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Eversense Continuous Glucose Montioring System - P160048

Image. 90-day implantable sensor (subcutaneous), removable transmitter (worn over skin), and 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 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: