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Frequently Asked Questions

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What are the main differences between Dexcom G5 Mobile and G6?

The Dexcom G6 is the latest generation of CGM available from Dexcom. New features include factory calibration, a 10-day sensor wear period, a one-touch auto-applicator, a new “Urgent Low Soon” Alert, acetaminophen blocking* and a discreet, low-profile wearable transmitter.

*G6 readings can be used to make diabetes treatment decisions when taking up to a maximum acetaminophen dose of 1,000mg every 6 hours. Taking a higher dose may affect the G6 readings.

Is this product approved for Pediatrics?

Yes, Dexcom G6 is indicated for children as young as 2 years old.

Is the G6 covered by Medicare?

The Dexcom G6 is currently not available for Medicare patients.  Until then, Medicare users can continue to use the Dexcom G5.

Will Dexcom CLARITY work with G6?

Yes, G6 does work with CLARITY. Patients will not need to register again nor download a new CLARITY App if they have already established an account. If you are already sharing with your clinic, the clinic will not need to reconnect.

When is Dexcom G6 launching?

Our targeted ship date is June 4th, 2018.

What is the Dexcom G6 Upgrade Program?

The targeted ship date for the Dexcom G6 CGM System is June 4th, 2018. Dexcom will provide a seamless upgrade program so that all customers can migrate to our newest CGM system as soon as possible.

New Customers

New customers should get started on the Dexcom G5 Mobile CGM System as soon as possible. These customers will automatically be enrolled in the Dexcom G6 Upgrade Program. New customers who start on Dexcom G5 Mobile after March 27th will automatically receive Dexcom G6 after 90 days in the order which they signed up for the Dexcom G6 Upgrade Program. New customers should go to the Dexcom website and completely fill out the required information to get started.

Current Customers

Current customers who are out of warranty should continue to reorder their current Dexcom CGM System supplies. Current customers who order after March 27th will automatically be enrolled in the Dexcom G6 Upgrade Program and will receive Dexcom G6 after 90 days.

Current customers who are in-warranty past early June will be upgraded to Dexcom G6 when their system components reach out of warranty status. Dexcom or your distributor will discuss an upgrade to Dexcom G6 with you when you are due to place your next order.

All customers will continue to get supplies through their current supplier (eg Dexcom, Edgepark, Byram).

How do patients share data with my clinic?

If your clinic has a Dexcom CLARITY account, add the patient to your patient list, then click Share data to print or email a share invitation. The patient enters the Temporary Authorization Key from the invitation in either their personal Dexcom CLARITY account or in their Dexcom CLARITY app. Once sharing is established, it continues until the patient or clinic decides to stop sharing and manually stops it within Dexcom CLARITY.

If your clinic does not have a Dexcom CLARITY account, patients can provide a share code generated from the Dexcom CLARITY app for your clinic to enter at https://clarity.dexcom.com/professional or you can guest upload a receiver from the same link.

Is patient data shown in real-time or is it delayed?

For mobile users, CLARITY displays glucose data from a Dexcom CGM system 3 hours after the data is captured. This means that the most recent data you view in CLARITY is at least 3 hours old.

For Dexcom Receiver users, the data is as current as the last upload.

It is possible to use both a smartphone and a receiver to provide CGM data. The smartphone system streams data to the CLARITY server, where that data is made available for reports after three hours. The Dexcom receiver requires connection to a computer to upload the data periodically. If the patient uses a smart device part of the time and a receiver part of the time, then CLARITY needs data from both to provide accurate statistics. 

What reports can I view in Dexcom CLARITY?

  • Overview - presents up to four clinically relevant patterns, dashboard statistics as well as the patient’s Best Day. This quick summary can help focus the discussion on problem areas contributing to hyper- and hypoglycemia. When printed, this one page summary contains all information for billing 95251* -  a CPT code covered by most insurance carriers.
  • Patterns - dive deeper into each of the four clinically relevant patterns. Each pattern provides graphs of the days that contribute to that pattern.
  • Data - Trends and Overlay graphs show aggregate data with filtering options. Daily graphs are a detailed view of every glucose data point for each day selected.
  • Compare - report provides side-by-side comparison of Trends, Overlay and Daily graphs to encourage progress and highlight challenges patients may face.
  • Statistics - provides focused insight for both daily and hourly glucose metrics. Advanced metrics can be selected for deeper analytics.
  • AGP - standardized Ambulatory Glucose Profile (AGP) report provides a big picture view of diabetes management.

What do I do without eA1C? What do I tell my patients who use this metric?

Estimated A1C (eA1C) is not a replacement for a laboratory hemoglobin A1C test. eA1C is one measurement in the overall spectrum of diabetes management metrics. Dexcom CLARITY provides other measurements that can be useful for consideration in connection with management and therapeutic decisions such as time in range, average glucose, hypoglycemia risk, and glucose patterns.

How do I view patient data?

Once a patient has been added to the Patient list, click the patient name to invite them to share their data or choose to upload receiver data. Once sharing has initiated or receiver uploaded, click the patients' name, then click Go to interactive reports.

How does a clinic get started with Dexcom CLARITY?

Register your clinic at https://clarity.dexcom.com/professional/registration. Whoever completes the registration will be considered the account administrator with full ability to add and manage staff accounts. 

Who do I contact with questions about Dexcom CLARITY?

If you have questions about CLARITY, please contact the Dexcom Care Team at PatientCare@dexcom.com or call 1-888-738-3646, ext 4900.

How do I know when Dexcom CLARITY has been updated?

For every release, a notification banner is posted at the top of the Dexcom CLARITY on the day of the release. Follow the banner’s link to read the release notes. If the Uploader software is updated, the notification banner posts 2 weeks before the release.

What do I do without eA1C? What do I tell my patients who use this metric?

Estimated A1C (eA1C) is not a replacement for a laboratory hemoglobin A1C test. eA1C is one measurement in the overall spectrum of diabetes management metrics. Dexcom CLARITY provides other measurements that can be useful for consideration in connection with management and therapeutic decisions such as time in range, average glucose, hypoglycemia risk, and glucose patterns. 

Can I export raw data?

Yes. Dexcom CLARITY has the option to export data as a CSV file viewable in Excel. Export from one patient by clicking the patient name, then click Export. Or, export for all patients in your Partient List by clicking Export all data from the top of your Patient List page.

How do I save or print reports?

You can save or print all reports from Dexcom CLARITY for up to 90 days of data. While viewing a patient's interactive report, from the top of the page click Reports to save or print. Then, choose a date range and any or all of the reports.

Why do I need to change my clinic user password?

Dexcom CLARITY follows industry security standards, and password expirations are a best practice. You can change your clinic user password when prompted. You can also change your password or at anytime by logging in to your clinic account and navigating tofrom  My Profile at the top of the page.

How do I download reports from Dexcom CLARITY?

You can download all reports from Dexcom CLARITY that will show you an overview, patterns, specific data or up to 90 days of data. Clear infographics make it easy to identify opportunities to modify your patient’s diabetes management plan to achieve better A1C results. 

I just received a warning to change my clinic user password. Why do I have to do this?

Dexcom CLARITY follows industry security standards, and password expirations are a best practice. You can change your clinic user password when prompted. You can also change your password anytime by logging in to your clinic account and navigating to My Profile at the top of the page.

Can I change my clinic user (admin or staff) password anytime?

Yes! Login to your clinic account and navigate to the settings page. As a reminder, every user in your clinic should have their own user name and password to log in to the clinic portal. 

Will I be notified when eA1C is restored?

Yes. When eA1C is added back into Dexcom CLARITY, there will be a notification banner within Dexcom CLARITY.

Why is estimated A1C no longer available on the Dexcom CLARITY dashboard?

Dexcom has temporarily removed the estimated A1C (eA1C) statistic from all Dexcom CLARITY reports and screens. We have done this in response to feedback on the statistic. We’re working on revising the software to include more information on this statistic in the near future. We know that many of you have come to rely on this information and we apologize for any inconvenience.

What are the computer and software requirements for Dexcom CLARITY?

Users might need administrator privileges to install software on their computers.

A broadband network connection of 1.5 Mbps or more is required to install the software from the web, upload data or view the online User Guide.

It is recommended that you use an appropriate firewall program and an anti-virus program on your computer to protect against viruses, malware and unauthorized access to and use of your computer and the information stored, processed and transmitted by it.

Dexcom CLARITY supports the following minimum configurations:

  • Windows 7, 8 or 10
    • 1.3 gigahertz (GHz) processor and 1 gigabyte (GB) free RAM with 100 megabytes (MB) free disk space
    • Microsoft .NET Framework 4.0 or greater, full version
    •  Display resolution of 1024 x 768 pixels or greater
    • USB 2.0+ port to connect the USB cable to upload from your Dexcom receiver
    •  Chrome 53, Firefox 47, Internet Explorer 10 or 11 run in desktop mode or Microsoft Edge. Clinic Users can also use Internet Explorer 9 with Adobe Flash 
  • Mac OSX 10.10, 10.11 or 10.12
    • 2.3 gigahertz (GHz) processor and 4 gigabytes (GB) free RAM with 100 megabytes (MB) free disk space
    • Display resolution of 1280 x 800 pixels or greater 
    • Safari 9.1 or greater, Chrome 53 or Firefox 47 for Mac OSX. Clinic Users can also use Safari 8. 
    • USB 2.0+ port to connect the USB cable to upload from your Dexcom receiver

Optional computer requirements:

  • Mouse or track pad
  • A PDF reader (for example, Adobe Reader) for viewing, saving, and printing the reports
  • An Excel spreadsheet viewer (for example, Microsoft Excel or Excel Viewer)
  • Printer, for printed copies of reports

To run Dexcom CLARITY, your network must allow the following outbound network traffic, which might require changes to proxy and network configuration:

  • dexcom.com (and all subdomains) on port 443.
  • sweetspotdiabetes.com (and all subdomains) on port 443
  • agent.mydiabetesdata.com with DNS loopback support to 127.0.0.1

To run the Dexcom CLARITY Uploader, your network must allow the following outbound network traffic: *.dexcom.com (and all subdomains) on port 443.

How to share data through the App?

You can enter a Temporary Authorization Key to accept a sharing invitation from your clinic. See section 4.3.1 for more information about sharing invitations. You can also generate a code to share data with your clinic for a limited time. 

After signing in, tap Share Data, then choose a sharing option: 

• Tap Accept Invitation if your clinic has provided you with a Temporary Authorization Key. See section 12.2.1 for more information. 

• Tap Generate Code if you want to provide your clinic with limited access your data. See section 12.2.2 for more information.

 

Accept Invitation 

To accept a sharing invitation from your clinic: 

1. Tap Accept Invitation. 

2. Enter the Temporary Authorization Key provided by your clinic. 

3. Tap Enter Birthday to select your date of birth. 

4. Tap Continue. 

5. Tap the I consent to share my data with my clinic box. 

6. Tap Yes, Share My Data.

 

Generate Code 

To share your data for a limited time with your clinic: 

1. Tap Generate Code. 

2. Tap 3 Months, 6 Months or 1 Year to select the time limit of sharing. 

3. Tap Generate Code. A sharing code and access URL are displayed for you to provide to your clinic. 

How to navigate the Reports App?

Once you sign into the Reports app, you will remain logged in even if you close the app. 

To log out, from any screen: 

1. Tap the menu in the top right corner. 

2. Tap Sign out. 

To return to the main screen at any time, tap the back arrow in the top left corner until it disappears.

How to Access the Reports app from the App Store of your Apple device?

1. Search for Dexcom CLARITY Reports. 

2. Tap Get to download the app for free. 

3. Tap Install. 4. Tap the Report app to open it. 

5. Enter the username and password for your Dexcom G5 Mobile or any other Dexcom account. If you use G5 Mobile, you will automatically be logged in. 

6. Tap Sign in. 

How do I reset my password?

To reset your Dexcom password, follow the steps below.

If you know the username, do the following:

Go to https://store.dexcom.com/user/password. Under the “Username”, type in your username and click ‘Submit’. This send you an email.
Click on the link in the email.
The system will ask you to change your password.

If you do not know your username:

Go to https://store.dexcom.com/user/password. Under the “E-mail Address”, type in your e-mail address and click ‘Submit’. The system should send you a list of usernames associated with that email adders.
Go to https://store.dexcom.com/user/password. Under the “Username”, type in your username and click ‘Submit’. This will send you an email.
Click on the link in the email.
The system will ask you to change your password.

How do I change my mailing or shipping address?

To change your mailing or shipping address, do the following:

Log into your Dexcom Account at https://store.dexcom.com/user/login. If you do not have an account, you can create one at https://store.dexcom.com/user/register.
After logging in, go to https://store.dexcom.com/account/address. This will show the addresses we have on file for you.
To add an address, click on the 'Add New Address' button
To edit an existing address, click on the 'Edit' button associated with the address you would like to edit

Please note that you can designate a primary address when editing or creating a new email address. The primary address is the one Dexcom uses to contact you and is the default shipping address for future orders.

How do I view past orders?

To view past orders, do the following:

Log into your Dexcom Account at https://store.dexcom.com/user/login. If you do not have an account, you can create one at https://store.dexcom.com/user/register.
After logging in, go to https://store.dexcom.com/account/orders. This will show any open order we have for you.
To view older orders, click on the dropdown menu to select the time frame of order you would like to see and click the 'Go' button.

Please note that we only show invoices if the product was purchased and shipped through Dexcom.

How Do I recover my dexcom username?

To recover your username online, take the following steps:

Go to https://store.dexcom.com/user/password
Enter your email address and click on the 'Submit' button.
An email will be sent to that email address. It will list any usernames associated with that address.

How do I add Insurance Information to My Online Account?

To add insurance information to your Dexcom online account, take the following steps:

Go to https://store.dexcom.com/account/insurance
Click the 'Add' button under 'Primary Insurance Provider'.
Select your insurance provider within the 'Insurance Provider' dropdown menu options, or search by typing it into the dropdown field.
Fill out all required fields (with an asterisk) and hit 'Save'. Your insurance information will be added to your account. You may provide up to three different insurance providers (Primary, Secondary and Tertiary).

Are other CGM products covered as well?

The ruling specifically states that only CGM products labeled as a replacement of fingerstick blood glucose testing for diabetes treatment decisions by the FDA and referred to in the ruling as “therapeutic CGM” will be covered. The Dexcom G5® CGM System was the first therapeutic CGM on the market. 

What should I do if I have Medicare patients that can benefit from using a CGM?

For patients who could benefit from CGM, you will be able to write orders for “therapeutic CGM” for your patients very soon. In the interim, you can send them to Dexcom and we will notify them as soon as Medicare begins processing. Patients can be directed to https://www.dexcom.com/lead/1 or they can also contact our customer service team at 1 (888) 738-3646 to speak to a customer service agent.

Can physician assistants prescribe Therapeutic CGM?

A physician assistant (PA) may provide the dispensing order and write and sign the detailed written order if they satisfy all the following requirements:

• They meet the definition of physician assistant found in §1861(aa)(5)(A) of the Act;
• They are treating the beneficiary for the condition for which the item is needed;
• They are practicing under the supervision of a Doctor of Medicine or Doctor of Osteopathy;
• They have their own NPI; and
• They are permitted to perform services in accordance with State law.  

PAs may complete Section B and sign Section D of the CMN if they meet all the criteria described above for signing orders.

Can a nurse practitioner or clinical nurse specialist prescribe Therapeutic CGM?

 A nurse practitioner or clinical nurse specialist may give the dispensing order and sign the detailed written order in the following situations: 

• They are treating the beneficiary for the condition for which the item is needed; 
• They are practicing independently of a physician; 
• They bill Medicare for other covered services using their own provider number; and 
• They are permitted to do all of the above in the State in which the services are rendered. 

A nurse practitioner or clinical nurse specialist may complete Section B and sign Section D of the Certificate of Medical Necessity (CMN) if they meet all the criteria described above for signing orders.

Can physicians bill the CGM CPT code 95250 for personal use CGM systems under the Medicare rules?

No, healthcare professionals (HCPs) should not use CPT code 95250 (patient training, hook-up and calibration, sensor removal, data download) for personal use continuous glucose monitoring (CGM) for Medicare patients—this code can be used only for professional CGM services.  

If a physician or mid-level practitioner is interpreting personal or professional use CGM data they would bill under CPT code 95251. Services associated with CPT code 95251 may be a non-face-to-face service. 

If a physician or mid-level practitioner has office visits with a patient to discuss treatment changes based on personal or professional use CGM results, they should bill using Evaluation and Management (E/M) codes based on medical necessity and level of service provided. 

Office staff should consult with their payers for final coding advice.

What is the difference between the Medicare physician fee schedule and the outpatient diabetes center payment?

Medicare physician payments are fee schedules based on relative value units (RVUs). Hospital outpatient services are paid under the outpatient prospective payment system (OPPS). CPT code 95250 (for Professional CGM only) is paid under Ambulatory Procedure Classification (APC) 5012 with 2017 national average payment of $106.

What is Continuous Glucose Monitoring (CGM)?

A continuous glucose monitor (CGM) is an FDA-­approved device that provides continuous insight into glucose levels throughout the day and night. CGM also displays information about glucose direction and speed giving users additional information to help with their diabetes management. CGM also provides customizable alerts to warn the wearer of approaching glucose highs and lows. Studies have shown that CGM contributes to a decrease in HbA1c without increasing the risk for hypoglycemia.1

How is Dexcom CGM different from a blood glucose meter?

The traditional method of measuring glucose levels requires a fingerstick using a blood glucose meter (BGM). BGMs provide a glucose reading at a single point in time. The key difference between Dexcom CGM and BGM is that Dexcom CGM provides glucose readings throughout the day and night, including glucose speed and direction arrows that empower wearers with more information for more informed decision making*. Finally, Dexcom CGM is designed with alerts to warn the wearer of glucose highs and lows during critical times like playing, sleeping or exercising to help wearers catch high and lows before they become critical.

Here is an example of how Dexcom CGM information could impact glucose management decisions:

BLOOD GLUCOSE METER (BGM) READING: 105
CONTINUOUS GLUCOSE MONITOR (CGM) READING: 102
(The double arrows signal a rapid decline in glucose)

Based on the blood glucose meter (BGM) reading of 105, this person is likely to decide that no action is required. But, with a similar glucose level reading on the Dexcom CGM and two arrows facing down, the patient might decide to eat some carbohydrates to avoid having a hypoglycemic event.

*Fingerstick required prior to making treatment decisions

What is the Dexcom G5® Mobile CGM System?

The Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System is the first and only fully mobile CGM system approved by the U.S. Food and Drug Administration (FDA) for both adults and children as young as 2 years old. The Dexcom G5 Mobile CGM System is the newest CGM system available from Dexcom.

How does the Dexcom G5 Mobile CGM System work?

The Dexcom G5 Mobile CGM System features Bluetooth® wireless technology in the transmitter that enables direct transmission of CGM data to a receiver or compatible smart device. For a list of compatible smart devices, please refer to www.dexcom.com/compatibility.

The System features a small sensor that measures glucose levels just underneath the skin and a transmitter that is fastened on top of the sensor and sends data wirelessly to the System receiver or a compatible smart device. Out-of-range glucose alerts (with customizable sounds) may be sent to the user’s smart device, allowing for additional discretion and privacy. Additionally, using the Dexcom G5 Mobile App, users can share their glucose information with up to five individuals+for added support.

+Followers must separately download the Dexcom Follow App to view shared glucose information.

How many people can view the information from the Dexcom G5 Mobile CGM System?

Dexcom G5 Mobile CGM System users can invite up to five followers to remotely monitor their glucose information and receive alert notifications from almost anywhere using the Dexcom Follow App. The Dexcom Follow App is available as a free download through the Google Play store and the Apple® App Store and to the Apple Watch through the Apple Watch Store.

Who should not use the Dexcom G5 Mobile System?

Pregnant women and those on dialysis should not use the Dexcom G5 Mobile CGM System, as it has not been evaluated in these populations. Also, those who are critically ill should not use the device; it is not known how different conditions or medications common to the critically ill may affect the performance of the system.

Is there dosing guidance for HCPs?

Dexcom does not provide dosing guidance for HCPs. There are, however, three approaches to using the rate-of-change arrows for adjusting insulin doses. These are:

1. DirecNet Method

* Use of the DirecNet Applied Treatment Algorithm (DATA) for Diabetes Management with a Real-Time Continuous Glucose Monitor (the FreeStyle Navigator). Pediatr Diabetes. 2008 Apr; 9(2):142-147.

2. Jeremy Pettus and Steven Edelman Method

* Recommendations for using Real-Time Continuous Glucose Monitoring (rtCGM) Data for Insulin Adjustments in Type 1 Diabetes. Journal Diabetes Science and Technology. August 2016.

3. Gary Scheiner Method

* Practical CGM: Guide to Improving Outcomes Through Continuous Glucose Monitoring. American Diabetes Association, 2015.

If I have questions, whom should I contact?

If you have questions, please contact Dexcom CARE®, our team of certified diabetes educators and other healthcare professionals, at 877-339-2664 (ext.4950) or patientcare@dexcom.com; your local sales rep; or visit hcp.dexcom.com.

What ramifications does FDA approval have for the other CGM providers that do not have an indication for non-adjunctive use?

Only the Dexcom G5 Mobile is approved for CGM-based treatment decisions. No other CGMs by Dexcom or by other manufacturers have this indication. FDA has not publicized how this will affect other devices in the future.

What implications does this new indication have for securing Medicare coverage for CGM?

Previously, the Dexcom G5® Mobile CGM System—as an adjunctive device—could not be considered a primary tool for managing diabetes and thus did not meet the definition of Durable Medical Equipment (DME) under the Medicare rules. However, now that CGM is indicated as a replacement for blood glucose meters, one of the large barriers is removed.  Now that we have Medicare approval as a "therapeutic" device, we are moving forwarwd with determining coverage with the Medicare Administrative Contractors. As this progresses, we will be communicating with patients and physicians.

Will patients see reduced coverage for test strips with the approval for non-adjunctive CGM use?

Test strips fall under a different coverage category (SMBG) than CGM and we are unable to comment on whether non-adjunctive labeling has any impact. As a reminder, two fingersticks are still required for calibration.

Some patients have expressed concern that their Dexcom CGM readings are sometimes very different from their meter. How can I ease their concerns about using the Dexcom G5® Mobile CGM System non-adjunctively?

CGM is based on trends - not a single number. The continuous information provides a real-time, dynamic view of one’s glucose to facilitate better management decisions. To optimize the use of Dexcom CGM:

  • Patients should be reminded of proper fingerstick technique so they will use their "best" fingersticks for calibrating.
  • Patients need to understand that fingersticks are not always accurate, despite their long history. Advise patients to consider taking a second fingerstick when their CGM and first fingerstick do not match.
  • Remind patients they are not required to use the Dexcom G5 Mobile to make treatment decisions; they may still use their meter to guide their diabetes management decisions.

What resources are available to help me educate patients about this new indication?

The HCP Non-Adjunctive Training slide deck - a comprehensive web-based presentation to help guide patient communication as well as help you understand how the System can be used to make treatment decisions is being developed. Additionally, there will be two other training tools--the Dexcom G5 Mobile Treatment Decisions (The Basics) and the Dexcom G5 Mobile Treatment Decisions (Advanced). You can review the Basics handout with your patients, while the Advanced guide is designed for clinicians to educate them about how the rate-of-change arrows can be used to guide treatment decisions.

Your patients will also receive basic instructions and a tutorial (USB card) in product shipments, and you can also direct them to dexcom.com/guides for additional resources.

What should I communicate to my patients?

You should communicate:

1. A blood glucose meter should still be used to make treatment decisions under any of the these circumstances:

The patients’ Dexcom G5® Mobile CGM Receiver or compatible smart device* is not displaying both a glucose reading and a directional arrow.
Their symptoms or expectations do not match the CGM reading
They have taken acetaminophen.

2. For System calibration - a fingerstick is required every 12 hours to calibrate the Dexcom G5 Mobile CGM System.

3. Additionally, it is important to review the following with them:

Avoid insulin “stacking” (taking insulin doses too close together)
Proper fingerstick technique—especially to ensure accurate calibrations
To trust their instincts; in other words, “When in doubt, get your meter out.”

4. Inform them they can still use a meter to confirm treatment decisions if they are more comfortable doing so.

How will patients be informed of the new instructions for CGM-based dosing?

Dexcom G5 Mobile CGM Systems shipped after the new indication was approved will contain an updated Getting Started Guide, tutorial (USB insert) as well as abbreviated instructional inserts sheets in both sensor and receiver kits. The inserts will also be included in sensor re-order boxes. Patients may train with their HCP using the instruction sheet. Or they may choose to self-train with the Getting Started Guide, tutorial or full User Guide.

Existing patients (with a confirmed email) who had already purchased the G5 Mobile System will be notified via email and postal mail about the new indication and will receive sensor re-orders with the abbreviated instructional inserts.

Why is this new indication important to me?

This indication is approved by the FDA. The updated instructions now provide a framework for you to properly educate and train your patients about using CGM as the primary tool for making appropriate treatment decisions to optimize their treatment.

What data supports CGM-based treatment decisions?

Existing clinical performance data1 supports an accuracy level of the System that is approaching the accuracy of some blood glucose monitors. Additionally, computer simulation studies confirmed outcomes from non-adjunctive use were equivalent to outcomes when decisions were based on blood glucose measurements.

Will this indication impact the way glucose data that is shared via the Dexcom G5 Mobile app?

No, the non-adjunctive indication does not change the nature or display of CGM data to a user’s family, friends or caregivers (“Followers”). Remember that treatment decisions should not be made based on Dexcom Follow. Treatment decisions should be made based on the reading from Dexcom G5 Mobile or a blood glucose meter. The Follower may contact the patient to ask them to confirm their CGM reading before providing advice or guidance (e.g., Mom texts daughter, "Follow says you are low. What reading does your CGM show?").

Are there times when patients will still need to use a meter to make treatment decisions?

Yes, patients will still need to use a meter to calibrate the Dexcom G5 Mobile every 12 hours. Additionally, there are important exceptions to using the System to make treatment decisions. Please advise your patients that they must use a meter to make treatment decisions in the following situations:

  • Their Dexcom G5 Mobile Receiver or compatible smart device* is not showing both a glucose reading and a directional arrow. Both of these pieces of information must be displayed.
  • Their symptoms or expectations don’t match the CGM reading– if they are experiencing symptoms of hypoglycemia or hyperglycemia, they should use a meter before making a treatment decision.
  • They have taken acetaminophen

The revised instructions allow for CGM-based treatment decisions, but they do not require it. Patients who prefer to use CGM as a complement to SMBG may continue to do so. For some users, it might take a little time to become comfortable with CGM-based treatment decisions. Others may choose to use it at some times (e.g., night) and not at others (e.g., immediately after a new sensor is inserted).

*To view a list of compatible devices, visit dexcom.com/compatibility.

Has anything changed in the Dexcom G5 Mobile CGM System with this new indication?

Nothing has changed in the components, accuracy or functionality of the System. We have only revised the instructions to include CGM-based treatment decisions.

Does this new indication eliminate the need for fingersticks?

No. Two fingersticks per day (once every 12 hours) are still needed to calibrate Dexcom G5 Mobile. Additionally, there are important exceptions that require the use of a meter to make treatment decisions.

The revised instructions allow for CGM-based treatment decisions, but they do not require it. Patients who prefer to use CGM as a complement to SMBG may continue to do so. For some users, it might take a little time to become comfortable with CGM-based treatment decisions. Others may choose to use it at certain times (e.g., night) and not at others (e.g., immediately after a new sensor is inserted).

If patients are currently using a previous-generation System to the Dexcom G5® Mobile CGM System (such as the Dexcom G4® PLATINUM System with Share), can they use it to make treatment decisions?

No, the non-adjunctive indication is only approved for the Dexcom G5 Mobile. Other algorithms and user interfaces have not been approved. Patients can easily recognize if they have the Dexcom G5 Mobile because they will be using either the Dexcom G5 Mobile App or the Dexcom G5 Mobile Receiver that has a screen with a white background, similar to the app's white background.

Does the non-adjunctive indication for CGM-based treatment decisions apply to Dexcom CGM-integrated insulin pumps?

No, patients should not make CGM-based treatment decisions using the Animas and Tandem insulin pumps that are integrated with Dexcom CGM. These integrated pump systems are not currently approved for non-adjunctive use. Patients on insulin pump therapy would need to use the standalone Dexcom G5 Mobile (including the G5 Transmitter) to make treatment decisions.

Is the non-adjunctive indication for CGM-based treatment decisions approved for the Dexcom G4 PLATINUM Professional System?

No, making treatment decisions with CGM is approved only for personal use and only for the Dexcom G5 Mobile.

Does this non-adjunctive indication apply to both adult and pediatric patients?

Yes, the new indication is approved for both adult and pediatric users (as young as two years of age) of the Dexcom G5 Mobile.

The Dexcom G5 Mobile System is the first CGM System to receive FDA approval to make CGM-based treatment decisions ("non-adjunctive use"). What does this new indication mean?

It means the Dexcom G5 Mobile can now be used to make diabetes treatment decisions without confirming the reading with a blood glucose meter. Previously, all CGM devices were indicated for use only as a complement (adjunct), not a replacement, for blood glucose meters.

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