Non-Adjunctive Indication

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 indicated for the Dexcom G4 PLATINUM Professional System?

No, making treatment decisions with CGM is indicated only for personal use and only for the Dexcom G6 and 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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