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Eversense Continuous Glucose Monitoring System - P160048/S006

Diagram. 90-day implantable sensor (subcutaneous) uses WiFi to link to the removable transmitter (worn over skin) which uses bluetooth to link to mobile application.

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 System
PMA Applicant: Senseonics, Inc.
Address: 20451 Seneca Meadows Parkway, Germantown, MD 20876
Approval Date: June 6, 2019
Approval 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) :