Eversense xl continuous glucose monitoring system


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Say hello to the Eversense XL Continuous Glucose Monitoring (CGM) System, A new alternative to traditional CGM.

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Eversense XL is the world’s first long-term CGM, with exceptional accuracy and a fully insertable sensor that lasts for up to 180 days. It can help you better manage your diabetes1 by providing real-time insight into your changing glucose levels, which you can discreetly check on your compatible mobile device. People using Eversense say it helps them feel more confident about controlling their diabetes,2 and we hope it does the same for you.

Other CGM systems require a sensor removal and reinsertion every 2 weeks or more, while the Eversense XL Sensor lasts up to 180 days.

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With Eversense XL, you can see your readings directly on your compatible mobile device. And with readings every 5 minutes, you can see where you are now and where you’re headed with the trend arrows.3

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Eversense XL is the first and only long-term CMG that has a sensor that is changed only 2-3 times per year by a healthcare provider – no more weekly self-insertions. Eversense provides you with the Freedom you've always wanted in a CGM.

  • 288 readings every 24 hoursGlucose readings every 5 minutes help you not only where you are, but where you’re going. Trend arrows help you manage your diabetes before going too high or too low.

    Gentle, non-irritating adhesiveEversense uses a hypoallergenic silicone-based adhesive that’s gentle on the skin.

    Alerts you can see, feel and hearEversense XL can send you pop-up messages on your phone, sound an alarm or vibrate on your arm to alert you to highs and lows, based on your customized settings.

    No Sensor Self-Insertion Eversense XL is inserted by your healthcare provider 2-3 times per year, letting you avoid the burdensome self-insertion process every 7-14 days.

Learn about CGM and how Eversense XL can help you manage your diabetes.

Think all CGMs are the same? Learn why Eversense XL is the only long-term CGM.

Learn how Eversense XL can improve real-world outcomes for patients.

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Find out how long-term CGM can help your patients better manage their diabetes.

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global.eversensediabetes.com

Frequently Asked Questions | Eversense Continuous Glucose Monitoring

Continuous Glucose Monitoring, or CGM, is the process of automatically measuring the amount of sugar (glucose) in your body every few minutes with a sensor that is placed under your skin. The continuous readings allow the system to use the data to predict the direction your glucose level is heading and will display that information as an arrow. With the actual value of your glucose, plus the arrow, you can see more about what is happening with your glucose

CGM systems available today measure glucose in the interstitial fluid – the fluid between your cells just under the skin. Since CGM is measuring glucose in a different part of your body, it will not be the same concentration as in your blood, but very similar. A blood glucose meter requires that you take a small sample of blood from your fingertip and place it on a test strip that’s inserted inside a meter. The meter provides a glucose value based on the amount of glucose in the blood sample at that moment.

CGM automatically and continuously provides glucose values every few minutes, using a sensor inserted just below your skin. The glucose level taken from your blood can be different from the glucose level in the fluid below your skin. With ordinary CGM and FGM systems, you must insert a new sensor through the skin every 7-14 days. With the Eversense CGM System, a single sensor lasts for months.

One significant benefit of CGM is that it provides a “moving” picture of how your glucose levels change over time without samples from fingersticks. This can make it easier to see how diet, exercise and other health factors affect your glucose levels. CGM also provides alerts to let you know if your glucose levels are changing rapidly or approaching unsafe levels. Published research studies show using CGM regularly can reduce A1c without increasing hypoglycemia*.

The Eversense CGM System uses fluorescence technology to measure glucose with a tiny sensor implanted completely under the skin. This long-term CGM technology allows for up to 3 months of CGM readings with a single sensor. A smart transmitter is worn over the sensor using a gentle adhesive that is changed daily. The smart transmitter can be removed and replaced without ending the sensor session. The smart transmitter wirelessly powers the sensor, collects the glucose data and sends it to the Eversense Mobile App.

Flash Glucose Monitoring, or FGM, uses a body-worn sensor that requires insertions of a new sensor every 10-14 days. FGM provides a glucose value on demand by using a proprietary reader device. The reader is held over the sensor to wirelessly obtain a glucose value. The Eversense CGM System uses a small sensor that is inserted completely under the skin, and does not have to be changed for up to 3 months. A smart transmitter wirelessly powers the sensor, automatically collects the glucose data every 5 minutes and sends it to the Eversense Mobile App on your smartphone. The continuous readings allow the system to use the data to predict the direction your glucose level is heading and will automatically alert you of high and low glucose events.

The smart transmitter is worn on the arm using a gentle, silicone-based, adhesive designed to be changed daily.

The smart transmitter wirelessly powers the sensor and the sensor sends data to the smart transmitter via NFC (near-field communication).

The Eversense CGM System is compatible with various devices. For a complete list visit the Compatibility Page.

Yes. In most circumstances, the Eversense Sensor can safely remain in place during an MRI. However, the Eversense Smart Transmitter, like other CGM transmitters, MUST BE REMOVED and stored outside the procedure room before undergoing an MRI procedure.

NOTE: Non-clinical testing has demonstrated the Eversense Sensor is MR Conditional, which means the MR system must meet certain standard conditions—these are noted on the updated Eversense Medical Device Notification Card (PDF). Please download and print the updated card to keep in your wallet. You will want to share the information on this card with any physician prescribing an MRI and the MRI staff so they can ensure that all the necessary specifications are met.

For complete safety information, go to:

https://www.eversensediabetes.com/safety-info.

www.eversensediabetes.com

Benefits of Eversense CGM | Eversense Continuous Glucose Monitoring

Wearing a CGM sensor 80% of the time or more has been clinically shown to improve control in diabetes.

In clinical trials, Eversense was shown to help patients keep their blood sugar levels more stable, and to reduce A1C levels by 0.5% on average.

Eversense reduces the number of unpredictable “day 1” glucose measurements from 26-52 episodes to 4.

Say goodbye to frequent and painful self-insertions.

Eversense is the only CGM with on-body vibrations that alert you to potentially dangerous swings in blood sugar, even when you can’t check your mobile device (e.g., when sleeping or driving).

Wearing a CGM sensor 80% of the time or more has been clinically shown to improve control in diabetes.

Participants in the PRECISE clinical trial reported an increased sense of safety, confidence, and reduced day-to-day burden.1 get-your-eversense-benefits

www.eversensediabetes.com

Eversense Continuous Glucose Monitoring System - P160048/S006 | FDA

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Eversense Continuous Glucose Monitoring SystemPMA Applicant: Senseonics, Inc.Address: 20451 Seneca Meadows Parkway, Germantown, MD 20876Approval Date: June 6, 2019Approval Letter: Approval Order

What is it? The Eversense Continuous Glucose Monitoring System is a prescription device that provides real-time glucose monitoring every five minutes for up to 90 days at a time for people with diabetes. The system consists of an implantable fluorescence-based sensor, a smart transmitter, and a mobile app for displaying glucose values, trends and alerts on the patient's compatible mobile device (smart phone, tablet, etc.).

This supplement expands the indications for the Eversense CGM system to allow for replacement of fingerstick blood glucose testing for diabetes treatment decisions.

How does it work? A sensor is implanted just below the patient's skin by a physician. A fluorescent chemical coating on the outside of the sensor generates a small amount of light in response to the amount of sugar that is present in fluid under the skin (interstitial glucose). This light signal is converted into a glucose reading and transmitted wirelessly every five minutes to a compatible mobile device (smart phone, tablet, etc.) for display to a user. The associated Eversense mobile app can alert the user to low and high sensor glucose values based on alert settings programmed by the user. The user can also enter events, such as blood glucose measurements, meals, exercise, or insulin dosing, using the app. For the Eversense System to function properly the mobile device must be on and fully operational with Bluetooth enabled and notifications for the Eversense mobile app enabled. The system must be calibrated at least two times per day by testing a fingertip blood sample with a blood glucose meter.

When is it used? The Eversense CGM System is indicated for continually measuring glucose levels in adults ages 18 years and older with diabetes for up to 90 days. It is designed to replace fingerstick blood glucose testing for diabetes treatment decisions. The system is intended to provide real-time glucose readings, provide glucose trend information, and provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia). Data from the system can be used to facilitate both acute and long-term therapy adjustments. The Eversense CGM System is intended for single patient use and requires a prescription.

What will it accomplish? People with diabetes can use the information from this device to make diabetes treatment decisions (for example, administer insulin or carbohydrates). People with diabetes can use the glucose information from this device to help determine patterns in  their glucose levels and make long-term adjustments to diabetes treatment plans to keep blood glucose levels in a safe range. The Eversense CGM System can alert users when glucose values are approaching potentially dangerously high (hyperglycemic) and/or dangerously low (hypoglycemic) levels.

When should it not be used?

The following procedures should not be done on people who have the Eversense CGM System sensor implanted:

  • MRI: 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.
  • Lithotripsy: The use of lithotripsy (a treatment that typically uses ultrasound shock waves to break up masses like kidney stones or gallstones) is not recommended for people who have an inserted sensor because the effects are unknown.
  • Diathermy: Diathermy (the generation of heat using electrical pulses) should not be used on people with an inserted sensor, because energy from diathermy therapy can transfer through the sensor and cause tissue damage in the insertion area.
  • Electrocautery: The use of electrocautery (a heated electrode applied to living tissue to stop blood flow or destroy tissue) near an inserted sensor may damage the device.

The following medication could interfere with Eversense CGM System:

  • 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.
  • Tetracycline class antibiotics may falsely lower sensor glucose readings. Patients should not rely on sensor glucose readings while taking tetracyclines.

Additional information (including warnings, precautions, and adverse events) :

  • Summary of Safety and Effectiveness Data
  • Labeling

www.fda.gov

Senseonics Eversense Continuous Glucose Monitoring System, USA

The Eversense® continuous glucose monitoring (CGM) system is a device used to monitor blood glucose levels in people living with diabetes.

Developed by Senseonics, the device was approved by the US Food and Drug Administration (FDA) as a prescription device in June 2018. It is one of the first approved long-term CGM systems and is able to monitor blood glucose levels every five minutes for up to 90 days. The device was commercially launched in August 2018.

Horizon Blue Cross Blue Shield and Horizon Healthcare of New Jersey became the first commercial provider of the device under its medical policy.

Eversense continuous glucose monitoring system components and usage

The Eversense® CGM system provides blood glucose level readings from 40mg/dl to 400mg/dl in real-time. The system consists of a subcutaneously implantable sensor, a removable transmitter and a mobile app.

A single implantable sensor coated with a fluorescent polymer is implanted subcutaneously in the upper arm of the patient. It responds to the glucose concentration present in the interstitial fluid of the body and emits a small amount of fluorescent light.

A transmitter is worn over the sensor on the body, which receives the blood glucose level reading from the sensor and calculates the value of blood glucose. The blood glucose value is then transmitted to the mobile app via Bluetooth.

“A single implantable sensor coated with a fluorescent polymer is implanted subcutaneously in the upper arm.”

The mobile app sends alerts to the user about the fluctuating glucose values sent by the sensor. It also tracks daily activities such as intake of meals and exercise to provide a graph for identifying trends and patterns.

Eversense CGM system sensor details

The implantable sensor is made up of biocompatible materials such as homopolymer polymethylmethacrylate, hydroxyethylmethacrylate-based hydrogel, platinum, silicone, and epoxy 301-2. It measures 18.3mm in length and 3.5mm in diameter and is sterilised by ethylene oxide.

The sensor features a silicone elution ring containing a small amount of an anti-inflammatory drug called dexamethasone acetate. When the sensor comes in contact with the interstitial fluids, the ring releases a small amount of the drug, which helps in reducing the inflammatory response of the body against the implanted sensor.

Details of the smart transmitter in Eversense CGM system

The transmitter in Eversense® continuous glucose monitoring system is a round-shaped, water-resistant device with a polycarbonate body. It is designed to provide on-body vibratory alerts when the blood glucose levels fluctuate, even when the mobile device is away.

The transmitter also powers the sensor and contains a non-replaceable, rechargeable lithium polymer battery, which can be reused for up to one year.

The transmitter measures 37.6mm-long, 48mm-wide and 8.8mm-thick, and offers a communication distance of up to 24.9ft between the app and the transmitter.

Benefits of CGM technology

The global prevalence of diabetes has spiked from 108 million in 1980 to 422 million in 2014. According to the World Health Organization (WHO), approximately 1.6 million deaths were directly related to diabetes worldwide in 2016.

CGM systems enable efficient diabetes management and blood glucose control in people, thus improving the quality of life. The conventional blood glucose meter provides the blood glucose level reading only for a particular moment, while the Eversense® CGM system offers blood glucose level reading in real-time.

The Eversense® CGM system also furnishes glucose trend information and alerts for detecting and predicting low or high blood glucose episodes. The blood glucose data is stored in the mobile app as well as in the transmitter.

www.medicaldevice-network.com

Eversense Continuous Glucose Montioring System - P160048 | FDA

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Eversense Continuous Glucose Montioring System PMA Applicant: Senseonics, Inc. Address: 20451 Seneca Meadows Parkway, Germantown, MD 20876 Approval Date: June 21, 2018 Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160048a.pdf

What is it? The Eversense Continuous Glucose Monitoring System, is a prescription device that provides real-time glucose monitoring every five minutes for up to 90 days at a time for people with diabetes. The system consists of an implantable fluorescence-based sensor, a smart transmitter, and a mobile app for displaying glucose values, trends and alerts on the patient's compatible mobile device (smart phone, tablet, etc.)..

How does it work? A sensor is implanted just below the patient's skin by a physician. A fluorescent chemical coating on the outside of the sensor generates a small amount of light in response to the amount of sugar that is present in fluid under the skin (interstitial glucose). This light signal is converted into a glucose reading and transmitted wirelessly every five minutes to a compatible mobile device. The associated Eversense mobile app can alert the user about low and high sensor glucose values based on alert settings programmed by the user. The user can also enter events, such as blood glucose measurements, meals, exercise, or insulin dosing, using the app. For the Eversense System to function properly, the mobile device must be on and fully operational with Bluetooth enabled and notifications for the Eversense mobile app enabled. The system must be calibrated at least two times per day by testing a fingertip blood sample with a blood glucose meter.

When is it used? The Eversense CGM System is indicated for continually measuring glucose levels in adults ages 18 years or older with diabetes for up to 90 days. The system is intended to: provide real-time glucose readings, provide glucose trend information, and provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia). 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.The system is indicated for use to complement, not replace, information obtained from standard home blood glucose monitoring devices.

What will it accomplish? People with diabetes can use the glucose information from this device to help determine patterns in their glucose levels. The Eversense System can alert users when glucose values are approaching potentially dangerously high (hyperglycemic) and/or dangerously low (hypoglycemic) levels. It can also help people with diabetes make long-term adjustments to their treatment plan to keep blood glucose levels in a safe range.

When should it not be used?

The following procedures should not be done on people who have the Eversense System sensor implanted:

  • MRI: The sensor and smart transmitter are incompatible with magnetic resonance imaging (MRI) procedures. Patients should not undergo an MRI procedure while the sensor is inserted or when wearing the smart transmitter. Patients who need an MRI should contact their physician to arrange for sensor removal before the procedure.
  • Lithotripsy: The use of lithotripsy (a treatment that typically uses ultrasound shock waves to break up masses like kidney stones or gallstones) is not recommended for people who have an inserted sensor because the effects are unknown.
  • Diathermy: Diathermy (the generation of heat using electrical pulses) should not be used on people with an inserted sensor, because energy from diathermy therapy can transfer through the sensor and cause tissue damage in the insertion area.
  • Electrocautery: The use of electrocautery (a heated electrode applied to living tissue to stop blood flow or destroy tissue) near an inserted sensor may damage the device.

The following medications could interfere with the Eversense System:

  • The system should not be used in people for whom dexamethasone or dexamethasone acetate may be contraindicated.
  • Mannitol or sorbitol, when administered in high doses intravenously or as part of an irrigation solution or peritoneal dialysis solution, may increase blood mannitol or sorbitol concentrations and cause falsely elevated readings of the sensor glucose results. Sorbitol is used in some artificial sweeteners, and concentration levels from typical dietary intake do not impact sensor glucose results.
  • Tetracycline class antibiotics may falsely lower sensor glucose readings. Patients should not rely on sensor glucose readings while taking tetracyclines.

Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data and labeling are available at:

  • Summary of Safety and Effectiveness Data (SSED)
  • Labeling

www.fda.gov


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