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treatment decisions without a confirmatory fingerstick*

Basics

treatment decisions without a confirmatory fingerstick*

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When Eversense CGM received FDA approval for non-adjunctive use, users were still required to perform a confirmatory fingerstick for treatment decisions until the new Eversense Mobile App was launched and updated product instructions were provided. Are they able to use Eversense non-adjunctively now?

Yes, with the new Eversense app, Eversense can now be used without a confirmatory fingerstick when making treatment decisions.* The new Eversense app is available for download now in the App Store (iOS devices) and Google Play (Android devices) and updated product instructions have been mailed to current Eversense wearers. These guides are also available here.

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My patient is having an issue downloading the new non-adjunctive app on their Android phone. What can I advise them to do?

To ensure that your patient can experience all of the new non-adjunctive features of the Eversense Mobile app, we are recommending they go to the website for instructions on how to install the new Android app – https://www.eversensediabetes.com/android-info

Or they can call Customer Care at 1-844-SENSE4U (1-844-736-7348).

Why was Eversense approved for treatment decisions?

The FDA reviewed both device performance data and the new Eversense Mobile App, and determined that Eversense is safe for making diabetes treatment decisions without a confirmatory fingerstick (also known as “non-adjunctive use”). Treatment decisions include determining a patient’s insulin dose and whether or not they should consume carbohydrates.

Does the non-adjunctive indication mean patients don’t need to perform any fingersticks at all?

No, fingersticks are still required in the following situations:

•  For daily calibrations (2 times/day).

•  When symptoms do not match the glucose reading displayed on the
   Eversense Mobile App.

•  If the Eversense Mobile App does not show both a number and a trend arrow.

•  If users are taking medications of the tetracycline class.

Are there resources available to help my patients learn about using their Eversense glucose data non-adjunctively?

Yes, we have updated the following product instructions and training guides with additional information about when users should and should not use Eversense for treatment decisions.

• Eversense CGM System User Guide

• Eversense CGM System Quick Reference Guide

• Eversense CGM System Today, Tomorrow and Beyond Training Reference

 

NEW RESOURCE!

We have added a new advanced training guide—Trend Arrows and Treatment Decisions—to the Living Fully with Eversense Series. You can review this resource with your patients to help them interpret the information provided by the glucose trend arrows, and understand how it can be used to determine whether they may need to adjust their insulin dose or consume carbs.

Example screen-shots are shown with the trend arrow in various positions, along with suggested solutions. Discussing this resource may give patients a greater comfort level with using Eversense non-adjunctively to make the best choices for them in managing their diabetes.

As you know, patients may have differing reactions to the same treatment decisions, and therefore each patient will have individual diabetes management risks and needs. The information in this resource draws upon recommendations from the Edelman-Pettus study for using CGM data for insulin dosing adjustments and other diabetes treatment decisions.¹

Has something changed in the product to allow patients to use Eversense for treatment decisions?

The Eversense CGM System components (sensor and transmitter) have not changed and the functionality and exceptional performance of Eversense remain the same. There are some changes in the Eversense Mobile App that will let patients know when they should and shouldn’t use their CGM data to make treatment decisions.

UPDATES TO EVERSENSE MOBILE APP

  Tutorial Screens

   After downloading the updated Mobile App, during installation patients will
   see a series of screens that explain when they should and should not use
   Eversense CGM information to make a treatment decision.

•  Glucose Number is Gray

   If there is not enough data to calculate a trend arrow, the sensor glucose value
   will be displayed in gray. Patients should always use their BG meter to make a
   treatment decision in this case.

  Status Banner

   In some cases when the trend arrow is absent, patients will see a new, orange
   status banner advising them to use their BG meter before making a
   treatment decision. It’s worth noting that the status banner may show higher
   priority messages under certain conditions, such as a glucose value below
   their Low Glucose Alert setting. In all cases, patients should always use their
   BG meter to make a treatment decision if there is no trend arrow, no matter
   what status banner is shown.

What CGM information should patients consider in making a treatment decision?

Treatment decisions should be made based on a review of the following: sensor glucose values, trend arrows, recent glucose trend graphs, and system alerts/notifications. Patients who have questions about using Eversense for treatment decisions will be instructed to talk to you.

Are there other changes to the Eversense Mobile App besides those related to non-adjunctive use?

Yes, in addition to the updates that support non-adjunctive use, there are several new feature enhancements that will allow users even more flexibility and convenience in managing their diabetes with Eversense. These changes include the ability to turn off the High Glucose Alert and separate settings for Predicted High and Low Glucose Alerts. Learn more by visiting this page:
https://www.eversensediabetes.com/nofingersticks.

Now that Eversense is approved for non-adjunctive use, does this mean the product is covered by Medicare?

The Centers for Medicare & Medicaid Services (CMS) published the CY2020 Physician Fee Schedule, including payment rates on the codes for Implantable Long-Term CGM Systems like Eversense. Starting in Q1 2020, health care professionals will be able to offer Eversense to appropriate Medicare patients. Contact your local Eversense rep for more details. 

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