FAQs for HCP segment New Instructions for Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System Non-Adjunctive Indication

Transcription

1 FAQs for HCP segment New Instructions for Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System Non-Adjunctive Indication Q1. The Dexcom G5 Mobile System is the first CGM System to receive FDA approval to make CGMbased 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. *Fingersticks required for calibration, or if symptoms or expectations do not match readings, or when taking medications containing acetaminophen. Q2. 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. Q3. Is the non-adjunctive indication for CGM-based treatment decisions approved for the Dexcom G4 Professional System? No, making treatment decisions with CGM is approved only for personal use and only for the Dexcom G5 Mobile. Q4. Does the non-adjunctive indication for CGM-based treatment decisions apply to Dexcom CGMintegrated insulin pumps? No, patients should not make CGM-based treatment decisions using the Animas and Tandem insulin pumps that are integrated with any Dexcom CGM systems. 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. Q5. If patients are currently using a previous-generation System to the Dexcom Mobile G5 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. Q6. 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, including: 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. Patient 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.

2 Patients have taken medications containing 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 certain 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 Q7. 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. Q8. 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 medications containing 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 Q9. 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?"). Q10. What data supports CGM-based treatment decisions? Existing clinical performance data 1 supports an accuracy level of the Dexcom G5 Mobile 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. 2

3 Q11. 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 the Dexcom G5 Mobile as the primary tool for making appropriate treatment decisions to optimize their treatment. Q12. How will patients be informed of the new instructions for CGM-based dosing? Dexcom G5 Mobile CGM Systems will be updated with a revised 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 (available at dexcom.com/guides). Existing patients (with a confirmed ) who had already purchased the G5 Mobile System will be notified via and postal mail about the new indication and will receive sensor re-orders with the abbreviated instructional inserts. Q13. 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 medications containing 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. Q14. What resources are available to help me educate patients about this new indication? To familiarize yourself with the non-adjunctive indication, please review 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. You may also refer to 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 specifically for clinicians to educate them about how the rate-of-change arrows can be used to guide treatment decisions.

4 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. Q15. 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 the Dexcom G5 Mobile: 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 for their diabetes management. Q16. 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 (ext.4950) or patientcare@dexcom.com; your local sales rep; or visit hcp.dexcom.com. Q17. Is there dosing guidance for HCPs? Dexcom does not provide dosing guidance for HCPs. There are, however, there are three approaches to using the rate-of-change arrows to adjust 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 Apr; 9(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 Gary Scheiner Method Practical CGM: Guide to Improving Outcomes Through Continuous Glucose Monitoring. American Diabetes Association, BRIEF SAFETY STATEMENT The Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System ( G5 ) is a glucose monitoring system indicated for detecting trends and tracking patterns in persons (age 2 years and older) with diabetes. CONTRAINDICATIONS Do not rely on the G5 CGM data if you have recently taken acetaminophen. Remove the System (sensor, transmitter, and receiver) before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The System is MR Unsafe. Do not bring any portion of the System into the MR environment. WARNING CGM-based diabetes treatment decisions are only approved with the G5, not previous generations. Calibrate at least once every 12 hours using a

5 fingerstick. If your G5 does not display a sensor glucose reading and an arrow, or if you are getting inaccurate or inconsistent readings, take a fingerstick. If your glucose readings and alerts do not match your symptoms or expectations, take a fingerstick to confirm. Failure to do so may lead to hyperglycemia or hypoglycemia. The System is not approved for use in pregnant women, persons on dialysis or critically ill persons. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have infection or inflammation. Report broken sensors to Dexcom Technical Support. Sensor placement is not approved for sites other than under the skin of the belly (ages 2 years and older) or upper buttocks (ages 2-17 years). To share data, you need an internet connection and a separate smart device running the Dexcom Follow App. Contact Dexcom Toll Free at or for detailed indications for use and safety information. References 1. Bailey TS, Chang A, Christiansen M. Clinical accuracy of a continuous glucose monitoring system with an advanced algorithm. J Diabetes Sci Technol. 2015;9(2): Dexcom G5 Mobile Continuous Glucose Monitoring System FDA Advisory Panel Committee Briefing Materials, presented July 21, 2016, Washington, DC. Available at: aldevicesadvisorycommittee/clinicalchemistryandclinicaltoxicologydevicespanel/ucm h tml. Accessed July 21, 2016.