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eversense CGM Sensor Insertion And Removal Instructions

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IMPORTANT:
•
Only physicians who have successfully completed the Eversense CGM Insertion and Removal Training Program and have read and understood the Eversense CGM Sensor Insertion and Removal
Instructions may perform the insertion and removal procedure on patients. Contact Senseonics (in the US toll free at 844-SENSE4U (844-736-7348)) if training has yet to be conducted or if you
experience any difficulty or issues with the insertion or removal procedure. Calls received after business hours (8am to 8pm Eastern US time) will be returned within two business days.
To see a list of certified Eversense providers, go to https://www.eversensediabetes.com/find-a-provider/
•
All symptoms of infection (e.g., increased temperature, inflammation, redness, pain, tenderness, warmth, swelling or purulence) at the insertion or removal area should be reported. If any of the
above occurs, please advise patients to contact their physician immediately.
•
Store the sensor pack refrigerated at the labeled temperature range.
•
Review the Eversense CGM System User Guide to help facilitate your patient's understanding of their new Eversense CGM System and determining their personalized glucose settings.
CGM Sensor Insertion and Removal Instructions

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  • Page 1 • Only physicians who have successfully completed the Eversense CGM Insertion and Removal Training Program and have read and understood the Eversense CGM Sensor Insertion and Removal Instructions may perform the insertion and removal procedure on patients. Contact Senseonics (in the US toll free at 844-SENSE4U (844-736-7348)) if training has yet to be conducted or if you experience any difficulty or issues with the insertion or removal procedure.
  • Page 2 Eversense CGM Sensor Insertion and Removal Instructions...
  • Page 3 Continuous Glucose Monitoring (CGM) System Congratulations on having Eversense CGM technology to assist your patients in managing their diabetes. The Eversense CGM System is for people with diabetes to continually measure glucose levels for up to 90 days from the time of sensor insertion.
  • Page 4 Note: Not actual size The Eversense App is a software application that runs on a mobile device (e.g., smartphone) and displays glucose data in a variety of ways. It also provides alerts based on the pre-set glucose level settings. Eversense CGM Sensor Insertion and Removal Instructions...

  • Page 5: Benefits And Risks

    Dexamethasone acetate in the ring may also cause other adverse events not previously seen with the injectable form. Indications for Use The Eversense CGM System is indicated for continually measuring glucose levels in adults (18 years or older) with diabetes for up to 90 days. The system is intended to: •...

  • Page 6: Mri Safety Information

    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.

  • Page 7: Risks And Side Effects

    Warnings • The Eversense CGM System has not been tested using insertion sites other than the upper arm. • Patients should always test glucose with a blood glucose meter before making a treatment decision. Using the sensor glucose value to make a treatment decision could result in a high or low blood glucose.
  • Page 8 • The following medical therapies or procedures have not been tested with the Eversense Sensor and 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.
  • Page 9 • 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).
  • Page 10 • Willing to enter a calibration blood glucose (BG) into the app twice a day. • Discuss appropriate placement of sensor insertion and smart transmitter wear. • No known contraindication to dexamethasone acetate. Eversense CGM Sensor Insertion and Removal Instructions...
  • Page 11 Practice, 2010; 16(5): A. Pre-Insertion Training Activities for Patient • Download Eversense App to compatible mobile device (requirements are listed in User Guide) and become familiar with functionality. • Discuss the importance of setting the correct “Unit of Measure” in the Eversense App.
  • Page 12 4. Eversense CGM System Kit The Eversense CGM System Kit comes in three packages: 1) Sensor Pack, 2) Insertion Tools Pack, and the 3) Smart Transmitter Pack. IMPORTANT: The Sensor Pack and Insertion Tools Pack contain components that are packaged sterile. Both packs are designed for single patient-use only. DO NOT re-use, re-process or re-sterilize the sensor, blunt dissector, or insertion tool.
  • Page 13 Use only the Power Supply included in this kit to charge the smart transmitter. The User Guide and Quick Reference Guide are designed for the patient to learn about their Eversense CGM System. Eversense CGM Sensor Insertion and Removal Instructions...

  • Page 14: Product Handling

    DO NOT use the sensor or any kit component if it has been dropped on a hard surface from a height of more than 30 cm. • Store the sensor package refrigerated at the labeled temperature range. • Dispose of product packaging in accordance with clinic, administrative and/or local government policy. Eversense CGM Sensor Insertion and Removal Instructions...

  • Page 15: Suggested Equipment

    1 Lidocaine HCL without epinephrine (1-2 mL) • 1 Surgical skin marker • 3 Sterile, non-latex surgical gloves, physician-preferred size • 1 10 mL sterile saline filled syringe (for insertion only) • 1 Sterile surgical clamp 10-16cm Eversense CGM Sensor Insertion and Removal Instructions...

  • Page 16: Insertion Procedure

    Not too lateral such that patient cannot easily apply adhesive patch. Area • Avoid area with loose skin such as back of arm. • Avoid areas with scar tissue, tattoo, nevus, or apparent or noticeable blood vessels that could be incised. Epicondyle Eversense CGM Sensor Insertion and Removal Instructions...
  • Page 17 DO NOT insert a sensor if it has been dropped from a height of 30 cm or more. • Use only the insertion tools provided in the insertion tool kit to insert the sensor. Other insertion tools may damage the sensor. Eversense CGM Sensor Insertion and Removal Instructions...
  • Page 18 Slots aligned Align the slot of the sensor holder with the exposed slot of the thumb slide and the triangle on the side of the sensor holder with the triangle on the insertion tool. Eversense CGM Sensor Insertion and Removal Instructions...
  • Page 19 Depress the blue thumb slide down to unlock and advance it all the way forward until it stops. This action secures the sensor inside the cannula. The cannula is now visible through the slot in the sensor holder. DO NOT RETRACT the thumb slide at this step. Eversense CGM Sensor Insertion and Removal Instructions...
  • Page 20 Wet the cannula and sensor by filling the preformed well with enough sterile saline (0.95 sterile saline for injection) to completely cover the cannula and sensor (approximately 10 mL). To ensure proper hydration, submerge the tip in the well for a few minutes (approximately 5 minutes). Eversense CGM Sensor Insertion and Removal Instructions...
  • Page 21 Local anesthesia (approximately 2 mL of Lidocaine) should be injected approximately 5 mm along the planned incision (along AB) and approximately 30 mm perpendicular to the planned incision (along CD) which is the planned track of the blunt dissector tool. (Figure 1). Figure 1 Eversense CGM Sensor Insertion and Removal Instructions...
  • Page 22 A and B (Figures 1 & 2) so that the tip and tapered portion of the blunt dissector are under the skin, and until the depth guards are touching the skin. Dissector Dissector Shoulder Shoulder Elbow Elbow Figure 2 Figure 2 Eversense CGM Sensor Insertion and Removal Instructions...
  • Page 23 It is important to ensure that the subcutaneous pocket is parallel to and along the same axis as the humerus bone. When you place Figure 4 the sensor, it should be level in the pocket, which will facilitate communication between the sensor and the smart transmitter. Eversense CGM Sensor Insertion and Removal Instructions...
  • Page 24 Lightly palpate the insertion area to confirm that the sensor is in place; remove the insertion tool from the incision. Close and dress the incision in the appropriate manner using adhesive skin closure (e.g., Steri-Strip™) or suture and dressing, making sure the two sides of the incision are closed together. Eversense CGM Sensor Insertion and Removal Instructions...
  • Page 25 It may take up to 5 minutes to receive the notification for “New Sensor Detected”. DO NOT remove the smart transmitter from over the insertion site until the linking process is complete. You may use the Eversense adhesive to place the smart transmitter over the bandage of the insertion site.
  • Page 26 8. Post-Insertion Patient CGM Start-Up Your patients may need assistance in getting started with the Eversense CGM System. Refer to the User Guide and Quick Reference Guide that is included in the smart transmitter pack for information on getting the smart transmitter and mobile device ready for use.
  • Page 27 Position the patient in a reclined position, preferably on their side, with the elbow flexed up to 90 degrees and the palm resting on the chest or abdomen. Clean and disinfect the insertion area. Prepare the insertion site and surrounding area, using aseptic technique. Anesthetize the insertion area as appropriate for the patient similar to step D3 in section 7. Eversense CGM Sensor Insertion and Removal Instructions...

  • Page 28: Remove The Sensor

    Close and dress the incision in the appropriate manner using adhesive skin closure (e.g., Steri-Strip™) or suture, making sure the two sides of the incision are closed together. Sensor Disposal Dispose of sensor according to your area’s local regulations. Eversense CGM Sensor Insertion and Removal Instructions...

  • Page 29: Potential Complications

    10. Potential Complications The insertion and removal of the Eversense Sensor is a minor procedure and requires aseptic technique to minimize the possibility of infection. Please review this document for complete training. During Insertion Process Unable to insert blunt dissector through incision Unable to locate the subcutaneous pocket with the insertion tool when inserting the sensor a.
  • Page 30 Gently rotate the clamp with the secured sensor to release any small fibrous Excessive bleeding after the sensor is removed tissue encapsulation. Apply pressure and, if necessary, use sutures to close incision in place of Steri-Strips Eversense CGM Sensor Insertion and Removal Instructions...

  • Page 31: Device Performance

    Clinical Study Performance The safety and effectiveness of the Eversense CGM System has been evaluated in several feasibility and pivotal studies. Two studies – PRECISE II (2016) and PRECISION (2018) – were conducted in the U.S. to evaluate the Eversense CGM System performance in terms of safety and effectiveness. The data collected was analyzed using a new algorithm, SW 602. Accuracy assessments were made at various points during the studies and subjects were asked to report any adverse events throughout the studies.
  • Page 32 *Data is from primary sensors only; glucose values between 40 and 400 mg/dL. Since the two studies are similar, the PRECISION study is included in this report. For detailed information on the PRECISE II results, please go to our website www.eversensediabetes.com. Eversense CGM Sensor Insertion and Removal Instructions...
  • Page 33 Eversense Accuracy to YSI in PRECISION Study Accuracy was measured by comparing the Eversense sensor glucose values to YSI blood glucose values. For blood glucose values less than or equal to 80 mg/dL, the mean absolute difference between the two results was calculated. For values greater than 80 mg/dL, the mean absolute relative difference was calculated.
  • Page 34 80 mg/dL reflect the percentage within reference. As an example, glucose values between 40 and 60 mg/dL were within 15 mg/dL of the reference value 91.9% of the time. Table 3 – Eversense Percentage of Readings in Agreement Overall in the PRECISION study...
  • Page 35 Table 4 – Eversense Percentage of Readings in Agreement on Day 1 in the PRECISION study Percent of CGM System Readings Within CGM System Glucose Paired CGM and Percent 15/15% of Percent 20/20% Percent 30/30% Percent 40/40% > 40/40% Range (mg/dL)
  • Page 36 Table 5 – Eversense Percentage of Readings in Agreement on Day 7 in the PRECISION study Percent of CGM System Readings Within CGM System Glucose Paired CGM and Percent 15/15% of Percent 20/20% Percent 30/30% Percent 40/40% > 40/40% Range (mg/dL)
  • Page 37 Table 6 – Eversense Percentage of Readings in Agreement on Day 14 in the PRECISION study Percent of CGM System Readings Within CGM System Glucose Paired CGM and Percent 15/15% of Percent 20/20% Percent 30/30% Percent 40/40% > 40/40% Range (mg/dL)
  • Page 38 Table 7 – Eversense Percentage of Readings in Agreement on Day 30 in the PRECISION study Percent of CGM System Readings Within CGM System Glucose Paired CGM and Percent 15/15% of Percent 20/20% Percent 30/30% Percent 40/40% > 40/40% Range (mg/dL)
  • Page 39 Table 8 – Eversense Percentage of Readings in Agreement on Day 60 in the PRECISION study Percent of CGM System Readings Within CGM System Glucose Paired CGM and Percent 15/15% of Percent 20/20% Percent 30/30% Percent 40/40% > 40/40% Range (mg/dL)
  • Page 40 Table 9 – Eversense Percentage of Readings in Agreement on Day 90 in the PRECISION study Percent of CGM System Readings Within CGM System Glucose Paired CGM and Percent 15/15% of Percent 20/20% Percent 30/30% Percent 40/40% > 40/40% Range (mg/dL)
  • Page 41 The tables in this section show an alert performance assessment. The Confirmed Event Detection Rate shows the percentage of time the Eversense CGM System confirmed the reference value by presenting an alert within a 15 minute window of a reference value beyond the alert setting threshold. The Missed Detection Rate shows the percentage of time the Eversense CGM System did not present an alert within a 15 minute window of a reference value beyond the alert setting threshold.
  • Page 42 The table below shows an assessment of the ability of the Eversense CGM System to detect high and low glucose levels, and assess true positive alerts vs false positive alerts. These are shown as a percentage of alerts provided compared to the YSI reference values at various thresholds.
  • Page 43 The table below shows an assessment of the ability of the Eversense CGM System to detect high, low, and predictive high and low alerts, and assess true positive alerts vs false positive alerts. These are shown as a percentage of alerts provided compared to the YSI reference values at various thresholds.
  • Page 44 Eversense Rate of Change Trend Agreement The shaded area of the table below shows agreement between the Eversense glucose trends and the YSI reference trends while glucose is trending at different rates (mg/dL per minute). As an example, when glucose is trending at a rate of between -1 and 1 mg/dL/minute, Eversense glucose trends are in agreement with the reference trends 89% of the time.
  • Page 45 40 - 60 1,236 61 - 80 2,003 81 - 120 2,524 121 - 160 2,342 161 - 200 1,727 201 - 250 1,502 251 - 300 1,257 301 - 350 1,628 351 - 400 Eversense CGM Sensor Insertion and Removal Instructions...
  • Page 46 161 - 200 201 - 250 251 - 300 301 - 350 351 - 400 > 400 (mg/dL) CGM-YSI (n) 40 - 60 61 - 80 81 - 120 121 - 160 161 - 200 201 - 250 251 - 300 301 - 350 351 - 400 Eversense CGM Sensor Insertion and Removal Instructions...
  • Page 47 Calibration Stability Agreement The table below compares the percentage of sensor glucose values to the YSI reference at various time points after a calibration entry. As an example, in the table below, 88% of the Eversense values were within 15 mg/dL (for reference readings of 80 mg/dL or less), and within 15% (for reference readings over 80 mg/dL) of the reference value 8 to 10 hours after a calibration entry.

  • Page 48: Sensor Life

    Function stopped at days 10, 30, 53, 67, 70, 80, 81, 83, and 85. The sensor failure on day 10 was due to a software anomaly that has since been resolved. Overall, the analysis estimated that 91% of sensors remained functioning through 90 days. In the PRECISION study, all sensors functioned through 90 days. Eversense CGM Sensor Insertion and Removal Instructions...
  • Page 49 Median # of Days Data Availability A total of 97% (821,296 out of expected 842,814) glucose values were available during the 90 day study. Table 17 – Eversense Data Availability in the PRECISION Study Days 1 - 30 Days 31 - 60...
  • Page 50 Safety Both the PRECISE II and PRECISION studies lasted 90 days, and the number of related adverse events was recorded. The Eversense CGM System was well tolerated in the studies. During the studies’ 15,921 sensor wear days, there were no unanticipated adverse events. Twenty-two adverse events were reported in 12 participants, including one serious adverse event related to the removal procedure.

  • Page 51: Technical Specifications

    Acrylonitrile butadiene styrene (ABS) and Polytetrafluoroethylene (PTFE) Blunt Dissector Description Materials Acrylonitrile butadiene styrene (ABS), Stainless Steel Storage Temp Between 50 °F (10 °C) and 86 °F (30 °C) Sterilization Sterile by Ethylene Oxide Eversense CGM Sensor Insertion and Removal Instructions...
  • Page 52 If you charge the smart transmitter using a USB port on Eversense Insertion Tools Kit FG-8211-01-201 your personal computer, ensure the personal computer complies the IEC 60950-1 (or equivalent) safety standard. Eversense CGM Sensor Insertion and Removal Instructions...
  • Page 53 Consult accompanying documents Part number Caution, consult accompanying documents Serial number Use by Type BF Applied Part Manufacturer Non-ionizing electromagnetic radiation Date of manufacture Not made with natural rubber latex Storage temperature limits Eversense CGM Sensor Insertion and Removal Instructions...
  • Page 54 No known hazards for leaving the sensor inserted in use with MR with a U.S. (Federal) law restricts the sale of the Eversense CGM System to sale static magnetic field of 1.5T or 3.0T by or on the order of a physician...
  • Page 55 Eversense CGM Sensor Insertion and Removal Instructions...
  • Page 56 Eversense, Eversense Continuous Glucose Monitoring, Eversense CGM, Eversense Sensor, • 20451 Seneca Meadows Parkway Germantown, MD 20876-7005 USA Eversense Smart Transmitter, Eversense App and the Eversense logo are trademarks of • Phone: 844.SENSE4U (844.736.7348) 301.515.7260 Senseonics, Incorporated. Other brands and their products are trademarks or registered www.eversensediabetes.com...

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