Non-Adjunctive Indication

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

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.

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:

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.

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.

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.

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.

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