turned on. If turned off, Follower won’t receive any notifications• Follower’s smart device has an Internet connectionDexcom recommends charging the smart device when sharing.20.3 Risks and BenefitsRisksDexcom Share is a feature of the Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System. The main risks involved with using the feature Dexcom Share are based on misunderstanding its purpose. Remember that the Dexcom Share in the Dexcom G5 Mobile CGM System is a secondary notification feature, not a real-time remote monitoring system. With using the Dexcom Share feature, there are 3 distinct parts of glucose monitoring: 1. Blood glucose meter - use this to make any treatment decisions.2. Dexcom G5 Mobile CGM System - use the Dexcom G5 Mobile CGM System to complement, but not replace, information obtained from the blood glucose meter. It detects glucose trends and tracks glucose patterns.3. Dexcom Share - this is an optional add-on to the Dexcom G5 Mobile CGM System that can share glucose information and notifications with up to five (5) other people. Shared sensor glucose readings and information can add another level of awareness.Using the wrong glucose information for treatment decisions could lead to low or high glucose. Blood glucose values from a blood glucose meter may differ from the information displayed on Dexcom Follow App. All treatment decisions should be made using a blood glucose value from your meter, not the glucose information displayed on the Dexcom Follow App.Followers who are concerned by notifications on the Dexcom Follow App should contact the patients and remind them to check their blood glucose with a blood glucose meter
Dexcom G5 Mobile System User Guide310Sharing Is Caringbefore driving a car or making any treatment decisions, such as taking insulin or eating fast-acting carbohydrates.Sharers should not rely on Followers to notify them about low or high glucose. Any problems with smart device(s), Bluetooth, wireless Internet connection, mobile data connection, Dexcom Share Cloud or not being in the communication range could cause data to not be shared with the Follower. In addition, if the Delay setting is too long, the Follower might not be aware of glucose level changes in a reasonable time. Therefore, the Dexcom Share feature should be used only to give a secondary level of awareness and should not be expected to always communicate and transfer sensor glucose readings and information.BenefitsPatients usually respond when their continuous glucose monitoring (CGM) systems alert them.However, experts advise that an additional CGM alert to another person may be helpful in increasing the detection of low glucose or high glucose values, especially at night. The Dexcom Share feature enables this additional awareness, even when the Sharer and Follower are not in the same place. The Dexcom Share feature may provide improved quality of life and greater peace of mind to patients, their caregivers and their support team by allowing the Dexcom G5 Mobile Continuous Glucose Monitoring System Alerts, Alarms and trend graphs to be checked remotely.20.4 Safety StatementIntended UseThe purpose of Dexcom Share Direct Secondary Displays is to notify another person, the Follower, of the patient’s Dexcom Continuous Glucose Monitoring (CGM) System sensor glucose information.The Secondary Displays is intended for providing secondary notification of a continuous glucose monitoring system and does not replace real time continuous glucose monitoring (Dexcom G5 Mobile System) or standard home blood glucose monitoring. The Dexcom Share Direct Secondary Displays is not intended to modify or analyze data received from the continuous glucose monitor system. Nor is it intended to instruct, or to transmit information to the continuous glucose monitor system.
311Dexcom G5 Mobile System User GuideSharing Is CaringThe Dexcom Share Direct Secondary Displays is not intended to serve as a replacement for a primary display device for a continuous glucose monitoring system. The Dexcom Share Direct Secondary Displays is not intended to receive information directly from the sensor or transmitter of a continuous glucose monitoring system.Important User InformationPlease review the indications, contraindications, warnings, precautions, cautions and other important information in the Dexcom G5 Mobile System User Guide. Dexcom Share is a feature of the Dexcom G5 Mobile System. If you do not have the Dexcom G5 Mobile System User Guide, you can view it on dexcom.com or call 1.877.339.2664 to request a copy. Availability hours: Monday-Friday, 6am-6pm PST. Please contact your healthcare professional during hours the line is unavailable.ContraindicationsDo not bring the smart device (e.g., mobile phone, tablet computer) into a room containing medical equipment such as Magnetic Resonance Imaging (MRI), Computed Tomography (CT), or diathermy.These smart devices have not been tested with this equipment. Exposure to these types of equipment could heat and damage the smart devices so that they are unable to send or receive glucose information.WarningsDosing decisions should not be made based on this device. The user should follow instructions on the continuous glucose monitoring system. This device is not intended to replace self-monitoring practices advised by a physician. Dexcom Share does not work alone. Dexcom Share does not replace the Dexcom G5 Mobile System and requires Share to be turned “On” to communicate glucose information to the Follower.You cannot use Dexcom Share to make treatment decisions, such as how much insulin to take. Dexcom Share does not replace a blood glucose meter. Always use the values from a blood glucose meter for treatment decisions.Blood glucose values may differ from the sensor glucose information. Using the sensor glucose information for treatment decisions could lead to low or high blood glucose values.
Dexcom G5 Mobile System User Guide312Sharing Is CaringPrecautionsDo not use Dexcom Share as the main source of CGM glucose trend information. Use the Dexcom G5 Mobile Receiver as the main device to track sensor glucose information, notifications and alarms.At times, the patient will be unable to share data using Dexcom Share, and the Follower might miss helping the patient in the event of low or high blood glucose values. Do not rely solely on the Follower to alert the patient of low or high glucose events or other important information. At times, the Follower may not receive data, and the patient will not be notified of this fact. When using Dexcom Share, make sure Share is turned “On.” If not, the patient will be unable to share data, and the Follower might miss helping the patient in the event of low or high blood glucose values. If the patient’s smart device does not have a connection or loses the connection, the patient will be unable to share data, and the Follower might miss helping the patient in the event of low or high blood glucose values. Do not use Dexcom Share unless both the patient’s and Follower’s smart devices have active Internet connections in order to share data. If either the patient or the Follower does not have a connection, loses their connection, turns off the connection (“Airplane Mode”) or if the smart device is in Do Not Disturb mode, the patient will be unable to share data and the Follower might miss helping the patient in the event of low or high blood glucose values. To check this, make sure that the Follower’s smart device can receive text messages. Follow notifications and text messages work by a similar process. Make sure the patient’s and Follower’s smart devices have charged batteries or are connected to electrical outlets. If the smart device shuts down due to low battery, the patient will be unable to share data, and the Follower might miss helping the patient in the event of low or high blood glucose values. If the patient’s smart device is powered off or restarted, make sure the Dexcom G5 Mobile App is reopened after the smart device is turned back on in order to resume sharing. If the G5 Mobile App is not reopened, the patient will be unable to share data, and the Follower might miss helping the patient in the event of low or high blood glucose values. Do not turn off sounds in the Follower’s smart device at any time that he or she wants Follow notifications to be heard. The smart device settings override the Dexcom Follow App, and all notifications will be silent even if the Follower has selected a Dexcom Follow App notification sound. If the smart device has a vibrate feature and vibrate is On, the Dexcom Follow App notifications will only vibrate.
313Dexcom G5 Mobile System User GuideSharing Is CaringCheck the delay settings on the patient’s smart device to make sure they are not too long. The Follower will not receive notifications until after the time period in the delay has passed, and the Follower might miss helping the patient in the event of low or high blood glucose values if the delay is too long. The patient should not choose to “Not Share” with the Follower at any time when he or she wants the Follower to get notifications. During the time the patient chooses to “Not Share,” the Follower will not receive notifications and might miss helping the patient in the event of low or high blood glucose values.Check the Dexcom Follow App’s trend graph if the Follower’s smart device has been off or if there is no data connection (e.g., Internet/Wi-Fi or mobile data service/3G/4G/LTE is lost, connection is turned off in Airplane Mode, or smart device touch is placed in Do Not Disturb mode). When the smart device is turned back on, the Follower will only receive the most recent notification and might miss helping the patient in the event of prior low or high blood glucose values. Sharers and Followers should check whether their cellular service carriers support voice and data at the same time (simultaneous voice and data). If their carriers do not support simultaneous voice and data, the Dexcom G5 Mobile App may not be able to share glucose readings and the Dexcom Follow App may not be able to receive notifications or glucose readings during phone calls. Dexcom Share will resume sharing after the phone call has ended, and the Follower will receive any waiting notifications after the phone call has ended.20.5 Setting up Dexcom ShareDexcom Share DescriptionWhat Dexcom Share does:• Connects your smart device with your Follower’s smart device via either a Wi-Fi or mobile data connection (connect to Wi-Fi through a secured network to maintain data security)• Invites and sends Followers your setting recommendations• Displays the status of your smart device, and the Dexcom Share Cloud ○Confirms your sensor glucose readings are being shared with your Follower(s)What Dexcom Share does not do:• Let you know when the Follower is not receiving your sensor glucose readings and information
Dexcom G5 Mobile System User Guide314Sharing Is CaringTips• Read the rest of the Dexcom G5 Mobile CGM System User Guide before using Dexcom Share• Always confirm information with a BG meter before making treatment decisions• Check the status screen after turning Dexcom Share “On” on the smart device to make sure it is workingInstalling the Dexcom G5 Mobile AppStep What you see What you do1Download the Dexcom G5 Mobile App from your app store.See your smart device’s user manual for instructions.Download the Dexcom G5 Mobile App to use Dexcom Share. 2Launch the Dexcom G5 Mobile App.Setup your smart device (see the Dexcom G5 Mobile User Guide) before sharing.Once your App has set up, activate Dexcom Share.A series of screens walk you through Dexcom Share’s features highlighting important information.
315Dexcom G5 Mobile System User GuideSharing Is CaringActivating Your Share FeatureStep What you see What it means What you do1Activates Dexcom Share.If Dexcom Share icon is gray, your Share feature has not been turned on.Tap Dexcom Share icon in the upper right corner of your smart device’s home screen.2Dexcom Share Welcome Screen.Read screen.Tap Next when done.(Continued on next page)
Dexcom G5 Mobile System User Guide316Sharing Is Caring(Continued from previous page)Step What you see What it means What you do3Message about Internet access. Tap Next.4How to know you are sharing your data. Tap Next.(Continued on next page)
317Dexcom G5 Mobile System User GuideSharing Is Caring(Continued from previous page)Step What you see What it means What you do5How to know your Follower is not getting your sensor data.Tap Let’s Get Started to move on and invite your Followers.
Dexcom G5 Mobile System User Guide318Sharing Is CaringInviting FollowersStep What you see What you do1Tap Invite Followers to set up your Followers.(Continued on next page)
319Dexcom G5 Mobile System User GuideSharing Is Caring(Continued from previous page)Step What you see What you do2Enter the Follower’s nickname and email address.Confirm Follower’s email address.The Follower will get a Follow Invitation email.Make sure the Follower can access this email account from their smart device.Tap Next.(Continued on next page)
Dexcom G5 Mobile System User Guide320Sharing Is Caring(Continued from previous page)Step What you see What you do3Tap Allow Trend Graph View’s On/Off switch if you want Follower to see your trend graph.Tap Next.Turned Off: Follower sees only your sensor glucose reading and trend arrow.Turned On: Follower sees your sensor glucose reading, trend arrow and trend graph.(Continued on next page)
321Dexcom G5 Mobile System User GuideSharing Is Caring(Continued from previous page)Step What you see What you do4Choose if your Follower gets your urgent low, low and high sensor glucose Alarm/Alerts.Choose if you want your Follower to get prompts if they are not receiving your sensor glucose readings.Select what Alarms/Alerts your follower gets and how long you are low/high or not sharing data (for example, if you want your Follower to know when your glucose is above 200 mg/dL for more than 2 hours, you can set up in the Follower Settings Menu).Tap Save for each Follower Setting “Save.”Tap Next when done.(Continued on next page)
Dexcom G5 Mobile System User Guide322Sharing Is Caring(Continued from previous page)Step What you see What you do5Before Follower invitation is sent, review the Summary screen.Tap Send Invitation.After sending invitation, you cannot adjust the Follower’s settings.6To add more Followers:Tap Followers tab on the Share Status screen.Invite up to a total of five (5) Followers.
323Dexcom G5 Mobile System User GuideSharing Is Caring20.6 Using Dexcom ShareDexcom Share StatusYou can look at the Dexcom Share icon on your home screen to see if Dexcom Share is working. After turning Dexcom Share on, check its status.Figure 11. Dexcom G5 Mobile App Home ScreenDexcom Share Status IconsStatus Tab What it isThe Share icon is in color when Dexcom Share is sending sensor glucose readings and information.1The Share icon is gray with a red circle when Dexcom Share is not working.The sharer should tap on the grayed out Share icon when it is not working to get further information about the error.(Continued on next page)Share icon
Dexcom G5 Mobile System User Guide324Sharing Is Caring(Continued from previous page)Status Tab What it isThe Share icon is light gray when Dexcom Share has not been activated.The sharer should tap the light gray icon to get started using Dexcom Share.When a device or connection is not working, Dexcom Share will not work. The Sharer will not be able to send their sensor glucose readings and data to their Follower.Troubleshooting Status IssuesDexcom Share’s status bar is a useful tool. It can help identify if there is a problem and Dexcom Share is not working. The following table provides troubleshooting tips for the Share status bar.Figure 12. Dexcom Share ScreenNOTE: Whether or not Dexcom Share is working and the Followers are receiving glucose Alarm/Alerts, you must always refer to your Dexcom G5 Mobile display device for your sensor glucose readings and alerts.All treatment decisions must be based on your BG value from your BG meter.On/Off Switch - Turns sharing on or offSharing Status Bar - Status of sharing your sensor glucose readings with your FollowersFollower List - Add Followers and lists status of Followers.
325Dexcom G5 Mobile System User GuideSharing Is CaringWhat you see What it means What you doGreen Check:All connections are working N/A.Issue with:• Sharer’s CGM data• Your smart deviceThe Sharer should make sure:• There is a glucose value on the smart device• Transmitter is in range of the smart device• Tap on blue “?” to learn more about how to troubleshoot this issue• The Sharer should allow up to 10 minutes for their status to turn green and a green check mark to appearIf the Sharer continues to see this, the Sharer should turn off Share and then turn it back on.(Continued on next page)
Dexcom G5 Mobile System User Guide326Sharing Is Caring(Continued from previous page)What you see What it means What you doIssue with:• Sharer’s Internet connection• Dexcom Share CloudThe Sharer should make sure:• Their Wi-Fi or cellular connection is ON• They are in an area that has cellular reception• They are not on a voice call• They can access the web via a browser• Check later or follow up with their Internet connectivity provider• Tap on blue “?” to learn more about how to troubleshoot this issueFollower ListThe Followers list allows the Sharer to manage their Followers.In the Follower list you can:• Invite a new Follower• See the status of Followers you have invited• Glance at what options your current Followers haveIcon/StatusWhat you see What it meansInvite a new Follower.(Continued on next page)
327Dexcom G5 Mobile System User GuideSharing Is Caring(Continued from previous page)What you see What it meansFollower is set to get prompts from their Sharer.Follower is able to view their Sharer’s trend graph.Follower did not accept their Sharer’s Follow Invitation email within 7 days.The Sharer can invite their Follower again by pressing on the + icon in the top right corner of the screen.Follower has been sent a Follow Invitation email but has not accepted it yet.Sharer stopped sharing with Follower.Follower will not get any of the Sharer’s glucose information, Alarm/Alerts, or trend graph updates.Editing/Removing FollowersTap on a Follower to edit the Follower’s profile (nickname or ability to view trend graph) or remove a follower. Remove a follower by tapping “Remove Follower.” Once removed, they won’t get glucose information or Alarm/Alerts.NOTE: The Sharer cannot change any Follower settings after the Follow Invitation email is sent.Stop SharingThe Sharer can swipe the On/Off switch to temporarily stop glucose information and Alarm/Alerts from being sent to Followers. Sharing stops until the Sharer turns the On/Off Switch back on.
Dexcom G5 Mobile System User Guide328Sharing Is CaringFor reasons of safety and intended use, the Follower will get a message telling them their Sharer’s data was set to Not Sharing. The Follower’s dashboard will show the Sharer has stopped sharing glucose information.20.7 Dexcom Follow AppDexcom Follow App DescriptionThe Dexcom Follow App is a separate App from the Dexcom G5 Mobile App. Your Followers only need to download and install the Dexcom Follow App.What the Dexcom Follow App does:• Allows Follower to view the Sharer’s glucose information• Allows Follower to get Alerts and Alarms• Allows the Follower to view the Sharer’s trend graphWhat the Follower app does not do:• Provide treatment advice• Interact with the Dexcom G5 Mobile AppReceiving Dexcom Follow Invitation EmailAfter getting the Sharer’s Follow invitation by email, the Follower sets up their smart device.Glucose Alarm and AlertsA glucose prompt is a visual message saying “Glucose notification from [Sharer’s name]” that appears on the screen of the Follower’s smart device. The prompt may include sounds, depending on their smart devices settings.Types of prompts your Followers get:• Low Sensor Glucose Reading• Urgent Low Sensor Glucose Reading (< 55 mg/dL)• High Sensor Glucose ReadingYour Follower can change some of the initial settings to fit their needs. The Follower cannot change your permission settings to see your Trend Graph.Sharer Status Changes That Notify the FollowerSome Sharer status changes will prompt your Followers.
329Dexcom G5 Mobile System User GuideSharing Is Caring• Not Sharing - Sharer decides to temporarily stop sharing• Removed by Sharer - Sharer removes Follower• No More Data - Prompt Sent when active glucose sharing is stopped for any reason, other than the Sharer turning Share “Off” ○The Follower should contact the Sharer for more information about the data interruptionThe Follower DashboardFigure 13. Follower DashboardIf you don’t allow your Follower to see your Trend Graph, they will only see your glucose reading and trend arrow.
Dexcom G5 Mobile System User Guide330Sharing Is Caring20.8 TroubleshootingDexcom Share TroubleshootingTroubleshooting Status - See the Troubleshooting Status Issues portion of Section 20.6.Figure 14. Follower InformationIf you choose to have your Follower see your Trend Graph, they see:Figure 15. Follower Information With Trend GraphSharer’s glucose reading and trend arrowSharer’s pictureHow long ago the Sharer’s glucose reading and trend arrow were last updatedSharer’s name Notification settingsHome iconTime duration setting of 3, 6, 12 or 24 hoursTrend graphTrend arrowSharer’s glucose readingGlucose range (between high and low alerts)
331Dexcom G5 Mobile System User GuideSharing Is CaringSharing ChecklistTo share, you need to:Make sure your smart device works with the Dexcom G5 Mobile App. To see a list of supported smart devices and operating systems, go to: dexcom.com/compatibility• The Dexcom G5 Mobile App is open or running in the background• Smart device has an active Internet connection (Wi-Fi, 3G, 4G, LTE). The Sharer can check to see if the Internet connection is working by trying to open a web page on the Sharer’s smart device• If on a phone call using your smart device, your CGM information may not upload into the Share Cloud while on your call• Airplane Mode turned off• Do Not Disturb is turned off• Smart device sound is on in order to hear prompts• Smart device is sufficiently charged or charging• Smart device is within 20 feet of the transmitter• Smart device has 35 MB of available memory• Refer to the smart device user manual for further instructionsTips• Read the Dexcom G5 Mobile CGM System User Guide before using the Dexcom Share feature• Always confirm information with a BG meter before you make treatment decisionsFigure 16. Sharing Status Troubleshooting
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333Dexcom G5 Mobile System User GuideIndexAAlarm, 175 App Recommended Settings, 183 Clearing, 188 Prompts, 178 Receiver Beeps and Vibrations, 184 What is an, 176Alarm and Alerts Changing Receiver, 204 Customizing, 195Alerts, 175 Clearing, 188 Default, 176 Low Repeat/High Repeat, 185 Low/High Glucose, 179,180 Main Menu, 207 Receiver Default Beep and Vibrations, 184 Rise Rate/Fall Rate, 181, 182 Rise Rate/Fall Rate/Repeat/Signal Loss, 177 What are, 176CCalibration, 92 Entering into app, 101 Entering into your receiver, 104 Errors, 106 Preparing for, 100 Prompts, 96, 98, 99 What is it, 92 When to Calibrate, 95 Why is Calibrating important, 92CGM System Basic Maintenance, 222 Different Monitoring Methods, 50 Disposal, 228 Overview, 42 Storage, 226EError Messages, 147Event Categories, 154 Definition, 153Events, 153 Entering App, 162 Receiver, 168 Viewing, 170GGlucose Information Rate of Change Arrows, 146 Trend Screen, 137, 145RRate of Change Arrows, 138, 146Receiver Home Screen, 142 Initial set up, 64 Overview, 46SSafety Statement Contraindications, 19 Indications, 18 Precautions, 21, 23, 24, 25, 27 Warnings, 20, 21, 22, 24, 26Sensor Insertion Choosing site, 75Sensor Session Attaching transmitter, 80 Definition, 8 Ending, 110 Ending EarlyIndex
Dexcom G5 Mobile System User Guide334Index App, 119 Receiver, 121 Ending Seven Day, 111 Inserting sensor, 76 Prepping for Sensor Insertion, 72 Preventing Sensor Failures, 123 Receiver: Starting a Session, 84 Remove Sensor Pod and Transmitter, 124 Starting a, 69 Starting with app, 83Sensor Session Warmup Warmup, 90Signal Loss Alert Signal Loss, 183, 187, 208Sound/Vibration Prompts, 116System Components, 39TTechnical Information, 237Transmitter Attaching, 80 Battery Messages, 127 Connecting/Pairing Transmitter with App, 58 Connecting/Pairing with Receiver, 66 End of Transmitter Battery, 127 Overview, 45 Remove from Sensor Pod, 124 Safety Statements, 24Troubleshooting, 287WWarranty, 215Notes________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
© 2016 Dexcom, Inc. All rights reserved.Covered by patents www.dexcom.com/patents.Dexcom, Dexcom Follow, Dexcom G4, Dexcom G4 PLATINUM, Dexcom G5, Dexcom G5 Mobile, Dexcom Share, Follow Dashboard, and G5 are either registered trademarks or trademarks of Dexcom, Inc. in the United States and/or other countries. All other product or company names that may be mentioned in this publication are tradenames, trademarks or registered trademarks of their respective owners.
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