Dexcom ONE+ User Manual
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Dexcom ONE+ User Manual

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Summary of Contents for Dexcom ONE+

  • Page 1 Instructions for Use User Guide...

  • Page 3: Table Of Contents

    Navigation Trend graph history Tips from banners, tooltips, and icons 5 • Treatment decisions When to use your BG meter instead of Dexcom ONE+ When to watch and wait Using the trend arrows Treat with professional advice Practice making treatment decisions 6 •...
  • Page 4 Travel with Dexcom ONE+ Update display device Water and Dexcom ONE+ X-ray, CT scan, or radiation therapy A • Clarity B • Taking care of your Dexcom ONE+ Dexcom ONE+ maintenance Storage Table of contents | Dexcom ONE+ User Guide...
  • Page 5 System disposal C • Professional use instructions Introduction Prepare Dexcom ONE+ for patient Explain Dexcom ONE+ to patient Set up Dexcom ONE+ with patient Check patient reports in Clarity End of sensor session Next steps D • Warranty Dexcom receiver limited warranty Dexcom sensor limited warranty E •...

  • Page 6: Welcome

    (Turn on alerts during setup to get glucose and System alerts when warmup is complete.) Bring more peace of mind: Dexcom ONE+ lets you share glucose data with your support team to keep them informed about your glucose levels in real time.
  • Page 7 If you don’t turn on optional alerts, you might miss a severe low or high glucose event. Dexcom ONE+ alerts won’t override your display device settings If your display device (phone or Dexcom ONE+ receiver) is on silent or vibrate, you won’t hear high or low glucose alerts. Turn on display device sound to hear alerts.

  • Page 8: Product Highlights

    App makes it easy to manage your glucose Fast setup Receiver (optional) Small size Dedicated medical device For more information about setting up Dexcom ONE+, go to the Set up your Dexcom ONE+ chapter. For more information on the grace period, go to the Next sensor session chapter.

  • Page 9: Safety Information

    Dexcom ONE+ hasn't been tested in those situations. When used during an MRI scan, diathermy, or in the scanned area of a CT scan, the magnetic fields and heat could damage components of Dexcom ONE+, which may cause inaccurate sensor readings or prevent alerts.
  • Page 10 Inspect: Don't use any damaged or cracked Dexcom ONE+ component because it may not work correctly and could cause injuries from electrical shocks. Use as directed: Dexcom ONE+ is small and may pose a choking hazard if swallowed. Don't put it in your mouth or let children hold it without adult supervision.
  • Page 11 The level of inaccuracy depends on the amount of hydroxyurea in your body. Use your meter if you have taken hydroxyurea. Be accurate, be quick: If you calibrate your Dexcom ONE+ using your BG meter, enter the BG meter value on your meter within five minutes of measuring your BG.

  • Page 12: Share And Follow Safety Information

    Share and Follow safety information If available in your region, use Dexcom Share (Share) to send your sensor information from your app to your Followers’ smart devices (Dexcom Follow app). Use as secondary notice: Your Followers’ information is always older than yours.
  • Page 13 In rare cases, inserting the sensor can cause infection, bleeding, or pain, and wearing the adhesive patch can irritate your skin. In most patients, the adhesive reactions are mild and resolve within a week. Only a few patients in the Dexcom ONE+ clinical studies got slight redness and swelling.
  • Page 14 Wadwa RP, Laffel LM, Shah VN, Garg SK. Accuracy of a factory-calibrated, real-time continuous glucose monitoring system during 10 days of use in youth and adults with diabetes. Diabetes Technol Ther. 2018;20(6):395-402. 2 • Safety information | Dexcom ONE+ User Guide...

  • Page 15: Glossary

    Glucose a display device. Monitoring (CGM) Contraindication A situation where Dexcom ONE+ shouldn't be used because it may be harmful to you. The risk of use outweighs the benefit. Default A manufacturer’s preset option for a device setting. Display Device A device with a screen used for monitoring your glucose information and alerts, for example, a smartphone app or the Dexcom receiver.
  • Page 16 A statement of the intended uses of Dexcom ONE+ and relevant warnings, precautions, and contraindications. Share A feature of the Dexcom ONE+ app that lets you securely send your information to Followers. Sharer The Dexcom ONE+ user who shares their information with Followers.
  • Page 17 Replace Sensor Now, Sensor Failed, Set Date/Time, Signal Loss, System Check, Very Low Battery, Weak Charger Transmitter Sends sensor readings to the display device. In Dexcom ONE+, the transmitter is built into the sensor. Warning Describes serious and life-threatening circumstances, the consequences, and how to avoid the hazard while using Dexcom ONE+.

  • Page 18: Set Up Your Dexcom One

    To get started, set up the app, the optional receiver, or both. If you’re using both, it doesn’t matter which you set up first. If you want to use your Apple Watch, set up the Dexcom ONE+ app first, then use the instructions in...

  • Page 19: Set Up The App

    Set up the app You can set up the Dexcom ONE+ app on only one smartphone. You need a secure internet connection to set up your system. 1. Go to the Apple App Store or Google Play Store to download the Dexcom ONE+ app.

  • Page 20: Set Up The Optional Receiver

    If you use both the app and the receiver, you'll need to acknowledge alerts on both display devices. If you use the optional receiver, be sure to use the Dexcom ONE+ receiver. Receivers from other systems won't work with Dexcom ONE+.
  • Page 21 Scroll down Your sensor session To learn more about using your Dexcom ONE+, read the rest of this guide, or go to dexcom.com, where you’ll find answers to frequently asked questions and more. 3 • Set up your Dexcom ONE+ |...

  • Page 22: Insert Sensor

    6 Rub and press To help keep the patch on your skin: a. Rub firmly around patch 3 times. b. Gently press on top of sensor for 10 seconds. 3 • Set up your Dexcom ONE+ | Dexcom ONE+ User Guide...

  • Page 23: Quick Glance (Android)

    Quick Glance (Android) If you set up your Dexcom ONE+ app on an Android phone, you can check your sensor reading, trend arrow, trend graph (3- hour view), and other Dexcom ONE+ information from the notification drawer. Swipe down from the top of your screen to see Quick Glance.

  • Page 24: Smartwatch (Apple)

    In your smart device settings, make sure notifications are sent to both your phone and watch. Don't disable or block notifications from the app. Waking up your watch updates your Dexcom ONE+ data from your phone. There may be a brief delay before your watch app shows current information.

  • Page 25: Display Device Screens

    Change level in Profile > Alerts > Low. Consider using the optional receiver if you're more comfortable with a dedicated medical device. On the phone, Dexcom ONE+ may compete with other apps for battery and storage capacity and may require certain phone settings to function. The receiver doesn't have these limitations.

  • Page 26: Sensor Reading And Trend Arrow

    A number and color tell you where your glucose is now. Receiver What it means Red: Low mmol/L mmol/L Yellow: High 13.9 mmol/L mmol/L White: Between your high and low alert levels mmol/L mmol/L 4 • Display device screens | Dexcom ONE+ User Guide...
  • Page 27 They aren't related to your glucose. No alerts Brief Sensor Issue Brief Sensor Issue Don’t remove sensor. Don’t remove sensor. Temporary issue. Temporary issue. Wait up to 3 hours. Wait up to 3 hours. Help 4 • Display device screens | Dexcom ONE+ User Guide...
  • Page 28 Changing 1.7–3.3 mmol/L in 30 minutes Rising or falling: Changing 3.3–5.0 mmol/L in 30 minutes Rapidly rising or falling: Changing more than 5.0 mmol/L in 30 minutes No arrow: Can't determine trend; use BG meter for treatment decisions 4 • Display device screens | Dexcom ONE+ User Guide...

  • Page 29: Navigation

    History, Connections, and Profile tabs Use the tabs at the bottom of the screen to get to other features. Glucose History Connections Profile 4 • Display device screens | Dexcom ONE+ User Guide...
  • Page 30 Support: Recommended settings Review your software and account information. Avoid phone settings that stop your alerts and app from working. Support Contact Dexcom Technical Support at dexcom.com or contact your local Dexcom distributor. About Review and revise data consents. Account Get help (Profile >...
  • Page 31 Replace sensor and stop sensor session: Stop this sensor and start a new one. (More in Next sensor session.) Stop sensor session Power off: Turn off the receiver. No readings or alerts when powered off. Power off 4 • Display device screens | Dexcom ONE+ User Guide...

  • Page 32: Trend Graph History

    Tap the icon in the upper left corner to return to portrait mode. Receiver 14.0 On the home screen, use the up and down arrows to switch between the 1, 3, 6, 12, 3 Hours Menu and 24-hour views. 4 • Display device screens | Dexcom ONE+ User Guide...

  • Page 33: Tips From Banners, Tooltips, And Icons

    Tips from banners, tooltips, and icons Banners, tooltips, and icons appear on your screen to help you use Dexcom ONE+. They'll give you helpful information, reminders, and even suggestions for next steps. See the following examples. Phone settings conflict icon: The phone icon at the top left of the screen appears...

  • Page 34: Treatment Decisions

    5 • Treatment decisions With Dexcom ONE+, you can treat without using your blood glucose meter (BG meter). But don't rush it. You should keep using your BG meter to make treatment decisions until you know how Dexcom ONE+ works for you. Sometimes you must use your BG meter instead of Dexcom ONE+.

  • Page 35: When To Watch And Wait

    Trending down: Consider taking a little less insulin than usual when your glucose is falling. Treat with professional advice Confirm with your healthcare provider about: Using Dexcom ONE+ to manage your glucose Setting alert levels Comparing BG meter values and sensor readings Fingerstick best practices 5 •...

  • Page 36: Practice Making Treatment Decisions

    Up arrow: Glucose is rising up to 3.3–5.0 mmol/L in 30 minutes. What you should do: Use your Dexcom ONE+ to treat. Take your normal dose and, because of the up arrow, consider taking a little more. 5 • Treatment decisions |...
  • Page 37 Number and arrow: You have neither. Error message: You aren't getting sensor readings. What you should do: Use your BG meter for treatment decisions. Keep your display device closer to your sensor. 5 • Treatment decisions | Dexcom ONE+ User Guide...
  • Page 38 Number and arrow: You have both. Down arrow: Your glucose is falling between 3.3–5.0 mmol/L in 30 minutes. What you should do: Use your Dexcom ONE+ to treat. Because the down arrow shows your glucose is falling, consider taking a little less insulin than usual. Situation: Mid-afternoon It's 3 hours after lunch.

  • Page 39: Alerts

    6 • Alerts Dexcom ONE+ gives you the option of turning on alerts when you set up your system. You just follow the prompts on your screen. You can also turn on or change your alerts after setup. Turning alerts on can help you stay in your target range. They are an important tool when making treatment decisions with Dexcom ONE+.

  • Page 40: System Alerts

    No readings or alerts until off patch from the edge. you start a new sensor. For a list of System and Technical alerts, go to the Glossary in the Safety information chapter. 6 • Alerts | Dexcom ONE+ User Guide...

  • Page 41: Responding To App Alerts

    Alert vibrations in your app feel the same as notifications you get from other apps on your phone. The only way to know if it’s from Dexcom ONE+ is to look at your phone. In the app, you get notifications on your Lock screen. If you're not getting any data, open your app.

  • Page 42: Turn On Alerts Or Change Settings

    Alerts High Signal Loss Brief Sensor Issue Technical alerts Dexcom ONE+ will not override your phone settings. You will NOT hear or feel alerts if your phone is set to silent. Receiver 1. Go to Menu > Settings > Alerts.

  • Page 43: Customizing Alert Sounds

    It’s the red line on the glucose graph. Level 3.9 mmol/L Tone Low (Default) Dexcom ONE+ alerts will not override your phone settings. You will NOT hear or feel alerts if your phone is set to silent. Receiver To choose different alert sounds on your receiver: 1.

  • Page 44: Use Alerts To Achieve Goals

    – taking doses too close together? To use your Dexcom ONE+ as a tool to avoid insulin stacking, your healthcare provider may advise you to turn on the Snooze feature in your High alert setting. That way, you can choose how long you want to wait before getting another High alert after you confirm the first one.

  • Page 45: App Connections

    Use the app's Share feature to let friends and family members view your glucose information. Share sends your information every 5 minutes — almost as soon as you get it. Always treat using the primary Dexcom ONE+ app, not the Follow app.
  • Page 46 No Internet Connection: Your phone must be connected to the internet for Status Share to work. Working Data Consent Required: You must consent to share data with Dexcom for FOLLOWERS Share to work. Server Outage: Dexcom server isn't working. Jeff Followers: This shows the name and status of your inactive Followers.

  • Page 47: Dexcom Follow App

    Followers get the email inviting them to follow you. Using a smartphone or tablet, the Follower should: 1. Download the Dexcom Follow app. 2. Open the Dexcom Share email and tap Accept Invitation. Follower access Followers see only the information you choose to share.
  • Page 48 Follow notifications match your phone settings and will sound or vibrate based on phone settings. Responding to notifications Notifications repeat every 5 minutes until acknowledged. To acknowledge a Follow notification: Open the app, or Tap the notification on the lock screen. 7 • App connections | Dexcom ONE+ User Guide...

  • Page 49: Health Apps

    Removed by Sharer: Sharer deletes the Follower. mmol/L There are times when the Follow app information may be out of sync with the Sharer's Dexcom ONE+ information. Because of the delay, Sharers should always treat using the primary Dexcom ONE+ app, not the Follow app.

  • Page 50: Receiver Calibration

    Your sensor readings come from different fluids than your BG meter values, so they won't usually match. Neither number is as accurate as the lab test your healthcare provider does. For information on accuracy and calibrating your Dexcom ONE+, go to the Accuracy and calibration section of the Troubleshooting chapter.

  • Page 51: Events And History

    Using events to manage glucose Dexcom ONE+ gives you a graph showing where your glucose has been. Events can help you understand why your glucose changed. For example, what happened to your glucose level after breakfast? Discuss your reflections with your healthcare provider to find even more ways to manage your blood glucose.
  • Page 52 Insulin amount: 8.0u Scroll to the event you want to edit or delete, select Next, and follow the instructions Time entered: on the screen. 08/10/2021 2:42 Edit event Delete event 9 • Events and history | Dexcom ONE+ User Guide...

  • Page 53: Logging Bg Meter Values Or Calibrating

    Logging BG meter values or calibrating Your healthcare provider may ask you to keep track of your BG meter values, or you may want to calibrate your Dexcom ONE+. If you calibrate, enter it into the app or the receiver, not both. The other device will update after about 5 minutes.

  • Page 54: Reports

    Time in range change from Very low: Below 3.0 mmol/L the prior 3 days: These reports are updated hourly. If you upload your receiver data, you can get more detailed reports at dexcom.com/clarityapp. For more information, go to Clarity appendix. 10 • Reports |...

  • Page 55: Next Sensor Session

    Stop sensor session: If you want to stop this sensor without starting a new one Sensor expires 19/10/24, 12:36 Then, follow the instructions on the app screens. Replace sensor Stop sensor session 11 • Next sensor session | Dexcom ONE+ User Guide...

  • Page 56: Remove Your Sensor

    Stretch loosened edge, and push your fingers under the patch to pull it off skin. For more tips, go to dexcom.com/faqs. Before inserting a new sensor, remove the old one. You can use only one sensor at a time with Dexcom ONE+. Throw out the used sensor following local guidelines.
  • Page 57 All Dexcom sensors are listed as not connected, even the current one. The current sensor’s status changes to connected during the few seconds every 5 minutes when it’s sending your sensor reading to your phone. If you watch the list for up to 5 minutes, you’ll see which sensor is the current one.

  • Page 58: Troubleshooting

    Update display device Water and Dexcom ONE+ X-ray, CT scan, or radiation therapy For more troubleshooting information, see the frequently asked questions section on the Dexcom website (dexcom.com/faqs) or contact Dexcom Technical Support at dexcom.com or contact your local Dexcom distributor.

  • Page 59: Accuracy And Calibration

    You can log your BG meter value by tapping the plus sign (+) in the Glucose or History tabs. In the receiver, go to Menu > Events > Blood glucose > Use as calibration. If Events isn't an option on your Dexcom ONE+ receiver menu, go to Menu >...
  • Page 60 Save Last calibration When you calibrate your Dexcom ONE+ using your BG meter, remember: Calibrate in one display device: Calibrate in one display device, even if you use both the app and receiver. The sensor sends calibration information between them.

  • Page 61: Adhesive Patch

    1. Gently peel off adhesive patch with applicator attached. 2. Check insertion site to make sure the sensor isn't left in the skin. 3. Don't reuse applicator. 4. Contact Dexcom Technical Support at dexcom.com or contact your local Dexcom distributor.

  • Page 62: Can't Hear Alerts

    Receiver is on: Verify that the receiver is on. Alert sounds: Make sure you aren't using Vibrate Only. Dexcom ONE+ optional alerts won't override your display device settings. If your receiver is set to Vibrate, you won't hear your alerts. For more information, go to the Alerts chapter.

  • Page 63: Common Alerts

    Don't remove sensor. Use BG meter for treatment decisions. Check your sensor. Tap Help in app for more information on troubleshooting. If Brief Sensor Issue continues for more than 3 hours, contact Dexcom Technical Support at dexcom.com or contact your local Dexcom distributor.
  • Page 64 For pairing, you may have to go to a different area to get far enough away from other people wearing sensors. Check display device: Sensor can be paired with only one receiver. Sensor can be paired with only one smartphone. Keep app open: Don't swipe it closed during pairing. 12 • Troubleshooting | Dexcom ONE+ User Guide...
  • Page 65 Use recommended phone settings listed in the app at Profile > Settings. Keep your phone battery charged to at least 20%. If Signal Loss continues for more than 30 minutes, contact Dexcom Technical Support at dexcom.com or contact your local Dexcom distributor.

  • Page 66: Gap In Trend Graph

    Solution Contact Dexcom Technical Support at dexcom.com or contact your local Dexcom distributor. Give them the error code. Gap in trend graph Issue When you aren't getting sensor readings, your trend graph may show a gap in the trend dots.

  • Page 67: Recharge Receiver

    Your receiver may need to be charged after shipping and storage. Solution Use Dexcom supplied charger and USB cable. If the charger you use is too weak, the receiver will alert you. Full charge may take up to 3 hours. Travel with Dexcom ONE+ Issue You want to use your Dexcom ONE+ when going through security or flying.

  • Page 68: Water And Dexcom One

    Water and Dexcom ONE+ Issue You want to shower, swim, or bathe wearing your Dexcom ONE+. Solution Once inserted, the sensor is waterproof up to 2.4 meters. The receiver isn't. Swim, shower, and take a bath with the sensor, but leave the receiver out of the water.
  • Page 69 Appendix...

  • Page 70: A • Clarity

    A • Clarity Dexcom Clarity is an important part of your CGM system, providing a holistic view of your diabetes management by highlighting glucose patterns, trends, and statistics. It can help you identify glucose patterns and, with your healthcare provider, determine the potential causes of those patterns.

  • Page 71: B • Taking Care Of Your Dexcom One

    If the receiver has a screen protector, remove it before cleaning and disinfecting. Using alcohol wipes to clean the receiver hasn't been tested. All Dexcom ONE+ components Dexcom ONE+ components work together. Don't mix components from other Dexcom products. Don't use damaged components. B • Taking care of your Dexcom ONE+ |...

  • Page 72: Storage

    Storage Storing your Dexcom ONE+ correctly helps prevent system failures. Sensor Keep in its sterile packaging until you're ready to use it. Store at temperatures between 2°C and 30°C, but not in a freezer. Store between 10% and 90% relative humidity.

  • Page 73: C • Professional Use Instructions

    Must carry their receiver so it records their data for later analysis Get alerts Go to dexcom.com/clarityapp, choose your country, and select the Healthcare Professional option for instructions for resetting the receiver and more (may not be available in all regions).

  • Page 74: Set Up Dexcom One+ With Patient

    For patients using only the receiver, that data is available after they return the receiver and you upload the data at dexcom.com/clarityapp. End of sensor session At the end of the sensor session, remove Dexcom ONE+ from the patient. Go to the Remove your sensor section of the Next sensor session chapter for more information.

  • Page 75: D • Warranty

    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 ONE+ or any feature or service provided by Dexcom for use with Dexcom ONE+.

  • Page 76: Dexcom Sensor Limited Warranty

    Dexcom sensor limited warranty To the extent allowed by law, the Dexcom ONE+ sensor is provided to you without any warranty by Dexcom. Dexcom hereby disclaims all warranties (express, implied, and statutory) with respect to the sensor, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose.

  • Page 77: E • Terms Of Use And Open Source Software Code

    Terms of use I have read and agree to the Dexcom Terms of Use and the included provisions for binding individual arbitration, as well as the Privacy Policy, including what personal information Dexcom collects from me and how Dexcom uses my personal information.

  • Page 78: F • Technical Information

    Satish K. Garg, Mark Kipnes, Kristin Castorino, Timothy S. Bailey, Halis Kaan Akturk, John B. Welsh, Mark P. Christiansen, Andrew K. Balo, Sue A. Brown, Jennifer L. Reid, and Stayce E. Beck. Accuracy and Safety of Dexcom G7 Continuous Glucose Monitoring in Adults with Diabetes.

  • Page 79: Product Specifications

    Portable radio frequency communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 centimeters to any part of Dexcom ONE+ including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
  • Page 80 TX/RX Frequencies 2.402–2.480 GHz Bandwidth 1.07 MHz 1.39 MHz Maximum Output Power 1.0 mW EIRP 7.4 mW EIRP Modulation Gaussian Frequency-Shift Keying Data Rate 1 Mbps Data Communication 6 meters Range The maximum surface temperature of Applied part = 43°C. F • Technical information | Dexcom ONE+ User Guide...
  • Page 81 5-minute intervals. If connection is lost between the transmitter and display device, upon re-connection any missed packets (up to 24 hours) will be transmitted from the transmitter to the display device. The Dexcom ONE+ CGM System is designed to only accept radio frequency (RF) communications from recognized and paired display devices.
  • Page 82 150 kHz to 80 MHz Radiated Fields Disturbance 10 V/m IEC 61000-4-3 at 80 MHz to 2700 MHz (AM Modulation) Radiated and Conducted Fields Meets RTCA /DO-160 edition G Section 20, Category T Aircraft use F • Technical information | Dexcom ONE+ User Guide...

  • Page 83: Radio Regulations Compliance

    BG meter values, then talk to your healthcare provider about how you should be using Dexcom ONE+ to help manage your diabetes. Your healthcare provider can help you decide how you should best use this device.

  • Page 84: G • Packaging Symbols

    G • Packaging symbols Symbols are on the Dexcom ONE+ packaging. They show proper and safe use of Dexcom ONE+. Some of these symbols may not have meaning in your region and are listed for informational purposes only. Below is a list of each symbol and its meaning.
  • Page 85 IPXX Degree of Ingress Protection, see Technical Information for product detail IPXX Class II Equipment Input Alternating Current Direct Current Bluetooth is on; device pairing is enabled EC REP Authorized Representative in the European Community UK Responsible Person UK REP G • Packaging symbols | Dexcom ONE+ User Guide...
  • Page 86 Independent Communications Authority of South Africa R-NZ New Zealand Radio Compliance French Triman logo: Recycle and dispose separately Danger: Piercing object Piercing object disposal box Electronic piercing waste Electronic piercing waste disposal box Pharmacy G • Packaging symbols | Dexcom ONE+ User Guide...

  • Page 87: H • Index

    Technical information , 73 Treatment decisions , 29, 31 Trend arrow , 20-21 Troubleshooting , 53 Use meter instead of Dexcom ONE+ , 29 Warranty , 70 Watch and wait , 30 Water and Dexcom ONE+ , 63 H • Index |...
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  • Page 91 Covered by patents dexcom.com/patents. Dexcom, Dexcom One, Dexcom Share, Share, Dexcom Follow, and Dexcom Clarity are registered trademarks of Dexcom, Inc. in the United States and/or other countries. Bluetooth is a registered trademark owned by Bluetooth SIG. Apple is a trademark of Apple Inc., registered in the U.S.
  • Page 92 30175 Hannover, Germany Dexcom, Inc. 6340 Sequence Drive San Diego, CA 92121 USA UK REP +1-858-200-0200 dexcom.com MDSS-UK RP Ltd. 6 Wilmslow Road, Rusholme Outside US: Contact your local Dexcom Manchester M14 5TP representative United Kingdom AW-1000027-05 Rev 002 Rev Date 2023/12...

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