Weekly Modal Summary This report shows your last seven days of glucose readings summarized in a 24-hour line graph format to help find patterns during the day. • The blue line is the average of the last seven days of your readings in an hour time block. • The red bars show the highest and lowest actual readings in the same hour time block. • The red horizontal dotted lines are your pre-set High and Low Glucose Alert levels.
Glucose Pie Chart Glucose Statistics This report shows in graphical format what percent of your readings within a given time period are within, below or above your Glucose Target levels. You can choose the last 1, 7, 14, 30 or 90 days. This report shows your average, low and high glucose readings, along with standard deviation within a mealtime slot period. You can choose the last 1, 7, 14, 30 or 90 days. 11 78 Eversense CGM User Guide LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.
Eversense Data Management Software (DMS) Program The Eversense DMS Program is a web-based application that enables patients, caregivers, and health care professionals to view and analyze glucose data that has been transmitted from the Eversense Smart Transmitter or application. This program is offered at no cost to users of the Eversense CGM System. To learn about the Eversense DMS Program, go to www.eversensediabetes.com. IMPORTANT: EVERSENSE DATA MANAGEMENT SYSTEM DOES NOT PROVIDE MEDICAL ADVICE.
12. Product and General Information on the App This section describes the information available from the About section of the Main Menu. You can view product information about your smart transmitter, your sensor and your Eversense mobile app. 1. Tap Menu > About and then tap My Transmitter, My Sensor or Product Information. On the MY TRANSMITTER screen, you can find information that includes the serial number, calibration information and battery level.
On the PRODUCT INFORMATION screen, you can view information about the mobile app software version and Senseonics, Inc., the manufacturer of the Eversense CGM System. You can also send feedback or view the End User License Agreement and Privacy Policy from the About menu. To read the End User License Agreement and the Privacy Policy, tap either option. • Tap Contact Us to send an email to Senseonics, Inc. 12 IMPORTANT: This email is not monitored 24/7.
13. Viewing Eversense Data on the Apple Watch You can view a snapshot of your Eversense CGM data on your Apple Watch. Once you’ve downloaded and installed the Eversense mobile app on your mobile device, follow the Apple Watch instructions for adding the app to your watch. Glance View If you have already set the Eversense App on your mobile device to Show in Glances under the Apple Watch settings, simply swipe up on the watch HOME screen to display the Eversense App Glance View.
The My Glucose screen shows your current glucose with trend arrow, and a trend graph of your last three hours of CGM data. Swipe left to the next screen showing a pie chart of your total time within and outside your target range for the past 24 hours. Swipe left to the next screen showing your current glucose with trend arrow, and the date, time and BG value for your last calibration. Swipe up to display the same data shown as percentages.
14. About the Sensor This section describes the Eversense Sensor and how it is inserted by your physician. The Eversense Sensor is a miniaturized fluorometer that uses fluorescent intensity to measure glucose in interstitial fluid. The sensor is implanted subcutaneously (under the skin) on the upper arm, leaving no part of the sensor protruding from the skin. The sensor remains in place and provides CGM measurements for up to 90 days.
Step 1: Site preparation – the insertion site will be cleaned, disinfected, then anesthetized using lidocaine. Step 2: Incision – a small (less than 1 centimeter) incision will be made at the insertion site. Step 3: Sensor insertion – a subcutaneous pocket will be created under the skin and the sensor will be inserted in this pocket. Step 4: Site closure - the incision will be closed with an adhesive bandage. Steri Strips™ are typically used to close the incision.
15. Travel This section describes the safety issues when traveling with your Eversense smart transmitter and sensor. When traveling, your smart transmitter and sensor are safe to go through airport security without removing them. You may inform security that you have an implanted medical device. Your smart transmitter will automatically sync to your smartphone’s current time and date when time zones are changed. The Eversense CGM System is safe for use on U.S. commercial airlines.
16. Troubleshooting This section lists information about troubleshooting your Eversense CGM System and includes a list of frequently asked questions (FAQs). Smart Transmitter Q: My smart transmitter will not vibrate? Why? Q: How do I turn my smart transmitter OFF? A: If the smart transmitter does not vibrate, try the following steps: A: Press and hold the smart transmitter power button for 5 seconds. Release the button when the smart transmitter begins to vibrate.
Q: How do I customize the name of my smart transmitter? Smart Transmitter Battery and Charging A: Tap Menu > Settings > System > Transmitter Name. Type in the name you desire. The updated name of the smart transmitter will appear in your connection status screen.
Connection with Smart Transmitter • The condition may only be temporary. Tap Menu > Connect. Q: How do I pair my mobile device and smart transmitter for the first time? If your smart transmitter name indicates Disconnected, tap the smart transmitter name to connect manually. • Your smart transmitter and mobile device may be out of wireless range. Move your mobile device closer to the smart transmitter. • Your smart transmitter may be turned off, out of battery power or is currently being charged.
16 90 Q: How do I reset my smart transmitter? Q: Can other people connect to my smart transmitter? A: F ollow the steps below. 1. Connect the smart transmitter to the USB cable and adapter that came with your smart transmitter. Plug the cable into the wall outlet. (You can also plug the standard USB end of the cable directly into a USB port on your computer.) 2. Press and hold the smart transmitter’s power button for about 10 seconds until it begins to vibrate.
Q: W hy do I see Searching on the CONNECT screen? A: The app will continue to show Searching for any of the following reasons: • The smart transmitter is currently charging. • The smart transmitter is turned OFF. • The smart transmitter battery is completely drained. • Bluetooth on your mobile device is turned OFF. • Smart transmitter pairing to your mobile device has not been established or has been “un-paired”. You must re-establish pairing.
Calibration Q: Why am I unable to calibrate? Q: W ill doing more than 2 fingerstick calibrations per day affect the accuracy of the system? A: You may not be able to calibrate for any of the following reasons: A: The accuracy will not be negatively impacted if you do more than the required 2 calibrations per day. • Not enough sensor glucose data has been collected, which may take up to 5 minutes. • Sensor glucose values are changing rapidly, such as after eating or taking insulin.
Q: H ow do I change my scheduled morning and evening Daily Calibration times? A: Tap Menu > Settings > Daily Calibration. Select the morning or evening time to change. Morning and evening times must be set a minimum of 10 hours apart and maximum of 14 hours apart. Q: Can I calibrate earlier than my scheduled time? A: You can calibrate up to 2 hours before the scheduled time. If you miss your scheduled time, the system will send an hourly calibration prompt.
Q: W hat is the difference between a notification and alert? A: A Notification is a non-critical, low priority message (e.g., calibration reminder). An Alert is an important message that needs your attention and may require you to respond/take action. Q: W hat are rate of change alerts? A: Rate of Change Alerts notify you when your glucose level is falling or rising faster than the setting you entered in Settings > Glucose.
Glucose Readings Q. W hy is my sensor reading different from my blood glucose meter reading? A: The Eversense CGM System measures glucose in interstitial fluid (ISF) between the body’s cells. Physiologic differences between ISF and blood from a fingerstick may result in differences in glucose measurements. These differences are especially evident during times of rapid change in blood glucose (e.g., after eating, dosing insulin, or exercising).
Trend Arrows App Q: My trend arrows and glucose alerts do not match. Q: What will happen if I re-install the app? A: Trend arrows indicate the rate and direction of change in glucose levels. For example, you may have a trend arrow that points up or down (indicating slow or rapid changes). Glucose alerts notify you when your current glucose level reaches the alert level you set, regardless of the rate or direction of change.
Q: W hat is the Do Not Disturb option? Sensor A: When Do Not Disturb is enabled in the Eversense App Settings, the smart transmitter will stop providing vibratory alerts for non-critical alerts. Critical alerts will still be provided via on-body vibe alerts. All alerts and notifications will continue to be provided on the mobile app.
Q: Why do I see a “New Sensor Detected” notification? Events A: T his message appears when your smart transmitter detects a new sensor so you may link the smart transmitter and sensor. The smart transmitter can only be linked to one sensor at a time. If you see a New Sensor Detected message and you already have a sensor inserted and linked to your smart transmitter, tap Not Now. If unsure, contact Customer Support for more information.
17. Device Performance This section lists Device Performance Characteristics. Clinical Study Performance The performance of the Eversense CGM System was evaluated in a multi-site, non-randomized clinical study. Adult (18 years and older) subjects with diabetes were enrolled at 7 different sites in 3 different countries. Each subject had 2 separate sensors inserted, one in each upper arm.
Although device measurement errors may have been present in either YSI or sensor readings, and interstitial values (sensor) are known to have time lags in responses to changing blood glucose levels compared to blood values (YSI), it was demonstrated that 80% or greater of differences were within 20%/20 mg/dL (20% for YSI values greater than 70 mg/dL, within 20 mg/dL for YSI values ≤ 70 mg/dL).
Clarke Error Grid Scatterplot Clarke Error Grid percentages were calculated by glucose range, and at certain “wear duration” points in the study. 400 350 Eversense CGM (mg/dL) 300 250 200 150 100 50 0 0 50 100 150 200 250 300 350 400 YSI (mg/dL) 17 Eversense CGM User Guide LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.
Clarke Error Grid Accuracy by Glucose Level Clarke Score YSI Glucose Range (mg/dL) Number of paired CGM-YSI Readings A B C D E ≤70 422 77.2% 2.4% 0.0% 20.4% 0.0% 71-180 6633 80.6% 19.4% 0.0% 0.0% 0.0% >180 3387 90.4% 9.4% 0.1% 0.1% 0.0% Overall 10442 83.6% 15.4% 0.1% 0.9% 0.0% Overall, 83.6% of CGM readings fell within zone A. This indicates CGM readings were in close agreement with reference values for the great majority of readings.
Consensus (Parkes) Error Grid Analysis The Consensus Error Grid Analysis (CEG) is another standard for quantifying the accuracy of CGM systems. CEG is similar to the Clarke EGA in that it assigns the differences (errors) between the CGM system values and reference values to one of 5 “clinical risk” regions. But the CEG differs from the Clarke EGA in that the risk regions are continuous (A through E), whereas with the Clarke EGA they are not continuous (e.g., A is next to D).
Consensus Error Grid Accuracy by Glucose Level Zone Frequency Percent A 8922 85.4% B 1481 14.2% C 39 0.4% D 0 0.0% E 0 0.0% Total 10442 100.0% Overall, 85.4% of CGM readings fell within zone A. This indicates CGM readings were in close agreement with reference values for the great majority of readings. 17 104 Eversense CGM User Guide LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.
Calibration Performance Calibration performance looks at whether accuracy is affected by how much time has elapsed since the last system calibration with a blood glucose value. CGM System Performance by Time Since Last Calibration Time from Calibration Number of paired CGM-YSI Readings Percent within 20% Percent within 30% Percent within 40% 0-4 hrs 6043 83.1% 93.1% 97.0% 4-8 hrs 2479 85.0% 94.5% 97.7% 8-12 hrs 1663 83.6% 95.6% 98.6% Total 10185 83.6% 93.8% 97.
Sensor Life Sensor life measured how many days out of the intended 90-day duration period subjects were able to continue using the sensor to record CGM readings. Overall, the analysis estimated that 87.5% of sensors remained functioning through 90 days. Smart Transmitter Wear Smart transmitter wear measured how many hours of the day subjects wore the smart transmitter. Overall, subjects wore their smart transmitters an average of 22.3 hours per day, with a median of 23.5 hours.
Safety The number of adverse events were recorded over the first 90 days of the study period. The CGM system was extremely well tolerated in the study. There were no serious adverse events reported that were related to use of the system or the insertion procedure. A total of 37 adverse events were reported in 26 subjects, all recorded as mild. Twelve (12) of these were related to the sensor insertion procedure.
18. Technical Specifications Sensor Smart Transmitter Characteristic Description Characteristic Description Dimensions Dimensions Length: 3.9 cm Width: 4.2 cm Thickness: 1.
Electrical and Safety Standards Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The transmitter is intended for use in the electromagnetic environment specified in the next table. The customer or the user of the transmitter should ensure that it is used in such an environment.
Electrical and Safety Standards (continued) The Eversense CGM System is intended to be used in the electromagnetic environment detailed in the table below. Users of the System should ensure it is used according to these specifications.
Electrical and Safety Standards (continued) Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Eversense CGM Mobile System is intended for use in the electromagnetic environment specified in the next table. The customer or the user of the System should ensure that it is used in such an environment. Emissions Test RF Emissions CISPR 11 RF Emissions CISPR 11 Compliance Electromagnetic Environment Guidance Group 1 The Eversense CGM System uses RF energy only for its internal function.
Electrical and Safety Standards (continued) Minimum Recommended Distance Between Other RF Transmitters and the Eversense Smart Transmitter Rated Maximum Output Power of Transmitter (W) Separation Distance According to Frequency of Transmitter (m) 150 kHz to 80 MHz d = 1.2 P½ 80 MHz to 800 MHz d = 1.2 P½ 800 MHz to 2.5 GHz d = 2.3 P½ 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.
Symbols on the Eversense Mobile App Symbol Explanation Glucose Alert Appears when the glucose is above the high glucose alert range and below the low glucose alert range. The icon appears in the ALERT HISTORY screen. Falling Rate Alert Appears when the glucose value is falling beyond a defined rate. Rising Rate Alert Appears when the glucose value is rising beyond a defined rate. Empty Battery Alert Appears when the smart transmitter battery is empty.
Symbols on the Eversense Mobile App (continued) Symbol Explanation Calibration Alert Appears when there are calibration-related alerts. Calibration Notification Appears when there are calibration-related notifications. Calibration Failure Appears when the smart transmitter rejects the user-entered calibration value. Connection Failure Appears when the smart transmitter is disconnected from the smartphone or when the sensor is not linked to the smart transmitter.
