Indications for Use
The Eversense CGM System is indicated for continually measuring glucose levels in adults (18 years and older) with diabetes for up to 90 days. It is designed to replace blood glucose testing for diabetes treatment decisions.
The system is intended to:
- Provide real-time glucose readings.
- Provide glucose trend information.
- Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia).
The system is a prescription device. Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns and trends seen over time.
MRI Safety Information
Non-clinical testing has demonstrated the Eversense Sensor is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
- Static magnetic field of 1.5T or 3.0T
- Maximum spatial field gradient of 2000 gauss/cm (20 T/m)
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg (First Level Controlled Operating Mode)
Under the scan conditions defined above, non-clinical testing results indicate the Eversense Sensor is expected to produce a maximum temperature rise of less than 5.4 °C after 15 minutes of continuous scanning. In non-clinical testing, the image artifact caused by the device extends approximately 2.83 inches (72 mm) from the Eversense Sensor when imaged with a gradient echo pulse sequence and a 3T MR system. The Eversense Smart Transmitter is MR Unsafe and MUST BE REMOVED before undergoing an MRI procedure.
Before you undergo an MRI procedure, tell the MRI staff that you have an Eversense Sensor and Smart Transmitter.
The smart transmitter is incompatible with magnetic resonance imaging (MRI) procedures. The smart transmitter is MR Unsafe and MUST BE REMOVED before undergoing an MRI (magnetic resonance imaging) procedure. For information on the sensor, please see MRI Safety Information.
The system is contraindicated in people for whom dexamethasone or dexamethasone acetate may be contraindicated.
Mannitol or sorbitol, when administered intravenously, or as a component of an irrigation solution or peritoneal dialysis solution, may increase blood mannitol or sorbitol concentrations and cause falsely elevated readings of your sensor glucose results. Sorbitol is used in some artificial sweeteners, and concentration levels from typical dietary intake do not impact sensor glucose results.
DO NOT use the Eversense Apps on jailbroken iPhones or iPods. Jailbroken devices do not provide an acceptable level of security and accuracy for the user and are not approved for use by Senseonics.
Broken Screen or Button
If the screen of your mobile device is broken, or the buttons do not work, then you may not be able to use your Eversense System and you may miss low or high glucose events.
Make diabetes treatment decisions based on the combination of the sensor glucose reading, trend arrow, recent glucose trend graph and alerts/notifications generated by the Eversense CGM System.
Risks and Side Effects
The glucose alerts and notifications will not audibly notify the user when the sound on the mobile device is turned off. If the system cannot display a glucose value, it also cannot provide glucose alerts. If you are unable to feel the vibration of the smart transmitter you may not notice the alerts. The system’s calculated glucose can be slightly different from your blood glucose meter. This may cause an alert to activate at a different time than they would have if the system’s values always matched the blood glucose meter values. If you do not take frequent blood glucose measurements and miss an alert, you may not be aware of high or low glucose levels. You may need medical attention in the event that you have high or low glucose and are unaware of it.
If you do not test your glucose with a blood glucose meter when you have symptoms of a low or high blood glucose level OR when your symptoms are not consistent with the sensor glucose readings, you may miss a high or low glucose event. Treatment decisions made without confirming with a blood glucose meter check may result in a high or low glucose event, since blood glucose values can be slightly different than your sensor glucose values measured in interstitial fluid.
The sensor is inserted by making a small incision and placing it under the skin. This process may cause infection, pain or skin irritation. Additionally, the adhesive may cause a reaction or skin irritation.
- The Eversense CGM System has not been tested using insertion sites other than the upper arm.
- If at any time you have symptoms of a low or high blood glucose level OR if your symptoms are not consistent with the sensor glucose readings, you should test your glucose with a blood glucose meter.
- Under the following conditions, sensor glucose readings may not be accurate, and you should conduct a fingerstick test using a blood glucose meter. You should NOT use sensor glucose readings to make a diabetes treatment decision if/when:
- Your sensor glucose is very low (below 40 mg/dL) or very high (above 400 mg/dL);
- The Eversense CGM System cannot display a glucose value;
- The Eversense CGM System does not have enough data to display a trend arrow;
- You are experiencing symptoms that do not match the sensor glucose reading;
- The current sensor glucose value is displayed in grey;
- The status bar in displayed in grey; -or-
- You have not followed the instructions for daily calibration.
- If your smart transmitter is damaged or cracked, DO NOT use, as this could create an electrical safety hazard or malfunction, and could result in electrical shock.
- Close contact with direct EMI may interfere with the smart transmitter’s ability to send data to your mobile device. Move away from the source of EMI and check that your mobile device is connected to your smart transmitter.
- Antibiotics of the tetracycline class may falsely lower sensor glucose readings. You should not rely on sensor glucose readings while taking tetracyclines.
- The bandage should remain covering the incision for 48 hours as this is a standard of care to allow formation of a water-tight seal to help protect against infection. Until it has healed, always cover the insertion site with a sterile bandage before placing the smart transmitter adhesive over the sensor. Failure to do so could result in infection at the insertion site.
- Please review this User Guide with your health care provider. For additional Eversense product questions and
troubleshooting issues, contact Customer Support toll free in the US at 844-SENSE4U (844-736-7348).
- Always calibrate the system using only a fingerstick blood sample. DO NOT use an alternative site (such as forearm or palm) blood glucose reading to calibrate the system.
- DO NOT insert your infusion set or inject insulin within 4 in (10.16 cm) of the sensor site. If the insulin delivery site is within 4 in (10.16 cm) of the sensor site, it may interfere with sensor glucose readings and can cause inaccurate glucose readings.
- Always follow your health care provider’s instructions for care after the sensor insertion or removal. Contact your health care provider if any of the following events occur:
- You have pain, redness, or swelling at the incision site(s) later than 5 days after the sensor insertion or removal.
- The Eversense CGM System will not provide readings during the 24 hour Warm-Up Phase and until a second calibration is successful during the Initialization Phase. During this time, you should monitor your glucose using a home blood glucose monitor.
- Certain conditions and alerts will prevent glucose data from being displayed. During these times, you should use a home blood glucose monitor to make treatment decisions. You should carefully read the Alerts and Notifications section of the Eversense CGM System User Guide to understand these conditions.
- The glucose alerts and notifications will not audibly notify you when the sound on your mobile device is turned off. If the system cannot display a glucose value, it also cannot provide glucose alerts. Also, if you are unable to feel the vibration of the smart transmitter, you may not notice the alerts.
- When the smart transmitter is not worn over the sensor, such as during charging, the Eversense CGM System will not provide alerts and notifications on the mobile device or through vibration alerts from the smart transmitter.
- DO NOT exchange smart transmitters with another person. Each smart transmitter can be linked to only one sensor at a time. The system is to be used by one person in the home environment.
- The following medical therapies or procedures may cause permanent damage to the sensor particularly if used in close proximity to the device:
- Lithotripsy – The use of lithotripsy is not recommended for people who have an inserted sensor because the effects are unknown.
- Diathermy – DO NOT use diathermy on people who have an inserted sensor. Energy from the diathermy can transfer through the sensor and cause tissue damage in the insertion area.
- Electrocautery – The use of electrocautery near the inserted sensor may damage the device. DO NOT use electrocautery near the sensor.
- Steroid use – It has not been determined whether the risks usually associated with injectable dexamethasone acetate apply to the use of this dexamethasone acetate elution ring, a highly localized, controlled-release device. The dexamethasone acetate ring could cause other adverse events not listed or previously seen.
- DO NOT wear the smart transmitter during medical x-rays or computed tomography (CT) scans. To avoid interference with results, remove the smart transmitter before undergoing medical x-ray or CT scans. Make sure your health care provider knows about your smart transmitter.
- The sensor and smart transmitter should be linked the day of insertion. Failure to link the sensor and smart transmitter could result in a delay in receiving glucose readings.
- If the sensor, insertion site or smart transmitter feels warm, remove the smart transmitter immediately and contact your health care provider for further advice. A warm sensor could mean there is an infection or a sensor malfunction.
- DO NOT attempt to use the Eversense App while operating a motor vehicle.
- You should not receive massage therapy near the inserted sensor site. Massage therapy near the sensor site could cause discomfort or skin irritation.
- Use only the AC power adapter and USB cable provided with the smart transmitter when charging the smart transmitter battery. Use of another power supply could damage the smart transmitter, not allowing glucose readings to be received properly, and could result in voiding your warranty.
- If you have any concerns about allergic reaction to adhesive products containing silicone, contact your health care provider prior to use. Discard the Eversense adhesive patch after each use of up to 24 hours.
- DO NOT change the unit of measurement unless you have discussed it with your health care provider. Using the incorrect unit of measure could result in missing a high or low glucose event.
- Entering incorrect blood glucose values for calibration can result in inaccurate sensor glucose readings, which may result in you missing a high or low glucose event.
- Follow your health care provider’s recommendation for setting your glucose alerts. Incorrectly setting your glucose alerts can result in you missing a high or low glucose event.
- Pay attention to the glucose alerts the system provides. Failure to appropriately respond to an alert might result in you missing a high or low glucose event.
- The Eversense NOW Remote Monitoring App does not replace the monitoring regimen as directed by your health care provider. The Eversense NOW App cannot change the settings on the Eversense CGM App. If the Eversense NOW user does not allow notifications from the Eversense NOW App, they will not receive glucose related alerts from you. If you have your mobile device set to Do Not Disturb, you will not hear any notifications from the Eversense NOW App.
- The Eversense CGM System has not been tested in the following populations: women who are pregnant or nursing, people under the age of 18, critically ill or hospitalized patients, people receiving immunosuppressant therapy, chemotherapy or anti-coagulant therapy, those with another active implantable device, e.g., an implantable defibrillator (passive implants are allowed, e.g., cardiac stents), those with known allergies to or using systemic glucocorticoids (excluding topical, optical or nasal, but including inhaled). The system’s accuracy hasn’t been tested in these populations, and sensor glucose readings may be inaccurate, resulting in missing a severe low or high glucose event.
- The Apple Watch is a secondary display of Eversense CGM data and should not be used in place of the primary Eversense CGM display.
The Eversense Data Management System (DMS) is intended for use as an accessory to compatible Eversense CGM products. It is a web based application that may be used to view, analyze, and store glucose information from your Eversense CGM System. The DMS is designed to view the data from your Eversense CGM System in a useful, easy to read format to help you in the management of your diabetes.
You can sync your CGM data wirelessly to the Eversense DMS using the Share My Data feature on the Eversense mobile app. PC users can also upload smart transmitter data via the USB cable provided with your Eversense CGM System.
- You will be uploading the same data whether you sync from the mobile app or use the USB cable.
- For more information on the Eversense CGM System, visit www.eversensediabetes.com.
- For further information on compatible browsers and browser versions please visit eversensediabetes.com.
- Uploading from the smart transmitter using the USB cable is only supported on PCs.
IMPORTANT: EVERSENSE DATA MANAGEMENT SYSTEM DOES NOT PROVIDE MEDICAL ADVICE. DO NOT MAKE TREATMENT DECISIONS WITHOUT CONSULTING WITH YOUR HEALTH CARE TEAM.
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